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Comparison of a New Cervical Specimen Collection and

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Comparison of a New Cervical Specimen Collection and Powered By Docstoc
					1    Performance of a New HPV Cervi-Collect Collection and Transportation Kit

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3    M. Chernesky1*, S. Huang2, D. Jang1, B. Erickson2 , J. Salituro2 , H. Engel3 , J.

4                 Gilchrist1, P. Neuscheler3 , W.B. Mak2 , K. Abravaya2

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6          McMaster University/ St. Joseph’s Healthcare, Hamilton, ON, Canada
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7                        Abbott Molecular Inc., Des Plaines, IL, USA
                      3
8                         Abbott Diagnostics, Wiesbaden, Germany

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13                              * Corresponding Author at:

14                                St. Joseph’s Healthcare

15                               50 Charlton Avenue East

16                           Hamilton, ON, L8N 4A6, Canada

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18                            Email: chernesk@mcmaster.ca

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                                                                                         1
28                                     Abstract

29   Background: Liquid based Pap (L-Pap) media are used for Pap and human

30   papillomavirus (HPV) testing. Objectives: To compare RealTime high risk (HR)

31   HPV of a new collection kit (Cervi-Collect) and PreservCyt L-Pap specimens with

32   Hybrid Capture 2 (HC2). To determine ease of use and safety of Cervi-Collect.

33   Methods: L-Pap samples (n=203) were tested with HC2 and RealTime HR HPV

34   and Cervi-Collect with RealTime HR HPV. Discordant samples were genotyped.

35   Results: L-Pap and Cervi-Collect specimens tested by RealTime HR HPV

36   showed 93.1% agreement [Kappa 0.86]. RealTime HR HPV and HC2 on L-Pap

37   had 90.3% agreement [Kappa 0.80]. RealTime HR HPV on Cervi-Collect and

38   HC2 on L-Pap showed 88.2% agreement [Kappa 0.76]. Samples (16 of 21)

39   negative HC2 and positive RealTime HR HPV on L-Pap or Cervi-Collect

40   contained HR HPV genotypes. Eleven healthcare collectors were in strong

41   agreement on a usability questionnaire. Conclusion: Cervi-Collect samples were

42   easy to collect and showed strong agreement with L-Pap samples tested with

43   RealTime HR HPV or HC2.

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51

52   1. Introduction

53         High risk human papillomaviruses (HR HPV) are a major cause of cervical

54   cancer [1]. HR HPV testing either adjunctively with cytology or as the primary

55   screening test has shown increased sensitivity for detecting CIN2+ precancerous

56   lesions when compared with Pap testing alone [2]. ThinPrep PreservCyt Solution

57   and SurePath Preservative Fluid are transportation and storage media enabling

58   Pap and HPV testing. PreservCyt liquid-based (L-Pap) medium has been

59   validated with the Abbott RealTime HR HPV assay. In cases where Pap testing is

60   performed using non-L-Pap samples or HPV testing is performed as the primary

61   screening method, a cervical specimen is collected for HPV testing. A collection

62   brush and transportation medium kit (Cervi-Collect) was designed by Abbott

63   Molecular for testing with the Abbott RealTime HR HPV assay. The principles

64   and analytical performance of this assay have been described [3] and there are

65   several reports comparing it to HC2 in archived samples [4, 5, 6] and to various

66   DNA and RNA detection methods in L-Pap samples [7, 8, 9].

67         The aims were as follows: (a) to compare the performance of the

68   RealTime HR HPV assay by testing Cervi-Collect and PreservCyt L-Pap

69   specimens; (b) to compare the RealTime HR HPV and HC2 assays on L-Pap

70   specimens; (c) to test discordant samples in a Linear Array (LA) assay; and (d) to

71   analyze the strength of agreement of healthcare workers on ease of use and

72   safety of the collection device and its package insert using a questionnaire.

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74

75   2. Material and Methods

76          A total of 203 women attending a women’s health clinic undergoing a

77   routine gynecological exam or a follow-up exam due to an abnormal Pap or

78   positive HR HPV test signed consent to have 2 cervical specimens collected: the

79   first was collected with a Cervex-Brush (Rovers Medical devices, Oss, The

80   Netherlands) and placed into an L-Pap PreservCyt collection medium tube

81   (Hologic Inc, Marlborough, MA, USA) and the second was collected with the

82   Cervi-Collect brush and placed into a Cervi-Collect transportation tube.

83   Specimen collection was performed according to the respective manufacturers’

84   instructions. The PreservCyt sample was processed for cytology in the Patholog y

85   Laboratory at the Juravinski Hospital, Hamilton, Ontario Canada and the

86   remainder of the sample was sent to the Infection Research Laboratory (IRL) at

87   St. Joseph’s Healthcare, Hamilton, Ontario Canada. Both samples were received

88   within 24 hours in the IRL.

