{"title":"[Efficacy of Human Immunodeficiency Virus (HIV) Antigen-Antibody Combination Assay as a Screening Test and Factors Causing False-Positivity].","authors":"Takako Inoue, Takaaki Goto, Takayuki Ogiwara, Minoru Oohashi, Tomoyuki Ohike, Satomi Kani, Noboru Shinkai, Yukio Wakimoto, Shigeru Sato, Yusuhito Tanaka","doi":"","DOIUrl":null,"url":null,"abstract":"<p><strong>Purpose: </strong>We aimed to evaluate the performance of an HIV antigen-antibody combination assay (fourth-generation) by comparing it with second generation assays that detect anti-HIV.</p><p><strong>Methods: </strong>A total of 105,439 HIV screening tests were performed from January 2004 to March 2015; the second - and fourth generation assays were used for 75,302 and 30,137 samples, respectively. Samples positive on a screening test were confirmed by anti-HIV-1 western blotting (WB) and nucleic acid amplification. By the results of confirmation tests, the efficacies of the second and fourth generation assays were estimated. The clinical backgrounds with false-positive samples were examined.</p><p><strong>Results: </strong>Of 75,302 samples, 136(0.18%) were positive by the second-generation assay; 14 were confirmed positives, and 122 were false positives. Of 30,137 samples, 18(0.06%) were positive by the fourth-generation assay; 6 were confirmed positives, and 12 were false positives. The reliability of the positives by fourth-generation assay was significantly improved (p=0.006) Samples form individuals with malignant neoplasms were frequently false positive by both the second and fourth-generation assays. Of 67 samples performed by WB, 10 samples, including 6 from patients with a malignancy, showed indeterminate results. All indeterminate samples were found to have antibodies responding to HIV core protein.</p><p><strong>Conclusion: </strong>The fourth-generation assay had satisfactory reliability of the positives for HIV screening. Antibodies responding to HIV core protein may result in false positive HIV screening tests. [Original]</p>","PeriodicalId":21457,"journal":{"name":"Rinsho byori. The Japanese journal of clinical pathology","volume":"64 12","pages":"1335-40"},"PeriodicalIF":0.0000,"publicationDate":"2016-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Rinsho byori. The Japanese journal of clinical pathology","FirstCategoryId":"1085","ListUrlMain":"","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
引用次数: 0
Abstract
Purpose: We aimed to evaluate the performance of an HIV antigen-antibody combination assay (fourth-generation) by comparing it with second generation assays that detect anti-HIV.
Methods: A total of 105,439 HIV screening tests were performed from January 2004 to March 2015; the second - and fourth generation assays were used for 75,302 and 30,137 samples, respectively. Samples positive on a screening test were confirmed by anti-HIV-1 western blotting (WB) and nucleic acid amplification. By the results of confirmation tests, the efficacies of the second and fourth generation assays were estimated. The clinical backgrounds with false-positive samples were examined.
Results: Of 75,302 samples, 136(0.18%) were positive by the second-generation assay; 14 were confirmed positives, and 122 were false positives. Of 30,137 samples, 18(0.06%) were positive by the fourth-generation assay; 6 were confirmed positives, and 12 were false positives. The reliability of the positives by fourth-generation assay was significantly improved (p=0.006) Samples form individuals with malignant neoplasms were frequently false positive by both the second and fourth-generation assays. Of 67 samples performed by WB, 10 samples, including 6 from patients with a malignancy, showed indeterminate results. All indeterminate samples were found to have antibodies responding to HIV core protein.
Conclusion: The fourth-generation assay had satisfactory reliability of the positives for HIV screening. Antibodies responding to HIV core protein may result in false positive HIV screening tests. [Original]