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Detection of Viral Diarrheal Pathogens by the FilmArray - BioFire

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Detection of Viral Diarrheal Pathogens by the FilmArray - BioFire Powered By Docstoc
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                                                               DETECTION OF VIRAL DIARRHEAL PATHOGENS BY THE FILMARRAY GI POUCH                                                                                                                                                                                                                                                                                                                                                                           ®

                                                                                                                                       B. Harrel1, R. Crisp1, J. Gardner1, C. Li1, M. Vaughn1, R. Wallace, J. Daly2, T. Barney2, G. Alger2, M. Rogatcheva1
                                                                                                                                                                                                                                                          1
                                                                                                                                                                                                                                                              Idaho Technology, Inc, Salt Lake City, UT, 2 Primary Children’s Medical Center, Salt Lake City, UT




                                                                                                                         Currently Targeted Organisms                                                                                                                                                                                                                                                                                                                                               FilmArray GI panel evaluation on clinical specimens characterized with
    FILMARRAY GI PANEL                                                                                                                                                                                                                                                                                                                                                                SPECIFICITY                                                                                                   reference methods
    An estimated 211–375 million episodes of diarrheal illness occur each year in the United States,                                                                                                                                                                                                                                                                                  The ability of the FA GI pouch to detect a broad range of enteric viruses was assessed on
                                                                                                                                   Bacteria                                                                                                                          Viruses
    resulting in 73 million physician consultations, 1.8 million hospitalizations, and 3100 deaths1-3. The                                                                                                                                                                                                                                                                            characterized strains or clinical isolates obtained from viral collections.
                                                                                                                                   • Diarrheagenic E. coli                                                                                                           • Norovirus (GI, GII, and GIV)                                                                                                                                                                                                                                                                                The FA GI pouch performance was assessed
    overwhelming challenge in diagnosing infectious diarrhea is the large number of pathogens that are                                  • ETEC                                                                                                                       • Adenovirus F (40/41)                                                                                                                                                                                                                                                NOROVIRUS          ROTAVIRUS            against conventional methods used in clini-
                                                                                                                                                                                                                                                                                                                                                                                      The Adenovirus assay specifically detected both serotypes F40 and F41 while proving exclusive
    known to cause diarrhea, including viruses, bacteria and protozoa. Present diagnostic practice is                                   • EPEC                                                                                                                       • Rotavirus (A, B, and C)                                                                                                                                                                                                                                                                                     cal laboratories. Specimens determined to be
                                                                                                                                        • STEC/EHEC                                                                                                                  • Human Astrovirus                                                                                               for 16 strains of serotypes A, B, C, D, and E. It is expected to exclude serotype G as well.                                                                                                 positive for given viruses were tested by the
    inefficient as it requires multiple tests which are labor-intensive, expensive, and slow. Additionally,




                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      Negative Positive
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          GI    GII     GIV   A      B      C




