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Clinical and Diagnostic Laboratory Immunology, March 2001, p. 346-348, Vol. 8, No. 2
1071-412X/01/$04.00+0   DOI: 10.1128/CDLI.8.2.346-348.2001
Copyright © 2001, American Society for Microbiology. All rights reserved.

Validation of a Modified Commercial Enzyme-Linked Immunoassay for Detection of Human Immunodeficiency Virus Type 1 Immunoglobulin G Antibodies in Saliva

Bhavna H. Chohan,1 Ludo Lavreys,2 Kishorchandra N. Mandaliya,3 Joan K. Kreiss,2,* Job J. Bwayo,1 Jeckoniah O. Ndinya-Achola,1 and Harold L. Martin Jr.2,dagger

Department of Medical Microbiology, University of Nairobi, Nairobi,1 and Coast Provincial General Hospital, Mombasa,3 Kenya, and Departments of Epidemiology and Medicine, University of Washington, Seattle, Washington2

Received 19 June 2000/Returned for modification 6 October 2000/Accepted 13 December 2000

This study was performed to evaluate the performance of a saliva collection device (OmniSal) and an enzyme-linked immunoassay (EIA) designed for use on serum samples (Detect HIV1/2) to detect human immunodeficiency virus type 1 (HIV-1) antibodies in the saliva of high-risk women in Mombasa, Kenya. The results of the saliva assay were compared to a "gold standard" of a double-EIA testing algorithm performed on serum. Individuals were considered HIV-1 seropositive if their serum tested positive for antibodies to HIV-1 by two different EIAs. The commercial serum-based EIA was modified to test the saliva samples by altering the dilution and lowering the cutoff point of the assay. Using the saliva sample, the EIA correctly identified 102 of the 103 seropositive individuals, yielding a sensitivity of 99% (95% confidence interval [CI], 94 to 100%), and 96 of the 96 seronegative individuals, yielding a specificity of 100% (95% CI, 95 to 100%). In this high-risk population, the positive predictive value of the assay was 100% and the negative predictive value was 99%. We conclude that HIV-1 antibody testing of saliva samples collected with this device and tested by this EIA is of sufficient sensitivity and specificity to make this protocol useful in epidemiological studies.

* Corresponding author. Mailing address: IARTP, Box 359909, 325 9th Ave. Seattle, WA 98104. Phone: (206) 731-2822. Fax: (206) 731-2427. E-mail: iartp{at}u.washington.edu.

dagger Present address: Park Nicollet Clinic, Minneapolis, MN 55416.

Clinical and Diagnostic Laboratory Immunology, March 2001, p. 346-348, Vol. 8, No. 2
1071-412X/01/$04.00+0   DOI: 10.1128/CDLI.8.2.346-348.2001
Copyright © 2001, American Society for Microbiology. All rights reserved.




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