Summary of Changes in the Ninth edition
This list includes major changes to both the printed and on-line versions of the manual. Some other minor changes were made to general formatting and are not included in this list:
Chapter 3 – Quality Assurance
3.1 Details of the March 2016 TGA update “Regulatory requirements for in-house IVDs version 2.0” are included. Amongst other requirements this important update states that from 1st July 2017 each laboratory must have a list of Class 1-3 IVDs registered with TGA Business services.
3.2 The CDS Reference Laboratory undertook a review of the reference cultures many of which were old and there could be some doubt as to their providence and authenticity. All the reference strains have been replaced with either ATCC or NCTC standard strains (listed in table 3.1) that were acquired from either of the reference laboratories. The contacts for the acquisition of the reference strains are updated in section 3.2.1.
Also included is Figure 3.1, an updated example of record keeping of using the reference strains for quality assurance purposes.
Chapter 4 – Application of the CDS to Gram positive species
4.2.8 The explanation regarding high level aminoglycoside resistance in Enterococcus faecalis is revised.
Chapter 5 – Application of the CDS to Gram negative species
5.5 Now includes details of testing in parallel of ampicillin 25 µg and cephalexin 100 µg discs with all members of Enterobacteriaceae to detect the presence of AmpC mediated resistance.
5.5.8 Metallo-β-lactamases (MBLs)
Some parts of this section, including co-expression of MBL and ESBL were revised.
5.6 Haemophilus influenza ad Haemophilus species
Further information was added to the paragraph on “Other Haemophili”.
Chapter 6 – Application of the CDS to Neisseria spp
6.2. Testing by Reference Laboratory
An update of the section on Neisseria gonorrhoeae was provided by Prof Monica Lahra, WHO Collaborating Centre for STD and Neisseria Reference Laboratory.
Interpretative criteria for Neisseria meningitidis has been removed.
Chapter 8 – Application of the CDS to Unusual organisms.
Reference to testing of yeast (ex chapter 8) was removed and this and all subsequent chapters have been renumbered..
Chapter 9 – Application of the CDS to Veterinary medicine
9.4. This chapter now includes the calibration details of Florfenicol and Pradofloxacin.
Chapter 11 –Tables
All tables have been configured to a new format and the footnotes have been updated. The trade names of the combination discs have been replaced by the generic names of the two antibiotics.
11.3. Quality assurance:
The ATCC reference strains have been tested and annular radii are included for the Gram positive, Gram negative and anaerobic organisms in tables11.3.a and11.3.b. Included in table 11.3.are the reference ranges for Staphylococcus aureus ATCC 9144 on both sensitest agar and blood sensitest agar.
Kanamycin, piperacillin, enoxacin and cefpirome have beenremoved from the tables.
Appendix
The NATA document outlining TGA requirements for registration of Antibiotic Susceptibility Tests as IVDs has been deleted because it is redundant as TGA has updated its requirements. These are now described in the ninth edition under Quality Assurance. The NATA document is still a valuable resource and can be accessed on the CDS website in the archived 8th edition of the CDS Manual.