89   2.1 HC2 Testing

90          The L-Pap sample was tested for HR HPV with the HC2 test (Qiagen,

91   Gaithersburg, MD, USA) at the IRL according to the package insert. Previous

92   positive and negative clinical samples were included with each run as controls.

93   Samples were scored negative if relative light units/cutoff (RLU/CO) ratios were <

94   1.0; indeterminate when > 1.0 and < 2.5; and positive when > 2.5. Indeterminate

95   samples were repeated in duplicates: a sample with an RLU/CO ratio  1.0 in

96   either replicate was considered positive.




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 97   2.2 RealTime HR HPV Testing

 98         The Cervi-Collect sample and one milliliter of the L-Pap sample were

 99   packaged and shipped to Abbott Diagnostics in Wiesbaden, Germany, where

100   they were tested in a blinded fashion with the RealTime HR HPV assay on the

101   Abbott m2000 instrument. The automated test procedure consisted of sample

102   preparation, reaction assembly, real-time PCR, and result reporting [3]. During

103   sample preparation using the Abbott m2000sp, 0.4 mL of sample was processed

104   using the Abbott mSample Preparation SystemDNA where it was lysed with

105   chaotrophic reagents, allowing the DNA         to be captured on magnetic

106   microparticles. The bound purified DNA was washed and then eluted. An

107   amplification master mix was created with AmpliTaq Gold enzyme (Roche

108   Molecular Systems Inc., Branchburg, NJ, USA), magnesium chloride and an

109   oligonucleotide reagent containing primers, probes and dNTPs. The PCR

110   reaction was then assembled in a 96-well optical reaction plate by combining

111   aliquots of the master mix and the extracted DNA eluate. Thermocycling and

112   fluorescence detection of the amplified products were carried out in the Abbott

113   m2000 real-time PCR instrument and results were automatically reported . The

114   assay detects 14 HR HPV genotypes (16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58,

115   59, 66 and 68) with type specific detection for types 16 and 18 and detection of

116   the other 12 non-HPV 16/18 types as a group. A separate detection category of

117   β-globin is included as an internal control to validate sample adequacy, DNA

118   recovery and PCR efficiency. Clinical samples previously positive and negative

119   were included with each run. Results for each sample were reported based on all




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120   three HPV signals, corresponding to HPV16, HPV 18 and no n-HPV 16/18 HR

121   types, as well as the internal control signal.

122   2.3 LA Testing

123          Samples which showed discordant results after testing by HC2 and

124   RealTime HR HPV assays were tested using the LA HPV Genotyping Test

125   (Roche    Molecular Systems       Inc., Branchburg, NJ,     USA)    following   the

126   manufacturer’s protocol. PCR was performed in a final reaction volume of 100 µl

127   containing 50 µl of kit master mix. The genotyping strips were visually interpreted

128   using the HPV reference guide provided in the kit package insert. The same high

129   risk genotypes represented in the Abbott assay were considered high risk.

130   2.4 Questionnaires

131          Sample collectors (physicians and nurses) were asked to complete a

132   questionnaire rating whether the product labeling information was adequate and

133   easy to understand in the following areas: the intended use statement, the

134   instructions for safe use, collection, storage and transport, and limitation of use

135   statement in the package insert. They also evaluated the usability aspects (such

136   as whether the kit package was easy to open, whether the tube cap was easy to

137   take off and replace, and whether any leakage was present) as well as the safety

138   aspects for the collection kit and instructions. In total, eleven questions were

139   answered by each of the eleven collectors. Each question was answered on a

140   scale of 1 to 5, with 5 indicating strong agreement with a statement and 1 if there

141   was strong disagreement. The overall rating across all collectors for each




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142   question was calculated as the combined score as a percentage of a maximal

143   score of 55 (i.e. 11 times 5).

