Biokit Best 2000 laboratory analyser used in combination with the BioMerieux Vironostika HIV Uni-Form II Ag/Ab assay

Biokit Best 2000 laboratory analyser used in combination with the BioMerieux Vironostika HIV Uni-Form II Ag/Ab assay. The Biokit Best 2000 is also on the market as the Dynex Technologies DSX laboratory analyser. PROBLEM: The MHRA has received a report from a laboratory of an unrepeatable positive HIV test result. The positive result was not confirmed when further routine testing was carried out. The result was generated using a Biokit Best 2000 laboratory analyser in combination with the BioMerieux Vironostika HIV Uni-Form II Ag/Ab assay. The cause of the false result has not been determined. However, Biokit has stated that they have not validated this test for use on the analyser and they cannot guarantee the accuracy, reproducibility or performance of this combination. BioMerieux has stated that although the analyser meets the specifications set out in their instructions for use, this combination of assay and laboratory analyser has not been validated by them. ACTION: