Routine HIV Test Results in 6 US Clinical Laboratories Using the Recommended Laboratory HIV Testing Algorithm With Geenius HIV 1/2 Supplemental Assay

Details

• Alternative Title:
  Sex Transm Dis
• Personal Author:
  Wesolowski, Laura G. ; Chavez, Pollyanna R. ; Cárdenas, Ana María ; Katayev, Alex ; Slev, Patricia ; Valsamakis, Alexandra ; Wang, Yun F. ; Yao, Joseph D. ; Dougherty, Caitlin ; Gillim-Ross, Laura ; Harmon, Christopher ; Delaney, Kevin P.
• Description:
  Background:
  
  Geenius HIV 1/2 Supplemental Assay (Geenius; Bio-Rad Laboratories) is the only Food and Drug Administration–approved HIV-1/HIV-2 antibody differentiation test for the second step in the HIV laboratory testing algorithm. We characterized the occurrence of true HIV-1 and HIV-2 infections as well as false results in 6 US clinical laboratories using Geenius.
  
  Methods:
  
  We examined routine HIV testing outcome data from the time the laboratories began using the algorithm with Geenius until September 30, 2017. We calculated the positive predictive value for Geenius HIV-1 and HIV-2 reactivity separately.
  
  Results:
  
  Of 5,046,684 specimens tested, 41,791 had reactive antigen/antibody test results. Most specimens with reactive antigen/antibody results were HIV-1 antibody–positive established infections (n = 32,421), 1,865 of which also had indeterminate HIV-2 bands present. Ninety-three specimens were HIV-2 antibody positive or untypable for HIV-1/HIV-2 antibody. Acute HIV-1 infections were found in 528 specimens; 881 specimens lacked the nucleic acid test to determine the possibility of acute HIV-1 infection. False-positive antigen/antibody test results were present in 7505 specimens. Few specimens (n = 363) had false-positive antigen/antibody results with indeterminate Geenius and negative HIV-1 nucleic acid test results. The positive predictive values of Geenius reactivity were 99.4% for HIV-1 and 4.3% for HIV-2.
  
  Conclusions:
  
  Routine testing using the laboratory testing algorithm with Geenius resulted in most specimens resolving as HIV negative or HIV-1 positive. The occurrence of indeterminate HIV-2 bands with a Geenius final assay interpretation of HIV-1 positive was more common than true HIV-2 infections. Reporting indeterminate HIV-2 results in this situation may cause confusion with interpreting HIV infection status.
  
  
• Subjects:
  Algorithms HIV-1 HIV-2 HIV Antibodies HIV Infections HIV Testing Humans Immunoassay Laboratories Predictive Value Of Tests Sensitivity And Specificity Serologic Tests

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• Source:
  Sex Transm Dis. 47(5):S13-S17
• Pubmed ID:
  32343517
• Pubmed Central ID:
  PMC10949926
• Document Type:
  Journal Article
• Funding:
  CC999999/ImCDC/Intramural CDC HHSUnited States/
• Volume:
  47
• Issue:
  5
• Collection(s):
  CDC Public Access
• Main Document Checksum:
  urn:sha256:79e3707e1d648cc8ad8b47a738e92598e0ebc1ff539795185c4c3f1dd17c1cce
• Download URL:
  https://stacks.cdc.gov/view/cdc/151784/cdc_151784_DS1.pdf
• File Type:
  [PDF - 169.20 KB ]