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Clin Chem 1999;45:1602; Eur J Clin Microbiol Infect Dis 2004;23:831). The supplier has included a pretest counseling form, which should be read to and initialed by the patient prior to administration. The assay is sold as a 192-test kit at $816 or a 480-test kit at $1,920. The cost per test is $4.00.

RNA QUALITATIVE TEST: The Aptima HIV-1 RNA Qualitative Assay (GenProbe, San Diego, CA) detects HIV-1 RNA in plasma and can be used to detect acute HIV or it can be used to confirm a standard serologic test. Aptima is FDA-cleared, (October, 2006) and is the only FDA cleared test for detecting acute HIV infection. However, most would conclude that the standard HIV viral load tests can easily be used for this purpose at no extra cost and far greater experience. 

TABLE 2-4:

Tests for HIV-1
Assay Sensitivity Comments
Routine
serology		 99.7% Readily available and inexpensive. Sensitivity >99.7%
and specificity >99.9% (MMWR 1990;39:380; N Engl
J Med 1988;319:961; JAMA 1991;266:2861).
Rapid test
See pg 13 and
Table 2-2		 99.6% Results are available in 20 min. Advantages with CLIA-waived tests (OraQuick, Clearview and Uni-Gold
Recombigen) are that the test requires no lab
equipment, results are available in ≤20 minutes, and
interpretation may be done by the provider. Negative
tests are definitive; positive tests must be confirmed
with a WB. Table 2-2 lists the FDA-approved rapid tests
in the U.S. (www.cdc.gov/hiv/rapid_testing). Other
rapid tests are available but are not FDA-approved (Int J
STD AIDS 2006;17:357; Vox Sang 1997;72:11; J Clin
Microbiol 2004;42:3850).
Salivary test
(OraSure Test
System) See
pg 16		 99.6% Salivary collection device to collect lgG for EIA and WB.
Advantage is avoidance of the need for blood.
Sensitivity is rapid tests using blood if properly
interpreted (JAMA 1997;227:254), but specificity is a
problem in some studies (see text).
Urine test
(Calypte HIV-1
Test) See pg 16		 >99% Used for EIA test only, so positive results must be
verified by serology. Must be administered by a
physician. Cost to provider is low – about $4 per test.
PBMC culture 95% to
100%		 Viral isolation by co-cultivation of patient’s PBMC with
phytohemagglutinin-stimulated donor PBMC with IL-2
over 28 days. Expensive and labor-intensive. May be
qualitative or quantitative. Main use of qualitative
technique is viral isolation for further study such as
sequence analysis. Studies prior to availability of
quantitative HIV RNA PCR showed quantitative culture
results correlated with stage of disease: Mean titer was
2000/106 cells in patients with AIDS (NEJM
1989;321:1621).
(continued)

 

 

2007 © John G. Bartlett, M.D. All rights reserved.17

Chapter 2: Laboratory Tests

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