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The presence of HIV RNA in an HIV antibody-negative sample may be due to the presence of acute HIV infection prior to seroconversion. Repeat HIV antibody and Western blot confirmatory testing from a newly collected sample is needed to confirm the diagnosis of HIV. In a recent study, the interval from nucleic acid detection to first antibody reactivity ranged from 6-42 days with a median interval of 11.5 days. The nucleic acid test has been FDA approved for the screening of plasma products but is not approved for HIV clinical diagnostics. The result should not be used as a definitive diagnosis of HIV infection without confirmation by HIV antibody and Western blot from a subsequent blood draw.
This test uses recombinant antigen sources and detects antibodies by specific immune binding and subsequent chemiluminescent reaction (ICMA technology). Sensitivity and specificity of this assay are 100% to 99.9% respectively. Sera which are repeatedly reactive in two out of three tests are subject to confirmatory testing by the Western blot method. Some individuals may be initially reactive by the preliminary test and negative or indeterminate by Western blot. This may be caused by other viral antibodies or autoantibodies which cross react with the viral antigens although this is rare. The addition of nucleic acid testing to HIV antibody testing algorithms significantly increases the detection of acute HIV cases and identifies highly contagious individuals providing an HIV public health prevention targeting opportunity. Because acute infection, prior to seroconversion, is usually accompanied by high viral titers (10E5 - 10E7), it is possible to identify viral nucleic acid with sufficient sensitivity in pools of >100 samples per test. Pooled sample testing is the basis for widespread use of nucleic acid testing of antibody-negative samples in the blood screening industry. The nucleic acid test has been optimized to detect 1-5 copies/mL of HIV viral RNA in a 512 specimen pool of HIV antibody-negative samples (The sensitivity per individual sample included in the pool is approximately 2,000 copies/mL).
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