EU-funded programmes on viral meningitis and encephalitis diagnostics and management bring together leading experts across Europe to standardise emerging molecular testing approaches – shaping the concepts behind molecular EQA as we know it today.
The EU-supported Quality Control Concerted Action (EU-QCCA) expands molecular EQA activities beyond viral CNS infections into wider clinical virology and microbiology.
The project enables the distribution of molecular QC material, the development of further EQA and proficiency programmes, and the establishment of consensus best-practice approaches and standards. This paves the way for a permanent organisation, supported by collaboration with scientific societies (ESCV, PASCV, SoGAT, ESCMID) and industry partners.
QCMD is formally established as an independent not-for-profit organisation to continue and expand molecular EQA activities internationally – at a time when PCR is rapidly moving into routine clinical diagnostics.
QCMD launches its first online participant platform (ITEMS), enabling online registration, result submission, reporting and scheme management – an important step towards digital EQA operations.
QCMD evolves from a European initiative into a global EQA organisation, extending coverage to more pathogens, targets and applications (e.g., detection, quantification, genotyping, sequence analysis). Two important developments for emerging pathogens are the dedicated influenza H-subtyping scheme, launched in 2006 (incl. H1N1nv, H5N1 and H7N7), and the inclusion of enterovirus D68 in the enterovirus scheme. Long-running schemes for HIV, HBV, HCV, HSV, enteroviruses, Chlamydia trachomatis, Mycobacterium tuberculosis and other pathogens drive continuous improvements in laboratory performance worldwide.
Participant registrations grow from:
600+ registrations in 36 countries (2002)
to
5,500+ registrations in 80+ countries (2010)
QCMD is first accredited to ISO/IEC 17043 by UKAS, strengthening its role as an internationally recognised provider of molecular proficiency testing.
Until then, QCMD’s quality management system is certified to ISO 9001, and the EQA schemes are conducted in accordance with a strict Code of Practice compliant with the requirements of the time, such as ISO/IEC Guide 43-1, ILAC-G13 and ISO/IEC 17025.
By 2009, MALDI-TOF has been widely introduced into routine clinical laboratories as a reliable method for identifying bacteria and fungi. Its ease of use and cost-effectiveness lead to the integration of MALDI-TOF workflows into everyday clinical practice.
While general bacterial and fungal identification EQA schemes are available, QCMD launches an ISO/IEC 17043 accredited EQA scheme designed specifically for MALDI-TOF, highlighting the method’s strengths and weaknesses as workflows mature.
A new version of ITEMS (QCMD’s online EQA management system) is launched. It supports the entire EQA lifecycle and introduces many new features, including a participant management dashboard, reusable workflows and a suite of automated data analysis and report generation tools.
Since then, ITEMS has proven to be a robust platform for adapting to the changing needs of EQA.
Participant registrations exceed 10,000 for the first time, across 96 countries.
QCMD distributes an outbreak-related EQA to help laboratories in Latin America, the Caribbean and other affected countries worldwide. Its swift introduction is made possible by collaboration with the Paul Ehrlich Institute.
This EQA includes the 1st WHO International Standard for ZIKV NAT together with additional candidate reference material. Both remain part of the current scheme design, supporting assay standardisation and preparedness for a high-priority arboviral pathogen.
As molecular diagnostics evolve from single-target PCR to multiplex syndromic testing, sequencing and genomics, QCMD broadens its EQA portfolio accordingly.
New scheme areas include:
During the 2022-2023 mpox outbreak, QCMD develops and launches an international EQA scheme at short notice, in collaboration with the Bundeswehr Institute of Microbiology in Munich.
The scheme helps laboratories worldwide validate newly established molecular diagnostic workflows and contributes to the growth of diagnostic preparedness during the outbreak.
Together with partners from the RECOVER project and collaborating networks (PREPARE, COMBACTE LAB-Net and EVD-LabNet), QCMD quickly provides laboratories worldwide with one of the earliest available molecular EQA schemes, helping verify assay performance, laboratory readiness and diagnostic quality during an unprecedented expansion in testing.
This strengthens QCMD’s role in global public health preparedness and in the ability to respond swiftly to emerging pathogens.
Today QCMD:
QCMD continues to promote quality, standardisation and innovation in molecular infectious disease diagnostics – powered by the expertise, dedication and teamwork of the people behind QCMD in Glasgow.
