Abstract

A Simple Whole-Blood Test for Detecting Antibodies to Human Immunodeficiency Virus Willfried Schramm 1 , † , Stephen E. Wade 1 , Gustavo Barriga Angulo 2 , Patricia Castillo Torres 2 , and Anthony Burgess-Cassler 1 , * Saliva Diagnostic Systems, Inc., Vancouver, Washington 98682-2444, 1 and Clinical Laboratory, Hospital de Infectologia, Centro Medico Nacional la Raza, Instituto Mexicano del Seguro Social, Mexico City, Mexico 2 ABSTRACT We developed an immunochromatographic whole-blood test (WBT) which detects antibodies to human immunodeficiency virus types 1 and 2 (HIV-1 and HIV-2) from fingerstick blood. The sensitivity and specificity of the WBT were 99.41% (1,018 confirmed positive patients) and 99.89% (941 uninfected patients), respectively (enzyme immunoassay (EIA) on serum or plasma as a reference). WBT performance was comparable to those of licensed EIAs and Western blotting, using 18 HIV-2 sera, 23 HIV-1 seroconversion panels, and a low-titer performance panel (in lieu of whole blood).