A customer from (b)(6) notified biomérieux of false susceptible voriconazole results when testing a candida glabrata biologie prospective survey strain (myco 2018-2a) with the vitek® 2 ast-ys08 test kit, lot 2880585403.The customer obtained the following results: voriconazole susceptible (mic = 1) two times and intermediate (mic = 2) one time.The customer retested the strain using a different lot of the vitek 2 ys08 cards and obtained a resistant result (mic = 4).The expected result for this strain is resistant.As there is no patient associated with this quality control strain, there is no adverse event related to any patient's state of health.A biomérieux internal investigation has been initiated.
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This investigation was initiated due to a customer reporting a false susceptible voriconazole (vrc) result with candida glabrata bp survey strain (myco 2018-2a) on vitek® 2 v7.01 ast-ys08 card.Identification of the submitted organism was confirmed and testing included one card from the customer lot (2880585403 cl) of ast-ys08 cards, as well as one card from a random lot (2880600203 rl).The reference method broth microdilution (bmd), used for the development of the incriminated drug (vrc01n formulary), was performed in parallel of vitek 2 testing: vrc mic = 4 mg/l resistant.On vitek 2 v7.01 ast-ys08 card (aes parameters : casfm eucast 2016 + phenotypic) : the vrc values (4 and >/= 8 mg/l) are within essential agreement (within 1 doubling dilution for the value at >/= 8) compared to the reference mic (bmd - 4 mg/l resistant), without category error.Susceptible customer results are not reproduced in-house on both lots tested.The vitek 2 ast-ys08 cards performed as intended and no further action is required.
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