144   2.5 Statistical Analysis

145          Agreement between tests was assessed by kappa statistic (k).

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148   3. Results

149          There was strong agreement between the L-Pap and Cervi-Collect

150   specimens tested by RealTime HR HPV (Table 1). The positive agreement was

151   85.7% (84/98), negative agreement was 88.2% (105/119) and overall agreement

152   was 93.1% (189/203) [Kappa 0.86]. There were 8 L-Pap samples with insufficient

153   volume for HC2 testing (4 were from patients who were negative in Cervi-Collect

154   and L-Pap samples and 4 were positive in both by RealTime HR HPV). Table 2

155   shows agreement between RealTime HR HPV and HC2 performed on 195 L-Pap

156   specimens. The assays agreed on 73 positives and 103 negatives. There were

157   15 samples which were positive by the RealTime HR HPV test and negative by

158   HC2, and 4 other samples which were positive by HC2 but negative by the

159   RealTime HR HPV test. The positive agreement was 79.3% (73/92), negative

160   agreement was 84.4% (103/122) and the overall agreement was 90.3%

161   (176/195) [Kappa 0.80]. When the RealTime HR HPV test was performed on

162   Cervi-Collect specimens and HC2 was performed on L-Pap (Table 3), positive

163   agreement was 75.3% (70/93), negative agreement was 81.6% (102/125) and

164   overall agreement was 88.2% (172/195) [Kappa 0.76].




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165           Table 4 summarizes the results of LA testing of 28 discordant samples

166   from the 3 testing strategies (HC2 on L-Pap; RealTime HR HPV on L-Pap; and

167   RealTime HR HPV on Cervi-Collect). Samples from 16 of 21 patients with a

168   negative HC2 result and a positive RealTime HR PCR result obtained either from

169   L-Pap or Cervi-Collect samples contained HR HPV genotypes. Samples from 4

170   patients (026, 040, C121 and 190) which were positive by HC2 and negative by

171   the RealTime HR HPV assay in the L-Pap and Cervi-Collect samples contained

172   low-risk HPV genotypes. Three patients (099, C169 and C193), which were HC2

173   and RealTime positive in L-Pap but were negative in the Cervi-Collect sample,

174   contained HR genotypes.

175           Figure 1 summarizes the outcomes from the questionnaires. Four of 11

176   categories received a full score (100%) out of a maximal score of 55 (5 from all

177   11 collectors) and the other 7 categories were graded at the maximum by most

178   collectors (8 or greater) with an o verall rating between 93% and 98%. The lower

179   scores (93%) were recorded in categories for unscrewing and recapping the

180   tube.

181   4. Discussion

182           The new Cervi-Collect kit compared well to PreservCyt when tested by the

183   RealTime HR HPV assay (Table 1), showing strong agreement of 93.1%

184   (Кappa=0.86). Analysis of the 98 samples which were positive in either sample

185   type from Table 1 showed that 27 were positive in the type 16 signal (with or

186   without the non-HPV 16/18 HR HPV signal), 12 were positive in the type 18

187   signal, 3 were positive in both the HPV 16 and 18 signals and the rest were




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188   positive only in the non-HPV 16/18 HR HPV signal. The higher agreement

189   between the two RealTime HR HPV results for different transport media

190   compared to that between RealTime HR HPV and HC2 was mainly due to more

191   positives in agreement (n=84 in Table 1 vs. 70 or 73 in Tables 2 and 3

192   respectively).

193          Comparing assays in Table 2 and 3 showed more cases of HC2

194   negative/RealTime HR HPV positive than HC2 positive/RealTime HR HPV

195   negative samples. These differences are consistent with findings in other studies

196   [7, 8, 9] which showed that the RealTime HR HPV assay detected the same

197   number or more cases of HPV infection than the HC2 test. The HR HPV positive

198   samples that were not detected by the HC2 test contained HR genotypes by the

199   LA test (Table 4). There were 16 patients positive by RealTime HR HPV in the

200   Cervi-Collect sample and negative by HC2 in the L-Pap sample, 13 of which

201   contained HR HPV by LA testing. Ten of the 13 were also positive by RealTime

202   HR HPV in the L-Pap samples. Of the total 28 discordant samples, 24 were

203   positive for HPV and 19 showed the presence of HR HPV genotypes by LA

204   testing. Of these 19 samples, 13 Cervi-Collect samples were identified as HR

205   HPV positive by the RealTime HR HPV assay, 16 L-Pap samples positive by

206   RealTime HR HPV and 3 L-Pap samples positive by HC2 (Table 4). The study

207   was not designed to follow patients to colposcopy and biopsy, so one can only

208   speculate what the significance of these additional positive infections would be in

209   predicting precancerous lesions. Examination of the 7 samples positive by HC2

