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Precision and accuracy are the two pillars of quality in analytical testing process of a clinical laboratory. External quality assurance (EQA) holds a major share in shaping the analytical quality from accuracy perspective. But this depends on how laboratory perceives an EQA, understands it, and uses it effectively for inaccuracy assessment. External quality assurance has its own advantages and limitations, including the commutability of EQA sample, traceability of methods of comparison, the statistical procedure used for evaluation, etc. Our study discusses three brief case reports through which we have tried to explore the advantages and limitations of EQA.

Introduction: Down syndrome is one of the common chromosomal anomaly which has various endocrinological abnormalities, of which thyroid dysfunction is very common. When Down syndrome and thyroid dysfunction are present together, it leads to amplification of the clinical problem. Aims and objectives: With this background, it was aimed to study the incidence of thyroid dysfunction in Down syndrome in pediatric (<12 years) age group and measure the growth velocity before and after initiation of treatment. Materials and methods: It is a retrospective analysis, which includes 50 children of Indian origin with Down syndrome between the age group of 1 and 12 years from neurodevelopmental clinic (multicentric) who met the phenotypic criteria for establishing the diagnosis of Down syndrome. The thyroid reports and ultrasound reports of thyroid gland for children with hypothyroidism were extrapolated and analyzed. Birth history, age of diagnosis of thyroid disorder, initiation of treatment, normalization of thyroid function, and anthropometric measurements before and 1 year after initiation of treatment were noted. Results: In this study, thyroid disorder (hypothyroidism) was found in 12 (24%) children, of which 7 (14%) were diagnosed at the age group of 0 to 1 year and 5 (10%) were diagnosed at the age of 1 to 12 years. The mean height in percentile was 9.92 ± 5.63 before and 43.75 ± 12.68 after supplementation of these children with L-thyroxine. None of the children had hyperthyroidism (p = 0.0001). Conclusion: As mental and physical retardation are common denominators in both Down syndrome and hypothyroidism, coexistence of both the conditions would lead to further developmental delay in terms of mental as well as physical health. Annual screening of thyroid function should be employed in these children to diagnose the problem at the earliest and initiate treatment, thereby improving the quality of life.

Introduction: Thyroid hormones influence renal development, renal hemodynamics, glomerular filtration rate (GFR), electrolytes, and water homeostasis. The location of the present study is situated at Darjeeling district of West Bengal, which is a part of sub-Himalayan Terai regions with high prevalence of thyroid dysfunctions, especially hypothyroidism. The objective of this observational cross-sectional study is to substantiate the effects of thyroid hormonal status on kidney by estimating serum creatinine, serum urea, albumin-to-creatinine ratio (ACR), and estimated GFR (eGFR) among drug naïve primary hypothyroid patients, hypothyroid patients under treatment for more than 2 months, and age- and sex-matched control group. Materials and methods: The study includes 48 patients with primary hypothyroidism in a drug naïve status, 40 hypothyroid patients under treatment, and 44 healthy control in the age group of 25 to 55 years. The collected blood and urine samples from the study population have been estimated for the study parameters. Both Chronic Kidney Disease Epidemiology (CKDEPI) equation and four-variable Modification of Diet in Renal Disease (MDRD) Study equation were used to calculate eGFR. Results: The mean values of serum creatinine, urea, and ACR are significantly increased among untreated patients with primary hypothyroidism, with the decrease in the eGFR, in comparison to healthy control group (p < 0.001); whereas patients on treatment for hypothyroidism show fall in serum creatinine, serum urea, and ACR level, with increase in eGFR values compared with drug naïve primary hypothyroid patients (p < 0.001). In addition, the results of eGFR and ACR are significantly correlated with thyroid-stimulating hormone (TSH) values. Conclusion: Statistically significant alteration in renal function parameters is associated with untreated primary hypothyroidism. Moreover, with the initiation of the treatment for the same can cause reversal of the altered status of renal function.

