D
Patient 1
ON 12/15/93, THE PT SPECIMENS WERE TESTED. OUT OF 17 SPECIMENS TESTED ON THAT DAY, THERE WERE FOUR POSITIVE TEST RESULTS. THE RESULTS OF THE POSITIVE AND NEGATIVE CONTROLS FOR THE ASSAY WERE ALL IN AN ACCEPTABLE RANGE; HOWEVER, THE TECHNOLOGIST PERFORMING THE ASSAY WAS CONCERNED WITH FOUR POSITIVE RESULTS IN ONE RUN AND OPTED TO RETEST THE FOUR SPECIMENS. THE REPEAT TEST RESULTS ON ALL FOUR WERE POSITIVE. ON 12/20/93, MULTIPLE POSITIVE TEST RESULTS WERE AGAIN NOTED ON A RUN OF THE ASSAY. ATTEMPTS TO REPRODUCE THE POSITIVE TEST RESULTS USING A DIFFERENT LOT NUMBER WERE INCONCLUSIVE. ALL SPECIMENS WERE RETESTED ON 12/21/93. AGAIN THERE WAS SOME VARIATION IN THE TEST RESULTS. A REP FOR MFR, TOLD HOSP THAT IT WAS THE THIRD CLIENT THAT HAD CALLED WITH A SIMILAR PROBLEMS. THE REP ALSO STATED THAT SHE WAS CALLING ALL OF HER CUSTOMERS THAT WERE USING THIS PARTICULAR PRODUCT AND ASKING THEM TO STOP USING THE TEST. CO IMMEDIATELY SHIPPED TEST KITS TO HOSP FOR FURTHER TESTING OF THE SPECIMENS. IT WAS AT THIS POINT THAT RPTR DECIDED TO RETEST THE SPECIMENS FROM 12/15/93. THE SPECIMENS FROM 12/15/93 HAD BEEN RETAINED FOR POTENTIAL USE IN THE EVAL OF AN EIA FOR ANOTHER PARASITE, TOTALLY UNRELATED TO THE TEST. THE SPECIMENS WERE KEPT IN A FORMALIN PRESERVATIVE WHICH ENSURED THAT THERE WAS NO DETERIORATION OF ANY PARASITES DURING THE TIME OF STORAGE. WHEN THE FOUR SPECIMENS FROM 12/15/93 WERE RETESTED WITH THE NEW TEST, ALL FOUR TEST RESULTS WERE NEGATIVE. IN AN ATTEMPT TO FURTHER RESOLVE THE DISCREPANCY, EACH OF THE FOUR SPECIMENS WERE SUBJECTED TO A CONCENTRATION PROCEDURE AND A MICROSCOPIC OVA-PARASITE EXAM. NO GIARDIA CYSTS OR TROPHS WERE NOTED IN THE MICROSCOPIC EXAM. ALL 5 SPECIMENS WERE CONSIDERED FALSE POSITIVES AND WERE RENOTIFIED TO THE ATTENDING PHYSICIAN AS SUCH. (*)