Past Activities 2016-2018

Dear Participants,
Welcome to the online discussions of the Network of Laboratories for the Detection and Identification of Living Modified Organisms.

At their last meeting, on Decision CP VIII/16,  the Parties to the Cartagena Protocol on Biosafety requested the Executive Secretary to continue working on the draft training manual, in collaboration with the Network of Laboratories for the Detection and identification of Living Modified organisms, and make a draft version available for consideration at their ninth meeting. Accordingly, an updated version of the draft manual has been prepared by the Secretariat, in collaboration with a small group of experts from the Network, and it is available for review by all participants of the Network.

This discussion will focus on module 5 which provides information on minimal performance criteria and requirements for quality assurance including details on documentation, laboratory set-up requirements and environment and information on method validation/verification. An overview of the implementation of proficiency testing requirements and non-conformance, root cause analysis and corrective actions requirements in a laboratory's quality assurance and quality control system are also included.

Participants are invited to review and provide feedback on the contents for each module during the course of the next 2 weeks. We request that you review the manual from both a technical and editorial perspective focusing on edits and comments that  would provide additional clarity to the manual. In providing your comments, please refer to specific line numbers or highlight the text directly in the Word document containing the module and upload it together with your message.

We look forward to two weeks of constructive and fruitful discussions which will bring us a step closer to the goal of developing and improved version of the manual for the consideration of the COPMOP.

Kindest regards,
Secretariat

In the document adjoined was added for your consideration  in lines 250 to 260 the definition of reference material according to the international vocabulary of metrology, and
in lines 545 to 553 was added the Mexican database with two links to a Manual of measurement protocols for genetically modified organisms. 1st Edition, 2013, and Validated Reference Methods for Analysis of Genetically Modified Organisms, by digital PCR, and massive parallel sequencing 1st Edition, 2017. Both Spanish versions.

I would like to add the following very important reviewing points.
Of course , as much as i can , i have been trying to review the modules(2-6) separately and at each unit what i have detected are:-
   * some units ( standard units of measurements) are not mentioned,
   * reference materials are not well mentioned
  But i would like to appreciate the over all assessment and findings of Dr. MELINA PEREZ-URQUIZA, Mexico and also i share her  comments.
   Generally,  i have the following assumption to be add as additional material which is " THE SAFE HANDLING METHODS AND PRECAUTIONARY ACTIVITIES WHILE USING DURING THE LABORATORY EXPERIMENTS "

Dear Forum Participants,

I would like to thank everyone who has shared their comments on this module so far.

As previously indicated, the main objective of this discussion is to review and provide feedback on the contents of module 5 which can be accessed at http://bch.cbd.int/detectionlabs/trainingmanual/module%205_27mar18_posted.docx.

We request that you review the manual from both a technical and editorial perspective focusing on edits and comments that  would provide additional clarity to the manual. In providing your comments, please refer to specific line numbers or highlight the text directly in the Word document containing the module and upload it together with your message.

I hope you will be able to contribute to this discussion in the coming week and share your knowledge with us in order to contribute to the development of a through and comprehensive training manual.

Kindest regards
Dina

Thank you for compiling an excellent document for this area of detection and identification.  The document has a focus only on PCR methods, and thus I have tried to add material in a number of places to make it more useful for those who wish to use protein-based methods.  I added  a section on protein extraction, as this was not considered, and also one on Controls in protein methods.  Where text was PCR focused and could be adapted, I generalized it so that it can apply to both protein and PCR-based methods (eg equipment).

The choice of method and the type of laboratory is primarily defined by the Party, and the level of resources that they wish to apply to detection of LMOs under the protocol, and thus I have highlighted that in a couple of places.

Many of the definitions refer to EU/JRC definitions, so in order to maintain global relevance I have replaced these where possible with international materials such as those from ISO, and added a list of internationally recognized standards covering this area.  I included the source of the information in table 4.  I have also changed terminology (eg for retained samples) to meet international definitions and practices, and inserted the ISO definition of a reference material from ISO guide 30 in place of the JRC one.  All ISO defitnions can be accessed open source at https://www.iso.org/obp/ui/#search

Some of the material in this module is duplicative of other modules, or even contradictory (such as information on databases) – I suspect this is because the modules were written by different teams, so I suggest that an effort is made to remove that duplication by combining information.

