4.7 Article

Diagnostic Accuracy of the Biosynex CryptoPS Cryptococcal Antigen Semiquantitative Lateral Flow Assay in Patients with Advanced HIV Disease

期刊

JOURNAL OF CLINICAL MICROBIOLOGY
卷 59, 期 1, 页码 -

出版社

AMER SOC MICROBIOLOGY
DOI: 10.1128/JCM.02307-20

关键词

cryptococcal meningitis; CrAg; semiquantitative; HIV; lateral flow assay; Botswana; cryptococcal antigen; cryptococcosis; diagnostics

资金

  1. National Institute for Health Research (NIHR) through a Global Health Professorship from the UK Government [RP-2017-08-ST2-012]
  2. Penn Center for AIDS Research (CFAR), a U.S. National Institutes of Health (NIH) [P30AI045008]
  3. NIH National Institute of Allergy andd Infectious Diseases (NIAID) [T32AI007044, F32AI140511]
  4. U.S. Centers for Disease Control and Prevention (CDC) Foundation [950]
  5. Wellcome Trust Master's Fellowship in Public Health and Tropical Medicine [212638]
  6. National Institute of Allergy and Infectious Diseases of the National Institutes of Health [R01AI118511]

向作者/读者索取更多资源

The CryptoPS assay showed suboptimal diagnostic accuracy for CrAg screening, with poor sensitivity at low CrAg titers but reliably detecting individuals with high titers associated with poor outcomes.
High cryptococcal antigen (CrAg) titers in blood are associated with subclinical meningitis and mortality in CrAg-positive individuals with advanced HIV disease (AHD). We evaluated a novel semiquantitative lateral flow assay (LFA), CryptoPS, that may be able to identify individuals with high CrAg titers in a cohort of AHD patients undergoing CrAg screening. In a prospective cohort of patients with AHD (CD4 cell count, <= 200/mu l) receiving CD4 count testing, whole blood was tested for CrAg by CryptoPS and the IMMY LEA; the two assays were conducted by two different operators, each blind to the results of the other assay. The sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of CryptoPS were assessed against the IMMY LFA as a reference. CryptoPS low-titer (T1 band) and high-titer (T2 band) results were compared with IMMY LFA titers obtained through serial dilution. A total of 916 specimens were tested. The sensitivity of the CryptoPS assay was 61.0% (25/41) (95% confidence interval [95% Cl], 44.5 to 75.8%), its specificity was 96.6% (845/875) (95% CI, 95.1 to 97.7%), its PPV was 45.5% (95% CI, 32.0 to 59.4%), and its NPV was 98.1% (95% CI, 97.0 to 98.9%). All (16/16) CryptoPS false-negative results were obtained for samples with IMMY titers of 1:160. Of 29 patients (30 specimens) who tested positive by CryptoPS but negative by the IMMY LFA, none developed cryptococcal meningitis over 3 months of follow-up without fluconazole. Median CrAg titers were 1:20 (interquartile range [IQR], 0 to 1:160) in CryptoPS T1-positive samples and 1:2,560 (IQR, 1:1,280 to 1:10,240) in T2-positive samples. We conclude that the diagnostic accuracy of the CryptoPS assay was suboptimal in the context of CrAg screening, with poor sensitivity at low CrAg titers. However, the CryptoPS assay reliably detected individuals with high titers, which are associated with poor outcomes.

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