The aim of the study was to know the effects of steam sauna bath on fasting blood glucose levels (FBGLs). A total of 80 subjects, 40 males and 40 females, in the age group of 30 to 50 years were subjected to seven steam baths on alternate days. The temperature of the steam sauna was maintained at 50°C and each bath was taken for 15 minutes. Blood for FBGL was taken before the first steam bath and blood was taken again after seven steam sauna baths and the FBGL was estimated. The FBGLs after seven steam sauna baths were significantly decreased as compared with presteam sauna FBGLs. Steam saunas may help in preventing hyperglycemia and hence diabetes mellitus. It is also beneficial for healthy, asymptomatic subjects.

Aim: The purpose of the study is to assess the glomerular filtration rate (GFR) using Modification of Diet in Renal Disease (MDRD) formulae, and to estimate renal parameters including electrolytes in chronic alcoholics and compare all the parameters with normal controls. Materials and methods: A total of 50 male alcoholics were taken for the study on admission to the deaddiction center in Father Muller Medical College and Hospital. All the serum parameters were analyzed in auto analyzer Cobas c 311, and qualitative analysis of urine was done using dipsticks. Statistical evaluation was done using Student's t-test and Karl Pearson's correlation coefficient. Results: The mean estimated GFR (eGFR) in alcoholics of our study was slightly increased with an increase in 32% of alcoholics. A significant negative correlation of eGFR with age (p = 0.027) and urea (p = 0.039) was seen. There was a significant decrease in the levels of urea (p = –0.022) and potassium (p = –0.008). There was a mean increase in uric acid and decrease in phosphate levels. Qualitative analysis of urine showed proteinuria and hematuria in alcoholics with eGFR < 110. Conclusion: The study showed a spectrum of variation in the renal parameters assayed, with a significant decrease in urea and potassium levels. Validation of the findings by large-scale cohort studies is needed. Clinical significance: There is a significant decrease in the renal function with variations in electrolytes and a decrease in phosphate levels. Some cases also had proteinuria and hematuria, indicating progress toward chronic renal disease.

Introduction: Diabetes mellitus (DM) is a widely prevalent disease that has apparently become a global epidemic. Long-standing diabetes is characterized by development of several complications, including cardiovascular disease (CVD), nephropathy, neuropathy, and retinopathy. These complications share a common etiology of poor glycemic control and endothelial dysfunctions. Any metabolite which is atherosclerotic in nature may contribute to the development of such chronic complications. Dyslipidemia and hyperhomocysteinemia have been recognized as independent markers of atherosclerosis. However, their influence on each other and on insulin metabolism is highly debated. Evaluation of the association of these risk markers may be helpful in decreasing the occurrence of complications and increasing the age of diabetic patients. Aim: The present study was planned to study the association of homocysteine with the components of lipid profile and glycated hemoglobin in type II diabetic patients. Serum homocysteine and lipid profile levels of diabetic patients were also compared with those of healthy nondiabetic subjects. Results: Serum homocysteine and lipid profile were observed to have a strong association. Diabetic patients with hyperhomocysteinemia were reported to have higher S. cholesterol and low-density lipoprotein (LDL) levels. S. homocysteine was also found to be elevated in patients with HbA1c levels >8.0%, which indicates a poor glycemic control. On comparing with healthy subjects, S. homocysteine, cholesterol, triglycerides, LDL, and very low-density lipoprotein (VLDL) were also significantly higher in diabetic patients. Conclusion: Regular screening for serum lipid profile and hyperhomocysteinemia is strongly recommended in patients suffering from type II DM. Proper patient management in terms of controlling lipid levels, hyperhomocysteinemia, and maintenance of a good glycemic control can assist in averting the development of various complications and enhancing the quality of life.

Introduction: Diabetes mellitus (DM) is an epidemic facing the world today. The disease is characterized by a multitude of metabolic derangements which eventually lead to hyperglycemia and its associated complications. Trace elements, such as copper and zinc act as cofactors for essential enzymes of the metabolic pathways. Studies have reported conflicting results about their purported role in DM. Materials and methods: The study was conducted on 22 newly diagnosed cases of type II DM (T2DM) and 30 age- and sexmatched healthy controls over a period of 2 months under the Indian Council of Medical Research Short Term Research Studentship (ICMR-STS) scheme. Blood glucose, serum zinc, copper, and glycated hemoglobin (HbA1c) levels were estimated using commercially available kits on Transasia XL 640. Data were collected and analyzed using appropriate statistical tests. Results: The zinc levels were significantly decreased in the cases as compared with controls while there was no significant difference in the copper levels. A positive correlation between the copper and zinc levels was seen in the cases. Conclusion: Trace elements play an important role in the maintenance of blood sugar levels and an in-depth understanding of the underlying pathways may help in a better management of DM.