210   and negative by RealTime HR HPV on Cervi-Collect revealed 3 samples that




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211   were confirmed positive by LA and RealTime HR HPV on the L-Pap sample. All 3

212   samples contained a low level of HPV targets as indicated by results from both

213   the assays. Because the new collection device was experimental, the L-Pap

214   sample was required to be collected first and the Cervi-Collect brush was used to

215   collect the second sample. Low levels of target, collection order and analytical

216   sensitivity differences for HC2, RealTime HR HPV and LA may contribute to

217   variability of assay comparison. The other 4 samples, only positive by HC2

218   testing, were shown to contain no HR HPV but a variety of low risk (LR)

219   genotypes by LA (Table 4, patients 26, 40, C121 and 190). Cross reactivity of the

220   HC2 test with low risk HPV genotypes has been reported previously. Sandri et

221   al10 showed that low risk genotypes such as HPV types 6, 42, 62, 71, 73 and 81

222   were found to be reactive in the HR HC2 test. Castle et al. [11] showed that

223   genotypes not targeted in the HR HC2 panel most often testing positive were

224   HPV 82 (80%), HPV 70 (59.1%) and HPV 67 (56.3%).

225          Analysis of the questionnaire scores (Figure 1) showed that 4 of the

226   eleven categories received the maximum score of 5 by all respondents

227   (55=100%). Unscrewing and recapping the tube received scores of 3 or 4 by 3 of

228   the eleven collectors suggesting that these maneuvers may be difficult for some

229   collectors due to a certain degree of dexterity required.

230   5. Conclusion

231          Because cervical samples may be collected specifically for HPV testi ng, a

232   system suitable for the collection, transportation and storage of specimens for the

233   detection of HR HPV DNA by the Abbott RealTime HR HPV was developed and




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234   evaluated. Cervi-Collect was designed to achieve efficient cervical collection,

235   optimal sample stability and compatibility with the automated sample preparation

236   instrument (Abbott m2000sp) as the primary input tube. This study demonstrated

237   excellent performance for the Cervi-Collect samples for the detection of HR HPV

238   DNA when tested with RealTime HR HPV and compared with the PreservCyt L-

239   Pap samples tested with RealTime HR HPV or HC2. The Cervi-Collect samples

240   were not evaluated as a source for cytological examination. Healthcare collectors

241   showed strong agreement with the usability and safety design features of Cervi-

242   Collect and its package insert. Further studies need to be conducted to

243   determine the versatility of this new collection kit for other anatomical sites such

244   as the vagina [12], anus [13] and oropharynx [14] as well as other sexually

245   transmitted infections [15, 16].

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257   6. References

258   1. F. Bosch, A. Lorincz, N. Munoz, C. Meijer and K. Shah, “The Causal Relation
259   between Human Papillomavirus and Cervical Cancer,” Journal of Clinical
260   Pathology , vol. 55, pp. 244 – 265, 2002.
261
262   2. M. Mayrand, E. Duarte-Franco, I. Rodrigues, S. Walter, J. Hanley, A.
263   Ferenczy, S. Ratnam, F. Coutlée and E. Franco, “Human Papillomavirus DNA
264   versus Papanicolaou Screening Tests for Cervical Cancer,” New England
265   Journal of Medicine, Vol. 357, pp. 1579 – 1588, 2007.
266
267   3. S. Huang, N. Tang, W. Mak, B. Erickson, J. Salituro, Y., Li, E. Krumpe, G.
268   Schneider, H. Yu, J. Robinson and K. Abravaya, “Principles and Analytical
269   Performance of Abbott RealTime High Risk HPV Test,” Journal of Clinical
270   Virology, vol. 45, pp. S13 – S17, 2009.
271
272   4. N. Tang, S. Huang, B. Erickson, W. Mak, J. Salituro, J. Robinson and K.
273   Abravaya, “High-Risk HPV Detection and Concurrent HPV 16 and 18 Typing with
274   Abbott RealTime High Risk HPV Test,” Journal of Clinical Virology, vol. 45, pp.
275   S25 – S28, 2009.
276
277   5. M. Poljak, A. Kovanda, B. Kocjan, S. Jancar and E. Vrtacnik-Bokal, “The
278   Abbott RealTime High Risk HPV Test: Comparative Evaluation of Analytical
279   Specificity and Clinical Sensitivity for Cervical Carcinoma and CIN 3 Lesions with
280   the Hybrid Capture 2 HPV DNA Test,” Acta Dermatovenerologica APA, vol. 18,
281   pp 94 – 103, 2009.
282
283   6. V. Kaliterna, S. Lepej and A. Vince, “Comparison between the Abbott
284   RealTime High Risk HPV Assay and the Hybrid Capture 2 Assay for Detecting
285   High-Risk Human Papillomavirus DNA in Cervical Specimens,” Journal of
286   Medical Microbiology, vol.58, pp.1662 – 1663, 2009.
287
288   7. A. Huang, B. Erickson, N. Tang, W. Mak, J. Salituro, J. Robinson and K.
289   Abravaya, “Clinical Performance of Abbott RealTime High Risk HPV Test for
290   Detection of High-Grade Cervical Intraepithelial Neoplasia in Women with
291   Abnormal Cytology,” Journal of Clinical Virology, vol. 45, pp. S19 – S23, 2009.
292
293   8. P. Halfon, D. Benmoura, A. Agostini, H. Khiri, G. Penaranda, A. Martineau and
294   B. Blanc, “Evaluation of the Clinical Performance of the Abbott RealTime High-
295   Risk HPV for Carcinogenic HPV Detection,” Journal of Clinical Virology, vol. 48,
296   pp. 246 – 250, 2010.
297
298   9. J. Cuzick, L. Ambroisine, L. Cadman, J. Austin, L. Ho, G. Terry, S. Liddle, R.
299   Dina, J. McCarthy, H. Buckley, C. Bergeron, W. Soutter, D. Lyons and A.
300   Szarewski, “Performance of the Abbott RealTime High-Risk HPV Test in Women




