laboratory tests for HIV infection
Last edited 02/2018
The laboratory diagnosis of HIV infection is usually made on the basis of serology - detection of HIV antibody i.e. the detection of HIV-1/2 antibodies or simultaneous detection of HIV-1/2 antibodies and HIV-1 p24 antigen
- most widely used means of diagnosing HIV
- results are reported as non-reactive or reactive
- generally classified as either
- first-line assays (sometimes referred to as screening assays)
- can provide the presumptive identification of reactive specimens and thus should have superior sensitivity e.g -
- enzyme linked immunosorbent assay (ELISA)/enzyme immuno assay (EIA) test
- rapid HIV tests/point-of-care tests (POCTs)
- oral fluid or pin prick blood samples can be used
- results can be given within minutes of the specimen being taken
- specificity is lower than laboratory tests
- all “reactive” POCT tests should be confirmed with a conventional blood test
- simple assays e.g. – combo immunoassays and particle or latex agglutination assays that detect the presence of HIV-1/2 antibodies and/or HIV-1 p24 antigen.
- second or third-line assays (sometimes referred to as supplemental assays, or confirmatory assays)
- a combination of rapid HIV tests, simple assays and EIAs can be used as second- and third-line assays to confirm an initial reactive test result
- in addition, line immunoassays (LIAs), based on recombinant proteins and/or synthetic peptides capable of detecting antibodies to specific HIV-1 and/or HIV-2 proteins, have been widely used to confirm HIV infection.
- line immunoassays have replaced Western blotting n many settings and serve a similar purpose (1,2)
In addition HIV infection can also be diagnosed by detecting the presence of the virus itself.
- presence of the virus itself
- p24 antigen
- 4th generation combination test is used to detect p24 antigen
- presence of its genetic material (DNA PCR, viral load)
- RNA/DNA polymerase chain reaction tests
- these quantitative assays are a form of Nucleic Acid Amplification Test (NAAT)
- not often used as an initial diagnostic test for HIV in adults as they are expensive and can risk a high false positive rate in the absence of laboratory interpretation
- preferred test of specialists if primary HIV infection is suspected and the antibody/antigen test is negative
- viral load
- primarily used for monitoring antiretroviral treatment, but have been validated by many labs as a supplemental test during the window period of HIV infection (2,3)
Patients who identify a specific risk occurring more than 4 weeks previously should be offered a 4th generation HIV test immediately without waiting for 3 months (12 weeks).
- a negative test will exclude HIV infection in majority of patients
- additional test should be offered at 3 months (12 weeks) to all patients to exclude HIV infection definitively
- low risk patients may wait for 3 months to avoid doing the test twice (4)
HIV antibody tests are used for diagnosis and screening.
Reference:
- (1) World Health Organization (WHO) 2015. HIV assays: laboratory performance and other operational characteristics: rapid diagnostic tests (combined detection of HIV-1/2 antibodies and discriminatory detection of HIV-1 and HIV-2 antibodies): report 18.
- (2) Public Health Agency of Canada. Human Immunodeficiency Virus. HIV Screening and Testing Guide.
- (3) The Medical Foundation for AIDS & Sexual Health (MedFASH) 2016. HIV in primary care. A practical guide for primary healthcare professionals in Europe.
- (4) British HIV Association, British Association for Sexual Health and HIV · British Infection Society 2008. UK National Guidelines for HIV Testing 2008