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HIV-1 RNA, Quantitative
Test CodeLab1343
CPT Codes
87536
Preferred Specimen
BD Vacutainer Plasma Preparation Tubes (PPT)
Minimum Volume
3 mL
Other Acceptable Specimens
BD Vacutainer EDTA tubes
Transport Container
BD Vacutainer Plasma Preparation Tubes (PPT)
BD Vacutainer EDTA tubes
BD Vacutainer EDTA tubes
Transport Temperature
Ambient
Refrigerated if specimen centrifuged prior to transport
Refrigerated if specimen centrifuged prior to transport
Specimen Stability
Prior to plasma/serum preparation:
Up to 24 hours refrigerated or ambient
Up to 24 hours refrigerated or ambient
After plasma/serum separation:
Up to 6 days refrigerated
Up to 12 weeks frozen
For long-term storage up to 6 months, temperatures ≤-60°C are recommended.
Up to 6 days refrigerated
Up to 12 weeks frozen
For long-term storage up to 6 months, temperatures ≤-60°C are recommended.
Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Storage and stability requirements not met
Improper or no label on container
Improper container
Leaking container
Quantity not sufficient
Expired collection tube
Improper or no label on container
Improper container
Leaking container
Quantity not sufficient
Expired collection tube
Methodology
Cobas® PCR
Setup Schedule
Tuesday and Friday
Reference Range
HIV RNA Quant PCR IU/mL <20
HIV RNA Quant PCR logIU/mL <1.3
HIV RNA Quant Interpretation Not detected
HIV RNA Quant PCR logIU/mL <1.3
HIV RNA Quant Interpretation Not detected
Clinical Significance
Cobas® HIV-1 is an in vitro nucleic acid amplification test for the quantitation of human immunodeficiency virus type 1 (HIV-1) in EDTA plasma of HIV-1-infected individuals.
This 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.
Cobas® HIV-1 is not intended for use as a screening test for the presence of HIV-1 in donated blood or plasma or as a diagnostic test to confirm the presence of HIV-1 infection.
This 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.
Cobas® HIV-1 is not intended for use as a screening test for the presence of HIV-1 in donated blood or plasma or as a diagnostic test to confirm the presence of HIV-1 infection.
Performing Laboratory
Meritus Molecular Diagnostics – Microbiology
