Characteristics of HIV Tests
Specimen
Type
Sensitivity
(95%)
Specificity
(95%)
“Window
Period”++
(time of infection to time
of detection by this test)
NUCLEIC ACID TESTS (NAT)
Plasma
APTIMA HIV-1
RNA Qualitative
Assay
Time to perform
test and receive
results+++
Approved for
HIV-2 Detection?
Comments
100%
99.3%
7 – 14 days
4 hours to perform
test
No
Expensive.
Availability depends on lab.
Intended for use as an aid in
diagnosis of infection.
Limit of
detection varies
99.4 – 100%
7 – 14 days
1 – 2 days depending
on test kit to perform
test
No
Not intended for use as
diagnostic tests.
100%
99.89 %
3 – 4 weeks
~ 4 hours to perform
test
Dependant on test
Inexpensive.
Requires Western Blot
confirmation.
97.5% – 100%
99.9% – 100%
~6 – 12 weeks
Indeterminate may
indicate early HIV
infection in source
1 – 2 days depending
on kit
No FDA-approved
HIV-2 Western Blot;
Laboratory-validated
HIV-2 Western Blots
are available at some
laboratories.
Accepted as confirmatory
test.
Moderate cost.
Whole blood,
(fingerstick or
venipuncture)
99.8%
(fingerstick);
99.9%
(venipuncture)
99.5%
(fingerstick);
100%
(venipuncture)
4 – 6 weeks
60 seconds (should
be read within 5
minutes to avoid
erroneous results)
No approval for HIV2 detection, although
approval is under
review
Must be done by a licensed
lab. Must confirm by
Western Blot.
Plasma
99.9%
100%
MultiSpot
HIV1/HIV2
Rapid Test
Serum, Plasma
100%
99.93%
4 – 6 weeks
10 – 15 minutes
Yes – differentiates
HIV-1 from HIV-2
Must be done by a licensed
lab. Must confirm by
Western Blot.
Reveal G-3
Rapid HIV-1
Antibody Test
Serum, Plasma
99.8%
99.1%, 98.6%
4 – 6 weeks
30 – 60 minutes
No
Must be done by a licensed
lab. Must confirm by
Western Blot.
Clearview HIV
1/2 Stat-Pak and
Clearview
Complete
HIV1/2
Whole Blood
(fingerstick or
venipuncture)
Serum, Plasma
99.7%
99.9%
4 – 6 weeks
20 minutes
Yes
99.7%
99.9%
CLIA++++ waived for
both venipuncture and
fingerstick whole blood
only. Must confirm by
Western Blot.
Quantitative
viral load assays
Plasma
STANDARD ANTIBODY TESTS
Serum or
HIV EIA
Plasma
Elisa
3rd Generation
HIV
Western Blot
RAPID TESTS
INSTI HIV-1
Antibody Test
01/11
Serum or
Plasma
New York State Department of Health AIDS Institute: www.hivguidelines.org
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OraQuick
ADVANCE
Rapid HIV-1/2
Antibody Test
Uni-Gold
Recombigen
HIV
Oral Fluid
Whole Blood
(fingerstick or
venipuncture)
Plasma
99.3%
99.6%
99.8%
100%
99.6%
99.9%
Whole Blood
(fingerstick or
venipuncture)
Serum, Plasma
100%
99.7%
100%
99.8%
4 – 6 weeks
25 – 30 minutes
Yes
4 – 6 weeks
10 – 15 minutes
No
CLIA++++ waived for
oral fluid and both
venipuncture and
fingerstick whole blood
only. Must confirm by
Western Blot.
CLIA++++ waived for
both venipuncture and
fingerstick whole blood
only. Must confirm by
Western Blot.
+ Data shown are for HIV-1 only. For HIV-2 data, see package inserts.
++ Window periods are averages and may vary for some individuals.
+++ The time indicated represents the time it takes to complete the test. The actual time may vary depending on specimen processing, specimen transportation to the testing site,
and specimen batching procedures.
++++ CLIA, Clinical Laboratory Improvement Amendments. Information regarding CLIA waivers of HIV tests is available at
www.cdc.gov/hiv/topics/testing/resources/factsheets/roltCLIA.htm. Information about or assistance with completing the CLIA waiver application can be obtained by calling
Centers for Medicare & Medicaid Services toll-free at: 877-267-2323.
NOTE:
If initial HIV test is negative, an antibody test should be obtained again at 3 months. If at 3 months the test is negative and no high-risk behavior has taken place in
the prior 3 months, patient is HIV negative.
References:
1. Stekler J, Maenza J, Stevens CE, et al. Screening for acute HIV infection: Lessons learned. Clin Infect Dis 2007;44:459-461. [PubMed]
2. Fiebig EW, Wright DJ, Rawal BD, et al. Dynamics of HIV viremia and antibody seroconversion in plasma donors: Implications for diagnosis and staging
of primary HIV infection. AIDS 2003;17:1871-1879. [PubMed]
3. Roland ME, Elbeik TA, Kahn JO, et al. HIV RNA testing in the context of nonoccupational postexposure prophylaxis. J Infect Dis 2004;190: 598-604.
[PubMed]
Resources:
Rapid Testing – Charts Comparing Rapid HIV Antibody Screening Tests.
New York State Department of Health Clinical Guidelines – Diagnostic, Monitoring, and Resistance Laboratory Tests for HIV.
01/11
New York State Department of Health AIDS Institute: www.hivguidelines.org
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