Traceability in Laboratory Medicine: supporting the COVID-19 response
The coronavirus pandemic has stopped large parts of the world in its tracks. Presently, countries across the globe are experiencing different stages of the wave of the infection, leading to varying levels of lockdown reinstallments and attempts to resume normality.
Importantly, governmental decisions to ease lockdown restrictions are strongly influenced by the rate of accrual of new infections for any given population.
Reliable testing results are thus essential to delineate true cases from other non-coronavirus ‘flu-like’ symptoms - even at the very onset of the infection and for those with just mild symptoms.
In response to an urgent global need, healthcare professionals, laboratory medicine specialists and diagnostic assay developers worldwide have sprung into action - and today a multitude of COVID-19 tests continue to be developed, including those that cater specially for the European market.
Members of EURAMET's Metrology Network for Traceability in Laboratory Medicine (EMN TraceLabMed) are key drivers behind these efforts. The network is proud to assist on several levels:
- providing metrological expertise;
- coordinating European proficiency testing schemes;
- providing reference values for common reference materials; and much more.
Traceability for COVID-19 tests
At the onset of the COVID-19 infection, the virus multiplies in its human host, shedding multiple copies of its heritable material (its RNA) throughout the system of the host. This RNA can be extracted from a patient's sample together with massive amounts of other nucleic acids from its human host. Highly specific nucleic acid amplification techniques (polymerase chain reaction, PCR) are needed to find the rare traces of the virus. It is the presence of viral RNA traces in the PCR that then confirms the infection.
Over the course of the infection, antibodies against viral surface proteins will form in the patient and can be identified even if the acute phase of the infection has passed. The testing procedure is therefore not as straightforward as often assumed. Given many of these tests are developed ad hoc and might not be particularly sensitive in patients, it is not surprising that many countries have resorted to testing serious cases of the infection only.
This lack of sensitivity in testing can result in an inevitable miss of a large fraction of the infections at a given time point. Results can also vary wildly for different test providers, even if material from the same patient is repeatedly analysed with different tests. Given the need for quick test results, many tests have been developed and have gained European market access under the still-applicable in vitro diagnostic directive (IVDD).
Comparing test quality
The quality of COVID-19 viral and antibody diagnostic tests can be compared through the use of well-characterized common reference materials. Important questions concerning the quality of testing that provide insight into the most preferable tests overall - including the limits of detection and quantification and the precision of measurements of known reference substance amounts in a sample - are all typically answered using metrological tools.
TraceLabMed members play a significant role here, and their work on enhancing the quality and validity of test diagnoses will support healthcare systems and contribute to the worldwide coronavirus response.
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