Leptospira DNA, Qualitative, Real-Time PCR
Order Code:
LEPTQL
Test Summary
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.
Aliases
- N/A
Specimen Collection
Special Instructions
N/A
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
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.
Patient Preparation
N/A
Storage
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
Limitations
N/A
Other Acceptable Specimens
1 mL whole blood collected in EDTA (lavender-top) tube • 1 mL CSF • 2 mL urine collected in Aptima®
Unacceptable Specimens
Urine received room temperature • Urine received refrigerated • APTIMA® Urine samples where the fluid level is not between the black fill lines
Order Code
LEPTQL
EPIC (Premier) Code
LAB5810
Includes
N/A
CPT Code
- 87798
Billing Code
- 670134
CPT Statement
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 U.S. Food and Drug Administration. The FDA has determined that such clearance or approval is not necessary. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.
Physician Attestation of Informed Consent
N/A
Testing Laboratory
Quest Diagnostics Nichols Institute
33608 Ortega Highway
San Juan Capistrano CA, 92675
33608 Ortega Highway
San Juan Capistrano CA, 92675
Department
Reference Testing
Reference Range
Not detected
Setup Schedule / Expected Turnaround Time
Monday, Wednesday, Friday; Report available: 1 - 3 days
Specimen Collection
Special Instructions
N/A
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
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.
Patient Preparation
N/A
Storage
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
Limitations
N/A
Other Acceptable Specimens
1 mL whole blood collected in EDTA (lavender-top) tube • 1 mL CSF • 2 mL urine collected in Aptima®
Unacceptable Specimens
Urine received room temperature • Urine received refrigerated • APTIMA® Urine samples where the fluid level is not between the black fill lines
Result Information
Methodology
Real-Time Polymerase Chain Reaction (RT-PCR)
Testing Laboratory
N/A
Reference Range
Not detected
Setup Schedule / Expected Turnaround Time
Monday, Wednesday, Friday; Report available: 1 - 3 days