Retrospective Assessment of a National Reflex Cryptococcal Antigen Screening Program in South Africa Through Interlaboratory Comparison of Lateral Flow Assay Results.

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  • Additional Information
    • Source:
      Publisher: Oxford University Press Country of Publication: England NLM ID: 0250641 Publication Model: Print Cited Medium: Internet ISSN: 1943-7730 (Electronic) Linking ISSN: 00075027 NLM ISO Abbreviation: Lab Med Subsets: MEDLINE
    • Publication Information:
      Publication: Oct. 2015- : Oxford, England: Oxford University Press
      Original Publication: Philadelphia, Lippincott.
    • Subject Terms:
      Meningitis, Cryptococcal*/diagnosis ; Meningitis, Cryptococcal*/prevention & control ; Cryptococcus* ; HIV Infections*/diagnosis ; HIV Infections*/epidemiology; Humans ; South Africa/epidemiology ; Retrospective Studies ; Reproducibility of Results ; Antigens, Fungal ; CD4 Lymphocyte Count ; Mass Screening ; Reflex
    • Abstract:
      Objective: Reflex cryptococcal antigen (CrAg) screening of blood specimens with a CD4 count of <100 cells/µL was performed at 45 South African CD4 laboratories using a lateral flow assay (LFA). Our objective was to evaluate the reliability of routine LFA results through comparative interlaboratory testing.
      Methods: All CrAg-positive and a selected number of CrAg-negative samples from the CD4 laboratories were retested at paired microbiology laboratories using the same LFA. Samples with discordant results were tested at a reference laboratory, using the LFA (with CrAg titers).
      Results: During interlaboratory testing, 12,502 samples were retested, with 93 (0.7%) discordant results and a between-laboratory agreement of 99.3% (Cohen's kappa, 0.98). The proportion of retested samples with discordant results ranged from 0.17% to 5.31% per laboratory pair (median 0.28%), with 3 reporting >3% of results as discordant.
      Conclusion: Routine CrAg screening results were reliable, with <1% of samples having discordant results, mainly due to interpretation and transcription errors.
      (© The Author(s) 2022. Published by Oxford University Press on behalf of American Society for Clinical Pathology. All rights reserved. For permissions, please e-mail: [email protected].)
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    • Grant Information:
      R01 AI118511 United States AI NIAID NIH HHS; CDC-RFA-GH15-1575 United States CC CDC HHS; R01AI118511 United States NH NIH HHS; CDC-RFA-GH15-1575 US Centers for Disease Control and Prevention
    • Contributed Indexing:
      Keywords: advanced HIV disease; cryptococcal antigen; cryptococcal meningitis; discordant results; interlaboratory comparison; lateral flow assay
    • Accession Number:
      0 (Antigens, Fungal)
    • Publication Date:
      Date Created: 20220606 Date Completed: 20221104 Latest Revision: 20230606
    • Publication Date:
      20240829
    • Accession Number:
      PMC9631796
    • Accession Number:
      10.1093/labmed/lmac037
    • Accession Number:
      35660925