Public Health Implications of Rapid Hepatitis C Screening With an Oral Swab for Community-Based Organizations Serving High-Risk Populations

Abstract

OraQuick's accuracy is comparable to the EIA. The oral swab rapid test could help HCV screening programs reach individuals unaware of their status and expand testing into nonclinical settings such as mobile units.

Field-based performance of three pre-market rapid hepatitis C virus antibody assays in STAHR (Study to Assess Hepatitis C Risk) among young adults who inject drugs in San Diego, CA

“…In this study, only 53.3% of persons tested in this study received their conventional anti-HCV test results and on average received them 27.5 days after testing, results which are comparable to those seen in other studies. 8 Rapid anti-HCV assays which utilize oral fluid or capillary blood have the benefit of not requiring a phlebotomist and can be provided at POC, expanding testing options for PWID. 12,14 Rapid anti-HCV assays could be administered in syringe exchange programs (both through store fronts and mobile units), methadone maintenance treatment programs, and other programs that provide direct services to persons who inject drugs.…”

Rapid diagnostic HCV antibody assays

“…The OraSure assay had a higher sensitivity than the other 2 assays. In one study, the OraSure assay outperformed the conventional EIA [19]. Of 10 specimens with discordant results, 5 of 6 specimens that were OraSure-negative and EIA-positive had no detectable HCV RNA, and 2 specimens that were OraSure-positive and EIA-negative were HCV-RNA-positive.…”

“…The total number of samples tested by the OraSure assay was greater than the number of samples tested by the Chembio and MedMira assays, providing OraSure with more opportunities for evaluation. Investigators of three of the six studies reviewed [19][20][21] had financial relationships with OraSure. The evaluation of the MedMira assay also was limited in that the platform did not allow for oral fluid testing.…”

“…The MedMira assay was evaluated in three studies using serum [22] and fingerstick blood [23] from PWID (n=1,940). The OraSure assay was evaluated in five studies, using serum [20][21][22], fingerstick blood [20,21,23] and oral fluid [19][20][21]23] from PWID, [17,19,22,23] low-risk individuals [21], and those with signs or symptoms of hepatitis C infection [20] (n=5,058).…”

“…Here, we summarize the outcomes of six studies [17,[19][20][21][22][23] conducted in the US that examined the performance characteristics of rapid anti-HCV tests and propose a research agenda to support their adoption in the field.…”