Leptospira DNA, Qualitative, Real-Time PCR

Test Code
17875


CPT Codes
87798

Preferred Specimen
5 mL frozen urine collected in a sterile, plastic, leak-proof container


Minimum Volume
1 mL urine • 0.8 mL whole blood • 0.5 mL CSF • 2 mL urine in aptima ®


Other Acceptable Specimens
1 mL whole blood collected in an EDTA (lavender-top) tube • 1 mL CSF collected in a sterile leak-proof container • 2 mL urine collected in Aptima ®


Instructions
Collect urine in a sterile, plastic container with a leak-proof cap. Freeze at -20° C immediately, and transport frozen. Do not thaw.


Transport Temperature
Urine: Frozen
Whole blood/CSF: Refrigerated (cold packs)


Specimen Stability
Urine
Room temperature: Unacceptable
Refrigerated: Unacceptable
Frozen: 30 days

Whole blood/CSF
Room temperature: 48 hours
Refrigerated: 7 days
Frozen: 30 days

Urine in Aptima ®
Room temperature: 5 days
Refrigerated: 7 days
Frozen: 30 days


Methodology
Real-Time Polymerase Chain Reaction (RT-PCR)

FDA Status
This test was developed and its analytical performance characteristics have been determined by Quest Diagnostics. It has not been cleared or approved by FDA. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.

Setup Schedule
Sets up 3 days a week.


Clinical Significance
PCR can be used to rapidly diagnose Leptospirosis, an infection caused by a waterborne spirochete of the genus Leptospira. In addition, testing of blood, CSF and urine may give an indication of the stage of infection.




The CPT Codes provided in this document are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed. Any Profile/panel component may be ordered separately. Reflex tests are performed at an additional charge.