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Updates to Nitrocefin Discs (D59)

31 May 2018

The following updates are be made to IFU 117 for the Nitrocefin discs (D59)

  • Version 3 to version 4:

A. Substitution of current QC test organisms:

  • Haemophilus influenza ATCC 35036, Neisseria gonorrhoeae ATCC 31426, Staphylococcus aureus ATCC 11632, Escherichia coli ATCC 25922.

With the following QC test organisms:

  • Bacteroides fragilis NCTC 9343, Staphylococcus aureus NCTC 12973 and Clostridium difficile NCTC 11204.

The suggested QC organisms have been changed to correspond with the intended use of this product, which is for detection of beta-lactamase in Neisseria gonorrhoeae, Moraxella catarrhalis, Staphylococcus spp., Haemophilus influenzae and anaerobic bacteria. Escherichia coli ATCC®25922 is no longer recommended as a QC organism, as detection of beta-lactamase activity in Enterobacteriaceae is not one of the intended uses of this product

B. Substitution of the following text in the limitation section:

  • “Detection of staphylococcal β-lactamase is enhanced by testing growth from a medium containing sub-inhibitory concentrations of a β-lactam antibiotic - MAST DST Agar (DM215) containing MAST β-Lactamase Inducer Selectatab™ (MS14).”

With the text:

  • “Detection of staphylococcal β-lactamase is enhanced by testing growth from around the outer edge of the zone of inhibition of an Oxacillin 1 µg disc (MAST OX1 or OX1C).”

The reason for the change in item B is the product MAST β-Lactamase Inducer Selectatab™ (MS14) is no longer available. Internal testing at Mast Group Ltd confirms that the same result can be obtained using OX1 or OX1C with regards to testing Staphylococcus spp. and D59.

Please click here to view the updated IFU


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