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Background: The application of the Six Sigma (σ) metric in biochemical laboratories is a powerful tool for reducing the occurrence of errors and prioritizing important improvements in laboratory quality control. The National Accreditation Board for Testing and Calibration Laboratories (NABL) is an accreditation body with an accreditation system established in accordance with ISO/IEC 17011, providing specialty- or scope-based certification based on the conformance of quality indices to medical laboratories. In this context, a study has been designed that considers the quality guidelines set by NABL as well as the sigma metric rule in the assessment of analytical performance. Aims and Objectives: The aims of this study were to identify the gaps and need for strategy modification for quality improvement by assessing the performance of two NABL-accredited medical testing laboratories on a Sigma metric scale. Materials and Methods: A retrospective analytical study was conducted over 6 months (January–June 2021). Internal quality control (IQC) and EQAS data were obtained from third-party QC providers (Bio-Rad, India) and analyzed by calculating sigma (σ) values based on the coefficient of variation, bias, and total error allowable in two NABL-accredited medical testing laboratories. To identify potential problems for analytes with poor sigma values, a quality goal index (QGI) analysis was performed. Results: By analyzing the sigma values obtained by both NABL-accredited laboratories, we can see that laboratory 2 performed better than laboratory 1. After calculating the QGI, there was a problem of inaccuracy and imprecision in laboratory 1, and laboratory 2 had QGI values that indicated only imprecision. Conclusion: Diagnostic laboratories should incorporate Six Sigma metrics to identify gaps in their performance to ensure better quality control and patient safety.

Introduction: Renal transplantation provides the best result as a long-term renal replacement therapy. Lymphorrhea is considered a common surgical complication of renal transplantation. Although nonsurgical factors are also associated, it is primarily due to damage and improper ligation of lymphatic vessels draining donor kidney and perivascular lymphatics of iliac vessels. Lymphorrhea is associated with prolongation of hospital stay and increased chances of infection and it may lead to lymphocele formation. Hence, to localize the origin of postoperative lymphorrhea in transplant recipients in wake for its definitive management, the enzymatic activity of the two enzymes, namely, creatine phosphokinase (CPK) and Lactate dehydrogenase (LDH) in the drain fluid was evaluated. Materials and Methods: A total of 68 renal transplant recipients (including live and deceased-donor [DD] transplantation) were evaluated for2 years. The enzymatic value of CPK and LDH was calculated in perigraft drain fluid. It was compared with the values of CPK and LDH in postradical cystectomy pelvic drain fluid and simple renal cortical cyst fluid. The average value of CPK in pelvic drain fluid and LDH in renal cortical cyst fluid was considered as their baseline value in lymphatics draining lower limb and renal lymphatics, respectively. Results: The source for postoperative lymphorrhea in DD and live-related donor was iliac lymphatics, whereas in live unrelated donor, it was iliac and graft kidney lymphatics. Conclusion: Drain fluid assessment for CPK and LDH activity can localize the origin of lymphatic leak in renal transplant recipients.

Context: Dengue, a mosquito-borne viral infection in the tropical regions of the world, has recently become a major public health concern. In West Bengal, several outbreaks of dengue fever occurred in the past few years. In the present study, serological analysis, molecular detection, and serotyping of dengue virus were done to identify the serotype/s presently circulating in the region. Methods: The present study was conducted for a period of 1 year from November 2017 to October 2018 in the Department of Microbiology, ID and BG Hospital, Kolkata. 5240 blood samples collected from clinically suspected dengue fever cases were screened for dengue specific immunoglobulin M (IgM) antibody by MAC-ELISA and NS1 antigen by NS1 ELISA according to the duration of fever as per the National Vector Borne Disease Control Program guidelines. Molecular detection and serotyping were done in 70 NS1 positive samples by nested reverse transcription-polymerase chain reaction. Results: Total 5240 samples were tested for dengue. About 30.48% (1597) were serologically reactive for dengue infection (either IgM or NS1). Among these, 80.52% (1286) were NS1 reactive and 19.47% (311) were IgM reactive. Male predominance (66.37%) was observed throughout the study period. A post monsoon season peak was also noted in our study. DEN2 was found as most prevalent serotype presently circulating in the region. Conclusions: Laboratory-based active surveillance system is required which can forecast dengue epidemics by detecting increasing number of dengue cases or changing pattern in the prevalent serotype as a specific serotype (viz.DEN2) is associated with higher incidence of complications. This will help alert the public and physicians to diagnose properly and treat cautiously the complicated dengue cases.

