Diagnostic Accuracy of the Biosynex CryptoPS Cryptococcal Antigen Semiquantitative Lateral Flow Assay in Patients with Advanced HIV Disease
| العنوان: | Diagnostic Accuracy of the Biosynex CryptoPS Cryptococcal Antigen Semiquantitative Lateral Flow Assay in Patients with Advanced HIV Disease |
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| المؤلفون: | Tenforde, MW, Boyer-Chammard, T, Muthoga, C, Tawe, L, Milton, T, Rulaganyang, I, Lechiile, K, Rukasha, I, Leeme, TB, Govender, NP, Ngidi, J, Mine, M, Molloy, SF, Harrison, TS, Lortholary, O, Jarvis, JN |
| بيانات النشر: | AMER SOC MICROBIOLOGY, 2021. |
| سنة النشر: | 2021 |
| الوصف: | 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/?l) receiving CD4 count testing, whole blood was tested for CrAg by CryptoPS and the IMMY LFA; 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% CI], 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. |
| وصف الملف: | application/pdf |
| اللغة: | English |
| تدمد: | 0095-1137 1098-660X |
| URL الوصول: | https://explore.openaire.eu/search/publication?articleId=dedup_wf_001::23c761214ebf45455508397df16e77a6 https://researchonline.lshtm.ac.uk/id/eprint/4661272/1/JCM.02307-20.pdf |
| Rights: | OPEN |
| رقم الانضمام: | edsair.dedup.wf.001..23c761214ebf45455508397df16e77a6 |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 00951137 1098660X |
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