                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     FilmArray Call
                                                                                                                                             -O157:H7                                                                                                                • Sapovirus                                                                                                      The Human Astrovirus (HAstV) assay is designed to detect serotypes 1-8 but not novel strains                                                                                                 FA GI pouch. 36 Norovirus GI and 33 Noro-
    many gastrointestinal (GI) pathogens have limited test availability and/or low sensitivity. There is
                                                                                                                                        • EIEC                                                                                                                                                                                                                                                                                                                                                                                                                                     virus GII positive fecal samples (by RT-PCR)
    a clear unmet clinical need for a rapid, easy-to-use, multi-target, and highly sensitive molecular                                  • EAEC                                                                                                                       Protozoa                                                                                                         MLB1, MLB2, VA1, VA2, nor VA3 for which clinical relevance is still under investigation. Detection                                                  30    36       0    19     0      0      were obtained. 66/69 (95.7%) of these sam-
    diagnostic test for the detection of pathogens causing diarrhea.                                                               •	 Aeromonas spp.                                                                                                                 •	 Cryptosporidium group                                                                                         of HAstV serotypes 1, 4, and 8 has been confirmed. The FA GI pouch detected types 1, 4 and 8                                                                                                 ples were identified as Norovirus by the FA
                                                                                                                                   •	 Salmonella spp.                                                                                                                •	 Giardia lamblia                                                                                               but not strains MLB1 and VA2. The remaining serotypes will be tested as they become available.                                                      3      0       0    3      0      0      GI pouch. Rotavirus positive fecal specimens
    ITI Is developing a new FilmArray panel for detection of GI pathogens (FA GI panel) from stool                                 •	 Vibrio spp.                                                                                                                    •	 Entamoeba histolytica                                                                                                                                                                                                                                                                                      were determined by EIA. 19/22 (86.4%) of the
    specimens of patients presenting with diarrhea. The FA GI panel targets 26 pathogens including                                      -V. cholorae                                                                                                                 •	 Cyclospora cayetanensis                                                                                       The Norovirus assays were designed to detect all strains of Noroviruses that cause illness in                                                                                                samples were identified as Rotavirus by the
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               66/69               19/22
    viruses, bacteria, and protozoa. Testing requires minimal pre-processing of specimens. The stool                               •	 Shigella spp.                                                                                                                                                                                                                                   humans, which include Norovirus GI.1-8, GII.1-20, and GIV. The FA GI detected Genogroup I                                                                                                    FA GI pouch.
                                                                                                                                        -S. dysenteriae                                                                                                                                                                                                                                                                                                                                             Sensitivty                                 95.65%              86.36%
    is diluted 1:10 in Cary-Blair, filtered by gravity-flow through a coarse strainer, and loaded into the                                                                                                                                                                                                                                                                            strains 1, 3, 4, 5, 6, and 8; Genogroup II strains 1, 2, 3, 4-2010, 6, 7, 8, 12, 13, 16, 20, b-3, and c-20;
                                                                                                                                   •	 Campylobacter group                                                                                                                                                                                                                                                                                                                                                                                                                          False negatives may be due to sample degra-
    FilmArray GI pouch using a novel filter-injection vial. An automated report listing all pathogens                                                                                                                                                                                                                                                                                 and a synthetic RNA based on Norovirus GIV.1/Venezia/1365-2/2009. Others were not tested.                     Samples were tested off-site, frozen, then delivered to ITI.
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   dation as specimens were not evaluated im-
                                                                                                                                   •	 Yersinia enterocolitica                                                                                                                                                                                                                                                                                                                                       Once thawed, they were diluted 1:10 in Cary-Blair and 10µl
    detected is ready in about an hour. A preliminary evaluation of both specificity and sensitivity of                            •	 Clostridium	difficile                                                                                                                                                                                                                           The Rotavirus assays were designed to be as inclusive as possible for all human serotypes of                  was run in the FilmArray.                                                      mediately prior to testing by the FilmArray GI
    viral detection by the FA GI panel is presented here. An assessment of the viral assays in the FA                              	    -C.difficile	Nap1                                                                                                                                                                                                                                                                                                                                                                                                                          panel.
                                                                                                                                                                                                                                                                                                                                                                                      Rotavirus A, B, and C. The FA GI pouch successfully detects Rotavirus A strains; Wa, RV4, ST-3
                                                                                                                                   •	 Plesiomonas shigelloides
    GI panel was performed on pediatric clinical specimens.                                                                                                                                                                                                                                                                                                                           and F45; and synthetic RNA based on Rotavirus B IDH-084 and Rotavirus C Wu82. Others were
                                                                                                                                                                                                                                                                                                                                                                                      not tested.

