The performance of hepatitis C virus (HCV) antibody point-of-care tests on oral fluid or whole blood and dried blood spot testing for HCV serology and viral load among individuals at higher risk for HCV in South Africa
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Date
Authors
Prabdial-Sing, Nishi
Gaelejwe, Lucinda
Makhathini, Lillian
Thaver, Jayendrie
Manamela, Morubula Jack
Malfeld, Susan
Spearman, C. Wendy
Sonderup, Mark
Scheibe, Andrew
Young, Katherine
Journal Title
Journal ISSN
Volume Title
Publisher
Wiley Open Access
Abstract
Background and Aims: To enhance screening and diagnosis in those at-risk of hepatitis
C virus (HCV), efficient and improved sampling and testing is required. We investigated
the performance of point-of-care (POC) tests and dried blood spots (DBS) for
HCV antibody and HCV RNA quantification in individuals at higher risk for HCV (people
who use and inject drugs, sex workers and men who have sex with men) in seven
South African cities.
Methods: Samples were screened on the OraQuick HCV POC test (471 whole blood
and 218 oral fluid); 218 whole blood and DBS paired samples were evaluated on the
ARCHITECT HCV antibody (Abbott) and HCV viral load (COBAS Ampliprep/COBAS
TaqMan version 2) assays. For HCV RNA quantification, 107 dB were analyzed with
and without normalization coefficients.
Results: POC on either whole blood or oral fluid showed an overall sensitivity of
98.5% (95% CI 97.4-99.5), specificity of 98.2% (95% CI 98.8-100) and accuracy of
98.4% (95% CI 96.5-99.3). On the antibody immunoassay, DBS showed a sensitivity
of 96.0% (95% CI 93.4-98.6), specificity of 97% (95% CI 94.8-99.3) and accuracy of
96.3% (95% CI 93.8-98.8). A strong correlation (R2 = 0.90) between viral load measurements
for DBS and plasma samples was observed. After normalization, DBS viral
load results showed an improved bias from 0.5 to 0.16 log10 IU/mL.
Conclusion: The POC test performed sufficiently well to be used for HCV screening in at-risk populations. DBS for diagnosis and quantification was accurate and should
be considered as an alternative sample to test. POC and DBS can help scale up hepatitis
services in the country, in light of our elimination goals.
Description
Keywords
High risk, Screening, Hepatitis C virus (HCV), Point-of-care (POC), Dried blood spots (DBS)
Sustainable Development Goals
Citation
Prabdial-Sing, N., Gaelejwe, L., Makhathini, L et al. The performance of hepatitis C virus
(HCV) antibody point-of-care tests on oral fluid or whole
blood and dried blood spot testing for HCV serology and viral
load among individuals at higher risk for HCV in South Africa.
Health Science Reports 2021;4:e229. https://DOI.org/10.1002/hsr2.229.