NEW YORK – Shanghai Kehua Bio-Engineering (KHB) said Wednesday that it secured IVDR certification for its Diagnostic Kit for HIV (1/2) Antibody (Colloidal Gold) V2, allowing it to be marketed and sold in Europe.
The firm said it is the first China-based company to obtain Class D IVDR certification, the highest of four risk classes, for a rapid diagnostic test. The kit is used to detect antibodies to HIV 1 or 2 in a blood sample.
KHK received certification from notified body TÜV SÜD Product Service.
The test previously received World Health Organization prequalification in 2016. KHB officials said the firm has partnered with organizations such as the World Health Organization, Clinton Health Access Initiative, and UNICEF, and the test is available in certain regions and countries including the United States, Switzerland, South Africa, Morocco, and Thailand.
The company said achieving IVDR certification for the HIV test demonstrates its commitment to delivering safe, reliable, and effective diagnostics, and it expects the certification will promote Chinese IVD products in the global market. The firm develops immunological, biochemical, and molecular diagnostics products, including point-of-care tests.