Diagnostic Accuracy of Assays Using Point-of-Care Testing or Dried Blood Spot Samples for the Determination of Hepatitis C Virus RNA: A Systematic Review.

Background: Finger-stick point-of-care and dried blood spot (DBS) hepatitis C virus (HCV) RNA testing increases testing uptake and linkage to care. This systematic review evaluated the diagnostic accuracy of point-of-care testing and DBS to detect HCV RNA.
Methods: Bibliographic databases and conference presentations were searched for eligible studies. Meta-analysis was used to pool estimates.
Results: Of 359 articles identified, 43 studies were eligible and included. When comparing the Xpert HCV Viral Load Fingerstick assay to venous blood samples (7 studies with 987 samples), the sensitivity and specificity for HCV RNA detection was 99% (95% confidence interval [CI], 97%-99%) and 99% (95% CI, 94%-100%) and for HCV RNA quantification was 100% (95% CI, 93%-100%) and 100% (95% CI, 94%-100%). The proportion of invalid results following Xpert HCV Viral Load Fingerstick testing was 6% (95% CI, 3%-11%). When comparing DBS to venous blood samples (28 studies with 3988 samples) the sensitivity and specificity for HCV RNA detection was 97% (95% CI, 95%-98%) and 100% (95% CI, 98%-100%) and for HCV RNA quantification was 98% (95% CI, 96%-99%) and 100% (95% CI, 95%-100%).
Conclusions: Excellent diagnostic accuracy was observed across assays for detection of HCV RNA from finger-stick and DBS samples. The proportion of invalid results following Xpert HCV Viral Load Fingerstick testing highlights the importance of operator training and quality assurance programs.
Competing Interests: Potential conflicts of interest. J. G. is a consultant/advisor and has received research grants from AbbVie, Cepheid, Gilead, Hologic, Indivior, and Merck; and personal fees from AbbVie, Cepheid, Gilead, and Merck, outside the submitted work. G. D. reports grants from Cepheid, during the conduct of the study; grants, personal fees, and nonfinancial support from Gilead, Abbvie, Merck, Bristol-Myers Squibb, Janssen, and Roche; personal fees from GlaxoSmithKline and Abbott Diagnostics; and grants from Cepheid outside the submitted work. T. A. reports grants and personal fees from Cepheid during the conduct of the study; and grants from Abbott Diagnostics, outside the submitted work. J. F. consults for and owns intellectual property rights in Gilead; and consults for AbbVie. All other authors report no potential conflicts. All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Conflicts that the editors consider relevant to the content of the manuscript have been disclosed.
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