  Figure 1                                                                                                               Analytical Testing - Sensitivity                                                                                                                                                                                                                             The Sapovirus assay was designed to detect all Genogroups known to cause diarrhea in humans                   Clinical Specimen Screening
                                                                                                                                                                                                                                                                                                                                                                                      which include Genogroups I, II, IV, and V. Detection of all Genogroups which cause illness in
    ITI has developed a lab-in-a-pouch system called “FilmArray”. It is a medium-scale fluid manipu-                                                                                                                                                                                                                                                                                  humans were confirmed by the FilmArray GI pouch.                                                              A number of randomly selected clinical
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            FA GI panel        % of
    lation system performed in a self-contained, disposable, thin-film plastic pouch. The FilmArray                                                                                                                                                                                                                                                                                                                                                                                                 samples obtained from children with undi-                                                   Tested
                                                                                                                                          Culturable Organisms                                                                                                         Quantity Detected*                                                                          Source             The detection of each virus was shown to be specific. No cross-reactivity with other pathogens                                                                                                                         positive        positives
    platform processes a single sample, from nucleic acid purification to result, in a fully automated                                                                                                                                                                                                                                                                                                                                                                                              agnosed diarrhea were tested with the FA
    fashion. These system characteristics are ideal for the multiplex testing of pathogens in standard                                                                                                                                                                                                                                                                                included in the FA GI panel was observed.                                                                     GI pouch. These samples were tested for                                     Adeno F           150             6             4.0%
                                                                                                                           Adeno F40 (Dugan)                                                                                                                                19.50 TCID50/mL                                                                                                                                                                                                         multiple pathogens in the clinical lab but not
    diagnostic sample matrices.                                                                                                                                                                                                                                                                                                                                  ZeptoMetrix                                                                                                                                                                                                    HAstV              97             2             2.1%
                                                                                                                           Adeno F41 (Tak)                                                                                                                                    2.19 TCID50/mL                                                                                          N/A: Samples were clinical specimens and no quantitative measurement of viral load was available.             for all organisms targeted by the FA GI Pan-
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                NoV               210            26            12.4%
                                                                      The FilmArray Test System                            HAstV_1358 (Serotype 4)                                                                                                                                15.20 FFU/mL                                                                 European Virus                                                                                                                       el. All five viruses were identified from the
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    clinical samples, with Norovirus being the                                  Rotavirus         134             4             3.0%
                                                                      A FilmArray test is initiated by injecting re-       HAstV_2371 (Serotype 8)                                                                                                                                 1.44 FFU/mL                                                                    Archive
                                                                      hydration solution and a patient sample                                                                                                                                                                                                                                                                                                                                                                                       most prevalent.                                                             SaV               88              5             5.7%
                                                                                                                                                                                                                                                                                                                                                              National Collection                                                                       Organism Detected by the FA GI panel
                                                                                                                           Rota A RV4 G1P[8]                                                                                                                                      13.00 FFU/mL
                                                                      into the FilmArray pouch and placing it                                                                                                                                                                                                                                                   of Pathogenic         Organism tested on FA GI
                                                                      in the FilmArray instrument. The user                Rota A ST-3 G4P[6]                                                                                                                                     62.00 FFU/mL                                                                                                                              Concentration           Adeno F     HAstV      NoV      Rota     SaV    These data suggest that the FA GI pouch might improve GI diagnostics by detecting viruses in an
                                                                                                                                                                                                                                                                                                                                                                   Viruses                    pouch
                                                                      enters the sample and pouch type (using                                                                                                                                                                                                                                                                                                                                                                                       additional ~25% children who remained undiagnosed by conventional methods.
                                                                                                                                                                                                                                                                                                                                                                                    Adeno_F40                             19,500 TCID50/mL              +         -         -        -         -
                                                                                                                           NoVGI (M87661) Recomb. in mouse PIV                                                                                                                0.81 TCID50/mL
                                                                      a barcode reader) into the software and                                                                                                                                                                                                                                                    ZeptoMetrix        Adeno_F41                             2,188 TCID50/mL               +         -         -        -         -
                                                                      initiates a run. Results are provided in ~ 1         NoVGII (EU310927) Recomb. in mouse PIV                                                                                                             0.19 TCID50/mL
                                                                                                                                                                                                                                                                                                                                                                                    Adeno_A31*                            22,560 TCID50/mL              -         -         -        -         -                                                  Cases with pathogens detected by the FA GI pouch only:
                                                                      hour.                                               *Data reflects the lowest level tested and detected. LOD studies will be performed on these organisms with the
                                                                                                                          finalized FA GI Panel.                                                                                                                                                                                                                                    Adeno_B03*                          1,000,000 TCID50/mL             -         -         -        -         -
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               ID:650                                                                   ID:595
                                                                                                                                                                                                                                                                                                                                                                                    Adeno_B7a*                           731,200 TCID50/mL              -         -         -        -         -               FilmArray GI:                                                            FilmArray GI:
                                                                      The FilmArray pouch has a fitment (see              Quantified Sapovirus, was unavailable at time of testing.
                                                                                                                                                                                                                                                                                                                                                                                    Adeno_B7d/d2*                       1,000,000 TCID50/mL             -         -         -        -         -               Norovirus                                                                Rotavirus
                                                                      label A) containing all needed freeze-dried         Rotavirus B and Rotavirus C are detected at 100 copies of synthetic RNA/pouch.
                                                                                                                                                                                                                                                                                                                                                                                    Adeno_B7h*                          1,000,000 TCID50/mL             -         -         -        -         -
                                                                      reagents.                                                                                                                                                                                                                                                                                                                                                                                                                                        Lab Tests Performed                     Result                        Lab Tests Performed             Result
                                                                                                                                                                                                                                                                                                                                                                                    Adeno_B11*                          1,000,000 TCID50/mL             -         -         -        -         -                      C. diff DNA amplification               Negative                      C. diff DNA amplification       Negative
                                                                                                                                                                                                                                                                                                                                                                                    Adeno_B14*                          1,000,000 TCID50/mL             -         -         -        -         -                              EHECT EIA                       Negative                              EHECT EIA               Negative
                                                                                                                                                                                                                                                                                                                                                                                    Adeno_B21a*                         1,000,000 TCID50/mL             -         -         -        -         -                        Giardia/Crypto DFA                    Negative                        Giardia/Crypto DFA            Negative
                                                                                                                         Performance of FilmArray assays vs comparator’s RT-PCR assays                                                                                                                                                                                                                                                                                                                                      Rota virus EIA                    Negative                             Stool Culture            Negative
                                                                                                                                                                                                                                                                                                                                                                                    Adeno_B34*                          1,000,000 TCID50/mL             -         -         -        -         -
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             Stool Culture                    Negative
                                                                                                                                                                                                                                                                                                                                                                                    Adeno_C2-1*                         1,000,000 TCID50/mL             -         -         -        -         -                           Yersinia culture                   Negative
                                                                                                                         The ability of the individual FilmArray assays to detect a broad range of Noro and Sapovirus strains                                                                                                                                                       Adeno_C2(Adenoid6)*                 1,000,000 TCID50/mL             -         -         -        -         -
                                                                                                                         was confirmed by testing an extensive collection of RNAs extracted from fecal specimens and                                                                                                                                                                Adeno_C5*                           1,000,000 TCID50/mL             -         -         -        -         -
  The film portion of the pouch has stations for:
                                                                                                                         characterized as specific strains of Noro or Sapovirus by the providing lab. The FA GI assays were                                                                                                                                                         Adeno_C6*                           1,000,000 TCID50/mL             -         -         -        -         -
  1.      Cell lysis (Blister C)                                       C          D       F             I                able to detect all strains shown below.                                                                                                                                                                                                                    Adeno_D8*                             22,560 TCID50/mL              -         -         -        -         -
  2.      Magnetic-bead based nucleic acid                                            E       G                                                                                                                                                                                                                                                                                     Adeno_E4a*                          1,000,000 TCID50/mL             -         -         -        -         -
          purification (D & E)                                                                                                                                                                                                                                                                                                                                                                                                                                                                 -
                                                                                                                                                                                                                                    Norovirus                                                                                                                                       Adeno_E4p3*                         1,000,000 TCID50/mL             -         -         -        -
  3.      First-stage multiplex PCR (F & G)                                                                                                         35.0
                                                                                                                                                    30.0
                                                                                                                                                                         28.4
                                                                                                                                                                              29.5
                                                                                                                                                                                28.4
                                                                                                                                                                                                                                                                                                                                                                                    HAstV_1_Oxford                              N/A                     -         +         -        -         -
  4.      Array of 102, second-stage nested PCRs (I)
                                                                                                                                                                                           28.3                                          26.1

