Preface to the Ninth Edition
In the 9th edition all sections of the Manual have been reviewed and a number of major and minor corrections, additions and deletions have been made. The major changes are listed in the “What’s New” section on the CDS website. The NATA document setting out the requirements for TGA registration of antibiotic susceptibility testing as an in vitro medical device (IVD) has been deleted. The latest TGA requirements are described in 3.1 in Quality Assurance in this edition. An upgrade of all the reference strains used in the CDS method was undertaken by the CDS Laboratory in the latter part of 2017 and the resultant changes in the relevant areas were previewed in Newsletter 41 in “What’s New” on our website in October 2017. The CDS team at Kogarah has been joined by Dr. Pratibha James, an experienced medical microbiologist and they have been actively engaged in the study comparing 3 methods of MIC determination. Despite this they have managed to complete a first class revision of the manual. My congratulations and thanks to them.
Preface to the Eighth Edition
There have been some major changes in the management of the CDS Laboratory since the publication of the 7th edition. However despite these changes the development of the method and support to the CDS Users has continued uninterrupted. Sadly Dr. Jeannette Pham has decided to retire but her role has been taken up by Dianne Rafferty who has returned to the CDS Laboratory after an absence of a number of years. Dianne has been joined by Julie Allerton, an experienced microbiologist and this team is providing a valuable service to the CDS users as well as undertaking a major project in reconciling the results of MIC determination by different techniques. The laboratory has been relocated to SEALS Microbiology at Kogarah and is supported bv A/Prof. Peter Taylor, the Director of Kogarah Microbiology and Chinmoy Mukerjee, the Laboratory Manager.
Sadly, Dr. Peter Newton was forced to withdraw as an author because of pressure of his other duties in Wollongong but on a brighter note Dr. Pham is staying on as an author despite being on LSL.
All sections of the Manual have been reviewed and a number of minor corrections, additions and deletions have been made. Major changes include a review of the section on quality assurance to ensure that CDS Test Method complies fully with TGA’s latest legislative requirements (2016) for in vitro devices (IVD). There has been a major change in the section on Neisseria. We have divided into 2 sections, the first is aimed at routine laboratories and the second kindly provided by Prof. Monica Lahra aimed at reference laboratories. Note the section on testing yeasts has been deleted entirely because we no longer have the resources to update it.
Preface to the Seventh Edition
This edition contains all the additions and modifications that have been added to the various iterations of the web-based manuals over the last 2 years. We have also made some additional changes to manual and these include a change in the authorship in that we welcome Dr. Peter Newton to the team. The section on Neisseria gonorrhoeae has been extensively revised by A/Prof. Monica Lahra and is contained in the manual as a stand alone section (section 6) . Laboratories should contact A/Prof. Lahra directly if they have any questions or wish to obtain the reference strains of Neisseria gonorrhoeae. A/Prof. Lahra’s contact details are shown in the quality assurance section on page 22. We have removed the section on testing Nocardia because on field testing it did not comply with the high standard demanded in the CDS Test. An account of all additions and changes included in this manual is available on the CDS website.
Added to the manual for the first time is a detailed description of the method of validation of the CDS (section 1.1.1.), a paragraph in section 3.1 on in house in vitro devices (IVDs) and a NATA communique (appendix 1) explaining laboratories statutory obligations related to IVDs. It does appear from the NPAAC and TGA documents that TGA classifies antibiotic disc testing as a class 2 in-house in vitro diagnostic procedure. It is possible that this interpretation may change in the future but as it stands disc testing must be included in the laboratory’s register of IVDs before 30th June 2014. The CDS Reference Laboratory keeps a considerable amount of documentation of validation of all aspects of the CDS Test and this is available to CDS users on request.
Preface to the online Editions
The online versions of the CDS Manual is intended to supplement the printed editions. The on-line version will be regularly updated and each updated version will be identified by the date of the most recent modification. At the time of writing this preface the information contained in the online edition, the downloadable pdf version and the printed version is identical. However as additions, modifications and corrections are made to the method they will be recorded first in the on-line manual which will include a note of the date that the change is made.
Preface to the Sixth Edition
Revision of the CDS is an ongoing process and the Manual continues to be updated on the CDS website. Nevertheless the vast majority of CDS Users have indicated that they prefer to have a hard copy. In response to these requests we have brought out this sixth edition of the Manual. There have been a fairly large number of changes in this edition with important changes in many of the tables and the addition of four new plates. Details of the technical changes that have been made are listed in the website but editorial changes have not been separately identified. I thank Monica Lahra, who has been appointed staff specialist in charge of the WHO Neisseria Reference Laboratory for providing the update to testing Neisseria. There have been some changes also in the staffing of the CDS Reference laboratory and contributors to the Manual. Greg Fisher has moved on from the laboratory and has been replaced by Jane Hanrahan and Ian Carter; the latter also assumes the role of webmaster. I would like to thank Greg for his contribution, particularly the innovative changes he introduced to CDS website. Also just a reminder that if you are looking for older versions of the Manual or other news that has been put on the Website you will find them in the Archives.
Finally, again, I would like to draw the reader’s attention to the acknowledgements on page 89, where recognition is given to all who have made contributions to the development of the method.
Addendum April 2012:
The modified version of the sixth edition of the Manual contains all the changes outlined in Newsletters 27 and 28 that can be found in “What’s New” on the CDS website. In addition a number of minor corrections have been made to Manual. I am grateful for the assistance of Thanh Nguyen, the newest member of our team, for adding the modifications to the manuscript.
Addendum September 2012
An update to the susceptibility testing of Neisseria gonorrhoeae has been added to the Manual. This update was provided by A/Prof. Monica Lahra.
Addendum June 2013
This modification of the sixth edition of the Manual incorporates all the changes outlined in the Newsletters up to and including Newsletter 33. We also welcome Dr. Peter Newton to the team and we are grateful to him for contribution to this version of the Manual.