Introduction: Ischaemic Heart Disease (IHD) is a common health burden. Dyslipidemia is an established risk factor for the disease. Studies have been conducted to evaluate any possible relation of the disease with alterations of magnesium and potassium. But, among patients of Eastern India, studies to associate the condition with these analytes as well as their possible relationship with serum lipid profile have been rare. Aim: To evaluate the non diabetic, normotensive IHD patients attending a tertiary care hospital to find out whether there was any association of the disease with altered serum Magnesium (Mg) and Potassium (K) and to detect possible correlation of these electrolytes with serum lipid levels. Materials and Methods: This case-control study was conducted in the Departments of Biochemistry and Medicine of the Institute of Postgraduate Medical Education and Research, Kolkata, West Bengal, India, from January 2019 to June 2020. This study included 106 non diabetic, normotensive IHD cases {encompassing 52 Chronic Coronary Syndrome (CCS) and 54 Acute Myocardial Infarction (AMI) patients} along with 103 age and sex matched healthy controls. Serum magnesium, potassium and lipid profiles were assessed. Student’s unpaired t-test and Pearson correlation tests were performed using Statistical Package for the Social Sciences (SPSS) version 23 software. Results: Mean age of the control and case groups were 63.95±7.94 and 63.60±7.56 years, respectively. The case and control groups were comparable for age and gender distribution as no statistically significant difference was found. The cases had a significantly lower serum Mg and K (p

Introduction: Management of post Coronavirus Disease-2019 (COVID-19) complications are the new challenges nowadays. It has been observed that in post COVID-19 cases the serum levels of several electrolytes and trace elements are deranged. Aim: This study was conducted to estimate the levels of different serum minerals and trace elements in one month post COVID-19 follow-up patients and compared with normal agesex matched controls. Materials and Methods: This hospital based cross-sectional study was conducted in the Department of Biochemistry in a tertiary care centre, over a period of six months (from January 2021 to June 2021). After fulfilling proper inclusion criteria, 223 COVID-19 follow-up patients of both genders (134 males and 89 females) were included as ‘case’ group. Age-sex matched 250 healthy volunteers were recruited as ‘control’ group. Levels of serum electrolytes (sodium and potassium) and trace elements (zinc, iron, calcium, phosphate, copper, magnesium and selenium) were estimated, analysed and compared against each other. Tables and statistical analysis was done using Statistical Package for the Social Sciences (SPSS) version 20.0. Results: In this study, the levels of serum zinc and iron were found to be higher and serum calcium, phosphate, copper, magnesium and selenium levels were reduced in post COVID-19 one month followup cases in comparison to controls. Female cases were in deficient state of iron, calcium, copper and magnesium but had high serum zinc and phosphate when compared to males. No abnormalities were noted in the level of electrolytes in post COVID-19 cases. Conclusion: Assessment and monitoring of levels of the mineral throughout the course of post COVID-19 follow-up is advisable for timely and appropriate measures to combat with post COVID-19 complications.

