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Test Code HV2QU HIV-2 RNA Detection and Quantification, Real-Time qRT-PCR, Plasma


Ordering Guidance


This test is indicated for either 1) confirmatory qualitative detection of HIV-2 RNA in individuals with indeterminate or positive HIV-2-specific antibody but negative HIV-1-specific antibody test results; or 2) baseline or serial monitoring of HIV-2 viral load in those with confirmed HIV-2 infection with or without antiretroviral therapy.



Shipping Instructions


Ship specimen frozen on dry ice. If shipment will be delayed for more than 24 hours, freeze specimen at -20 to -80° C (up to 35 days) before shipment and then transport on dry ice.



Specimen Required


Supplies: Sarstedt Aliquot Tube, 5 mL (T914)

Collection Container/Tube: Lavender top (EDTA)

Submission Container/Tube: Plastic vial

Specimen Volume: 2.1 mL Plasma

Collection Instructions: Centrifuge and aliquot plasma into a plastic vial.


Secondary ID

623478

Useful For

Confirmatory detection of human immunodeficiency virus type 2 (HIV-2) RNA in clinical plasma specimens for the diagnosis of acute or established HIV-2 infection

 

Quantifying plasma HIV-2 RNA levels (viral load) in individuals living with HIV-2:

-Before initiating antiretroviral therapy to obtain baseline viral load

-For monitoring HIV-2 disease progression with or without antiretroviral therapy

Method Name

Reverse Transcription Real-time Polymerase Chain Reaction (RT-qPCR)

Reporting Name

HIV-2 RNA Detect / Quant, P

Specimen Type

Plasma EDTA

Specimen Minimum Volume

Plasma: 1.1 mL

Specimen Stability Information

Specimen Type Temperature Time Special Container
Plasma EDTA Frozen (preferred) 60 days ALIQUOT TUBE
  Refrigerated  6 days ALIQUOT TUBE

Reject Due To

Gross hemolysis OK
Gross lipemia OK
Gross icterus OK

Clinical Information

Human immunodeficiency virus type 2 (HIV-2) is a lentivirus, a retrovirus in the same genus (Lentiviridae) as HIV-1. It was first isolated in 1986 in West Africa, where it is currently endemic. Most of these cases in the United States have been found in the northeastern United States, and the majority had a West African origin or connection.

 

Compared to HIV-1 infection, HIV-2 infection is associated with slower rate of progression, low viral load (which may not be reliably measured with current methods), slower rates of decline in CD4 cell count, and lower rates of transmission (sexually or vertically). Up to 95% of HIV-2-infected individuals are long-term non-progressors, and individuals with undetectable HIV-2 viral load have similar survival rates as that of the uninfected population. However, HIV-2 does cause immunosuppression as well as AIDS with the same signs, symptoms, and opportunistic infections seen in HIV-1. Due to the rarity of HIV-2, there are scant data from controlled trials to inform management decisions.

Reference Values

Undetected

Interpretation

The quantification range of this assay is 50 to 3,160,000 IU/mL (1.70 log to 6.50 log IU/mL), with a limit of detection (based on a 95% detection rate) of 18 IU/mL.

 

An "Undetected" result indicates that HIV-2 RNA is not detected in the plasma specimen (see Cautions). The limit of detection for this assay is 18 IU/mL.

 

A result of "<50 IU/mL" indicates that the HIV-2 RNA level present in the plasma specimen is below 50 IU/mL (1.70 log IU/mL), and the assay cannot accurately quantify the HIV-2 RNA present below this level.

 

A quantitative value (reported in IU/mL and log10 IU/mL) indicates the HIV-2 RNA level (i.e., viral load) present in the plasma specimen.

 

A result of ">3,160,000 IU/mL" indicates that the HIV-2 RNA level present in the plasma specimen is above 3,160,000 IU/mL (6.50 log IU/mL), and this assay cannot accurately quantify the HIV-2 RNA present above this level.

 

An "Indeterminate" result suggests the presence of an atypical HIV-2 target sequence. Since the HIV-2 RNA sequence is atypical, repeat testing is unlikely to change this result and therefore is not recommended.

 

An "Equivocal" result indicates that the presence or absence of HIV-2 RNA in the plasma specimen could not be determined with certainty due to atypical real-time reverse transcriptase-polymerase chain reaction (RT-qPCR) probe reactivity. Submission of a new specimen for testing is recommended.

 

An "Inconclusive" result indicates that the presence or absence of HIV-2 RNA in the plasma specimen could not be determined with certainty after repeat testing in the laboratory, possibly due to RT-qPCR inhibition. Submission of a new specimen for testing is recommended.

CPT Code Information

87539

LOINC Code Information

Test ID Test Order Name Order LOINC Value
HV2QU HIV-2 RNA Detect / Quant, P 69354-9

 

Result ID Test Result Name Result LOINC Value
623478 HIV-2 RNA Detect / Quant, P 69354-9