Performance evaluation of three automated human immunodeficiency virus antigen-antibody combination immunoassays.
Three fourth-generation antigen/antibody combination assays (Elecsys, AxSYM, Architect HIV) and two third-generation (AxSYM, Centaur) HIV antibody immunoassays were evaluated. The evaluation panel of 479 samples included: nine tissue culture derived HIV-1 strains at four different p24 antigen concentrations (n=36), a p24 antigen sensitivity panel (n=10), 149 HIV-1 or HIV-2 confirmed antibody positive samples, ten anti-HIV-1 positive low titer samples, three seroconversion panels (n=21), and 253 HIV negative samples. The Architect had the best sensitivity for detection of HIV-1 antigen across eight HIV-1 subtypes, followed by the AxSYM while the Elecsys could not detect the highest antigen concentration evaluated (25 pg/mL) for eight of nine virus isolates. All assays showed 100% sensitivity for detection of HIV-1, group M, group O, and HIV-2 antibody positive samples. The Architect Ag/Ab Combo assay detected the first positive bleed of the three seroconversion panels and detected infection 4-26 days earlier than the third generation assays. Based on evaluation of 253 negative samples, assay specificity varied from 98.0% to 99.6%. The Architect HIV Ag/Ab Combo exhibited the best performance for specificity and detection of p24 antigen leading to closure of seroconversion window and demonstrating its utility for early diagnosis of HIV infection.
Kwon
Jung-Ah
JA
Department of Laboratory Medicine, College of Medicine, Korea University, Seoul, Republic of Korea.
Yoon
Soo-Young
SY
Lee
Chang-Kyu
CK
Lim
Chae Seung
CS
Lee
Kap No
KN
Sung
Hyun Ju
HJ
Brennan
Catherine A
CA
Devare
Sushil G
SG
D000936:Antigen-Antibody Complex; D015153:Blotting, Western; D005069:Evaluation Studies as Topic; D005189:False Positive Reactions; D015483:HIV Antibodies / Q000097:blood*; D015488:HIV Antigens / Q000097:blood*; D016655:HIV Core Protein p24 / Q000097:blood*; D015658:HIV Infections / Q000175:diagnosis* / Q000821:virology; D006679:HIV Seropositivity / Q000175:diagnosis* / Q000821:virology; D015497:HIV-1 / Q000145:classification / Q000276:immunology / Q000302:isolation & purification; D015498:HIV-2 / Q000145:classification / Q000276:immunology / Q000302:isolation & purification; D006801:Humans; D007118:Immunoassay / Q000379:methods*; D021141:Nucleic Acid Amplification Techniques; D011933:Reagent Kits, Diagnostic; D012680:Sensitivity and Specificity
D000936:Antigen-Antibody Complex; D015483:HIV Antibodies; D015488:HIV Antigens; D016655:HIV Core Protein p24; D011933:Reagent Kits, Diagnostic