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Previous Volume 352:1873-1883 May 5, 2005 Number 18 Next

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ABSTRACT

Background North Carolina has added nucleic acid amplification testing for the human immunodeficiency virus (HIV) to standard HIV antibody tests to detect persons with acute HIV infection who are viremic but antibody-negative.

Methods To determine the effect of nucleic acid amplification testing on the yield and accuracy of HIV detection in public health practice, we conducted a 12-month observational study of methods for state-funded HIV testing. We compared the diagnostic performance of standard HIV antibody tests (i.e., enzyme immunoassay and Western blot analysis) with an algorithm whereby serum samples that yielded negative results on standard antibody tests were tested again with the use of nucleic acid amplification. A surveillance algorithm with repeated sensitive–less-sensitive enzyme immunoassay tests was also evaluated. HIV infection was defined as a confirmed positive result on a nucleic acid amplification test or as HIV antibody seroconversion.

Results Between November 1, 2002, and October 31, 2003, 109,250 persons at risk for HIV infection who had consented to HIV testing presented at state-funded sites. There were 606 HIV-positive results. Established infection, as identified by standard enzyme immunoassay or Western blot analysis, appeared in 583 participants; of these, 107 were identified, with the use of sensitive–less-sensitive enzyme immunoassay tests, as recent infections. A total of 23 acutely infected persons were identified only with the use of the nucleic acid amplification algorithm. With all detectable infections taken into account, the sensitivity of standard antibody testing was 0.962 (95 percent confidence interval, 0.944 to 0.976). There were two false positive results on nucleic acid amplification tests. The specificity and positive predictive value of the algorithm that included nucleic acid amplification testing were greater than 0.999 (95 percent confidence interval, 0.999 to >0.999) and 0.997 (95 percent confidence interval, 0.988 to >0.999), respectively. Of the 23 acute HIV infections, 16 were detected at sexually transmitted disease clinics. Emergency measures for HIV prevention protected 48 sex partners and one fetus from high-risk exposure to HIV.

Conclusions The addition of nucleic acid amplification testing to an HIV testing algorithm significantly increases the identification of cases of infection without impairing the performance of diagnostic testing. The detection of highly contagious, acutely infected persons creates new opportunities for HIV surveillance and prevention.

Source Information

From the Departments of Medicine (C.D.P., B.S., L.H., W.C.M., J.J.E., M.S.C., P.A.L.), Microbiology and Immunology (S.A.F.), and Epidemiology (T.Q.N., W.C.M., M.S.C.), University of North Carolina at Chapel Hill, Chapel Hill; and the North Carolina Department of Health and Human Services HIV/STD Prevention and Care Branch, Raleigh (E.F., L.W., D.W., R.A., J.O.O., J.T.M., P.A.L.).

Address reprint requests to Dr. Pilcher at C.B. 7215, University of North Carolina at Chapel Hill, 211A W. Cameron Ave., Chapel Hill, NC 27599-7215, or at cpilcher{at}med.unc.edu.

Full Text of this Article

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Detection of Acute HIV Infections
Klausner J. D., Grant R. M., Kent C. K., Turner V. F., Pilcher C. D., Leone P. A.
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N Engl J Med 2005; 353:631-633, Aug 11, 2005. Correspondence

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