title: Evaluation of the clinical effectiveness of HIV antigen/antibody screening using a chemiluminescence microparticle immunoassay.
abstract: Human immunodeficiency virus (HIV) screening assays have improved from single-antigen detection to detection of antigen-antibody combinations. However, concerns have been raised over the potential for false-positive results in antigen-antibody combination assays. The present study investigated the clinical effectiveness of HIV antigen/antibody (HIV Ag/Ab) combination screening by chemiluminescence microparticle immunoassay (CMIA) in over 88,000 samples from an HIV low-prevalence area of Beijing, China. The HIV Ag/Ab CMIA screening results were consistent with those obtained by Western blot and HIV-RNA testing, and had an accuracy of 99.74% (Kappa index=0.98). False-positive results were more common for women affected by clinical interfering factors (e.g., kidney disease, tumors) than for men (80.95% vs. 15.09%, P<0.001). When CMIA signal-to-cutoff ratio (S/CO) was 11.26, the sensitivity and specificity were highest (100%, 99.43%), and the area under the ROC curve (AUC) was 0.998. Specimens that were negative by CMIA (S/CO <1) were all negative by HIV-RNA testing. These results indicate that HIV Ag/Ab CMIA has a good clinical performance; however, some clinical interfering factors should be considered in HIV low-prevalence areas for their potential to skew testing results.
authors.affiliation: Department of Laboratory Medicine, Peking University First Hospital, Beijing 100034, China. Electronic address: chanjuancui@126.com.
authors.forename: Chanjuan
authors.initials: C
authors.lastname: Cui
authors.affiliation: Department of Laboratory Medicine, Peking University First Hospital, Beijing 100034, China.
authors.forename: Ping
authors.initials: P
authors.lastname: Liu
authors.affiliation: Department of Laboratory Medicine, Peking University First Hospital, Beijing 100034, China. Electronic address: fengzhenru@sina.com.
authors.forename: Zhenru
authors.initials: Z
authors.lastname: Feng
authors.affiliation: Beijing Center for Disease Prevention and Control, Beijing 100013, China.
authors.forename: Ruolei
authors.initials: R
authors.lastname: Xin
authors.affiliation: Department of Laboratory Medicine, Peking University First Hospital, Beijing 100034, China.
authors.forename: Cunling
authors.initials: C
authors.lastname: Yan
authors.affiliation: Department of Laboratory Medicine, Peking University First Hospital, Beijing 100034, China.
authors.forename: Zhiyan
authors.initials: Z
authors.lastname: Li
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002648:Child; D002675:Child, Preschool; D002681:China; D019411:Clinical Laboratory Techniques / Q000379:methods*; D005260:Female; D015483:HIV Antibodies / Q000097:blood*; D015488:HIV Antigens / Q000097:blood*; D015658:HIV Infections / Q000175:diagnosis*; D006801:Humans; D007118:Immunoassay / Q000379:methods; D007223:Infant; D008163:Luminescent Measurements / Q000379:methods*; D008297:Male; D008403:Mass Screening / Q000379:methods*; D008863:Microspheres; D008875:Middle Aged; D012372:ROC Curve; D012680:Sensitivity and Specificity; D055815:Young Adult
chemical_list: D015483:HIV Antibodies; D015488:HIV Antigens
keywords: Antigen; Chemiluminescent microparticle immunoassay; Human immunodeficiency virus; Interfering factors