HIV-1 RNA, Quantitative Real-Time PCR with Reflex to Coreceptor Tropism, UDS
Test Summary
This test is intended for use in conjunction with clinical presentation and other laboratory markers of disease progress for the clinical management of HIV-1 infected patients. The test can be used to assess patient prognosis by measuring the baseline HIV-1 RNA level or to monitor the effects of antiretroviral therapy by measuring changes in EDTA plasma HIV-1 RNA levels during the course of antiretroviral treatment. This test is not intended for use as a screening test for the presence of HIV-1 in blood or blood products or as a diagnostic test to confirm the presence of HIV-1 infection.
Aliases
- N/A
Specimen Collection
Special Instructions
N/A
Preferred Specimen
3 mL plasma collected in an EDTA (lavender-top) tube
Minimum Volume
2.5 mL
Instructions
Samples submitted in primary tube will be rejected.
Freshly drawn specimens (whole blood) may be stored at 2-25°C for up to 24 hours prior to centrifugation. Separate plasma from cells within 24 hours of collection by centrifugation and immediately transfer to a transport tube. Follow manufacturer's instructions for collection tube handling.
Freshly drawn specimens (whole blood) may be stored at 2-25°C for up to 24 hours prior to centrifugation. Separate plasma from cells within 24 hours of collection by centrifugation and immediately transfer to a transport tube. Follow manufacturer's instructions for collection tube handling.
Patient Preparation
N/A
Storage
Transport tube
Transport Temperature
Frozen
Specimen Stability
- Room temperature: Unacceptable
- Refrigerated: 5 days
- Frozen: 30 days
Limitations
N/A
Other Acceptable Specimens
Plasma collected in: PPT potassium EDTA (white-top) tube
Unacceptable Specimens
Samples received in primary collection tube • Gross hemolysis • Lipemia
Order Code
HV1QTR
EPIC (Premier) Code
LAB5863
Includes
If HIV-1 RNA, Quantitative, PCR is ≥1000 copies/mL, then HIV-1 Coreceptor Tropism, Ultradeep Sequencing will be performed at an additional charge (CPT code(s): 87906).
CPT Code
- 87536
Billing Code
- 670076
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
| HIV-1 RNA, QN,PCR | Not detected | copies/mL | |
| HIV-1 RNA, QN, PCR | Not detected | Log copies/mL | |
Setup Schedule / Expected Turnaround Time
Monday - Saturday; Report available: 2 - 4 days
Specimen Collection
Special Instructions
N/A
Preferred Specimen
3 mL plasma collected in an EDTA (lavender-top) tube
Minimum Volume
2.5 mL
Instructions
Samples submitted in primary tube will be rejected.
Freshly drawn specimens (whole blood) may be stored at 2-25°C for up to 24 hours prior to centrifugation. Separate plasma from cells within 24 hours of collection by centrifugation and immediately transfer to a transport tube. Follow manufacturer's instructions for collection tube handling.
Freshly drawn specimens (whole blood) may be stored at 2-25°C for up to 24 hours prior to centrifugation. Separate plasma from cells within 24 hours of collection by centrifugation and immediately transfer to a transport tube. Follow manufacturer's instructions for collection tube handling.
Patient Preparation
N/A
Storage
Transport tube
Transport Temperature
Frozen
Specimen Stability
- Room temperature: Unacceptable
- Refrigerated: 5 days
- Frozen: 30 days
Limitations
N/A
Other Acceptable Specimens
Plasma collected in: PPT potassium EDTA (white-top) tube
Unacceptable Specimens
Samples received in primary collection tube • Gross hemolysis • Lipemia
Result Information
Methodology
Real-Time Polymerase Chain Reaction (RT-PCR)
Testing Laboratory
N/A
Reference Range
| HIV-1 RNA, QN,PCR | Not detected | copies/mL | |
| HIV-1 RNA, QN, PCR | Not detected | Log copies/mL | |
Setup Schedule / Expected Turnaround Time
Monday - Saturday; Report available: 2 - 4 days