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Journal of Clinical Microbiology, November 1999, p. 3698-3700, Vol. 37, No. 11
0095-1137/99/$04.00+0
Copyright © 1999, American Society for Microbiology. All rights reserved.

Field Evaluation of the Determine Rapid Human Immunodeficiency Virus Diagnostic Test in Honduras and the Dominican Republic

Carol J. Palmer,1,2,* Jose M. Dubon,3 Ellen Koenig,4 Eddy Perez,5 Arba Ager,6 Dushyantha Jayaweera,6 Raul R. Cuadrado,1 Ada Rivera,3 Alex Rubido,2 and Dennis A. Palmer2

Health Professions Division, College of Allied Health, Nova Southeastern University, Ft. Lauderdale, Florida1; Social Security Hospital, San Pedro Sula, Honduras3; National Public Health Laboratory4 and CENISMI,5 Santo Domingo, Dominican Republic; and University of Miami6 and BioQuest Corp.,2 Miami, Florida

Received 9 April 1999/Returned for modification 25 May 1999/Accepted 22 June 1999

Rapid detection of human immunodeficiency virus (HIV) infection can result in improved patient care and/or faster implementation of public health preventive measures. A new rapid test, Determine (Abbott, Abbott Park, Ill.), detects HIV type 1 (HIV-1) and HIV-2 antibodies within 15 min by using 50 µl of serum or plasma. No specialized equipment or ancillary supplies are required, and results are read visually. A positive result is noted by the appearance of a red line. An operational control (red line) indicates proper test performance. We evaluated the Determine rapid HIV detection test with a group of well-characterized serum samples (CD4 counts and viral loads were known) and serum samples from HIV-positive individuals at field sites in Honduras and the Dominican Republic. In the field evaluations, the results obtained by the Determine assay were compared to those obtained by local in-country HIV screening procedures. We evaluated serum from 100 HIV-positive patients and 66 HIV-negative patients. All samples gave the expected results. In a companion study, 42 HIV-positive samples from a Miami, Fla., serum bank were tested by the Determine assay. The samples had been characterized in terms of CD4 counts and viral loads. Fifteen patients had CD4 counts <200 cells/mm3, while 27 patients had CD4 counts >200 cells/mm3. Viral loads ranged from 630 to 873,746 log10 copies/ml. All samples from the Miami serum bank were positive by the Determine test. Combined results from the multicenter studies indicated that the correct results were obtained by the Determine assay for 100% (142 of 142) of the HIV-positive serum samples and 100% (66 of 66) of the HIV-negative serum samples. The Determine test was simple to perform and the results were easy to interpret. The Determine test provides a valuable new method for the rapid identification of HIV-positive individuals, especially in developing countries with limited laboratory infrastructures.

* Corresponding author. Mailing address: Health Professions Division, Nova Southeastern University, 3200 South University Dr., Ft. Lauderdale, FL 33328. Phone: (954) 262-1205. Fax: (954) 262-1181. E-mail: Carpalmer{at}aol.com.

Journal of Clinical Microbiology, November 1999, p. 3698-3700, Vol. 37, No. 11
0095-1137/99/$04.00+0
Copyright © 1999, American Society for Microbiology. All rights reserved.


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