What are the FDA-approved rapid HIV tests?

Updated: Feb 04, 2019
  • Author: Jacob D Isserman, MD; Chief Editor: Steven C Dronen, MD, FAAEM  more...
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Answer

Answer

The US Food and Drug Administration (FDA) has approved a number of Clinical Laboratory Improvement Amendment (CLIA)–waived rapid HIV tests (see Table 1). [11] These tests assess for HIV antibodies with an enzyme-linked immunosorbent assay (ELISA). Sensitivity and specificity are greater than 99%. Results are reported as reactive or nonreactive.

The FDA-approved kits have been shown to perform similarly, [12] with the exception of the Determine HIV test, which is a fourth-generation test that also detects p24 antigen, increasing the ability to detect very early infection. [13]

Table 1. FDA-Approved CLIA-Waived Rapid HIV Tests (Open Table in a new window)

Test Name

Specimen Needed

Turnaround Time (minutes)

Median Days from Infection to Detection**

OraQuick Advance

Oral swab or blood (fingerstick or venipuncture)

20

34

Uni-Gold Recombigen

Whole blood

(fingerstick or venipuncture)

10

32

Chembio Sure Check

Whole blood

(fingerstick or venipuncture)

15

30

INSTI HIV

Fingerstick whole blood

< 2

24

Determine HIV

Whole blood

(fingerstick or venipuncture)

20

17

Chembio DPP

Fingerstick whole blood

15

28

Clearview Stat Pak Fingerstick or venous whole blood 15 ***

*CLIA (Clinical Laboratory Improvement Amendment) "waived" means testing does not have to be done by certified laboratory staff.

** Median days to detect infection is based on the estimated days from first infection that the test first detects the HIV infection, which includes the approximately 10-day period from initial infection to detection of HIV-1 RNA. [13]

***No data, as Clearview Stat Pak was not included in the referenced study.

Note: If the rapid test is reactive, confirm the result with Western blot or immunofluorescent assay (IFA). Western blot results are reported as positive, negative, or indeterminate. Indeterminate tests result from nonspecific reactions of HIV-negative sera with some HIV proteins. If the result is indeterminate, repeat the ELISA test in 1 month.

Nonreactive tests in patients with a strong likelihood of acute HIV infection should be followed up with a virologic test such as HIV RNA assay (viral load). Viral load is very high (>100,000 copies/mL) in acute HIV infection. If virologic test is positive, repeat antibody testing in 3 months after seroconversion.

False-positive and false-negative tests do occur with rapid testing. Positive predictive value is lower in populations with low HIV prevalence, so there will be relatively more false-positive tests in these groups with very low HIV risk factors.


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