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Human Immunodeficiency Virus 1 (HIV-1) by Quantitative PCR with Reflex to HIV-1 Genotype by Sequencing

Mnemonic

HIV RNA RG

Synonym

HIV-1 - HIV RNA Quantitation with Reflex - HIV Reflex to Genotyping - HIV Nucleic Acid Amplification Test (NAT or NAAT)

Guidelines

The HIV-1 Quantitative 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.  It 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.

If the HIV-1 Quantitative PCR result is greater than or equal to 1,000 copies/mL (3.0 log copies/mL), the HIV-1 Genotype by Sequencing will be added.  Additional charges apply.  This test is used to determine HIV drug resistance.
 

Specimen Collection Requirements

Collect

Plasma collected from lavender (EDTA) top tubes

Handling

Separate plasma from cells within 6 hours of collection. Transfer 3.5 mL plasma into two plastic aliquot tubes and freeze immediately.

Preferred Volume

7.0 mL

Minimum Volume

3.0 mL

Transport

Frozen

Rejection Criteria

Heparinized specimens, serum specimens, specimens collected in plasma preparation tube (PPT), specimens past stability, specimens with inadequate volume for testing, specimens tested first in non-molecular labs.

Stability

On cells – Ambient 6 hours

After separation from cells - Ambient: 24 hours; Refrigerated: 5 days; Frozen (preferred): 6 weeks

Testing Information

Note

Critical sterile. Samples cannot be shared with other laboratory departments unless molecular testing is performed first.

Performed

HIV-1 Quantitative by PCR: Mon - Fri, batched two times per week.
HIV-1 Genotype by Sequencing: Sun - Sat

 

 

Reported

Quant: 2-5 days
Genotype: 5-9 days

Method

Method: Reverse Transcription Polymerase Chain Reaction/Sequencing

HIV-1 Quantitative Range: 20 – 10,000,000 copies/mL
                                               (1.3 - 7.0 log copies/mL)

A result of ‘Not Detected’ does not rule out the presence of PCR inhibitors or HIV-1 RNA concentrations below the level of detection by the assay.

HIV-1 Quantitative Specificity: 100% with a confidence limit of 99.6% (A total of 660 EDTA plasma samples tested).

HIV-1 Quantitative Analytical Specificity: No cross reactivity was observed in samples spiked with other common pathogenic viruses, bacteria, or yeast.
 

Referral Lab

ARUP (0055670) - for genotyping only

Reference Values

Reference Values

HIV-1 Quantitative assay: Not Detected.
HIV-1 Genotype assay: Interpretation provided.
 

Comments

Though rare, mutations in the highly conserved regions of the viral genome covered by the COBAS® AmpliPrep/COBAS® TaqMan HIV-1 Test, v2.0 primers and/or probes may result in under-quantification of or failure to detect the virus.

Due to inherent differences between quantitative methodologies, it is recommended that prior to changing methodologies a new baseline is established before making clinical decisions.
 

CPT Codes

87536 (Quant) and 87901 (Genotype)

Last Updated: Thursday, March 14, 2019 12:50:48 PM


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