Dataset Information

Brief Report: Point of Care Cryptococcal Antigen Screening: Pipetting Finger-Prick Blood Improves Performance of Immunomycologics Lateral Flow Assay.

ABSTRACT: BACKGROUND:Cryptococcal antigen (CrAg) screening at the point of care could improve cryptococcal meningitis prevention where laboratory resources are limited. We evaluated the accuracy of Immunomycologics (IMMY, Norman, OK) CrAg lateral flow assay (LFA) using different techniques at point of care. SETTING:Two tertiary-level hospitals in Johannesburg and a community health clinic in Soweto, South Africa. METHODS:A case-control diagnostic validation study and a prospective clinic-based implementation study using the IMMY CrAg LFA on finger-prick blood. Accuracy, using direct application of LFA to sample, or pipette to transfer sample to diluent, and reading after 10 and 20 minutes, was compared with laboratory-based plasma testing. RESULTS:The validation study tested 64 CrAg-positive and 152 CrAg-negative patients with no symptoms or signs of meningitis, identified by routine laboratory screening, recruited by convenience sampling. Consecutively diagnosed HIV-infected adults (n = 654) were included in the implementation study. Sensitivity was 82% and 20% when the LFA was read 10 minutes after direct application to finger-prick blood in the validation and implementation studies, respectively. Using a pipette to transfer blood and reading after 20 minutes improved sensitivity to 100%, while retaining 100% specificity, in both studies. CONCLUSIONS:Although the IMMY CrAg LFA performs well when applied directly to finger-prick blood for diagnosing cryptococcal meningitis, this technique may not provide adequate volume to detect low concentrations of CrAg when screening asymptomatic patients. Using a pipette to transfer larger volumes of blood to diluent before CrAg LFA testing and reading results after 20 minutes is a more reliable point-of-care method.

SUBMITTER: Wake RM

PROVIDER: S-EPMC6381996 | biostudies-literature | 2018 Aug

REPOSITORIES: biostudies-literature

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Publications

Brief Report: Point of Care Cryptococcal Antigen Screening: Pipetting Finger-Prick Blood Improves Performance of Immunomycologics Lateral Flow Assay.

Wake Rachel M RM Jarvis Joseph N JN Harrison Thomas S TS Govender Nelesh P NP

Journal of acquired immune deficiency syndromes (1999) 20180801 5

<h4>Background</h4>Cryptococcal antigen (CrAg) screening at the point of care could improve cryptococcal meningitis prevention where laboratory resources are limited. We evaluated the accuracy of Immunomycologics (IMMY, Norman, OK) CrAg lateral flow assay (LFA) using different techniques at point of care.<h4>Setting</h4>Two tertiary-level hospitals in Johannesburg and a community health clinic in Soweto, South Africa.<h4>Methods</h4>A case-control diagnostic validation study and a prospective cl ...[more]

PMID: 29771787

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Project description:Higher cryptococcal antigen (CrAg) titers are strongly associated with mortality risk in individuals with HIV-associated cryptococcal disease. Rapid tests to quantify CrAg levels may provide important prognostic information and enable treatment stratification. We performed a laboratory-based validation of the IMMY semiquantitative cryptococcal antigen (CrAgSQ) lateral flow assay (LFA) against the current gold standard CrAg tests. We assessed the diagnostic accuracy of the CrAgSQ in HIV-positive individuals undergoing CrAg screening, determined the relationship between CrAgSQ scores and dilutional CrAg titers, assessed interrater reliability, and determined the clinical correlates of CrAgSQ scores. A total of 872 plasma samples were tested using both the CrAgSQ LFA and the conventional IMMY CrAg LFA, of which 692 were sequential samples from HIV-positive individuals undergoing CrAg screening and an additional 180 were known CrAg-positive plasma samples archived from prior studies. Interrater agreement in CrAgSQ reading was excellent (98.17% agreement, Cohen's kappa 0.962, P < 0.001). Using the IMMY CrAg LFA as a reference standard, CrAgSQ was 93.0% sensitive (95% confidence interval [CI] 80.9% to 98.5%) and 93.8% specific (95% CI, 91.7% to 95.6%). After reclassification of discordant results using CrAg enzyme immunoassay testing, the sensitivity was 98.1% (95% CI, 90.1% to 100%) and specificity 95.8% (95% CI, 93.9% to 97.2%). The median CrAg titers for semiquantitative score categories (1+ to 4+) were 1:10 (interquartile range [IQR], 1:5 to 1:20) in the CrAgSQ 1+ category, 1:40 (IQR, 1:20 to 1:80) in the CrAgSQ 2+ category, 1:640 (IQR, 1:160 to 1:2,560) in the CrAgSQ 3+ category, and 1:5,120 (IQR, 1:2,560 to 1:30,720) in the CrAgSQ 4+ category. Increasing CrAgSQ scores were strongly associated with 10-week mortality. The IMMY CrAgSQ test had high sensitivity and specificity compared to the results for the IMMY CrAg LFA and provided CrAg scores that were associated with both conventional CrAg titers and clinical outcomes.

Dataset Information

Brief Report: Point of Care Cryptococcal Antigen Screening: Pipetting Finger-Prick Blood Improves Performance of Immunomycologics Lateral Flow Assay.

Publications

Brief Report: Point of Care Cryptococcal Antigen Screening: Pipetting Finger-Prick Blood Improves Performance of Immunomycologics Lateral Flow Assay.

Similar Datasets

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