This report was initially submitted following notification from a customer in finland regarding multiple misidentifications of streptococcus isolates as streptococcus agalactiae in association with the vitek® ms (ref 410895, serial (b)(6) ).Remel¿ pathodxtra¿ streptococcus grouping tests were used as an alternative method.Isolate 1: pathodxtra¿: streptococcus pyogenes, vitek® ms: streptococcus agalactiae.Isolate 2: pathodxtra¿: streptococcus pyogenes, vitek® ms: streptococcus agalactiae.An internal biomerieux investigation was performed.Conclusion on the fine tuning: the analysis of the calibrator mzml files indicates that a fine tuning was needed during the tests made on (b)(6) 2019.A new fine tuning was done on (b)(6) 2019.Conclusion on spot preparation quality: the customer's spot preparation quality is good during the period of the tests.The calibrator and sample "all peaks" values are quite homogeneous.Conclusion on the identification: isolates 19nn29306 and 19nn29314: regarding the complaint description, the expected identification is streptococcus pyogenes (group a streptococci).As s.Agalactiae is a group b, misidentifications results are suspected for those isolates with vitek® ms.The customer's data reprocessed with vitek® ms knowledge base (kb) v3.2 eliminated the suspected misidentifications for isolate 9nn29306: s.Agalactiae results was changed into "no identification" result.However, to confirm the identification of these isolates, the reference method has to be done (sequencing).In addition, it is suggested to retest the isolates with the instrument recently fine tuned.Suspected cause: lack of system monitoring.
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