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301   with Abnormal Cervical Cytology Smears,” Journal of Medical Virology, vol. 82,
302   pp. 1186 – 1191, 2010.
303
304   10. M. Sandri, P. Lentati, E. Benini, P. Dell’Orto, L. Zorzino, F. Carozzi, P.
305   Maisonneuve, R. Passerini, M. Salvatici, C. Casadio, S. Boveri and M. Sideri,
306   “Comparison of the Digene HC2 Assay and the Roche AMPLICOR Human
307   Papillomavirus (HPV) test for Detection of High-Risk HPV Genotypes in Cervical
308   Samples,” Journal of Clinical Microbiology, vol. 44, pp. 2141 – 2146, 2006.
309
310   11. P. Castle, D. Solomon, C. Wheeler, P. Gravitt, S. Wacholder and M.
311   Schiffman, ”Human Papillomavirus Genotype Specificity of Hybrid Capture 2,”
312   Journal of Clinical Microbiology, vol. 46, pp. 2595 – 2604, 2008.
313
314   12. R. Winer, Q. Feng, J. Hughes, M. Yu, N. Kiviat, S. O’Reilly and L. Koutsky,
315   “Concordance of Self-Collected and Clinician-Collected Swab Samples for
316   Detecting Human Papillomavirus DNA in Women 18 to 32 Years of Age,”
317   Sexually Transmitted Diseases, vol. 34, pp. 371 – 377, 2007.
318
319   13. J. Palefsky, “Anal Squamous Intraepithelial Lesion in Human
320   Immunodeficiency Virus-Positive Men and Women,” Seminars in Oncology, vol.
321   27, pp. 471 – 479, 2000.
322
323   14. T. Ramqvist and T. Dalianis, “Oropharyngeal Cancer Epidemic and Human
324   Papillomavirus,” Emerging Infectious Disease, vol. 16, pp. 1671 – 1677, 2010.
325
326   15. M. Chernesky, E. Hook, D. Martin, J. Lane, R. Johnson, J. Jordan, D. Fuller,
327   D. Willis, P. Fine, W. Janda and J. Schachter, “Women Find it Easy to Prefer to
328   Collect their Own Vaginal Swabs to Diagnose Chlamydia trachomatis or
329   Neisseria gonorrhoeae Infections,” Sexually Transmitted Disease, vol. 32, pp.
330   729 – 733, 2005.
331
332   16. J. Schwebke, S. Morgan, S. and G. Pinson, “Validity of Self-Obtained
333   Specimens for Diagnosis of Trichomoniasis,” Journal of Clinical Microbiology, vol.
334   35, pp.1618 – 1619, 1997.
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343   Table 1 – Agreement between Cervi-Collect and PreservCyt L-Pap Specimens
344   Tested by the Abbott RealTime HR HPV Assay
                                                 Abbott RealTime HR HPV with
                                                                    Cervi-Collect

