Screening for human immunodeficiency virus using a newly developed fourth generation lateral flow immunochromatography assay

• Published in: Journal of virological methods Vol. 274; p. 113746
• Main Authors: Nakagiri, Itsuhiro, Tasaka, Taizo, Okai, Miki, Nakai, Fukue, Bunya, Ryoko, Nagai, Satomi, Yoshida, Tomoko, Tokunaga, Hirotoshi, Kondo, Eisei, Wada, Hideho
• Format: Journal Article
• Language: English
• Published: Netherlands Elsevier B.V 01.12.2019
• Subjects: Daina Screen® HIV Combo assay; HIV Antibodies - blood; HIV Core Protein p24 - blood; HIV infection; HIV Infections - diagnosis; HIV-1 p24 antigen; Humans; Immunoassay - methods; Japan; Mass Screening - methods; Sensitivity and Specificity; Japan; LOD; HIV-1 p24 antigen; WB; HIV infection; Daina Screen® HIV Combo assay
• ISSN: 0166-0934; 1879-0984
• DOI: 10.1016/j.jviromet.2019.113746

•Evaluation of a newly developed Daina Screen® HIV Combo (IC) rapid assay in Japan.•The assay uses clinical specimens in Japan where pretest probability is low.•We screened 17,373 preoperative outpatient blood samples.•Overall HIV positivity rate was 0.08% (14/17, 373; IC assay and confirmatory test).•For HIV screening, overall sensitivity was 100% and specificity was 99.7%. High sensitivity for detection of HIV-1 p24 antigen allows for early detection of primary HIV-1 infections. To evaluate the detection sensitivity and specificity of the Daina Screen® HIV Combo assay using clinical specimens in Japan where the pretest probability (prevalence) is low. We screened 17,373 preoperative outpatient blood samples using 4th generation lateral flow immunochromatography Daina Screen® HIV Combo assay for simultaneously detecting anti-HIV-1/2 and HIV-1 p24 antigen. Of the samples tested, 24 were positive for HIV-1 p24 antigen and 49 for HIV-1/2 antibody. Of the 49 samples, 36 were WB and HIV-1 RNA negative, 10 were WB and HIV-1 RNA positive, and 3 were WB positive, HIV-1 RNA negative, and in-house HIV-1 proviral DNA positive. RT-PCR revealed that of the 24 samples that were p24 antigen positive, one sample was HIV-1 RNA positive, which was reconfirmed using an in-house HIV-1 provirus DNA assay. From the 17,300 HIV-1 p24 antigen and anti-HIV-1/2 negative samples, pools containing 10 negative samples each were tested for HIV-1 by RT-PCR; all results were negative. The Daina Screen® HIV Combo assay had a sensitivity and specificity of 100% and 99.7%, respectively, which sufficiently detected HIV infection in the cohort.