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Clinical and Diagnostic Laboratory Immunology, March 1998, p. 171-175, Vol. 5, No. 2
1071-412X/98/$04.00+0
Copyright © 1998, American Society for Microbiology. All rights reserved.

Detection of Antibodies to Human Immunodeficiency Virus Type 1 in Oral Fluids: A Large-Scale Evaluation of Immunoassay Performance

Timothy C. Granade,1,* Susan K. Phillips,1 Bharat Parekh,1 Perry Gomez,2 Wendy Kitson-Piggott,3 Herbert Oleander,2 Bisram Mahabir,4 Waveney Charles,4 and Stephanie Lee-Thomas1

Division of AIDS, STD, and TB Laboratory Research, National Center for Infectious Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia 303331; Ministry of Health and Environment, Nassau, Bahamas2; and Caribbean Epidemiology Centre3 and Ministry of Health,4 Port-of-Spain, Trinidad and Tobago

Received 29 May 1997/Returned for modification 22 August 1997/Accepted 12 November 1997

Paired serum and oral-fluid (OF) specimens (n = 4,448) were collected from blood donors and patients attending local sexually transmitted disease clinics in Trinidad and Tobago and the Bahamas and were tested for the presence of human immunodeficiency virus type 1 (HIV-1) antibodies. Sera were tested by Abbott AB HIV-1/HIV-2 (rDNA) enzyme immunoassay (EIA), and positive specimens were confirmed by Cambridge HIV-1 and HIV-2 Western blotting (WB). OF specimens were collected with the OraSure collection device and were tested by Murex GACELISA and by two EIAs from Organon Teknika (the Oral Fluid Vironostika HIV-1 Microelisa System [OTC-L] and the Vironostika HIV-1 Microelisa System [OTC-M]). EIA-reactive OF specimens were confirmed by miniaturized WB (OFWB). GACELISA detected all 474 HIV-1 seropositive specimens (sensitivity, 100%). OTC-L detected 470 positive specimens (sensitivity, 99.2%), while OTC-M detected 468 positive specimens (sensitivity, 98.8%). Specificities ranged from 99.2 to 100% for the three assays. Concordance of OFWB with serum WB was 99.4%, and banding patterns determined by the two methods were similar. The immunoglobulin G (IgG) concentration of OF specimens ranged from 0.21 to 100 µg/ml, with a mean of 17.1 µg/ml. Significant differences in OF IgG concentrations were observed between HIV antibody-positive and HIV antibody-negative persons (31.94 versus 15.28 µg/ml, respectively [P < 0.0001]). These data further confirm the suitability of OF specimens for detection of HIV-1 antibodies. Currently available HIV-1 antibody assays provide sensitivities and specificities with OF specimens comparable to those achieved with serum specimens.

* Corresponding author. Mailing address: Centers for Disease Control and Prevention, 1600 Clifton Rd. D-12, Atlanta, GA 30333. Phone: (404) 639-3647. Fax: (404) 639-2660. E-mail: TXG1{at}CDC.GOV.

Clinical and Diagnostic Laboratory Immunology, March 1998, p. 171-175, Vol. 5, No. 2
1071-412X/98/$04.00+0
Copyright © 1998, American Society for Microbiology. All rights reserved.


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  • Granade, T. C., Phillips, S. K., Kitson-Piggott, W., Gomez, P., Mahabir, B., Oleander, H., George, J. R., Baggs, J., Parekh, B. (2002). Influence of Host Factors on Immunoglobulin G Concentration in Oral Fluid Specimens. CVI 9: 194-197 [Abstract] [Full Text]  
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