HIV-1 RNA quantification (viral load) - blood plasma specimen
- LIS Mnemonic: HIVRNAQT
Collect
PPT (Clear tube - K2 EDTA)
Volume Required
6 ml; Tube must be completely filled
Minimum Required
6 ml; Tube must be completely filled
Transport
Room temperature
Stability
6 hours at 15-30 C (room temperature); 24 hours at 2-8 C
Processing
Specimens should be processed without significant delay. Freshly collected whole blood specimens may be held at 15-30 C (room temperature) for up to 6 hours or at 2-8 C for up to 24 hours prior to processing. Remove plasma from the cells by centrifuging the PPT collection tube at 1,100 x g for 10-15 minutes. Plasma removed from the whole blood may be stored at 15-30 C for up to 24 hours or at 2-8 C for up to 5 days without significant loss of viral RNA. If longer storage is required, plasma specimens must be stored frozen at -70 C or lower. Multiple freeze-thaw cycles should be avoided and should not exceed three freeze/thaw cycles. Thaw plasma at 15-30 C or at 2-8 C. Once thawed, if plasma specimens are not processed immediately, they can be stored at 2-8 C for up to 6 hours.
Unacceptable conditions
Whole blood not collected in EDTA. Whole blood stored at inappropriate temperatures or for longer periods of time than recommended.
Days Performed
Wednesday
Reported
Same day
Reflex Testing
N/A
CPT
87536
Methodology
Amplification and quantification of HIV-1 RNA from the integrase region of the polymerase gene using real-time PCR technology. This test is performed pursuant to an agreement with Roche Molecular Systems, Inc.
Disease Information
Utility:
This test is intended for use in conjunction with clinical presentation and other laboratory markers of disease status as an aid in the management of individuals infected with HIV-1. The assay can be used to assess prognosis of disease progression and to monitor the efficacy of antiretroviral therapy by measuring changes in HIV-1 RNA levels in peripheral blood during the course of therapy. The assay can quantify HIV-1 RNA over a range of 40 (1.6 log) to 10,000,000 (7.0 log) copies/ml at a 95% detection rate and provides accurate quantification of all HIV groups and subtypes, including Group M subtypes A-H, Group O, and Group N. The assay is not intended for use as a donor screening test for HIV or as a diagnostic test to confirm the presence of HIV infection.
Interpretation
If positive, quantity of HIV-1 RNA is reported in copies/ml and log10 values. The dynamic range of the assay is 40 copies/ml to 10 million copies/ml or 1.60 log10 copies/ml to 7.00 log10 copies/ml.
Reference Values
Negative or quantity of HIV-1 RNA is less than the lower limit of detection
Remarks
As of 15 May 2012, written informed consent for HIV testing is no longer required; documentation of verbal consent is adequate. Our hospital policies have been modified to conform with the revised Pennsylvania Act 148 (state statute that governs HIV testing) and the emphasis of the Commonwealth of Pennsylvania and Centers for Diseases Control and Prevention to provide routine HIV testing of individuals 13-65 years of age. This policy change applies to CHOP affiliated inpatient and outpatient care sites in Pennsylvania, New Jersey and Delaware. The new HIV-related policies can be found in the online Patient Care Manual. The patient or person consenting to the test must still be notified of the intent to test and be provided with HIV-related information. Two handouts are available in the Patient-Family Education Manual to provide information about HIV and HIV testing: "Understanding HIV: Testing and Prevention" and "HIV Testing is for Everyone". A competent minor, regardless of age, is permitted under Pennsylvania state law to consent to HIV testing and/or treatment services. Parental consent is not required. Otherwise, verbal consent can be obtained only from a biologic parent, an adoptive parent, legal guardian, or by a court order. Documentation in the medical record must show that verbal consent was obtained. Documentation of verbal consent for an HIV-related test can be accomplished through the Epic hospital computer system by selecting one of two certifications; either "I certify that the patient and/or personal representative have been given information about HIV testing and have verbally consented to the test" OR "I certify that HIV testing is required because of a life threatening medical condition or occupational exposure, and obtaining consent is not possible at this time".
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