Background: Vitamin D (Vit D) is a steroid hormone essential for maintaining functional homeostasis in the body. Hypovitaminosis D has been a recognized worldwide problem affecting all age groups and sex. Its prevalence is very high in South Asia. Aims and Objectives: Therefore, this study was aimed to determine the spectrum of presentation of biochemical levels of hypovitaminosis D in Indian population in terms of age, sex, and multisystemic disorders. Materials and Methods: A cross-sectional study carried out on selective study population attending a tertiary care hospital from July 2019 to December 2020 with clinical presentations suspected to arise due to Vit D deficiency. Serum 25OH Vit D level was estimated by chemiluminescence method. Data were analyzed using GraphPad Prism 8. Results: Of the study population (n = 685), average serum 25(OH)D level in females and males was 24.13 ng/ml and 28.59 ng/ml, respectively. Significant difference in mean value of Vit D existed in males and females in the 21–40 years age group (p = 0.0048). Females in the Vit D deficient group (Vit D level

Objective: To determine correlation of important biochemical laboratory investigations in different trauma patients and their degree of injury severity and overall mortality association. Methods: In this hospital based retrospective observational study, 238 trauma patients were divided into two groups. Group I with injury severity score (ISS)16. Haemoglobin (Hb), international normalized ratio, serum creatinine, blood urea nitogen (BUN), serum electrolyte, serum uric acid and liver function parameters were recorded and statistically analyzed. Results: Group II had statistically significant (p 16). Conclusion: The study establishes the absolute need of doing three laboratory parameters (serum creatinine, serum blood urea nitrogen and serum potassium) instead of doing laboratory tests battery at the time of trauma victims admission and predicting survival among injured patients in trauma population from Indian settings.

Context: Malaria is one of the major public health problems worldwide with increased morbidity and mortality. India has the fourth highest malaria burden in the world. Malaria parasite affects multiple organs of the body including liver, spleen, brain, kidney, blood vessels etc. Organ dysfunction predominantly seen in Plasmodium falciparum malaria, is not in Plasmodium vivax infections. Aims: The present study investigated the abnormalities of liver function test in acute cases of Plasmodium Falciparum infection. Settings and Design: A hospital-based case–control study conducted in a tertiary care center in West Bengal, India, for a duration of 7 months and included 53 acute falciparum malaria cases attending the outpatient department (OPD) and 47 age and sex matched patients, with complaints unrelated to the present study, as controls. Materials and Methods: Serum levels of bilirubin, serum glutamic oxaloacetic transaminase (SGOT), serum glutamic pyruvate transaminase (SGPT), alkaline phosphatase, total protein and albumin were assayed using autoanalyzer (Konelab 60i autoanalyser). Statistical analysis used: SPSS software version 20 (IBM, New York, USA). Results: In this study serum bilirubin (total, conjugated and unconjugated ) SGOT, SGPT, alkaline phosphatase levels were highly significantly raised in cases with respect to controls. Levels of total protein, albumin and globulin in cases was not significantly different from the corresponding levels in controls. Conclusions: Hepatic function impairment in malaria is an important and potentially dangerous complication. Data from the present study can be useful for future research and also help in determining the prognosis and treatment.

Introduction: Graves’ Disease (GD), the leading cause of hyperthyroidism is caused by interaction between various autoantibodies generated as a result of autoimmune dysregulation in genetically suspected individuals. Aim: To study the prevalence of serum levels of Thyroid Stimulating Hormone (TSH) Receptor Antibody (TRAb), Antithyroid Peroxidase Antibody (Anti TPOAb) and Antithyroglobulin Antibodies (Anti TgAb) in subclinical cases of GD. Materials and Methods: This was a hospital based cross-sectional study conducted in the Department of Biochemistry, in a tertiary care hospital, over a period of one and half years from January 2019 to June 2020. A total of 120 patients with subtle symptoms of GD of age group between 30 to 60 years and same number of age and sex matched healthy controls were enrolled for the study. Collection of data was done and serum TRAb was estimated by Enzyme Linked Immunosorbent Assay (ELISA), while AntiTPO and AntiTg antibodies were measured using Electrochemiluminescence Immunoassay (ECLIA). Results: Serum levels of all the three antibody titres were found to be significantly higher in cases compared to controls. When diagnosis and differentiation of GD was done between cases and controls based on TRAb positivity (80.0%) or negativity (20.0%), it was found to have a sensitivity of 80% and specificity 98.3%. TRAb also had positive and negative predictive values of 97.9% and 84.3%, respectively. TRAb positive cases also had higher levels of Anti TPO and Anti TgAb in comparison to TRAb intermediate or negative group. Conclusion: Prevalence of high titres of autoantibodies especially TRAb are pathognomonic of early GD. Their detection in covert stages of disease shall provide insight into predicting outcome and frame management strategies in patients with this thyroid disorder.