                                                                                                                                                    25.0
                                                                                                                                                            24.9 25.5
                                                                                                                                                                                    22.2
                                                                                                                                                                                              19.5             20.0
                                                                                                                                                                                                                         22.0
                                                                                                                                                                                                                      20.8
                                                                                                                                                                                                                                 22.3
                                                                                                                                                                                                                               20.7                       20.0 19.5
                                                                                                                                                                                                                                                                           22.3
                                                                                                                                                                                                                                                                                  24.2
                                                                                                                                                                                                                                                                                                 22.3     22.9
                                                                                                                                                                                                                                                                                                                               21.3
                                                                                                                                                                                                                                                                                                                                                                                    HAstV_1_Dresden                             N/A                     -         +         -        -         -               ID:895                                                                   ID:421
                                                                                                                                                                                                                                                                                                                 18.9
                                                                                                                                                    20.0   18.1                                                             18.5
                                                                                                                                                                                                                                                              17.3
                                                                                                                                                                                                                                                                                                18.0    19.1
                                                                                                                                                                                                                                                                                                                16.3
                                                                                                                                                                                                                                                                                                                        18.8
                                                                                                                                                                                                                                                                                                                                       15.3 17.5 16.0
                                                                                                                                                                                                                                                                                                                                                                                    HAstV_1_Beijing                             N/A                     -         +         -        -         -               FilmArray GI:                                                            FilmArray GI:
                                                                                                                                               Ct




