Human Immunodeficiency Virus 1 (HIV-1) RNA, Quantitative PCR, Plasma
Test Mnemonic
HIVRNA
CPT Codes
- 87536 - QTY (1)
LOINC ®
20447-9
Aliases
- HIV RNA
- HIV RNA
- HIVRNA
- SQHIVRNA
- viral load
- AIDS
Includes
- HIV-1 RNA
- HIV-1 RNA (copies/mL)
- HIV-1 RNA (log copies/mL)
Performing Laboratory
Cleveland Clinic Laboratories
Specimen Requirements
| Volume | Type | Container | Collect Temperature | Transport Temperature | Special Instructions |
|---|---|---|---|---|---|
| 2 mL | Plasma | EDTA PPT (White) | Centrifuge and refrigerate. | Collect EDTA plasma according to standard protocol. Separate plasma by centrifugation (at 1,100 RCF for a minimum of 10 minutes) within 24 hours of collection. Plasma must be aliquoted first if sample is to be frozen. Sample cannot be shared with a test performed outside of Molecular Microbiology. Sample can only be shared with CMVQNT, HCQPCR, HIVRNA, HBVDNU, EBVQNT, or BKQUAN. |
Alternate Specimen Requirements
| Volume | Type | Container | Collect Temperature | Transport Temperature | Special Instructions |
|---|---|---|---|---|---|
| 2 mL | Plasma | EDTA (Lavender) | Centrifuge, aliquot and refrigerate ASAP. | Collect EDTA plasma according to standard protocol. Centrifuge (at >1300 RCF for a minimum of 10 minutes) and aliquot into a sterile secondary tube within 24 hours of collection. Plasma must be aliquoted first if sample is to be frozen. Sample cannot be shared with a test performed outside of Molecular Microbiology. Sample can only be shared with CMVQNT, HCQPCR, HIVRNA, HBVDNU, EBVQNT, or BKQUAN. | |
| 2 mL | Plasma | Pink KEDTA | Centrifuge and refrigerate. | Collect EDTA plasma according to standard protocol. Centrifuge (at >1300 RCF for a minimum of 10 minutes) and aliquot into a sterile secondary tube within 24 hours of collection. Plasma must be aliquoted first if sample is to be frozen. Sample cannot be shared with a test performed outside of Molecular Microbiology. Sample can only be shared with CMVQNT, HCQPCR, HIVRNA, HBVDNU, EBVQNT, or BKQUAN. |
Minimum Specimen Requirements
| Volume | Type | Container | Collect Temperature | Transport Temperature | Special Instructions |
|---|---|---|---|---|---|
| 1 mL | Minimum volume for testing is 1.0 mL of plasma. Aliquots must be made from specimen prior to testing in any lab outside of Molecular Microbiology, and must be placed in a sterile aliquot tube. |
Stability
| Environmental Condition | Description |
|---|---|
| Ambient | 24 hours for plasma or for whole blood unspun/unseparated |
| Refrigerated | 6 days for plasma separated from whole blood within 24 hours; 24 hours for whole blood unspun/unseparated |
| Frozen | 12 weeks for plasma if separated from whole blood and aliquoted into a secondary tube within 24 hours (plasma cannot be frozen in PPT tubes) |
Days Performed
7 days a week
Turnaround Time
1 - 3 days
Methodology
| Name | Description |
|---|---|
| Polymerase Chain Reaction (PCR), Quant |
Reference Range
| HIV-1 RNA | |||||
|---|---|---|---|---|---|
| Sex | Age From | Age To | Type | Range | Range Unit |
| Normal | Not detected |
Clinical Info
Human immunodeficiency virus (HIV) is the etiologic agent of acquired immunodeficiency syndrome (AIDS). Quantitative measurements of HIV viremia in the plasma have shown that higher virus levels are correlated with more rapid clinical progression of HIV disease. Furthermore, nearly two decades of clinical research have established that reductions in plasma virus levels with the use of antiretroviral therapy (ART) significantly decrease the risk of clinical progression, including death, development of AIDS, opportunistic infections, and HIV-associated morbidity. HIV viral load is also predictive of the risk of transmission of HIV, and randomized controlled clinical trials have established that early initiation of ART with suppression of the viral load reduces HIV transmission by 96%. cobas HIV-1 is an in vitro nucleic acid amplification test for the quantitation of human immunodeficiency virus type 1 (HIV-1) in EDTA plasma of HIV-1-infected individuals. This test is intended for use in conjunction with clinical presentation and other laboratory markers for the clinical management of HIV-1 infected patients. The test can be used to assess patient prognosis by measuring the baseline HIV-1 level or to monitor the effects of antiretroviral therapy by measuring changes in HIV-1 RNA levels during the course of antiretroviral treatment. This assay is not intended for use as a screening test for the presence of HIV-1 in donated blood or plasma or as a diagnostic test to confirm the presence of HIV-1 infection. The assay is a quantitative PCR assay that targets highly-conserved regions of the HIV-1 genome including the HIV-1 gag gene and the HIV-1 LTR region, and is reported out in copies/mL. The linear range of the assay is 20 to 10,000,000 copies/mL (1.30 - 7.00 log copies/mL). The lower limit of detection of the assay is 13.2 copies/mL.
Clinical Limitation
For full limitations, refer to the assay instructions for use available on the manufacturer's website. The most important limitations are summarized as follows. Though rare, mutations within the highly conserved regions of a viral genome covered by cobas HIV-1 may affect primers and/or probe binding resulting in the under-quantitation of virus or failure to detect the presence of virus. Samples from subjects under 19 years of age were not evaluated. False positive results have been reported in patients with history of chimeric antigen receptor (CAR) T cell immunotherapy using lentiviral vectors, which can cross react with assay targets (PMID: 31694968). This assay does not detect HIV-2.
Clinical Reference
1. Centers for Disease Control and Prevention. HIV screening and testing. Accessed July 5, 2024. https://www.cdc.gov/hiv/guidelines/testing.html. 2. U.S. Food and Drug Administration (FDA). Cobas HIV-1 Roche Molecular Systems Instructions for Use PMA BP150262. Accessed July 5, 2024. https://www.fda.gov/vaccines-blood-biologics/approved-blood-products/cobas-hiv-1.