Dr Barnali Das
MBBS, MD, DNB & PGDHHM
Consultant in Laboratory division of Kokilaben Dhirubhai Ambani Hospital & Medical Research Institute, Mumbai, Executive Member, Scientific Division, International Federation of Clinical Chemistry & Laboratory Medicine (IFCC), Chair of American Association of Clinical Chemistry (AACC) India Section and College of American Pathologist (CAP) Inspector & NABL Assessor shares insights on the key aspects of laboratory medicine in today’s times and talks about her experiences in this field.
Dr Das is a multifaceted talent and prominent professional on National and International Platforms in the realm of laboratory medicine. She is a recipient of two oration awards and four international and seven national awards from American Association of Clinical Chemistry (AACC Outstanding Speaker Award), International Federation of Clinical Chemistry & Laboratory Medicine (IFCC Development of Quality Competence in Medical Laboratories- DQMCL Award), College of American Pathologist (CAP Inspector Excellence Honour), Asia Pacific Federation of Clinical Biochemistry (APFCB Young Scientist Scholarship), Reliance Group Corporate Social Responsibility (The Woman of Substance Award), Association of Clinical Biochemists of India (Dr T N Pattabhiraman Oration Award, Pitabus Jamuna Burma Memorial Award and Dr C Sita Devi Award) and Association of Medical Biochemists of India (Dr Ajit Singh Saini Oration Award and also Brig Ramesh Sinha Memorial Certificate & Gold Medal). She is a recipient of 2019 “Diagnostic Leadership Award in Achiever Category” from Indian Express Group, MT India 2019 “Healthcare Leader in Quality & Management” in Voice of Healthcare and 2019 Zee Business National Healthcare Leadership Award in ‘Woman Leadership Category’.
Dr Das is quite aspirational about the future.“If you put passion and dedication in your work, it will give meaning to your life,” she philosophises.
She has recently been honoured as “Best Docs Mumbai 2020” in the General Pathology field in the magazine ‘Outlook’ issue of the year and “ Top Doctors Mumbai” in the ‘India Today’ September issue.
She has many publications in high impact factor international and national journals (recent ones are Clinical Chemistry, European Thyroid Journal, Clinical Biochemistry, Indian Heart Journal, Indian Journal of Medical Biochemistry, Indian Journal of Clinical Biochemistry etc.).
She has also delivered more than a hundred invited talks and plenary lectures at both national and international forums.
Her biography has been featured in a book (2018) named “And So Can You”, which contains stories of 17 renowned doctors in India.
Q. As a prominent professional in laboratory medicine, what according to you are the major challenges in the field of clinical chemistry and immunoassay?
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 & 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 and interfering substances. This variation can be to such an extent that, each individual may seem to have their own set-point of these hormones, as an example, for that of thyroid-stimulating hormone (TSH).
Therefore, harmonisation of procedures is the need of the hour. The clinicians and diagnosticians have to grapple with is the variability of test-results; even a broadly similar set of instruments and methods can provide different results, even as much as 40% more or less, for example, in case of TSH values. It is then a real challenge to the physician to decide whether the patient is suffering from a disease or is it something else, since other factors can also cause changes in test levels.
“If you put passion and dedication in your work, it will give meaning to your life”
Due to the lack of proper reference intervals and sometimes due to standardised measurement procedures, standardisation and harmonisation of clinical chemistry and immunoassay testing still remains a formidable challenge
Q. Have you done anything to establish a reference interval to address the above challenges?
Ethnicity-specific cut off of TSH is important for accurate test reports. I am also the corresponding member, IFCC Committee for Reference Interval & Decision Limit (IFCC C-RIDL) and was associated with IFCC Committee on standardisation and harmonisation of Thyroid Functions Tests (C-STFT). In India, we started by organising thyroid camps and every year around 1000 TSH screenings were done during World Thyroid Day. We have established reference interval for TSH and FT4 in the Indian population.
The reference interval (90 per cent confidence interval) for TSH by the non-parametric procedure (bootstrap) is 0.48-4.52 micro IU/ml, and by parametric one (after transformation of the data), it is 0.45-4.27 micro IU/ml for the adult population, which is little different from the manufacturer’s guidelines.
Secondly, the availability of high-sensitivity cardiac troponin assays (hs-cTnI or T)in the setting of Acute Coronary Syndrome (ACS) has allowed for rapid risk assessment of an ongoing myocardial infarction. However, there were concerns raised about the use of the single, universal cut-off value of hsTroponin I for both men and women, as there is a potential risk of under-diagnosis in women since they have a lower threshold value of troponin. We conducted a study for six months on 2804 patients and observed that around 14 per cent of women were under-diagnosed with an acute coronary syndrome, if we use gender-specific cut off (Male: 32.3 pg/ ml and Female: 14.6 pg/ml for the Indian population) with high sensitive troponin I assay, near the 99th percentile of a reference control population. However, implementation of gender-specific diagnostic threshold helped in identifying more women at increased risk of ACS or death, than a generic threshold.
Q. You are a part of the Executive Committe of IFCC Scientific Division Worldwide and also Chair of AACC India Section. How do you manage these additional responsibilities along with heading Biochemistry and Immunology Lab of one of the Topmost Corporate Hospital of India?
My mantra in life is ‘playing to my strengths and working with hundred per cent dedication in whatever I do.’ I very much enjoy my work at Kokilaben Dhirubhai Ambani Hospital and try to put my full strengths in work with empathy, team spirit and dedication. I try to celebrate different views, embrace change and respect innovation.