These edits have been made in in tracking mode and comments that provide additional clarity to my suggestions have been added.  I have attached the document with my tracked suggested changes and related comments to this reply.

This document and the other documents here described focus solely on the detection and identification of plant LMOs.   This limitation to the scope of the document should be stated in the title.  In addition, the databases in the document only pertain to plants.

Section numbering may need some attention, as at least two different systems seem to have been used.

The citation method used in this document differs from previous ones, in that footnotes are used.  This will need changing so as to have a consistent means of citing sources throughout the 5 modules.

Hi , all the participants for the LMOs detection and identification lab network members,as much as i can , i have been assessed and reviewed the most recent draft with numerous edits and documents( module 2-6)
   I would like to point out my view at module -4-  , TECHNIQUES FOR DETECTION AND IDENTIFICATION , with lines 320-322 which states '' the presence of primers at higher concentrations can result in mispriming   and amplification non- target sequences conversely, PCR efficiency is reduced in primers are available in limiting concentrations.'' This statement has its own ambiguity. And i would like to suggest that the statement should be rewrite as '' PRIMERS WORK BEST AT OPTIMUM CONCENTRATIONS''
  Also i would like to add the following things,
THESE ARE,

      *.  key terms should be defined as glossary,
      *. all acronyms should be written in their long form at each module to create clarity for the users ,
      *. symbols, graphs and pictures should be well- illustrated ,
      *. additional module should be prepared for the precaution, safe handling and usage while working with LMOs in any laboratory levels.

Hi!
I have read the draft with a high interest and congratulation for this excellent document on LMO detection, identification and quantification.
A few small corrections on Module 5 : 289 and 290.

Regards

Freddy Bulubulu

Dear colleagues,

many thanks to the authors for writing this module as a basis for the development of training materials, which is a very good starting point.

Module 5 should provide information on minimal performance criteria and requirements for quality assurance including details on documentation, laboratory set-up requirements and environment and information on method validation/verification.

Harmonisation in this area is brought thanks to the ISO standards since more than 10 years. These documents are agreed between the global stakeholders and describe the apporaches and strategies concerning LMO detection and identification and the corresponding minimal performance criteria and requirements for quality assurance. This should be reflected in the module 5.

My apologies, not providing comments  to specific line numbers. I added comments and changes/additions directly in the Word document containing the module 5, which is hereby uploaded  together with my message.

I am looking forward for a further and fruitful online discussion towards developing and improving the manuals for the consideration of the COPMOP. Please contact me, if further explanations are required.

Kind regards and have a nice weekend,
Lutz

Dear Dr. Ermias Mashresha
In your post you suggest that an additional module should be prepared for the precaution, safe handling and usage while working with LMOs in any laboratory levels. In these modules there is indeed a section on safety when handling the reagents.
It may however, be that you are referring to stewardship standards, as a laboratory handling LMOs unauthorized in the country should be aware and not release such LMOs into the environment.  An excellent source of such guidance is http://www.excellencethroughstewardship.org/.   The Guide for Stewardship of Biotechnology-Derived Plant Products is to be found at: http://www.excellencethroughstewardship.org/page/Guides and is available in 5 languages.

Dear All,

I looked at all the drafts posted in this discussion module and decided to add my comments and edits on the last RS edited file, since it showed the most additions.

I only have three main comments regarding laboratory set-up requirements:

Line 73: "Separate rooms or areas for each processing step should be used while maintaining a unidirectional forward workflow" should not be modified to "whenever practical or possible". In my experience this is crucial to avoid cross-contamination.

Line 79: "Each separate laboratory area must have dedicated equipment that cannot be moved from one laboratory or area to another without carrying out the necessary cleaning and decontamination steps to prevent contamination", I wouldn't modify this either.

We started as a low-budget LMO testing lab and had a lot of issues at the beginning when forced to share equipment and space. Now we have improved our infrastructure and separated everything among the different rooms and areas, up to having color-coded lab coats and exclusive pipettes per procedure, etc. We seldom have contamination now.

Line 141 to line 156: I found this section a bit confusing the way it is written. I did some edits, but the main point that I think should be highlighted is that 'the PCR master mix set-up area must be clean of nucleic acids', and that 'the PCR reaction set-up room should not be the same as the post-PCR room (where PCR reactions are opened)'. I think the section as written could be misleading.

That's it. I hope my comments are of help!

Best Regards,

Monica