HCV Point-of-Care Testing: Questions for Primary Care
Point of care HCV testing offers the promise of more widespread testing and more effective linkage to care. Find out what you know--and need to know.
1. Which of the above is a FDA-approved point of care test for HCV?
Answer: B. OraQuick HCV Antibody Test. The only FDA approved point-of-care test for HCV is OraQuick HCV Antibody Test. It is a single use test that detects HCV antibodies in oral fluid or blood from fingersticks. It delivers results within 20-40 minutes and can detect all HCV genotypes.
2. According to guidelines from the Infectious Disease Society of America (IDSA), which of the above is the next step in the management of a patient with a positive point-of-care test for HCV?
Answer: C. Immediate HCV-RNA confirmatory testing with Versant HCV RNA Qualitative Assay. According to IDSA guidelines, patients with a positive point-of-care test for HCV should receive immediate HCV-RNA confirmatory testing with an FDA approved qualitative or quantitative HCV-RNA test, with a detection level of ≤25 IU/mL.
3. Which of the above is not true regarding the OraQuick HCV Rapid Antibody test?
Answer: B. Sensitivity is lower in early infection. According to research, results for Oraquick were virtually the same as for laboratory-based enzyme-linked immunoassays, including results for early infection.
4. What is the window period for Oraquick HCV test using a fingerstick specimen?
Answer: D. Up to 11 wks. For Oraquick HCV test using a fingerstick specimen, the window period (during which infection has occurred but the test may not detect antibodies and may produce negative results) is up to 11 weeks.
5. Of the POC tests above, which have been developed but not yet FDA approved?
Answer: E. Both A and C. Chembio DPP and Multiplo Rapid HIV/HCV have both been developed as point-of-care tests for HCV, but have not yet been FDA approved. Chembio DPP is a fingerstick test for HCV, while Multiplo Rapid HBc/HIV/HCV simultaneously tests for HIV-1, HIV-2, hepatitis B and hepatitis C.
The approval of highly active direct-acting antiviral medications that eradicate hepatitis C infection is one of the greatest successes in modern medicine. But the primary challenge in managing--and eliminating--HCV worldwide is screening of undiagnosed HCV -infected individuals and providing rapid linkage to care.Point-of-care testing may become an important foundation for the expansion of screening and a tool for primary care physicians whose role in reigning in the epidemic will continue to grow. Find out what you know about POC testing available now with the short quiz below.
