Advice

Summary

Summary

The OraQuick HCV test detects antibodies against hepatitis C virus and can be used on oral fluid, fingerstick blood, venous blood, plasma or serum, giving results in 20–40 minutes. Eleven published studies showed that the OraQuick HCV has very high sensitivity and specificity. The cost per test is £12–15.

Product summary and likely place in therapy

  • The OraQuick HCV is a rapid, point‑of‑care diagnostic test to identify anti‑hepatitis C virus (HCV) antibodies. It can be used with oral fluid, fingerstick blood, venous blood, plasma or serum. It provides a result after 20–40 minutes and is quicker than testing venous blood samples or dried blood spot samples for anti‑HCV antibodies in a laboratory.

  • The OraQuick HCV is intended for use in the community, in GP practices or in mobile clinics targeted towards people at risk of hepatitis C (HCV).

  • In the case of a positive test result with either the OraQuick HCV or conventional testing, further investigation is needed to determine whether active virus is present and whether the person needs treatment.

Effectiveness and safety

  • Eleven studies were included in this briefing, 9 of which reported diagnostic performance data. Of these studies, 7 used oral fluid samples for OraQuick HCV testing and 9 used blood (fingerstick or venous blood) or blood‑fraction samples (plasma, serum). Five studies used the OraQuick HCV in a community or mobile clinic setting and 2 studies looked at cross‑reactions that could give rise to inaccurate OraQuick results.

  • The studies showed that the OraQuick HCV (using blood, plasma and serum samples) has a very high sensitivity and specificity.

  • No safety issues were identified with the OraQuick HCV.

Technical factors

  • Sensitivity is slightly lower for oral fluid samples than blood‑based samples with the OraQuick HCV. Specificity is comparable for the 2 sample types.

  • When using oral fluid sampling, tests should not be done within 15 minutes of a person eating, drinking or chewing gum, or within 30 minutes of using oral care products such as mouthwash or tooth whitener.

Cost and resource use

  • The initial cost of the OraQuick HCV is £12–15 per single test, depending on the volume purchased.

  • No published economic analyses of the OraQuick HCV were identified.