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Point-of-care HCV test shows high accuracy in real-life clinic setting

A novel point-of-care test for hepatitis C meets the recent Foundation for Innovation in New Diagnostics and World Health Organization’s Target Product Profile for HCV decentralized testing in low-income and middle-income countries, according to a recently published study.

“Although DAAs for HCV cure are now available, the challenge for HCV infection, and especially for HCV elimination programs, is the screening of undiagnosed HCV-infected subjects and the linkage to care, namely the availability of DAA at reasonable costs,” Alba Llibre, MD, from the Institut Pasteur, France, and colleagues wrote. “We provide proof of concept in a real-life clinical setting that the Genedrive HCV assay has great potential to provide an affordable and robust instrument for decentralized HCV [nucleic acid amplification testing (NAAT)] testing.”

The Genedrive instrument (Genedrive plc) is a handheld rapid thermocycler that permits NAAT on plasma or serum samples through a two-step procedure that requires plasma or serum preparation followed by reverse transcription reaction to generate complementary DNA from target HCV RNA.

Llibre and colleagues enrolled treatment-naive patients with chronic HCV and an HCV-negative control group from France for initial testing. The researchers then validated the instrument in a real-life setting with HCV-positive patients and negative controls from African clinics.

In the testing cohorts from all sites, the researchers obtained results during the first attempt for 97.2% of the samples and 61.5% of the retested samples. Multivariable analysis showed that low HCV RNA correlated independently with lack of a result at the first attempt (P < .001). Median HCV RNA in case results was 5.9 log₁₀ IU/mL compared with 2.9 log₁₀ IU/mL in cases without results.

Diagnostic sensitivity was 98.6% (95% CI, 96.9-99.5) and specificity was 100% (95% CI, 99.3-100) in the testing cohort.

In the clinical validation cohorts, 95.4% of samples returned results on the first attempt and 33.3% of the retested samples returned results. The Genedrive instrument demonstrated 100% specificity and 100% sensitivity compared with the Abbott m2000 (Abbott Molecular) after excluding the four cases without results.

Overall, the assay showed diagnostic accuracy for all six major HCV genotypes, although genotypes 2, 5 and 6 had limited presence in the samples tested.

“There is an urgent unmet clinical need for decentralized HCV testing that can provide rapid diagnosis that may result in improved patient outcome and public health as shown for other diseases,” the researchers wrote. “Devices like Genedrive could have a major impact in improving the chronic HCV care continuum, as diagnosis through HCV RNA detection could be performed in a wide range of field settings and no intermediate visits would be required.” – by Talitha Bennett

Disclosure: Llibre reports no relevant financial disclosures. Please see the full study for the other authors’ relevant financial disclosures.