WHO Prequalification Granted
September, Geneva: bioLytical’s INSTI Rapid HIV1/2 Antibody Test has been approved by the World Health Organization (WHO) for Prequalification Status, making it available for procurement by over 140 WHO member states worldwide. In addition, INSTI is now on a limited list of rapid HIV tests approved for purchase with Global Fund resources. Both designations are expected to lead to new opportunities in new jurisdictions where INSTI was previously unavailable. In addition to countries that are required to procure WHO-prequalified products, many nations simply look to the UN agency for guidance when selecting medical devices, due to the rigorous standards set for qualification.
The evaluation process for INSTI, which has substantially changed from the previous prequalification methods, involved a submission of a full dossier of clinical technical and production-related information as well as an evaluation of INSTI with 1,079 clinically derived samples. Much like Health Canada and FDA approval processes, an on-site inspection of bioLyticals facilities was performed. The resulting data for our laboratory evaluation was excellent: 100% sensitivity and 99.7% specificity.
Rick Galli, bioLyticals Chief Technical Officer is thrilled to have WHO Prequalification Status added to INSTIs already impressive regulatory credentials. There are very few rapid HIV assays that have been successfully prequalified under the new, more stringent WHO process, and we are very proud that INSTI is one of those assays. It is gratifying to know that INSTI is now available for use in these regions of the world where the need for quality, peer reviewed and approved rapid HIV testing devices like INSTI is high.