| Test Name: |
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HIV-RNA
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| Test Code(s): |
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HIVRNA / XHIV1
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| CPT Code(s): |
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87536
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| Methodology: |
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Reverse-Transcription plus Real-Time PCR
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| Clinical Significance: |
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This test is not a screening test for HIV. This test is used to determine viral burden in known HIV-1 positive patients.
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| Days Performed: |
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Mon and Thurs.
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| Turnaround Time: |
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Stat: Not available stat.
Routine: 5 days.
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Specimen Requirements
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| Specimen: |
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Blood
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| Collection Container: |
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Preferred: Lavender top
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| Collection Volume: |
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Preferred: 6 mL
Pediatrics: 2 mL
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| Sample Analyzed: |
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Plasma
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| Volume Required: |
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Preferred: 3 mL
Pediatrics: 1.2 mL
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| Specimen Processing: |
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Separate cell-free plasma from whole blood and transfer to a sterile polypropylene tube within 6 hours of collection. Freeze plasma at -60 to -80°C (preferred). Prior to freezing at -60 to -80°C, EDTA plasma may also be stored at either 2 to 8°C for up to 72 hours or frozen at -20°C for up to 7 days.
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| Specimen Transport: |
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Transport specimen to Core Laboratory (B4/220) immediately.
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| Outreach Specimen Transport: |
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Transport frozen plasma on dry ice to Core Laboratory (B4/220).
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| Stability: |
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Ambient: Whole blood - 6 hours
Refrigerated: Plasma - 3 days
Frozen: Whole blood - Not acceptable frozen; Plasma - 6 weeks at -70 degrees C.
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Interpretation
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Interpretive Guidelines:
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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 20 - 10,000,000 copies/mL (1.30-7.00 log10 copies/mL). In patients where HIV-1 is detected but outside of the analytical measurement range (AMR), a result of "Detected, below AMR" or "Detected, above AMR" will be reported. If no HIV-1 is detected, a result of "Not detected" will be reported.
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| Test Limitations: |
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This is a reverse-transcription real-time PCR assay. This assay is not a screening, confirmatory or test procedure for the diagnosis of HIV-1 infection.
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| Additional Information: |
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Specimens are assayed using the COBAS Ampliprep and COBAS Taqman methodology by Roche Diagnostics. This is a quantitative test for the HIV-1 virus group M subtypes A through H and HIV-1 group O.
This test is approved by the U.S. Food and Drug Administration.
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