This report was initially submitted following notification that a customer in (b)(6)reported occurrence of a low mic result for enterococcus faecalis atcc® 29212¿ in association with the etest® daptomycin kit.Biomérieux investigation was conducted.Expected values: 1-4 g/ml.Customer results: between (b)(6) 2016, four (4) results at 0.5 g/ml on twelve (12) data.Four (4) data at 0.75 g/ml are acceptable - instruction for use 9302553c indicates: an etest® mic value which falls between standard two-fold dilutions must be rounded up to the next upper two-fold value before categorization.The customer did not submit test strips for investigational testing.Retained samples (customer batches 1004340160 and 1004093520) were tested, in parallel with another batch as reference.The investigation did not reproduce the issue observed by the customer with the quality control strains.The conformity of this batch was confirmed with three (3) qc atcc® strains: atcc® 29212¿ enterococcus feacalis, atcc® 29213¿ staphylococcus aureus and atcc® 49619¿ streptococcus pneumoniae.The investigation concluded the etest® daptomycin kit is performing as intended.As the customer product was not submitted for internal biomérieux testing, it can be hypothesized: media: - as explained in cis 014 or 9302553c, daptomycin requires physiologic levels of calcium (ca2+) for expression of adequate activity.The bioavailable free ca2+ levels in brands and batches of mha powder and commercial mha plates can vary significantly and affect etest® dpc results.- use only mha plates with consistent and appropriate ca2+ levels (25-40 g/ml).- perform quality control (qc) using both enterococcus faecalis atcc® 29212¿ (1-4) and staphylococcus aureus atcc® 29213¿ (0.25-1 [ g/ml).Use of two qc strains allows verification of results within the susceptible range and around the breakpoint.When results are out of qc specifications or consistently skewed at the limits, repeat the test using a different brand of mha.Reading: the investigation observed microcolonies with enterococcus feacalis atcc® 29212¿.=> read different etest® mic endpoint patterns using the etest® reading guidelines = cis014.In this case, read where the microcolonies are inhibited.
|