HUMAN IMMUNODEFICIENCY VIRUS-1 RNA QUANTITATION

Mnemonic

HIVRNA

Synonym

HIV-1 - HIV RNA by PCR - HIV Viral Load - HIV RNA Quantitation - HIV Titer - HIV Nucleic Acid Amplification Test (NAT or NAAT)


Guidelines

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.
 
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.
 

Specimen Collection Requirements

Collect

Plasma collected from lavender (EDTA) top tubes

Handling

Separate plasma from cells within 24 hours of collection. Transfer 3.0 mL plasma into plastic aliquot tube and freeze immediately.

Preferred Volume

3.0 mL

Minimum Volume

1.5 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 in non-molecular labs.

Stability

On cells – Ambient or Refrigerated: 24 hours
After separation from cells - Ambient: 24 hours; Refrigerated: 6 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

Mon - Fri, batched two times per week.

Reported

2-5 days

Method

Method: Reverse Transcription Polymerase Chain Reaction

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.

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

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

Reference Values

Reference Values

Not Detected

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

Last Updated: Thursday, January 5, 2017 03:42:16 AM