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Objective: Compare the agreement between four third-generation rapid or automated human immunodeficiency virus (HIV) tests vs the fourth-generation Abbott ARCHITECT HIV Ag/Ab Combo assay (Combo Test) (Abbott Laboratories, Abbott Park, IL) in 7 clinical laboratories located throughout the Dallas-Fort Worth, TX, metroplex area.Methods: We tested a total of 220 specimens from the general population of patients being screened for HIV antibody status, including Western blot (WB) and HIV-1 RNA viral load by NAAT in patients with initially positive HIV screening tests. We performed a method precision study of the Combo Test and evaluated the agreement between the 4 comparative methods (CMs) against the Combo Test method (TM) using a 2 × 2 contingency table to determine values for positive percent agreement (PPA), negative percent agreement (NPA), and overall percent agreement (OPA) according to the guideline (EP12-A2) for the evaluation of qualitative assays published by the Clinical Laboratory Standards Institute (CLSI).Results: The Combo Test yielded consistent (reproducible) results when the HIV antibody (or p24 antigen) concentration was 20% away or more from C50. In addition, values for PPA, NPA, and OPA for CM vs TM results were all 100%, or not significantly different from 100%.Conclusion: The high detection rate of the Combo Test, when coupled with its high diagnostic sensitivity and specificity, rapid TAT (<30 minutes) of test results using a fully automated instrument (ARCHITECT), and excellent agreement with HIV-1/2 antibody results by several commercially available HIV-1/2 screening tests and with WB and NAAT results, indicate that the Abbott HIV-1/2 Ab/Ag Test is a useful screening test in the identification of HIV-infected individuals.* HIV : human immunodeficiency virus CM : comparative method TM : test method PPA : positive percent agreement NPA : negative percent agreement OPA : overall percent agreement CLSI : Clinical Laboratory Standards Institute AIDS : acquired immunodeficiency syndrome UNAIDS : United Nations Programme on HIV/acquired immunodeficiency syndrome CDC : Centers for Disease Control gag : group-specific antigen EIAs : enzyme immunoassays CAP : College of American Pathologists WB : Western blot NAAT : nucleic acid amplification test AMH : Arlington Memorial Hospital BAS : Baylor All-Saints BUMC : Baylor University Medical Center THD : Texas Health Presbyterian Hospital, Dallas THFW : Texas Health Harris Methodist Hospital THP : Texas Health Presbyterian Hospital THSW : Texas Health Harris Methodist Hospital Southwest R : reactive NR : nonreactive EDTA : ethylenediaminetetraacetic acid LL : lower limits UP : upper limits S/CO : signal-to-cutoff %pos : percentage of positive %neg : percentage of negative FP : false positive FN : false negative POC : point-of-care TAT : turnaround time

Evaluation of Four Qualitative Third-Generation HIV Antibody Assays and the Fourth-Generation Abbott HIV Ag/Ab Combo Test