                                                                                                                                                                                           15.6                15.7                             14.5 14.6                                14.3                                         15.2
                                                                                                                                                    15.0
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               -
                                                                                                                                                                                                                                                                                                                                                      12.9

                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               Norovirus                                                                Norovirus
                                                                                                                                                                                                                                                                       12.3                                                                13.2 12.5


                                                                                                                                                    10.0
                                                                                                                                                                                                                                                                                                                                                       8.8                          HAstV_4                                15,200 FFU/mL                -         +         -        -
  PCR primers are dried into the wells of the array and each primer set amplifies a unique product
                                                                                                                                                                                                                                            8.3                      8.1             8.3

                                                                                                                                                     5.0                                                                                                                                                                                                                            HAstV_8                                14,400 FFU/mL                -         +         -        -         -
  of the first-stage multiplex PCR. The second stage PCR product is detected in real-time using                                                      0.0                                                                                                                                                                                                                            HAstV_MLB1*                                 N/A                     -         -         -        -         -                       Lab Tests Performed                     Result                     Lab Tests Performed              Result
  a fluorescent-double-stranded DNA binding dye, LCGreen® Plus.                                                                                                                                                                                                                                                                                                                     HAstV_VA2*                                  N/A                     -         -         -        -         -                      C. diff DNA amplification               Negative                         Adenovirus                 Negative
                                                                                                                                                             I.3


                                                                                                                                                             I.5
                                                                                                                                                             I.6
                                                                                                                                                             I.8


                                                                                                                                                                                                                              2
                                                                                                                                                                                                               G 42 3


                                                                                                                                                                                                                G 200 a
                                                                                                                                                                                                                G 20 b
                                                                                                                                                                                                                G 20 7
                                                                                                                                                                                                                     4 8
                                                                                                                                                                                                                           10

                                                                                                                                                                                                                              5
                                                                                                                                                                                                                              6
                                                                                                                                                                                                                              7
                                                                                                                                                                                                                      G 8
                                                                                                                                                                                                                      G 2
                                                                                                                                                                                                                      G 3
                                                                                                                                                                                                                G GII 6
                                                                                                                                                                                                               G b-G 0
                                                                                                                                                                                                                     -G .3
                                                                                                                                                                                                                            20
                                                                                                                                                                                                               G 20 04
                                                                                                                                                            I.4




                                                                                                                                                                                                                          II.
                                                                                                                                                                                                                   II. II.


                                                                                                                                                                                                                   4 6
                                                                                                                                                                                                                  II. 6
                                                                                                                                                                                                                  II. 0
                                                                                                                                                                                                                  II. 0


                                                                                                                                                                                                                          II.
                                                                                                                                                                                                                          II.
                                                                                                                                                                                                                          II.
                                                                                                                                                                                                                          II.
                                                                                                                                                                                                                            1
                                                                                                                                                                                                                            1
                                                                                                                                                                                                                            1
                                                                                                                                                                                                                  II. .2
                                                                                                                                                                                                                 IIc II
                                                                                                                                                       G


                                                                                                                                                           G
                                                                                                                                                           G
                                                                                                                                                           G




                                                                                                                                                                                                                II. 0




                                                                                                                                                                                                                       20




                                                                                                                                                                                                                        II.
                                                                                                                                                                                                                        II.
                                                                                                                                                                                                                        II.




