VIDAS CHLAMYDIA TRACHOMATIS TEST KIT

Description of Event or Problem

THE MFR OF THIS PRODUCT, BIOMERIUX, IS TELLING PEOPLE TO USE THE PRODUCT OFF LABEL. THE MFR IN FRANCE HAS NOT BEEN ABLE TO PROVIDE THE TEST KIT FOR MANY MONTHS. SINCE THE PHYSICIANS KEEP SENDING THEIR PROPRIETARY COLLECTION DEVICE, THE MFR HAS TOLD CUSTOMERS THAT IN LIEU OF USING THE UNAVAILABLE KIT TO PORCESS THE COLLECTION DEVICE, TO TEST THE DEVICE WITH ANOTHER MFR PRODUCT (SYVA MICROTRAC, DFA). NEITHER BIOMERIUX OR SYVA HAVE CLAIM FOR SCREENING PTS FOR CHLAMYDIA USING THIS OFF LABEL METHOD. AN ABSTRACT IS BEING SENT TO CUSTOMERS TO CONVINCE THEM THAT THIS IS ACCEPTABLE. IT MAY BE ACCEPTABLE TO USE THE SECOND KIT AS A CONFIRMATION METHOD BUT THERE IS NO DATA ON THE USE OF THIS METHOD TO SCREEN PRIMARY SAMPLES. THE ABSTRACT ILLUSTRATES THAT THE SUGGESTED OFF LABEL METHOD IS ACTUALLY LESS SENSITIVE AND COULD THEREFORE CAUSE FALSE NEGATIVE REPORTS FOR THIS DANGEROUS DISEASE.