A customer from the united states reported to biomérieux a misidentification of an external quality control (cap) survey sample of enterococcus gallinarum, as enterococcus casseliflavus (98%) in association with vitek® 2 gp test kit.Repeat testing, following receipt of cap survey results, produced a result of enterococcus casseliflavus/gallinarum.The customer will submit the reports from the repeat test and the survey.The isolate and initial lab report are unavailable.An internal biomérieux investigation will be initiated.
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A biomérieux internal investigation was conducted for a misidentification of an external quality control (cap) survey isolate of enterococcus gallinarum with the vitek® 2 gp card lot 242393320.This isolate was not submitted to biomérieux so the internal lyophilized cap sample was reconstituted and tested.The reconstituted sample was subcultured and gp testing included two cards each from four of the implicated customer lots and two cards from a random lot.The api 20 strep test was also performed although it does not identify e.Casseliflavus or e.Gallinarum without supplemental testing.Nine of the ten gp cards tested resulted in low discrimination of e.Casseliflavus/e.Gallinarum.Vitek® 2 proposed additional testing to separate these species.The isolate did not demonstrate yellow pigmentation and tested hip positive on the api test kit, resulting in an identification of e.Gallinarum.The remaining card gave an excellent identifications of e.Gallinarum.Review of the e.Casseliflavus customer data against expected reactions for e.Gallinarum demonstrated two atypical negative reactions (adh1, cdex) and one atypical positive reaction (pul), contributing to the misidentification.The customer data shows the isolate exhibited atypical growth behavior.The investigation concluded the vitek 2® gp id test kit is performing as intended.
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