Field evaluation of the determine rapid human immunodeficiency virus diagnostic test in Honduras and the Dominican Republic

Rapid detection of human immunodeficiency virus (HIV) infection can result in improved patient care and/or faster implementation of public health prev entive measures. A new rapid test, Determine (Abbott, Abbott Park, Ill.), d etects HIV type 1 (HIV-1) and HN-2 antibodies within 15 min by using 50 mu 1 of serum or plasma. No specialized equipment or ancillary supplies are re quired, and results are read visually. A positive result is noted by the ap pearance 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 wer e known) and serum samples from HIV-positive individuals at field sites in Non-duras and the Dominican Republic, In the held 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 resul ts. In a companion study, 42 HIV-positive samples from a Miami, Fia., serum bank were tested by the Determine assay. The samples had been characterize d in terms of CD4 counts and viral loads. Fifteen patients had CD4 counts < 200 cells/mm(3), while 27 patients had CD4 counts >200 cells/mm(3). Viral l oads ranged from 630 to 873,746 log(10) copies/ml. All samples from the Mia mi serum bank were positive by the Determine test. Combined results from th e multicenter studies indicated that the correct results were obtained by t he Determine assay for 100% (142 of 142) of the HIV-positive serum samples and 100% (66 of 66) of the HN;negative serum samples. The Determine test wa s simple to perform and the results were easy to interpret, The Determine t est provides a valuable new method for the rapid identification of HIV-posi tive individuals, especially in developing countries with limited laborator y infrastructures.