An internal biomérieux investigation was initiated for a customer in (b)(6) who reported a misidentification of actinomyces israelii as gardnerella vaginalis when tested in the vitek® 2 gp id card.The strain was identified as actinomyces israelii by partial sequencing of the 16s rrna gene.Strain, lab reports, raw data, lot number, and software version were not available.Actinomyces israelii is not a claimed species for the vitek 2 gp knowledge base.When an isolate is tested in the vitek 2 gp id card, it will attempt to match the reactions to known reaction patterns stored in the knowledge base.If the reaction pattern of an unclaimed species is tested and match those in the knowledge base with a high degree of confidence, a misidentification can occur.The vitek 2 product instructions for use (ifu) contain the following warning in the limitations section: testing of unclaimed species may result in an unidentified result or a misidentification.The vitek 2 anc id card would be the appropriate identification card for this species.
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