The findings of laboratory tests are crucial in diagnosing medical disorders and making treatment options. Making measurements traceable to the International System of Units (SI), which represents the highest rank of a common measuring base, can yield uniform and comparable findings.
The European Metrology Network for Traceability in Laboratory Medicine (EMN TraceLabMed) has established a coordinated metrology infrastructure at EURAMET specifically for this purpose: to achieve metrological traceability of in-vitro diagnostics (IVDs), which are used to support an estimated 70% of all medical decisions. Today, the network continues to collaborate with key stakeholders to ensure that the health sector’s measurement needs are satisfied on a consistent basis.
Calibration laboratories are the link between National Metrology Institutes (NMIs) or Designated Institutes (DIs) and ordinary testing laboratories in the metrological traceability chain.
Calibration laboratories serve as multipliers to the IVD industry and medical laboratories by making their services traceable to the SI (e.g., by providing intercomparisons with metrology institutions). They can meet the demands of EU regulation, such as the directive 2017/746 on metrological traceability, by providing SI traceability to a broad base of end-users in this way.
Partnering with EMN TraceLabMed
The calibration laboratories INSTAND, Ref4U, RfB, and WEQAS have all officially joined EMN TraceLabMed as new partners. To formally join EURAMET’s network, the partners just signed a Memorandum of Understanding.
“The basic mission statement of RefU4, as a calibration laboratory, is to support efforts to design and deploy a measurement infrastructure for SI-traceable measurands in laboratory medicine,” said Katleen Van Uytfanghe of Ref4U. RefU4’s interactions will be further bolstered by a strong collaboration with NMIs, DIs, and calibration laboratories through a partnership in EMN TraceLabMed.”
Close collaboration between NMIs, DIs, and calibration laboratories, according to the EMN, will greatly increase the spread of metrological concepts in laboratory medicine, as well as stimulate the creation of novel reference measurement methods for additional laboratory measurands.
RfB’s Anja Kessler added, “In order to actively implement metrological traceability, a functioning network between NMIs and calibration laboratories is required.” As a result, the EMN represents a significant step toward ensuring long-term traceability in laboratory medicine for the benefit of patients. RfB is ecstatic to be a member of this community.”
Patricia Kaiser, writing in INSTAND, says: “For decades, Instand has supported the concept of metrological traceability of measurement findings as an internationally active EQA organisation with its own calibration laboratory. We place a high value on strong collaboration within the EMN metrological network. We are glad to be able to contribute to the future demands on metrology in laboratory medicine in the interest of patient safety as part of our collaboration.”
The European Metrology Network has effectively consolidated this vital strategic cooperation with INSTAND, Ref4u, RfB, and WEQAS.
More information about the new partnering laboratories
INSTAND, Ref4U, RfB, and WEQAS are non-profit organisations that run calibration labs that are ISO 17025 and ISO 15195 approved. The IVD industry, quality control manufacturers, External Quality Assessment (EQA) providers, and clinical laboratories can access accredited calibration services through the Joint Committee for Traceability in Laboratory Medicine (JCTLM) database.
Medical laboratories, independent pharmacies, primary care physicians, occupational health providers, forensic pathology services, veterinary pathology laboratories, clinical trial units, and diagnostic companies use the external quality assessment schemes offered by INSTAND, RfB, and WEQAS, which are all ISO 17043 accredited. Many of the EQA schemes available are supported by metrological traceability.