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| A B C D E F G H I J K L M N O P Q R S T U V W X Y Z # |
HIV-1 RNA, Quantitative, Real-Time PCR, with Reflex to Integrase Genotype
Test Code90926
CPT Codes
87536
Includes
If HIV-1 viral load is >400 copies/mL, then HIV-1 Integrase will be performed at an additional charge (CPT Code(s): 87906).
Preferred Specimen
3 mL plasma collected in an EDTA (lavender-top) tube
Minimum Volume
2.5 mL
Other Acceptable Specimens
Plasma collected in: PPT potassium EDTA (white-top) tube
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.
Transport Container
Transport tube
Transport Temperature
Frozen
Specimen Stability
Room temperature: Unacceptable
Refrigerated: 6 days
Frozen: 42 days
Refrigerated: 6 days
Frozen: 42 days
Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Samples received in primary collection tube • Gross hemolysis • Lipemia
Methodology
Real-Time Polymerase Chain Reaction
FDA Status
This test was developed and its analytical performance characteristics have been determined by Quest Diagnostics Infectious Disease. It has not been cleared or approved by the U.S. Food and Drug Administration. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.
Setup Schedule
Set up: Mon-Sat; Report available: 2-4 days
Reference Range
| HIV-1 RNA, QN, PCR | Not detected | copies/mL | |
| HIV-1 RNA, QN, PCR | Not detected | Log copies/mL | |
Clinical Significance
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.
The emergence of integrase drug resistance mutations has been observed in vitro and in patients experiencing virologic failure on Raltegravir in clinical trials. Twenty three percent of patients receiving Raltegravir in a clinical trial experience virologic failure at 48 weeks and genotypic analysis detected raltegravir associated resistance mutations in 68% of virologic failures. This assay amplifies and sequences the HIV-1 integrase gene and reports mutations at positions associated with integrase inhibitor drug resistance.
The emergence of integrase drug resistance mutations has been observed in vitro and in patients experiencing virologic failure on Raltegravir in clinical trials. Twenty three percent of patients receiving Raltegravir in a clinical trial experience virologic failure at 48 weeks and genotypic analysis detected raltegravir associated resistance mutations in 68% of virologic failures. This assay amplifies and sequences the HIV-1 integrase gene and reports mutations at positions associated with integrase inhibitor drug resistance.