Being an Executive Committee Member of the IFCC (International Federation of Clinical Chemistry and Laboratory Medicine) Scientific division and Chair of AACC (American Association for Clinical Chemistry) India section, I feel that I have a bigger role to play, so as to incorporate quality competence in healthcare, implementation of standardisation and harmonisation of laboratory testing, bridging the gap between diagnosticians and clinicians & also to connect with the professionals in clinical chemistry, pathology, molecular diagnostics and IVD industry.
Different Committees and Working Groups under the Scientific Division of International Federation of Clinical Chemistry & Laboratory Medicine (IFCC) has been formed to address the issues of standardisation and harmonisation of laboratory testing. Being a part of the Executive Member of IFCC Scientific Division, we have been entrusted with the responsibility on the need and methods of standardization and harmonization all around the globe. IFCC is encouraging a lot of awareness-channels - organizing events, research publications and news articles. The committee is discussing with Lab community, Clinicians, Clinical societies, IVD industry, Regulatory bodies and EQA providers to formulate guidelines for assisting in correct measurement, diagnosis and management of diseases.
Q. Can you please elaborate the above points with examples?
Here are a few examples and technical solutions to address laboratory challenges and to take it forward from both Clinical Chemistry as well as Immunoassay platforms.
There has been a continuous challenge within global healthcare systems such as the US, Europe and other countries to standardise and harmonise the HbA1c reporting. the decision on what to report in NGSP ( per cent) and/or IFCC (mmol/mol) units along with eAG (in either mmol/L or mg/dL). This globalisation places a responsibility on laboratory medicine specialists to work together to reduce the current variability in patient results, which arise 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 standardisation (with worldwide uniform clinical guidelines), with HbA1c reflecting the true estimated average glucose.
Due to the standardisation efforts of IFCC, NGSP and other national organisations, and also due to ongoing efforts of manufacturers and laboratories, the quality of HbA1c reporting has increased dramatically. It is so much so that, there has been a paradigm shift. HbA1c is now considered the gold standard, not only for monitoring but also for diagnosis of diabetes.
Similar standardisation and harmonisation efforts are ongoing on the other fields, like: Traceability in Laboratory Medicine (C-TLM), Reference Intervals and Decision Limits (C-RIDL), Harmonization of Autoimmune Tests (C-HAT) and Standardization of Thyroid Function Tests (C-STFT), Pregnency Associated Plasma Protein A (WG-PAPPA), Growth Hormone (WG-GH), Bone Metabolism (C-BM), Molecular Diagnostics (C-MD), & Troponin I (WG-TNI) to name a few.
Q. You have published several papers in scientific journals and newspapers on routine laboratory’s role in COVID-19. Can you please share your experience in Kokilaben Dhirubhai Ambani Hospital & Medical Research Institute?
The critical role of laboratory medicine in this pandemic extends far more than an etiological diagnosis of COVID-19, by reverse transcripase polymerase chain reaction (rRTPCR). Routine laboratory monitoring of COVID-19 patients through testing is critical, for assessing disease severity and progression, as well as monitoring therapeutic intervention. In addition to more common laboratory tests like LFT, KFT, Blood Gas, CBC, CRP etc. patients with severe COVID-19 could be at risk of macrophage activation syndrome (MAS) or cytokine storm. Therefore, routine biomarkers play an essential role in patient admission protocol, assessment of staging of disease according to severity, prognostication, patient monitoring and therapeutic guide.
We have analysed routine laboratory markers to test significance in Kokilaben Dhirubhai Ambani Hospital & Medical Research Institute. A total of 528 subjects were considered for the study which included 370 male (70 per cent) and 158 female (30 per cent) subjects. These subjects fall in the age group of 12 years to 93 years (median age 61 years). 40 healthy adults without any history and clinical evidence suggestive of COVID-19 and without any comorbidities, like diabetes, hypertension chronic lung disease, cardiac disease, cancer and immunocompromised individuals were considered as a control group for the study. The routine laboratory findings supported the diagnosis with elevated levels of Interleukin-6 (IL-6), C Reactive Protein (CRP), Procalcitonin, High Sensitive Tropinin I (hsTnI), AST, ALT, Direct Bilirubin, D Dimer, Ferritin, LDH, Creatinine, Blood Urea Nitrogen (BUN), Neutrophil count, WBC Count, Lactate, NT Pro BNP and decreased levels of Albumin, SO2 per cent and Lymphocyte count.
Q. What is your final message to healthcare providers?
The road map for laboratory medicine, therefore, will involve strategies for harmonising, 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.
Q. Any message to laboratory professionals during this pandemic time?
The role of the Laboratory Professionals has been redefined in the race against COVID-19. Hats off to laboratory professionals who are the frontline warriors in this pandemic, ready for any duty, filling our life with a positive attitude. This COVID-19 Pandemic is showing us the reality of life. I am proud of our unsung heroes. Moreover, the untiring service of lab professionals is very much valuable for all of us, for hospitals, for this country.
Q. What is your message to the younger generation?
We all struggle on our way to failure or success and each one of us deal with life in our unique ways. Passion, perseverance, resilience hold the key. Nevergive up on enthusiasm. Never compare yourself with others. Never bother about success or failure, just keep giving your best and keep improving yourself. Success, according to her, is relative and not absolute. Also, each one has their own definition of success. But one thing is sure, whatever success is, it is not something to be chased
