WAMPOLE

Description of Event or Problem

THE MICROBIOLOGY LAB AT HOSPITAL WAS DOING CORRELATION STUDIES ON THE "WAMPOLE CLEARVIEW" PLU A/B LATERAL FLOW TEST - A 15-MINUTE TEST FOR INFLUENZA TYPES A AND B WITH EXCELLENT SENSITIVITY AND SPECIFICITY. THE PRODUCT CLAIMS HIGH SENSITIVITY AND SPECIFICITY. IN THE HOSP'S VERY SHORT COMPARISON THEY FOUND VERY POOR PERFORMANCE. THE TEST LINE WAS VERY DIFFICULT TO READ ON KNOWN POSITIVE SAMPLES TO THE POINT IF THEY DID NOT KNOW THE SAMPLE WAS POSITIVE IT WOULD HAVE BEEN DIFFICULT TO INTERPRET. HOSP STOPPED THE STUDY AFTER TESTING ONLY 15 SAMPLES. COMPARED PERFORMANCE TO BOTH THE BINAX NOW KIT AND THE REMEL EXPECT, BOTH HAD GOOD PERFOROMANCE. THE TEST KIT APPEARS TO BE AN EXACT COPY OF THE REMEL EXPECT KIT, JUST DISTRIBUTED BY A DIFFERENT NAME. HOWEVER, THE PERFORMANCE IS NOT THE SAME AS THE REMEL KIT. RPTR TRIED THE KIT BECAUSE THEY ASSUMED IT WAS THE SAME AS THE REMEL KIT, BUT AT A MUCH LOWER PRICE.