Background: Pleural effusions often cause a diagnostic dilemma. The first step in the evaluation of pleural effusions is the distinction between exudates and transudates. Aims and Objectives: The current study was designed to distinguish these two broad subgroups of pleural effusions, based on the protein carbonyl gradient between pleural fluid and serum. Materials and Methods: Forty-four exudative and thirty-six transudative pleural effusion cases based on clinical findings and evaluation by Light’s criteria were selected. Protein carbonyl was measured by established photometric method using dinitrophenylhydrazine (DNPH) method in pleural fluid and serum of all the cases. Results: Oxidative stress, estimated by the protein carbonyl gradient between pleural fluid and serum, was found to be higher in exudates when compared to transudates. No significant difference was existent between exudates of different aetiology. However, the gradient was higher in exudates from males compared to females. No such difference was found among transudates. Conclusions: Carbonyl stress being a simple easily measurable biochemical parameter, pleural fluid to serum protein carbonyl gradient may serve as a useful tool for differentiating pleural effusions based on pathogenesis.

Introduction: Macroprolactin, an immunoreactive molecule resulting from association of monomeric Prolactin (mPRL) and immunoglobulin G is a significant cause of misdiagnosis, unnecessary radiological investigation and treatment for hyperprolactinaemia. Data on its prevalence and clinical manifestation varies regionally. Case presentation can vary with assymptomatic cases to those with galactorrhea and irregular menses. Aim: To find the prevalence and clinical features associated with macroprolactin in cases of hyperprolactinaemia in hospital patients. Materials and Methods: A cross-sectional study was conducted in the Department of Biochemistry, Institute of Postgraduate Medical Education and Research and SSKM hospital, Kolkata, India, from November 2018 to April 2019. Serum samples were assayed for serum PRL levels in 1400 subjects by Chemiluminescence immunoassay (Immulite 1000 siemens) based on presenting symptoms of galactorrhoea, amenorrhoea and infertility. Serum PRL samples (n=240) above the manufacturer’s reference cut-off level (PRL ≥30 ng/ mL) were obtained from patients with or without symptoms of hyperprolactinaemia. Retesting for PRL levels were done following precipitation of macroprolactin using Polyethylene Glycol (PEG, MW: 6000). Fourty cases with physiological causes of PRL excess, hypothyroidism, polycystic ovary syndrome, antidopaminergic drug intake, hepatorenal diseases and chest wall disorders were excluded. The results were expressed in terms of Mean±Standard Deviation (SD) and compared using student t-test. Results: Prevalence of macroprolactin was 16 (13.3%) out of 120 among true hyperprolactaemic cases (male=2; female, n=14) based on percentage recovery of PRL in post-PEG cases (Recovery Rate (RR)

