ProDiag BV has received its first shipment of 500,000 of InTec’s SARS-CoV-2 IgM/IgG antibody rapid tests!
Next shipments are lined up. It shows China’s NMPA and Ministry of Commerce have stepped up their role in granting export licenses for validated products only.
We base our Instructions For Use on a study performed at the CDC in Wuhan (n=454), resulting in a 94,4% sensitivity and 98% specificity. We are actively pursuing to add more data to this dataset.
InTec has been a specialized manufacturer of rapid tests in infectious diseases for 30 years and had 2 other rapid tests (HIV and HCV) succesfully pass the WHO Pre-Qualification program. This means that technical files, quality system and production sites have passed WHO teams’ audits.
We strongly believe launching products should be done in a responsible way. InTec’s test has therefore been entered into evaluations at China CDC locations, FIND, US FDA EUA, Erasmus Medical Center, RIVM, WHO EUL and many others.
Although interim reports on partial data sets are circulating, full study reports will come out soon.
This test is delivered to medical professionals and sub-distributors only.
We are proud to contribute in the fight against COVID19!
#Corona #antibody #serology #ivd #virology