- A new handheld point-of-care test (Genedrive) meets the recent Foundation for Innovation in New Diagnostics (FIND)/WHO Target Product Profile for HCV decentralized testing in low- and middle-income countries.
Why this matters
- HCV screening remains a key challenge to HCV eradication goals.
- Current WHO guidelines highlight lack of field-based testing options, given the limitations of the only other approved assay (Xpert HCV).
- French development cohort: 422 HCV+ samples, 503 HCV-negative control patients.
- Validation cohort: 130 samples from African clinics.
- Sensitivity/specificity were compared vs the gold standard (Abbott RealTime HCV Viral Load assay).
- Funding: European Commission, Genedrive plc.
- All major genotypes were identified (limit of detection, 2362 IU/mL [95% CI, 1966-2788 IU/mL]).
- Development cohort: results obtained on first attempt for 97.2% of samples, and 61.5% of retested samples.
- In multivariate analysis, low HCV RNA correlated with lack of first-attempt result (P<.001).
- Median HCV RNA: 5.9 log10 IU/mL for cases vs 2.9 log10 IU/mL for control patients.
- Diagnostic sensitivity and specificity were 98.6% (95% CI, 96.9-99.5%) and 100% (95% CI, 99.3-100%), respectively.
- Validation cohort: results obtained on first attempt for 95.4% of samples, and 33.3% of retested samples.
- Diagnostic sensitivity and specificity were 100% (95% CI, 96.8%-100%) and 100% (95% CI, 73.5%-100%), respectively.
- Limited sample sizes.