Introduction: Dengue, a vector borne viral infection transmitted by Aedes mosquito has recently become a major public health concern in the tropical regions of the world. In addition to the two major life threatening complications- Dengue Haemorrhagic Fever (DHF) and Dengue Shock Syndrome (DSS), a variety of cardiac complications have been recognised, the most common being myocarditis. Aim: To study and compare the quantity of different cardiac biomarkers in patients of Dengue Fever with and without myocarditis. Materials and Methods: This was a hospital-based retrospective observational study done in a Tertiary Care Hospital, Kolkata, West Bengal, India from June 2019 to November 2019. Dengue patients with diagnosed myocarditis on day 7 of fever based on electro and echocardiogram changes of left ventricular ejection fraction less than 50% were considered as cases (n=41). Age and sex matched dengue patients with normal electro and echocardiogram changes were considered as control (n=43). After obtaining Institutional Ethics Committee Clearance, laboratory data were collected from samples coded and assayed for markers of acute cardiac myocyte damage such as total Creatine Kinase (CK), CK-Muscle Brain (CK-MB), Troponin T (Trop T) and cardiac failure biomarker N-Terminal pro Brain Natriuretic Peptide (NT-proBNP). Statistical analysis of the data was performed using Statistical Package for Social Sciences (SPSS 20). Results: Cardiac biomarkers CK, CK-MB, Trop T and NT-proBNP levels in cases were higher compared to controls (p-value

Background: Atopic dermatitis (AD) is a common childhood dermatosis and a distressing cause of morbidity. The pathogenesis of AD is known to be associated with disorders of immune response and defect in antioxidant defense, genetic predisposition, environmental triggers, psychosomatic factors, and other mechanisms. Retinol has immunomodulatory and antioxidant effects, thus may have a protective role in AD. Objective: The objective of this study was to evaluate the correlation of retinol levels in skin lesions and serum, with AD. Materials and Methods: The study was a hospital-based, case–control study. Punch biopsy from the skin and venous blood of 86 participants (including 43 cases and 43 controls) were assayed for retinol levels by a reversed-phase high-performance liquid chromatography method. Analysis of data was performed using appropriate statistical methods. Results: Skin and serum retinol levels were highly significantly decreased in patients in respect to that of controls. Conclusion: Retinol levels were decreased in AD. Retinol estimation may be used as a promising parameter for the elaboration of treatment strategy and monitoring.

Background: The Human Immunodeficiency Virus (HIV) and the Tuberculosis (TB) co infection are contributory to each other in causing a progressive decline in the cell mediated immunity and a damage to the hepatobiliary system. The aim of our study was to estimate the extent of liver damage which was caused by these infections before the start of the therapy with hepatotoxic drugs like Antiretroviral Therapy (ART) and Antitubercular Drugs (ATD). Methods: One hundred and ninty three confirmed HIV positive cases were enrolled in this study. The cases were divided into 2 groups; Group 1-100 subjects with TB and Group 2-93 subjects without TB.80 age and sex matched controls were also included (Group 0). Some parameters of the serum Liver Function Test (LFT) were estimated biochemically by using an auto analyzer (ERBA XL600,Transasia). Results: The serum total bilirubin, Alanine Transaminase (ALT), Aspartate Transaminase (AST) and the Alkaline Phosphatase (ALK-P) levels were significantly higher in the cases as compared to those in the controls, more so in the cases with the associated TB co infection, except the AST levels. The Group 1subjects had lower serum total protein and albumin levels and altered albumin/globulin ratios as compared to the controls. A statistically significant difference was absent in the serum total protein levels between the Group 2 cases and the Group 0 controls. No significant differences were observed when the values for serum total protein, albumin and globulin and the albumin: globulin ratios among the two case groups (1 and 2) were compared. Conclusion: The results have shown the importance of estimating some LFT parameters, prior to the start of ATD and ART in these cases. Hence, a mandatory performance of LFT is recommended, as it is simple and cost effective.

Background: Hepatitis C virus infection is a leading cause for chronic liver disease. It has wide population specific genotype variability. Genotype knowledge and viral load assessment are equally important for designing therapeutic strategies and as predictors of treatment outcome among hepatitis C (HCV) infected patients. Materials and Methods: Between June 2012 and 2013 an observational study was conducted among 350 chronic hepatitis patients visiting Calcutta National Medical College, Kolkata, India. Among them, 110 anti-HCV antibody positive cases were diagnosed and subjected to viral RNA extraction, viral genotyping and viral load quantification using polymerase chain reaction (PCR) based techniques. Statistical Analysis: Statistical analysis was done with IBM SPSS Statistics software, version 20. p-value