Quality Control for Molecular Diagnostics (QCMD) celebrates its 25th anniversary and has a fairly interesting origin story because it grew directly out of early expert-driven and science-based European initiatives to standardise molecular infectious disease diagnostics in the 1990s. Here’s a structured timeline of its history and key milestones, from its roots to its current role as the global organisation for molecular External Quality Assessment (EQA).
QCMD Timeline
1998
A major milestone came with the launch of the EU supported Quality Control Concerted Action (EU-QCCA) project in 1998. This expanded earlier work beyond viral infections of the central nervous system into broader clinical virology and microbiology.
The project enabled the distribution of molecular QC material, development of further EQA and proficiency programmes, and establishment of consensus best-practice approaches and standards. The fundaments for the creation of a permanent organisation as requested by collaborating scientific societies (ESCV, ESCMID) and industry.
2001
QCMD was formally established in June 2001 as an independent, not-for-profit organisation run by experts from the field to continue and expand those EU-funded activities internationally by providing structured EQA schemes for molecular diagnostics.
This timing coincides with the period when clinical PCR transitioned from research-driven assays to routine diagnostics in clinical laboratories.
2000s
During the 2000s, QCMD evolved from a Europe-centric initiative into a global EQA organisation. Longitudinal EQA schemes such as for enteroviruses, HSV, chlamydia trachomatis, blood-borne viruses (HIV, HBV, HCV), or mycobacterium tuberculosis have now run for nearly two decades and more, demonstrating sustained global participation and measurable improvements in laboratory performance over time.
Important developments:
- Expansion beyond virology and bacteriology into broader microbiology targets, and increasing coverage for more pathogens, targets and applications (i.e., detection, quantification, genotyping, sequence analysis) related to
- respiratory viruses (e.g., influenza incl. HA typing, RSV)
- gastrointestinal pathogens (e.g., adenoviruses, clostridium difficile)
- transplant infections (e.g., BK virus, CMV, toxoplasmosis)
- drug resistance detection (e.g., HIVDR, MRSA)
- Integration into accreditation workflows (e.g., ISO 15189 support) and grow from over 600 registrations in 36 countries worldwide (2002) to over 5500 registrations in more than 80 countries worldwide (2010).
2005
In March 2005, the first version of the online Participant Profile Area (known as ITEMS) went live.
This software system has been developed to provide participating laboratories a major communication tool to take part in the EQA schemes online with direct registration, submission of results, reporting and questionnaires, status and history overviews. It was also developed to support the established Quality Management System of QCMD at that time.
As molecular diagnostics changed over time and QCMD’s portfolio evolution of EQA schemes mirrored the state-of-the-art itself by different EQA innovations and focus (late 1990s/early 2000s: single-pathogen PCR era; 2000s: qPCR, quantification and standardisation; 2010s: multiplex, syndromic testing and clinical interpretation era; 2015+: emerging pathogens and rapid EQA outbreak supports; late 2010s/2020s: genomics and NGS era), the ITEMS tool co-evolved the with analyses and reporting as required with the diagnostic technology advances.
This software system has been developed to provide participating laboratories a major communication tool to take part in the EQA schemes online with direct registration, submission of results, reporting and questionnaires, status and history overviews. It was also developed to support the established Quality Management System of QCMD at that time.
As molecular diagnostics changed over time and QCMD’s portfolio evolution of EQA schemes mirrored the state-of-the-art itself by different EQA innovations and focus (late 1990s/early 2000s: single-pathogen PCR era; 2000s: qPCR, quantification and standardisation; 2010s: multiplex, syndromic testing and clinical interpretation era; 2015+: emerging pathogens and rapid EQA outbreak supports; late 2010s/2020s: genomics and NGS era), the ITEMS tool co-evolved the with analyses and reporting as required with the diagnostic technology advances.
2010s
A defining milestone of the 2010s was QCMD’s growing role in rapid-response EQA for emerging infectious diseases (e.g., Zika virus molecular EQA launched in 2016). Today, there are many ongoing schemes supporting outbreak readiness and assay validation, which helped laboratories to verify diagnostic capability during global health events requiring rapid PCR deployment (e.g., for diverse arboviruses, influenza typing incl. H5N1, malaria, MERS, SARS-CoV-2, or poxviruses).
This positioned QCMD as a partner not just for laboratory accreditation – but also for public health preparedness activities.
2011
In June 2011, QCMD has been accredited for the first time to ISO 17043 as a provider of proficiency testing schemes by UKAS. So far, QCMD’s quality management system was certified to ISO 9001 and the EQA schemes were conducted in accordance with a strict Code of Practice compliant with requirement at that time, like ISO/IEC guide 43-1, ILAC-G13 and ISO 17025.
The current accreditation status of the EQA schemes is available in the QCMD catalogue, and the scope of accreditation is available on the UKAS website.
The current accreditation status of the EQA schemes is available in the QCMD catalogue, and the scope of accreditation is available on the UKAS website.
Today
Today QCMD:
- runs 100+ molecular EQA schemes for infectious diseases
- serves laboratories in 120+ countries
- supports >15,000 participant registrations annually
- builds on a wide network of experts (individually or through national and international organisations)