                                                               +                     -

       Abbott RealTime HR                +                    84                    8
       HPV with PreservCyt
              L-Pap                      -                     6                    105
345
346   Positive agreement – 85.7% (84/98); Negative agreement – 88.2% (105/119); Overall agreement
347   – 93.1% (189/203) (kappa = 0.86)
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383   Table 2 – Correlations between Abbott RealTime HR HPV and Hybrid Capture 2
384   with PreservC yt L-Pap Samples
                                                           Abbott RealTime HR HPV with
                                                                 PreservCyt L-Pap

                                                              +                     -
        Hybrid Capture 2                +                     73                    4
        with PreservCyt
             L-Pap                       -                    15                   103
385
386   Positive agreement – 79.3% (73/92); Negative agreement – 84.4% (103/122); Overall agreement
387   – 90.3% (176/195) (kappa = 0.80)
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423   Table 3 – Correlation between Abbott RealTime HR HPV with Cervi-Collect and
424   Hybrid Capture 2 with PreservCyt L-Pap Samples
                                                  Abbott RealTime HR HPV with
                                                                      Cervi-Collect

                                                               +                       -
        Hybrid Capture 2                 +                     70                     7
        with PreservCyt
             L-Pap                       -                     16                     102
425
426   Positive Agreement – 75.3% (70/93); Negative agreement – 81.6% (102/125); Overall
427   agreement– 88.2% (172/195) (kappa = 0.76)
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                                                                                            16
463      Table 4 – Comparison of Discordant Samples Tested by Linear Array (LA)
      Patient                                                                             1
                  RealTime HR HPV          RealTime HR     HC2 on       HPV Genotype s
      Number
                    on Cervi-Collect       HPV on L-Pap     L-Pap

       025              HR HPV                HR HPV        NEG            59,66, 68,81
       029              HR HPV                HR HPV        NEG                45
       058              HR HPV                HR HPV        NEG                51
       084              HR HPV                HR HPV        NEG     16,18, 39,51, 54,66,CP6108
       085              HR HPV                HR HPV        NEG               51,66
      C104              HR HPV                HR HPV        NEG               31,62
      C129              HR HPV                HR HPV        NEG               39,66
      C158              HR HPV                HR HPV        NEG                52
      C156              HPV 18                HPV 18        NEG               18,84
       177              HPV 16                HPV 16        NEG                16
      C112              HR HPV              Not Detected    NEG               NEG
      C131              HR HPV              Not Detected    NEG               NEG
      C173              HR HPV              Not Detected    NEG            16,59, 62,70
      C182              HPV 16              Not Detected    NEG            16,40, 53,55
       186              HPV 16              Not Detected    NEG            81,CP6108
      C167              HPV 18              Not Detected    NEG             18,42, 73
       081            Not Detected            HR HPV        NEG             35, 52, 59
      C128            Not Detected            HR HPV        NEG                18
       099            Not Detected            HR HPV        POS            51,54, 56,62
      C169            Not Detected            HR HPV        POS               56,84
       060            Not Detected            HR HPV        NEG               NEG
       070            Not Detected            HPV 16        NEG                16
       095            Not Detected            HPV 16        NEG               NEG
      C193            Not Detected            HPV 16        POS                16
       026            Not Detected          Not Detected    POS               IS39
       040            Not Detected          Not Detected    POS          40,53, CP6108
      C121            Not Detected          Not Detected    POS                53
       190            Not Detected          Not Detected    POS               81,84
464      1
465          High Risk HPV genotypes are bolded.
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475


                                    Easy to Understand
      Package Insert




                                  Adequate Information

                                 Collection Instructions
                         Storage/Transport Instructions

                                     Limitations of Use
       Safety




                                Specimen Collection Kit

                       Specimen Collection Instructions



                                          Kit Packaging
       Usability




                                           Specimen Kit
                                 Unscrewing Tube Cap

                                       Recapping Tube

                                                           0   20   40         60   80    100
                                                                         Percent
476
477
478           Figure 1 – Evaluation of the Cervi-Collect Package Insert, Safety and Usability
479           rated by 11 Healthcare collectors. (Each of the eleven questionnaire categories
480           were graded by the collectors, with 5 being the most favorable because of total
481           agreement with the statement. The final rating was based on the combined score
482           from all the collectors as a percentage of the maximal score of 55. For example,
483           100% is representative of 11 healthcare collectors giving a combined score of
484           55).




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