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Dec 4, 2017

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HIV-1 RNA, Quantitative (Viral Load)

HIV-1 RNA, Quantitative (Viral Load) (XHIV1) Molecular Diagnostics Lab Test

Name: HIV-1 RNA, Quantitative (Viral Load)

Test Name: HIV-1 RNA, Quantitative (Viral Load)

Health Link Test Code: XHIV1

LIS Test Code: HIVRNA

CPT Code(s): 87536

Methodology: Aptima

Clinical Information:

This test is not used for the diagnosis for HIV-1 infection. This test is used to determine viral burden in known HIV-1 positive patients.

 

Please contact clinical labs (608-263-7060) prior to adding on to make sure there is a usable specimen available.

Days Performed: Twice a week-days vary.

In-Lab Turnaround Time: 5 days.

Stat In-Lab Turnaround Time: Not available stat.

Specimen: Blood

Collection Container: Lavender top

Collection Volume: 6 mL

Pediatric Collection Volume: 2 mL

Stability Ambient:

Whole blood - 24 hours

Stability Refridgerated:

Plasma - 5 days

Stability Frozen:

Whole Blood Not acceptable
Plasma 12 weeks at -20 to -80°C

Sample Analyzed: Plasma

Testing Volume: 3 mL

Pediatric Testing Volume: 1.2 mL

Specimen Processing:

Separate cell-free plasma from whole blood and transfer to a sterile polypropylene tube within 6 hours of collection. Freeze plasma at -60°C to -80°C (preferred). Prior to freezing at -60°C to -80°C, EDTA plasma may also be stored at either 2°C to 8°C for up to 5 days or frozen at -20°C for up to 90 days.

Outreach Specimen Processing:

Transport frozen plasma on dry ice to Laboratory.

Specimen Transport:

Transport specimen to Laboratory immediately.

Interpretation:

If HIV-1 is detected, two results are reported for each assay: a measured log10 copies/mL and a calculated copies/mL result.

 

 

Analytical measurement range of this assay is 30 - 10,000,000 copies/mL (1.47-7.00 log10 copies/mL). In patients where HIV-1 is detected but outside of the analytical measurement range (AMR), a result of <30 copies/mL or >10,000,000 copies/mL will be reported.  If no HIV-1 is detected, a result of "Not detected" will be reported.

 

Interpretation Type: Interpretive Guidelines

Test Limitations:

This assay is not a screening, confirmatory or test procedure for the diagnosis of HIV-1 infection.

 

Though rare, mutations within the highly conserved regions of the viral genome covered by primers and/or probes in the Aptima HIV-1 quant assay may result in underquantification of or failure to detect the virus.

Additional Information:

Specimens are assayed using the Aptima HIV-1 Quant assay. This is a quantitative test for the HIV-1 RNA virus groups M, N and O.

 

This test is approved by the U.S. Food and Drug Administration.