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Dec 4, 2017

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Clinical Hub,Tools & Resources,UWHC Lab Test Directory,Molecular Diagnostics

HIV-1 RNA, Quant, Peds Screen 0-18 Months

HIV-1 RNA, Quant, Peds Screen 0-18 Months (HCPHIVRN) Molecular Diagnostics Lab Test

Name: HIV-1 RNA, Quant, Peds Screen 0-18 Months

Test Name: HIV-1 RNA, Quant, Peds Screen 0-18 Months

Health Link Test Code: HCPHIVRN

LIS Test Code: PHIVRN

CPT Code(s): 87536

Methodology: Aptima

Clinical Information:

This test should only be ordered for pediatric patients whose HIV status is being assessed by the Pediatric Infection Disease Protocol. Patients not on the protocol that require diagnostic testing should be tested using: HIV-1, PCR.

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 Instructions:

The DIAGNOSTIC HIV TEST form (SR301399-DT) is required when a UW Health provider submits a test order on a paper lab requisition form.

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 24 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 five 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 test should only be used for pediatric patients being assessed by the Pediatric Infection Disease Protocol. This assay should not be used as a screening, confirmatory or diagnostic test to confirm presence 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.