Lyme Disease PCR, Blood by odq14517

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									Lab Dept:                      Microbiolgy/Virology

Test Name:                     LYME DISEASE PCR, BLOOD

General Information

Lab Order Codes:               LYPCB


Synonyms:                      Borrelia burgdorferi PCR; Lyme Disease PCR; Lyme Disease by
                               Polymerase Chain Reaction

CPT Codes:                     87476 – Borrelia burgdorferi, amplified probe technique

Test Includes:                 A positive or negative result indicating the presence or absence of Borrelia
                               burgdorferi DNA in the specimen submitted.

Logistics

Test Indications:              Confirmation of active Lyme Disease. Monitoring Lyme Disease treatment.
                               Diagnosing and monitoring Lyme arthritis.

                               PCR testing should be limited to patients with at least an equivocal or
                               positive serologic test for antibody to Borrelia burgdorferi.

Lab Testing Sections:          Microbiology/Virology – Sendouts

Referred to:                   Mayo Medical Laboratories (MML Test# 87973)

Phone Numbers:

               Minneapolis:    612-813-6280

                 Saint Paul:   651-220-6550

Test Availability:             Daily, 24 hours

Turnaround Time:               1 – 4 days

Special Instructions:          N/A

Specimen

Specimen Type:                 Whole blood

Container:                     Lavender (EDTA) top
Draw Volume:           1.0 mL (Minimum: 0.5 mL) whole blood

Processed Volume:      Same as Draw Volume

Collection:            Rputine venipuncture

Special Processing:    Lab Staff: Do Not centrifuge. Submit specimen in original collection
                       container. Maintain sterility. Store at ship at refrigerated temperatures.

Patient Preparation:   None

Sample Rejection:      Mislabeled or unlabeled specimens

Interpretive

Reference Range:       Negative (reported as positive or negative)

Critical Values:       N/A

Limitations:           A negative result does not rule out Lyme disease, since inhibitory
                       substances may be present in the specimen and the assay has limited
                       diagnostic sensitivity when testing certain types of specimens. If clinical
                       features of illness are highly indicative of Lyme neuroborreliosis, serologic
                       testing on CSF is warranted.

                       Patients with active infection due to Borrelia afzelii, or Borrelia garinii may
                       have positive results from this PCR test, which can distinguish Borrelia
                       burgdorferi infection from those of Borrelia afzelii and Borrelia garinii.
                       However, the later 2 infections are indistinguishable from one another by
                       this PCR assay. Specimens with detectable DNA from either of these two
                       sprirochetes in this assay will be reported as “positive” for Borrelia
                       afzelii/Borrelia garini”.

                       PCR test results should be used as an aid in diagnosis and not considered
                       diagnostic by themselves. These results should be correlated with serologic
                       and epidemiologic data and clinical presentation of the patient.

                       Coinfection with Erhlichia chaffeensis/Anaplasma phagocytophilum and/or
                       Babesia microti have been reported in the United States.

Methodology:           Polymerase Chain Reaction (PCR)/DNA Probe Hybridization
                       (PCR is utilized pursuant to a license agreement with Roche Molecular
                       Systems, Inc.)

References:            Mayo Medical Laboratories Web Page November 2009

								
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