Introduction: Saliva as an alternative biological fluid of choice to blood in diagnosing systemic diseases evolved due to its noninvasive nature of collection. There is little information on the levels of thyroid stimulating hormone (TSH, thyrotropin) and T3 levels in saliva. The study was thus taken up to study the suitability of saliva for measurement of thyroid hormones in comparison to serum. Materials and methods: Fasting saliva and serum samples were collected from 30 healthy individuals for the measurement of total T3 (TT3), total T4 (TT4), TSH, free T3 (FT3), and free T4 (FT4). Timed samples were collected from 10 subjects for the evaluation of diurnal variation. Results: The thyroid hormones studied, i.e., TT3, TT4, FT4 and TSH were significantly higher in serum when compared to saliva (p < 0.01). A significant positive correlation was found between serum and salivary TSH (r = 0.420, p = 0.001). Variations in salivary TSH reflected the pattern seen in serum TSH. However, there was a lack of agreement between the measurement of TSH in serum and saliva when assessed using Bland Altman and Mountain plots. Conclusion: Saliva cannot be used as an alternate sample for analysis of thyroid hormones.

Introduction: Multiple teaching tools for medical undergraduates in biochemistry play a pivotal role for overall understanding of the subject and its applicability in clinical medicine. Students must be able to apply the knowledge of biochemistry effectively in dealing with real-life case scenarios. Objectives: To implement combination of multiple teaching tools topic wise; to evaluate the students’ perception toward effectiveness of combination of tutorials, case-based learning (CBL) sessions, video-based interactive sessions (VBIS) with demonstrations when they were supplemented and coordinated with didactic lectures (DLs) at regular intervals and also to evaluate the students’ perception toward usefulness of formative assessments. Materials and methods: Teaching methods were formulated for Carbohydrate metabolism and Genetics including multiple teaching tools. All 100 students of Phase 1 MBBS course were included. Formative assessments were conducted simultaneously with feedback to students. Students’ perception was collected regarding the effectiveness and usefulness of multiple teaching tools and formative assessments by a pretested questionnaire. Results: Regarding coordinated approach with multiple teaching tools like DL, tutorial, practical and CBL, most students felt that it was useful toward better understanding of the subject (83%), good retention of the subject (79%), improved communication skills (70%), and effective preparation for course end exams (83%). Students expressed that they want to have formative assessments regularly with feedback. Conclusion: Using a combination of multiple teaching tools separately for each topic improves the understanding and retention of the contents better as perceived by the students. Students felt that formative assessment with feedback reinforces their ability to perform better.

Introduction: Meningitis is one of the most serious health issues. The World Health Organization (WHO) defines as inflammation of the meninges, the covering of brain, and spinal cord. Most common cause is by infection. It is always reported with very aggressive and devastating outcome on health and continues to cause significant morbidity and mortality worldwide. The current study is focused on bioprofiling of cerebrospinal fluid (CSF) which can be aided for early diagnosis of meningitis and helpful for differentiating meningitis from nonmeningitis for deciding treatment regimen by the treating clinician. Objective: To study the biochemical parameters in meningitis patients and compare CSF bioprofile. Materials and methods: It is an observational analytical study with a total of 60 subjects aged between 18 and 60 years, conducted in Father Muller Medical College Hospital, Mangaluru, for a duration of 3 months, after obtaining clearance from the institutional ethics committee. The samples sent for the analysis to the clinical biochemistry laboratory were collected and the same were used for the study after obtaining the informed consent from the patient. The traumatic samples and systemic disorder patient samples were excluded form the study. The parameters analyzed were: CSF C-reactive protein (CRP), CSF electrolytes, CSF aspartate transaminase (AST), and CSF lactate dehydrogenase (LDH) apart from the routine CSF protein and glucose in both group I (meningitis) and group II (nonmeningitis). Results: The statistical analysis was performed using the Statistical Package for the Social Sciences (SPSS) version 23, with the significance value of 0.05. The mean of the CSF CRP was 2.0 ± 1.12 in group I compared with group II 0.09 ± 0.15; CSF AST was 17.42 ± 6.24, 5.1 ± 3.8 in groups I and II respectively; and CSF LDH was 211.1 ± 49.0, 23.71 ± 10.29 in groups I and II respectively, with p-value < 0.001 (highly significant). Conclusion: The CSF CRP was found to be increased in patients with meningitis compared with the negative CSF, and the significant increase in the CSF AST and LDH; this knowledge can help to aid the routine CSF protein and glucose to differentiate the meningitis before the result of the culture is reported for deciding the treatment regimen.

