The Odyssey Of Clinical Chemistry And Immunoassay Test Results: Harmonization Of Discordant Notes
Clinical chemistry and immunoassay tests form a very important set of tests in a pathology laboratory; a tool that clinicians and patients alike depend on to pin down the symptoms for treatment and relief. However, it is this very set of tests that have come in question. First, what is the normal and acceptable range (upper and lower limits) of different biomarkers in a particular population has been debated in different scientific fora.
A second problem which the doctors and technicians have to grapple with is the variability of test-results in itself; even a broadly similar set of instruments and methods can provide variable results. It is then a real challenge to the physician to decide whether the patient is suffering from a disease or something else, since other factors can also cause changes in test levels. Standardization and harmonization of clinical chemistry and immunoassay testing are therefore still a formidable challenge, due to the lack of proper reference intervals and sometimes due to standardized measurement procedures. Laboratory medicine community the world over has realized that variability in test results in different platforms can create a lot of confusion to clinicians and the general population; harmonization of procedures is therefore the need of the hour.
Different committees and working groups under the Scientific Division of International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) and American Association of Clinical Chemistry have been formed to address these issues. Being a part of the Executive Member of the IFCC Scientific Division, we have been entrusted with the responsibility to spread awareness on the need and methods of standardization all around the globe. IFCC is encouraging a lot of awareness-channels – organizing events, research publications, and news articles. The committee is discussing with the IVD industry, kit manufacturers, clinicians, hospitals, and laboratories to formulate guidelines for assisting in correct measurement, diagnosis, and management of diseases. Here, I will provide an example and technical solution to address laboratory challenges and to take it forward from both clinical chemistry as well as immunoassay platforms.
There has been a continuous challenge in the healthcare system in the United States of America, Europe, and other countries to standardize and harmonize the HbA1c reporting: the decision on what to report in NGSP (percentage) and/or IFCC (mmol/mol) units along with eAG (in either mmol/L or mg/dL). This globalization places a responsibility on laboratory medicine specialists to work together to reduce the current variability in patient results, which arises from differences between units, methods, and laboratory practices in different countries. The IFCC method is in place and opens up the perspective of a global standardization (with worldwide uniform clinical guidelines), with HbA1c reflecting the true estimated average glucose. Due to the standardization efforts of IFCC, NGSP, and other national organizations, and also due to ongoing efforts of manufacturers and laboratories, the quality of HbA1c reporting has increased dramatically. So much, that there has been a paradigm shift: HbA1c is now considered the gold standard, not only for monitoring, but also for diagnosis of diabetes.
The road map for laboratory medicine, therefore will involve strategies for harmonizing, communicating, and integrating with all stakeholders, like, clinicians, diagnosticians, and IVD industry, in order to formulate guidelines for assisting in correct measurement, diagnosis, and management of diseases.
