title: Evaluation of human immunodeficiency virus-1/2 antigen/antibody immunochromatographic assay.
abstract: BACKGROUND
  In Japan, an immunochromatographic HIV-1/2 assay has been used for local Health Care Centers to prevent HIV spread in early stages and for hospitals at night or on holidays, where automated instruments are not available. In 2009, a new immunochromatographic HIV-1/2 assay became available which detects both antigen (Ag) and antibody (Ab) simultaneously and on separate bars. This study was conducted to evaluate the clinical performance of this new assay against three HIV-1/2 assays.
  
  
  METHODS
  One immunochromatographic assay (ICA) for HIV Ab detection, one chemiluminescent enzyme immunoassay (CLEIA) for Ab detection and one ELISA for Ag/Ab combination assay were evaluated with the ICA for Ag/Ab detection. Serum samples from 955 patients were used at Osaka University Hospital, who had been tested initially for HIV infection status. The 900 were negative and 55 were positive. In addition, the samples in 10 commercially available panels [2 containing relatively rare HIV subtypes/genotypes and 8 containing seroconversion samples] were tested using all HIV assays.
  
  
  RESULTS
  The HIV Ag/Ab ICA showed 100% (900/900, 95% confidence interval (95 CI) 99.59 - 100%) clinical specificity and was better than 99.8% (898/900, 95 CI 99.20 - 99.97%) of the existing ICA. The CLEIA and ELISA showed 100% (600/600, 95 CI 99.39 - 100%) and 99.8% (598/600, 95 CI 98.80 - 99.96%) specificity, respectively. The HIV Ag/Ab ICA showed 100% (55/55, 95 CI 93.51 - 100%) clinical sensitivity and detected all the relatively rare HIV subtypes/genotype panels; these results were the same as the other three assays. The HIV Ag/Ab ICA detected 5 seroconversion panels earlier than antibody-only-detection assays but detected later with 2 panels than ELISA for Ag/Ab combination assay.
  
  
  CONCLUSIONS
  The HIV Ag/Ab ICA demonstrated good performances in clinical specificity and sensitivity as a rapid assay and is a suitable assay for qualitative judgement of HIV Ag and Ab simultaneously in human serum and plasma.
authors.affiliation: The Laboratory for Clinical Investigation, Osaka University Hospital, Suita, Osaka, Japan.
authors.forename: Matsuo
authors.initials: M
authors.lastname: Deguchi
authors.forename: Nori
authors.initials: N
authors.lastname: Yoshioka
authors.forename: Masanori
authors.initials: M
authors.lastname: Kagita
authors.forename: Mifumi
authors.initials: M
authors.lastname: Kita
authors.forename: Seishi
authors.initials: S
authors.lastname: Asari
authors.forename: Tomoe
authors.initials: T
authors.lastname: Honda
authors.forename: Eiji
authors.initials: E
authors.lastname: Kobayashi
mesh_terms: D002846:Chromatography, Affinity / Q000379:methods*; D004797:Enzyme-Linked Immunosorbent Assay; D015483:HIV Antibodies / Q000097:blood*; D015488:HIV Antigens / Q000097:blood*; D015497:HIV-1 / Q000276:immunology*; D015498:HIV-2 / Q000276:immunology*; D006801:Humans; D012680:Sensitivity and Specificity
chemical_list: D015483:HIV Antibodies; D015488:HIV Antigens