API® 20 STREP TEST KIT

Additional Manufacturer Narrative

A CUSTOMER NOTIFIED BIOMERIEUX THAT THEY HAD A MIS-IDENTIFICATION WHEN USING THE API 20 STREP TEST KIT. AN INTERNAL BIOMÉRIEUX INVESTIGATION WAS PERFORMED. THE CUSTOMER TESTED D3296 /S3250 (B)(6) STRAIN USING BOTH VITEK 2, VITEK MS AND API 20 STREP STRIP. THE STRIP BATCH REF 20600 IS 104333380. THE CUSTOMER USED TWO (2) STRIPS OF THIS SAME BATCH. THE EXPECTED STRAIN WAS E. GALLINARUM, BUT THE CUSTOMER OBTAINED THE FOLLOWING RESULTS: > LOW DISCRIMINATION E.GALLINARUM/E. CASSELIFLAVUS 50/50 ON VITEK 2. > E. CASSELIFLAVUS ON VITEK MS. > E.FAECIUM (99%) WITH API 20 STREP STRIPS. PROTOCOL OF THE CUSTOMER: > MEDIA : CHBA OXOID. > SUBCULTURED 2 OR 3 TIMES BEFORE MANIPULATION. > CORRECT METHODOLOGY. > STRIP READING AFTER 4H OF INCUBATION (E.FAECIUM / E.AVIUM), THEN READING AFTER 24H OF INCUBATION (E.FAECIUM 99%). > VANCOMYCIN SUSCEPTIBILITY : VANCOMYCIN = RESISTANT. > CUSTOMER BATCH EXPIRED ON 16 SEP 2016. TREND ANALYSIS : NO OTHER COMPLAINT REGISTERED FOR THIS BATCH. METHODS PERFORMED AND RESULTS : STRAIN SUBCULTURED ON CBA. > SEQUENCING 16S : IDENTIFICATION TO ENTEROCOCCUS GALLINARUM 100%, SO INTENDED (B)(6) RESULT IS CONFIRMED. > INCRIMINATED PRODUCT : **API 20 STREP STRIP (2 DIFFERENT LOTS 1004460590 AND 1004809730), EACH LOT TESTED THREE (3) TIMES: VERY GOOD IDENTIFICATION TO THE SPECIES E.FAECIUM POSSIBILITY OF E.CASSELIFLAVUS OR E.GALLINARUM IF VANCOMYCIN RESISTANT. REMARK : THE SUSCEPTIBILITY TO VANCOMYCIN WAS TESTED WITH THE REFERENCE METHOD BROTH MICRODILUTION AND GAVE MIC > 64 MG/L SO RESISTANT, IN FAVOR OF EXPECTED RESULT. THE STRAIN E. GALLINARUM IS NOT INCLUDED IN THE KNOWLEDGE BASE OF THIS STRIP API 20 STREP. **ADDITIONAL TEST: RAPID ID32STREP (LOT 1004430390) STRIP: GOOD IDENTIFICATION TO E.GALLINARUM 99.8% WITH FPUR (4) TESTS AGAINST SS-GUR (10), VP(99), MEL (90), CDEX (90). > ALTERNATIVE METHODS: **VITEK MS: ENTEROCOCCUS GALLINARUM 99.9% (5 SPOTS) **VITEK 2: FOUR (4) DIFFERENT LOTS WERE TESTED AND 5/8 TESTS WERE OBTAINED WITH A LOW DISCRIMINATION BETWEEN ENTEROCOCCUS GALLINARUM AND ENTEROCOCCUS CASSELIFLAVUS , WITH ONE (1) TEST AGAINST CDEX FOR E. GALLINARUM. FOR 3/8 TESTS, THE GP CARDS GAVE EXCELLENT IDENTIFICATION TO ENTEROCOCCUS GALLINARUM (98%). REMARK : VITEK 2 PROPOSED THREE (3) TESTS TO SEPARATE THE TWO (2) SPECIES : YELLOW (1), HIP (99), MDM (1) IN FAVOR OF E.GALLINARUM. THE NO YELLOW PIGMENTATION OF THE COLONY IS IN FAVOR OF E. GALLINARUM. IN CONCLUSION, ATYPICAL STRAIN FOR E. GALLINARUM. THE STRAIN E. GALLINARUM IS NOT INCLUDED IN THE KNOWLEDGE BASE OF THIS STRIP API 20 STREP, SO NO LOSS OF PERFORMANCE OF THE API 20 STREP STRIPS.

Description of Event or Problem

A CUSTOMER NOTIFIED BIOMERIEUX THAT THEY HAD A MIS-IDENTIFICATION WHEN USING THE API 20 STREP TEST KIT. A PROFICIENCY SAMPLE WAS IDENTIFIED BY THE TEST KIT AS ENTEROCOCCUS GALLINARUM INSTEAD OF AS ENTEROCOCCUS FAECIUM. SINCE THIS IS A PROFICIENCY SAMPLE AND NOT A PATIENT SAMPLE, NO INJURY OR DEATH HAPPENED AS A RESULT OF THE MIS-IDENTIFICATION. AN INVESTIGATION HAS BEEN INITIATED BY BIOMERIEUX TO INVESTIGATE THIS EVENT.