NEW YORK – Roche said on Thursday that its HIV and hepatitis C Cobas tests have received World Health Organization prequalification.
Both tests run on the fully automated Cobas 6800/8000 systems, and the Cobas HIV-1 test can be used with the Cobas Plasma Separation Card to process dried plasma spot samples in areas where there is little access to testing facilities, Roche said in a statement. The card filters samples of fingertip blood and dries the plasma. It is sent via mail to a laboratory with no refrigeration required. The card received CE marking in 2019 and meets WHO's sensitivity standard of less than 1,000 copies per milliliter, Roche said.
WHO prequalification is intended to help regulators in low- and middle-income countries determine whether products meet high quality standards and are safe for their intended use.
Roche said that it is committed to helping LMICs scale up HIV elimination programs and work towards WHO's 2030 goals of 95 percent of people with HIV knowing their HIV status, 95 percent of HIV-positive people receiving treatment, and 95 percent of people on treatment having suppressed viral loads.
WHO also has 2030 hepatitis elimination targets of 90 percent reduction in new chronic hepatitis B and C cases, 65 percent reduction in hepatitis-related deaths, and 80 percent of eligible hepatitis patients receiving treatment. In 2014, Roche implemented its Global Access Program, which includes diagnostic solutions for HIV, Mycobacterium tuberculosis, and hepatitis B and C, to meet the WHO goals.