Performance Evaluation of the OraQuick Hepatitis C Virus Rapid Antibody Test

Abstract

BackgroundA reliable rapid assay for hepatitis C virus (HCV) may be helpful in various clinical settings. We evaluated the performance of the OraQuick HCV Rapid Antibody Test (OraSure Technologies Inc., Bethlehem, PA, USA).MethodsClinical sensitivity and specificity were evaluated with oral fluids and sera from 137 patients diagnosed with hepatitis C and 300 healthy blood donors in a multi-center collaborative study. The stored sera of 200 proven HCV-infected patients and 200 healthy subjects were also evaluated. Analytical sensitivity was estimated with 4 commercial seroconversion panels and 7 Korean reference panels. The performance of 4 laboratory-based tests (3 chemiluminescence assays and 1 enzyme immunoassay) and 4 rapid test kits was compared. We also assessed the interference due to bilirubin, hemoglobin, lipid, rheumatoid factor, multipara, and several viral infections.ResultsThe clinical sensitivity and specificity of the OraQuick HCV test using oral fluid were 97.8% (95% confidence interval [CI], 93.2-99.4%) and 100% (95% CI, 98.4-100%), respectively. The clinical sensitivity using serum samples was 100%. Using the 4 seroconversion panels, the OraQuick HCV test showed results comparable to those of the laboratory-based assays; its analytical sensitivity was higher than that of the other rapid test kits. There was no cross-reactivity with common interfering factors.ConclusionsThe clinical performance of the OraQuick HCV Test is comparable to that of laboratory-based tests with both serum and oral fluid. This supports the supplementary use of rapid HCV testing using oral fluid in various medical and non-medical settings.

Diagnosis and Management of Hepatitis C Virus Infection

“…67 Only 5 µL of blood is required, which can be readily obtained via a finger prick. 72 Using oral fluid, the clinical sensitivity and specificity are 97.8% and 100%, respectively. 72 Testing based on oral fluid is less invasive, and medical personnel are protected from biohazards.…”

“…72 Using oral fluid, the clinical sensitivity and specificity are 97.8% and 100%, respectively. 72 Testing based on oral fluid is less invasive, and medical personnel are protected from biohazards. The lower sensitivity, however, poses challenges in low-prevalence settings.…”

“…In either case, the turnaround time is only 20 minutes, meaning that results can be quickly and easily delivered to the patients during their first visit. 72 The OraQuick assay therefore provides more accessibility and flexibility in low-resource, high-burden settings. 61,67,72 …”

“…The test has been FDA approved for use with venipuncture and fingerstick whole-blood samples, 71 but it can also detect anti-HCV antibodies from oral fluid samples. 72 The sample is mixed with the developer solution and then applied to the sample pad, on which it reconstitutes protein A-conjugated gold colloids deposited on the conjugate pad of the lateral flow strip (Fig. 5).…”

Point of Care Testing and Transfusion Safety in Resource Limited Settings: A Review

“…The reason for this may be the higher proportion of relatively low-titer reactive samples and the longer window period in the early phases of infection. However also for HbSAg and HCVAb there are kits that show promising results in terms of diagnostic accuracy [60][61][62][63][64][65] and a HbSAg RDT has been recently CE marked as it achieves the requested sensitivity of at least 0.125 I.U/mL [66].…”