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Journal of Clinical Microbiology, April 2009, p. 1058-1062, Vol. 47, No. 4
0095-1137/09/$08.00+0     doi:10.1128/JCM.01998-08
Copyright © 2009, American Society for Microbiology. All Rights Reserved.

Suitability of Simple Human Immunodeficiency Virus Rapid Tests in Clinical Trials in Community-Based Clinic Settings{triangledown}

Dean B. Everett,1,2* Kathy Baisley,1,2 John Changalucha,2 Andrew Vallely,1,3,{dagger} Deborah Watson-Jones,1,3 Claire Cook,1,2,{ddagger} Louise Knight,1,2,§ David A. Ross,1 Kokugonza Mugeye,3 Sheena McCormack,4 Charles J. Lacey,5 Ute Jentsch,6 and Richard J. Hayes1

London School of Hygiene and Tropical Medicine, Keppel Street, London WC1E 7HT, United Kingdom,1 National Institute for Medical Research, P.O. Box 1462, Mwanza, Tanzania,2 African Medical and Research Foundation, P.O. Box 1482, Mwanza, Tanzania,3 MRC Clinical Trials Unit, 222 Euston Road, London NW1 2DA, United Kingdom,4 Hull York Medical School, University of York, Heslington, York YO10 5DD, United Kingdom,5 University of the Witwatersrand Health Consortium, Johannesburg, South Africa6

Received 16 October 2008/ Returned for modification 9 January 2009/ Accepted 15 February 2009

The suitability and accuracy of using simple human immunodeficiency virus (HIV) rapid (SR) tests in community-based clinics in northwest Tanzania were determined to assess eligibility for participation in clinical trials. The HIV rapid and ELISA test results for 789 women aged 16 to 54 who were screened for two clinical trials of HIV prevention were compared. Women were offered voluntary HIV counseling and testing (VCT) at screening; those who accepted were tested with the Abbott Determine and Trinity Biotech Capillus SR tests in parallel. The results were confirmed by two parallel HIV enzyme-linked immunosorbent assay (ELISA) tests (Abbott Murex HIV Ag/Ab combination and Vironostika Uniform II HIV Ag/Ab) to determine eligibility. Positive samples for any of the four assays were confirmed by a line immunoassay and p24 testing. The parallel SR tests had high concordance (96.2%) with the parallel ELISA algorithm. The sensitivities of the SR tests were 98.6% for Capillus (95% confidence interval [CI], 95.1 to 99.8%), 99.3% for Determine (95% CI, 96.2 to 100%), and 98.6% for the parallel SR (95% CI, 95.1 to 99.8%). The specificities were 99.7% for Capillus (95% CI, 98.9 to 100%), 99.7% for Determine (95% CI, 98.9 to 100%), and 100% for the parallel SR (95% CI, 99.4 to 100%). SR tests are suitable for use in community-based clinical research settings to assess eligibility both for trial participation and for the provision of on-site VCT services.

* Corresponding author. Present address: Malawi-Liverpool-Wellcome Trust Clinical Research Programme, P.O. Box 30096, Chichiri, Blantyre 3, Malawi. Phone: 265 1875918. Fax: 265 1875774. E-mail: Dean.Everett{at}Liverpool.ac.uk

{triangledown} Published ahead of print on 25 February 2009.

{dagger} Present address: School of Population Health, University of Queensland, Herston, Brisbane QLD 4061, Australia.

{ddagger} Present address: MRC Clinical Trials Unit, 222 Euston Road, London NW1 2DA, United Kingdom.

§ Present address: Médecins Sans Frontières, Khayelitsha, South Africa.

Journal of Clinical Microbiology, April 2009, p. 1058-1062, Vol. 47, No. 4
0095-1137/09/$08.00+0     doi:10.1128/JCM.01998-08
Copyright © 2009, American Society for Microbiology. All Rights Reserved.





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