                                                                                                                                                                                                                        II.
                                                                                                                                                                                                                II. 0
                                                                                                                                                                  G




                                                                                                                                                                                                          G
                                                                                                                                                                                                                  G




                                                                                                                                                                                                                       G
                                                                                                                                                                                                                       G
                                                                                                                                                                                                                       G
                                                                                                                                                                                                                       G




                                                                                                                                                                                                                                                                                                                                                                                    NoVGI.1                                     N/A                     -         -         +        -         -                              EHECT EIA                       Negative
                                                                                                                                                                                                                     4
                                                                                                                                                                                                                     4
                                                                                                                                                                                                                   4
                                                                                                                                                                                                                  G




                                                                                                                                                                                                                                                    Strain
                                                                                                                                                                                                                                                                                                                                                                                    NoVGI.3                                     N/A                     -         -         +        -         -                        Giardia/Crypto DFA                    Negative
                                                                                                                                                ITI_NoVGI_Assay                           Comparator_NoVGI_Assay                                    ITI_NoVGII_Assay                                   Comparator_NoVGII_Assay
        A.     Fitment with freeze-dried reagents                                                                                                                                                                                                                                                                                                                                   NoVGI.4                                     N/A                     -         -         +        -         -
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             Stool Culture                    Negative
        B.     Plungers- deliver reagents to blisters                                                                                                                                                                                                                                                                                                                               NoVGI.6                                     N/A                     -         -         +        -         -
        C.     Sample lysis and bead collection                                                                                                                                                                                                                                                                                                                                     NoVGI.8                                     N/A                     -         -         +        -         -                                                                    HAstV                                                      Shigella
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 Adeno F
        D.     Wash station                                                                                                                                                                                                                                                                                                                                                         NoVGII.1                                    N/A                     -         -         +        -         -
        E.     Magnetic bead collection blister                                                                                                                                                                                    Sapovirus                                                                                                                                        NoVGII.2                                    N/A                     -         -         +        -         -                                                                                             Rotavirus
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               -
                                                                                                                                                                                                                                                                                                                                                37.3

        F.     Elution Station                                                                                                                       40.0
                                                                                                                                                     35.0                                 31.1                                                                             30.0                 29.4                           30.3      26.0
                                                                                                                                                                                                                                                                                                                                                                                    NoVGII.3                                    N/A                     -         -         +        -
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               -
                                                                                                                                                                                   27.4                                                                                             25.9                 26.6
                                                                                                                                                     30.0
        G.     Multiplex Outer PCR blister                                                                                                           25.0
                                                                                                                                                                            26.7
                                                                                                                                                                                                  21.0     22.1
                                                                                                                                                                                                                  19.6
                                                                                                                                                                                                                           24.3
                                                                                                                                                                                                                                    22.4    23.6
                                                                                                                                                                                                                                                      20.2
                                                                                                                                                                                                                                                                23.8
                                                                                                                                                                                                                                                                                                       17.8
                                                                                                                                                                                                                                                                                                                  24.5
                                                                                                                                                                                                                                                                                                               18.3
                                                                                                                                                                                                                                                                                                                      21.8
                                                                                                                                                                                                                                                                                                                                      24.5   25.7
                                                                                                                                                                                                                                                                                                                                                       21.9
                                                                                                                                                                                                                                                                                                                                                                                    NoVGII.4 2010                               N/A                     -         -         +        -
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               -
                                                                                                                                                                          16.7                                                                                                            17.0
                                                                                                                                                Ct




