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Leptospira DNA, Qualitative, Real-Time PCR [17875]
MessageFor Specimen Integrity during Extreme Weather see the “Lockbox Usage in Extreme Weather” document at the top of this page.
Test Code
LEPTQL
Alias/See Also
17875
CPT Codes
87798
Preferred Specimen
5 mL urine collected in a sterile, plastic, leak-roof container
Minimum Volume
1 mL urine • 0.8 mL whole blood • 0.5 mL CSF • 2 mL Aptima urine
Other Acceptable Specimens
1 mL whole blood collected in EDTA (lavender-top) tube • 1 mL CSF • 2 mL urine collected in Aptima®
Instructions
Urine: collect in a sterile, plastic container with a leak-proof cap. Freeze at -20°C immediately, and transport frozen. Do not thaw.
Urine in Aptima® (Acceptable): 2 mL of the urine specimen must be transferred into the APTIMA® Specimen Transport within 24 hours of collection and before being assayed. The fluid (urine plus transport media) level in the urine transport tube must fall within the clear pane of the tube label.
Urine in Aptima® (Acceptable): 2 mL of the urine specimen must be transferred into the APTIMA® Specimen Transport within 24 hours of collection and before being assayed. The fluid (urine plus transport media) level in the urine transport tube must fall within the clear pane of the tube label.
Transport Container
Sterile Container, leak-proof
Transport Temperature
Urine: Frozen
Whole blood/CSF: Refrigerated (cold packs)
Whole blood/CSF: Refrigerated (cold packs)
Specimen Stability
Urine in sterile container
Room temperature: Unacceptable
Refrigerated: Unacceptable
Frozen: 30 days
Whole blood/CSF
Room temperature: 48 hours
Refrigrated: 7 days
Frozen: 30 days
Aptima urine
Room temperature: 5 days
Refrigerated: 7 days
Frozen: 30 days
Room temperature: Unacceptable
Refrigerated: Unacceptable
Frozen: 30 days
Whole blood/CSF
Room temperature: 48 hours
Refrigrated: 7 days
Frozen: 30 days
Aptima urine
Room temperature: 5 days
Refrigerated: 7 days
Frozen: 30 days
Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Urine received room temperature • Urine received refrigerated • APTIMA® Urine samples where the fluid level is not between the black fill lines
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 the FDA. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.
Setup Schedule
Set up: Mon, Wed, Fri; Report available: 1-3 days
Reference Range
Not detected
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.
Performing Laboratory
| Quest Diagnostics Nichols Institute-San Juan Capistrano, CA |
| 33608 Ortega Highway |
| San Juan Capistrano, CA 92675-2042 |
Last Updated: November 30, 2021
