The main mission of the International Federation of Clinical Chemistry (IFCC) Education and Management Division (EMD) is to provide IFCC members and the healthcare community with education relevant to Clinical Chemistry and Laboratory Medicine focusing on scientific, management and clinical issues. Within this division, the Committee on Clinical Molecular Biology Curriculum (C-CMBC) has developed a curriculum and comprehensive hands-on laboratory training courses in basic diagnostic Molecular Biology techniques. These are intended to support laboratories in countries embarking on molecular diagnostics and have been offered since 2003.
During the first phase (2003-2008), annual C-CMBC Courses took place in a state-of-the-art teaching lab in Milan, where approximately twenty participants, coming from all over the world, convened with a team of 4-6 tutors and 5-7 speakers for the lectures. The course included both seminars reviewing basic concepts of molecular biology and practical training on basic methodologies for DNA diagnostics. The theoretical part included basic knowledge of molecular biology, the principles of diagnostic techniques, how to set up a new laboratory and examples of clinical applications. The practical parts were focused on DNA extraction, PCR and electrophoresis. During this first phase, five courses in Milan (2003-2008) were held and two seminars in Tunis (2005 and 2007) and one at Fiji Island (2008) utilizing local facilities were also organized.
Since 2009, a keystone change in the C-CMBC Course concept was the "lab-in-the-suitcase" principle (Figure 1) aiming to bring the molecular techniques to the participants´ countries and perform them in their every-day working environments. The scheme includes that the hosting country sends a Trainee prior to the course to a C-CMBC central laboratory (Mannheim, Univ. of Heidelberg, Germany) to become acquainted with all the laboratory techniques and protocols to be used during the course. After returning back to the Course venue-country, the trainee receives the lab-in-a-suitcase, a custom-made aluminum case on rollers packed with all necessary equipment. The trainee´s task is to set up the laboratory prior to the C-CMBC tutors arrival, thus providing students with simple and robust equipment that is cheap to purchase and reliable to use in their real laboratory environment.
Since 2009, C-CMBC Course was held in Syria (2009), Uruguay (2010), Guatemala (2011), Malaysia (2012) and South Africa (2013). So far, the courses have been attended by 81 participants from 9 countries (Figure 2). To warrant a high teacher-to-student ratio, registration to the courses was limited to a maximum of 16-20 students, and, where possible, the participants were selected to be disseminators of the newly acquired skills. Most participants are healthcare professionals, PhD and MSc holders, postgraduate students and lab technicians.
The activities of the C-CMBC committee have found the enthusiastic support of the EMD division chair, the IFCC president and the IFCC executive board and have unanimously been appreciated by the local national societies hosting the courses.
Figure 1. Lab-in-a-Suitcase Scheme
Figure 2. The C-CMBC Course during the last 5 years. Total number of participants: a) Syria, 2009: n=21, b) Uruguay 2010: n=11, c) Guatemala 2011: n=18 from Guatemala, n=3 from Honduras, d) Malaysia 2012: n=11 from Malaysia, n=3 from Indonesia and n=1 from Yemen, e) South Africa 2013: n=11 from South Africa and n=2 from Nigeria.
It is important to emphasize that the course program has continuously evolved based on the experiences and feedback of the previous years. Currently, it features intensive hands-on laboratory exercises in a standardized scheme of 6 days together with seminars and lectures, in-silico work on assay design and some basic principles of bioinformatics to touch on issues of complex molecular genetic diagnostics. Prior to the lab exercises, one full day is dedicated to a pre-course lecture program specifically designed to remind participants the basic principles of molecular biology like DNA chemistry, hybridization principles and PCR. During the next five days nineteen lectures are given in total. Particular emphasis is placed on the main principles and applications of molecular diagnostic techniques in the clinical lab, standard and real-time quantitative PCR and RT-qPCR and state of the art technologies like microarrays and Next Generation Sequencing. Accompanying lectures cover in detail the application of these techniques in various areas of molecular genetic testing, molecular diagnostics of genetic disorders, pharmacogenomics, molecular virology, molecular microbiology and molecular oncology. The development and limits of molecular diagnostic strategies and the potential of novel areas like epigenetics, DNA methylation, microRNAs, circulating tumor cells and companion Diagnostics are also highlighted.
During the course, many participants gain their first hands-on experience on practical work in Molecular Diagnostics starting with preparation of buffers and reagents, inexpensive and robust DNA isolation from whole blood, performance of PCR reactions, ARMS-PCR, multiplex PCR, preparation of agarose gels, electrophoresis, dot blots and genotyping. The participants are trained on genotyping issues, data interpretation and data navigation. The C-CMBC places particular emphasis on pre-analytical and quality aspects for the future clinical laboratory. Specifically, biomaterial resource establishment and how to make use of international external quality control programs are being discussed. All participants are entitled to a three year - free of charge - access to the external quality assessment schemes of the Reference Institute for Bioanalytics of the German Society for Clinical Chemistry and Laboratory Medicine (www.DGKL-RfB.de). This allows to reference their analytical quality to the community of the labs participating in these schemes on a regular basis.
An important aspect in the C-CMBC´s teaching concept is the introduction to genetic databases and online tools for assay development and validation using public databases and tools on the internet. It has turned out - and is proof of the adaptive course program structure - that participants feel the need to get acquainted with online "in-silico" tools, and this course section has therefore been expanded continuously. Specifically, the students are being trained to use NCBI databases, to design PCR-primers and PCR conditions, choose restriction enzymes for the identification of a defined mutation/sequence variation etc.
The courses conclude with a final written test consisting of 30 multiple choice questions carried out on the last day followed by the Certificates Award Ceremony. At the end of the course each participant is supplied with a CD including all lecture presentations, relevant publications, all protocols and their experimental results. C-CMBC encourages the participants to evaluate the program in detail for each day. This evaluation feedback has led to improvements and adaptations like inclusion of the written exams, additional time for in-silico training and quality control as well as adding lectures on real time PCR and bioinformatics.
Representative detailed course program
The main strategic advantages of our current system to teach basic molecular techniques are the following:
i) The trainee is a native speaker in the host country, so communication is greatly facilitated and more substantial with the tutors,
ii) More people from an area can be simultaneously trained allowing better contacts for subsequent local and regional collaborations,
iii) By encouraging registrations from neighboring countries, dissemination (teach the teachers) is thought to be more effective,
iv) Feedback allows tutors to adapt the program to the needs of the attendants,
v) Granting easy and free-of-charge access to molecular EQA schemes should improve confidence in diagnostic results,
vi) Junior members that are supported by their national societies have a more sustained access to their peers allowing networking in the areas the course had been held,
vii) As a bottom-up approach, sustainable success may be more likely. Suggestions of hosting a "second-stage" advanced course program have been suggested from participating countries.
Up to now feed-back encourages the C-CMBC to provide courses supporting National IFCC member Societies embarking on molecular diagnostics in the future.