This study aimed to find an association between G-75A sequence variations in the promoter region of apolipoprotein A1 (APO-A1) gene with respect to myocardial infarction (MI) and serum lipid profile. Fifty-two MI cases and 52 age-, gender-, and risk factor-matched controls were included in this study. Fasting venous blood was collected from each patient and baseline investigations, lipid profile, and polymorphic studies were done. Genotype frequency distribution between cases and controls was compared by chi-square test. Analysis of variance (ANOVA) was done to know the relationship between fasting serum lipid variables with the genotype distribution. Genotypes across the cases and control reveal that “GG” homozygous genotype was higher among cases and “GA” genotype seen more in controls, AA approximately equal among cases and controls. But the difference was statistically insignificant. “G” allele was higher among cases (0.75) than among controls (0.69) and frequency of “A” allele was higher among controls (0.30) than among cases (0.25). In GA genotype, mean high-density lipoprotein (HDL), APO-A1 were high and low APO-B/APO-A1 ratio as compared with GG genotype. But there were no statistically significant differences between G allele and A allele carriers for any lipid variables. There were no statistically significant differences across genotype as well as lipid variables in G-75A (promoter) region of APO-A1 gene for the development of MI.

Introduction: Clinical laboratories need to respond to the challenges of reducing manpower and decreasing the turnaround time by simplifying the process of report release. This can be achieved by building an autoverification (AV) system in the clinical chemistry laboratory. Aims and objectives: • To establish the criteria for AV. • To know the proportion of tests or the sample load which is autoverifiable. • To compare advantages and disadvantages of AV. Materials and methods: A descriptive observational study was conducted on test results in clinical chemistry laboratory of Sir Sayajirao General Hospital and Medical College, Vadodara, India, from April 15 to July 15, 2016. At the end of the day, all reports were analyzed and the ones autoverifiable along with their percentage were calculated. Results and observations: In our laboratory, percentage of autoverifiable reports was found to be between 71 and 89% for various parameters. Conclusion: Although AV is a complex task, the outcome is absolutely worth the effort. Autoverification, if properly integrated into laboratory information system (LIS), is very fast as compared with the manual verification done by skilled laboratory medical biochemists. Implementation of AV not only decreases the turnaround time but also leads to more consistent verification of test results as all results go through the same process before being released.

Introduction: Polycystic ovarian syndrome (PCOS) is the most common hormonal disorder prevailing in premenopausal women. These patients are 11 times more likely to encounter metabolic syndrome (MetS). There is a substantial overlap into the components of these two syndromes, which in turn leads to increased risk of type-2 diabetes mellitus (T2DM) and cardiovascular diseases (CVD) in the foreseeable future. In this perspective, the present study was planned to evaluate the prevalence of MetS and its individual components in PCOS in Indian scenario. Study design: This cross-sectional study included 150 women diagnosed with PCOS between 18 and 38 years age. Demographic variables including age, education, occupation, inhabitant area, history of infertility, and family history of diabetes mellitus and hypertension were collected. Anthropometric parameters like weight, height, body mass index (BMI), waist circumference (WC), and systolic/diastolic blood pressure (SBP/ DBP) were measured. Fasting venous blood samples were collected and analyzed for biochemical parameters like glucose, total cholesterol (TC), triglycerides (TG), and high-density lipoprotein (HDL) cholesterol. Result: The prevalence of MetS in women with PCOS was 38.67%. The most prevalent component was decreased HDL (84.67%), followed by increased WC (75.33%), followed by raised TG (42%). Conclusion: The analogy of PCOS with MetS implicates that it is crucial to analyze the emerging trend of MetS in patients with PCOS. Recognition of this high-risk group will aid in the enforcement of preventive strategies including therapeutic lifestyle modifications and risk factor management. This will have a promising impact on women's health and will prevent or delay the outset of varying cardiometabolic complications in PCOS.

