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HUMAN IMMUNODEFICIENCY VIRUS TYPE 1 (HIV-1) QUANTITATIVE PCR

Synonym(s):

​HIV-1 RNA Load

Description

Indications

The test is intended for use in conjunction with clinical presentation and other laboratory markers for the clinical management of HIV-1-infected patients. The test can be used to assess patient prognosis by measuring the baseline HIV-1 level or to monitor the effects of antiretroviral therapy by measuring changes in HIV-1 RNA levels during the course of antiretroviral treatment.


Specimen Required

3-5 mL of blood in sterile EDTA (lavender top) tube. Alternatively, at least 3 mL plasma (separated from EDTA-treated or whole blood within 6 hours of collection by centrifugation at 3000 rpm for 10 minutes at room temperature) in a sterile screw-capped polypropylene tube.  

Please note that sample types other than blood in EDTA or plasma have not been validated on this commercial system.

Storage and Transport

Refrigerate sample at 2-8°C until transfer to laboratory. Do not freeze.  Plasma may be transported at 2-8°C or frozen at ≤-20°C. Sample should reach the laboratory as soon as possible, preferably within 6 hours after collection.


Method

​Real-time Quantitative Reverse Transcription PCR (Roche COBAS 6800 HIV-1 Test)

Test Results

​Detected or Not Detected (quantity reported in copies/ml and IU/mL)
Linear Range : 20 to 1.00 X 107 copies/mL or 33 to 1.67 X 107 IU/mL

Reference Interval / Value

Turnaround Time

​1 - 8 days

Day(s) Test Set up

​Wednesday and Friday

Remarks

The assay detects HIV-1 group M (subtypes A-D, F-H, CRF01_AE, CRF02_AG), group N and group O viruses. Please note this assay does not detect nor quantitate HIV-2 virus.           

Change History Notes

Others

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