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Clinical chemistry and immunoassay test results: Harmonisation and standardization of discordant notes
Indian Journal of Clinical Biochemistry ; 36(SUPPL 1):S3-S4, 2021.
Article in English | EMBASE | ID: covidwho-1767673
ABSTRACT
However, it is this very set of tests that have come Hin question. First, what is the normal and acceptable range (upper & lower limits) of different Clinical Chemistry and Immunoassay biomarkers in a particular population has been debated in different scientific fora. This is because the level of markers can change in relation to other biochemicals, biomolecules and hormones, which themselves vary considerably with race, gender, age, different physiological conditions (like pregnancy, new-born) and other illnesses & interfering substances. The variation can be to an extent that each individual can seem to have their own set-point of these parameters. A second problem which the diagnosticians 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 physicians, to decide whether the patient is suffering from a disease or not, since other factors can also cause changes in test levels. Standardization and harmonization of clinical chemistry and immunoassay testingis 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. In this talk, I will provide few examples and technical solutions to address laboratory challenges and to take it forward from both Clinical Chemistry as well as Immunoassay platforms. To begin with, harmonization and standardization of TSH and other thyroid function tests are still a formidable challenge, due to the lack of proper reference intervals and standardized measurement procedures. It has been documented that even a broadly similar set of instruments and methods can give up to 40% more or less values in TSH levels. Based on a particular population's demographic variations, reference interval can be different for immunoassay like TSH. Therefore, we have verified the reference interval for the Indian population for TSH in our laboratory. We have screened 800 subjects, of which 630 healthy subjects were chosen in the study group for reference interval verification. The reference interval (90% Confidence interval) for TSH by non-parametric procedure (bootstrap) was 0.48- 4.52, and by parametric one (after transformation of the data) was 0.45-4.27 for the adult population, which is little different from the manufacturer's guidelines. Similarly, we have conducted a study of 2797 female patients and 2805 male patients in a six month period and have observed that, women have a greater risk of being 14% under-diagnosed of acute coronary syndrome, if we donot use gender specific cut off (Male 32.3 pg/ml and Female 14.6pg/ml for the Indian population), with high th sensitive troponin I assay near the 99 percentile of a reference control population. Therefore, implementation of sex-specific hs-cTnI assay was able to identify 14% of under-diagnosed women with ACS in 6 months period. This in turn also decreased the number of men being diagnosed by 3%. On a similar note, there has been a continuous challenge in the health care system in U.S, Europe and other countries to standardize and harmonize the HbA1c reporting the decision on what to report in NGSP (%) 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. Due to the standardization efforts of IFCC, NGSP, and also due to ongoing efforts of manufacturers and laboratories, the quality of HbA1c reporting has increased dramatically. Consequently, there has been a paradigm shift HbA1c is now considered the gold standard, not only for monitoring, but also for diagnosis of diabetes. We have performed verification studies of HbA1c by different

methods:

HPLC, Capillary Electrophoresis, Enzymatic, Immunoassays in 200 samples and compared 60 samples with hemoglobinopathies. Finally, we have also explored harmonizing the clinical protocol based on the use of inflammatory and routine laboratory biomarkers in 2,654 COVID-19 patients. To explain the role of harmonizing routine laboratory parameters in disease monitoring, two adult males, two adult females and one adolescent girl were selected. These are representative examples of different manifestations of COVID 19, with Adult Respiratory Distress Syndrome (ARDS), Cardiac Injury, Neurological manifestations and Pediatric Multi system inflammatory syndrome (PIMS), admitted in the Intensive care unit (ICU) of the hospital, which will be discussed. Therefore, the road map for laboratory medicine 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.
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Full text: Available Collection: Databases of international organizations Database: EMBASE Type of study: Prognostic study Language: English Journal: Indian Journal of Clinical Biochemistry Year: 2021 Document Type: Article

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Full text: Available Collection: Databases of international organizations Database: EMBASE Type of study: Prognostic study Language: English Journal: Indian Journal of Clinical Biochemistry Year: 2021 Document Type: Article