                                                                                                                                                                                                                                                                             16.4
                                                                                                                                                     20.0
        H.     Dilution blister                                                                                                                      15.0
                                                                                                                                                                  16.6
                                                                                                                                                                                           11.4          9.9   10.8      11.1     11.3
                                                                                                                                                                                                                                         12.9      13.2     13.4     14.8                                                                           15.5
                                                                                                                                                                                                                                                                                                                                                                                    NoVGII.6                                    N/A                     -         -         +        -
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               -
                                                                                                                                                              6.4
                                                                                                                                                     10.0
                                                                                                                                                                                                                                                                                                                                                                                    NoVGII.7                                    N/A                     -         -         +        -                     The FilmArray data agreed with all negative testing                        The FilmArray was concordant with the negative
        I.     Inner Nested PCR array                                                                                                                 5.0
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           results for PCMC_895 and positively detected a                             Adenovirus call and positively detected a co-in-
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               -
                                                                                                                                                      0.0
                                                                                                                                                                                                                                                                                                                                                                                    NoVGII.8                                    N/A                     -         -         +        -
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                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               -           co-infection of Adeno F and HAstV.                                         fection of Rotavirus and Enteroinvasive E. coli.
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                                                                                                                                                                                                                                                                                                                                                                                    NoVGII.12                                   N/A                     -         -         +        -
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                                                                                                                                                                                                                                                    Strain
                                                                                                                                                                                                                                                                                                                                                                                    NoVGII.13                                   N/A                     -         -         +        -         -
                                                                                                                                                                                                                                                                                                                                                                                    NoVGII.16                                   N/A                     -         -         +        -         -    Multi-target testing by the FA GI pouch revealed that multiple infections were common and found
                                                                                                                                                                                             ITI_SaV_PAN_Assay                                                 Comparator_Assay
                                                                                                                                                                                                                                                                                                                                                                                    NoVGII.20                                   N/A                     -         -         +        -         -    in about 30% of clinical specimens, with up to 5 pathogens detected in a single specimen. Two
                                                                                                                                                                                                                                                                                                                                                                                    NoVGIIb-GII.3                               N/A                     -         -         +        -         -    virus co-infections and combination of bacterial, viral and protozoa confections were observed.
   ACKNOWLEDGEMENTS                                                                                                                                                                                                                                                                                                                                                                 NoVGIIc-NoVGII.20                           N/A                     -         -         +        -         -
   Development of FilmArray GI Detection System is supported by NIH Grant #5R01AI089489.                                                                                                                                                                                                                                                                                            NoVGIV_Synthetic RNA                   ~10^12 GE/mL                 -         -         +        -         -
   A special thanks to all those who provided samples for the preliminary testing of the FA GI panel:                                                                                                                                                                                                                                                                               Rota A_RV4GIP[8]                      130,000 FFU/mL                -         -         -        +         -
                                                                                                                          REFERENCES                                                                                                                                                                                                                                                Rota A_ST-3G4P[6]                   62,000,000 FFU/mL               -         -         -        +         -
   ARUP, Salt Lake City, UT.
                                                                                                                          1. Herikstadt H, Vergia D, Hadler J, et al. Population-based estimate of the burden of diarrheal illnesses: FoodNet                                                                                                                                       Rota A_F45G9P[8]                      840,000 FFU/mL                -         -         -        +         -    CONCLUSION
   Dr. Gail Greening, Kenepuru Science Centre, Porirua, New Zealand.                                                      1996-1997. 1st International Conference on Emerging Infectious Diseases (Atlanta), March 1998.                                                                                                                                                            Rota A_Wa                             2,188 TCID50/mL               -         -         -        +         -    The FilmArray GI Panel, with its ability to rapidly and accurately identify the broad range of
   Dr. Frederick Hayden, Department of Pathology, University of Virginia School of Medicine, Charlottesville, VA.         2. LeClere FB, Moss AJ, Everhart JE, Roth HP. Prevalence of major digestive disorders and bowel symptoms, 1989.                                                                                                                                           Rota B_Synthetic RNA                    ~10^11GE/mL                 -         -         -        +         -    diarrheal pathogens, is expected to make diagnostic testing of diarrheal illness both more simple
   Dr. Xiaoli Pang, Department of Laboratory Medicine and Pathology, University of Alberta, Edmonton, Alberta, Canada.                                                                                                                                                                                                                                                              Rota C_Synthetic RNA                    ~10^11GE/mL                 -         -         -        +         -
                                                                                                                          Adv Data 1992; 212:1-15.                                                                                                                                                                                                                                                                                                                                                  and comprehensive. This will ensure accurate patient treatment and will reduce inappropriate
                                                                                                                                                                                                                                                                                                                                                                                    SaV_G1                                      N/A                     -         -         -        -         +
   This poster contains information regarding assays that have not been cleared by the FDA for in vitro diagnostic        3. Mead PS, Slutsker L, Dietz V, et al. Food-related illness and death in the United States. Emerg Infect Dis 1999;                                                                                                                                       SaV_G2                                      N/A                     -         -         -        -         +    antibiotic use and associated complications. Public health will benefit from more rapid detection of
   use.                                                                                                                   5:607-25.                                                                                                                                                                                                                                                 SaVG_4                                      N/A                     -         -         -        -         +    GI pathogen related outbreaks and a broader understanding of the epidemiology of enteric illness.
                                                                                                                                                                                                                                                                                                                                                                                    SaV_G5                                      N/A                     -         -         -        -         +




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Scientific Poster Page                                                                                                                                                                                                                                                                                                                Presented at the Clinical Virology Symposium, April 2012                                                                                                                                                                                                  Idaho Technology, Inc.
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