Aim: The aim of the study is to see the difference between high-sensitivity C-reactive protein (hsCRP) in subclinical hypothyroidism (SCH) and controls and find an association between hsCRP and thyroid-stimulating hormone (TSH) in SCH. Materials and methods: Totally, 60 subjects were selected for the study, which included 30 cases of SCH and 30 controls with normal thyroid status. Results: The mean TSH levels were significantly elevated in SCH when compared with controls (9.20 ± 2.12 mU/mL; 2.26 ± 0.78 mU/mL; p-value: <0.0001 respectively). Significantly elevated hsCRP was observed in SCH when compared with controls (3.05 ± 1.78 mg/L; 0.62 ± 0.39 mg/L; p < 0.0001 respectively). As per stratification of cardiovascular disease (CVD) risk by hsCRP, 23% of SCH had high risk of developing CVD. Multivariate linear regression suggested that hsCRP is significantly and positively associated with SCH after adjusting for age and body mass index (BMI). Conclusion: Elevated levels of hsCRP in SCH suggest inflammation as a possible factor for linking SCH and CVD. Clinical significance: Progression to overt hypothyroidism and cardiovascular risk are the major implications of SCH. The hsCRP is not only an inflammatory marker, but also a stimulator of inflammation and predictor of CVD. The hsCRP indicates the cardiovascular risk associated with SCH. Hence, it can be used to screen SCH patients who are at a risk of developing CVD.

Introduction: Vitamin D deficiency is an underdiagnosed, overlooked, yet a major health problem globally. It is prevalent in all the age groups and genders affecting various systems in the body. Materials and methods: A total of 360 patients attending the outpatient department were included in the study. Vitamin D levels were checked by enzyme-linked fluorescent assay (ELFA). Results: A total of 64% patients were found to be deficient in vitamin D followed by 20% insufficient (n = 71), whereas 15% had sufficient vitamin D and the remaining 1% were found to be under potential toxicity. Females (63%) were mostly deficient than males (37%). The deficiency was highly prevalent in between the age groups from 23 to 33 years (18%). Conclusion: Vitamin D deficiency is highly prevalent in Sikkim among the younger population which could be due to sedentary lifestyle, less exposure to sunlight, and low dietary intake.

Introduction: In a routine clinical laboratory having more than one automated system, comparison of methods experiment provides a means to assess any method's performance. It helps to estimate systematic (constant and proportional) difference between two methods. If the difference between two methods is small and clinically acceptable, then these two methods can be used interchangeably. In this study, we have compared direct bilirubin on two automated systems and tried to analyze the cause behind the difference between the two. Materials and methods: Serum samples obtained from normal individuals as well as those with unconjugated and conjugated hyperbilirubinemia were analyzed on Cobas 6000 and Olympus AU 2700 simultaneously. Results: There was a significant difference in the values of direct bilirubin in patients with conjugated hyperbilirubinemia on the two automated systems. No difference was seen in normal persons and in patients with unconjugated hyperbilirubinemia. Conclusion: Delta bilirubin might be a contributing factor to the difference between direct bilirubin on the two systems, as it is expected only in patients with conjugated hyperbilirubinemia.

Introduction: Myocardial ischemia and acute myocardial infarction are important episodes of cardiac ailments. Cardiac biomarkers are a growing area of interest, constantly evolving and presenting potential promises diagnostically to supplement the instrumental techniques. They play a vital role in every stage of sequel of cardiac ailment by contributing to the diagnosis and differentiating the conditions. Aim: To evaluate the diagnostic significance of emerging cardiac biomarkers during myocardial ischemia and infarction (AMI) and to construct a definitive pattern shift of markers in ischemia versus infarction in uncomplicated cases, hence the predictive element. Materials and methods: In this comparative cross-sectional study, three groups i.e. control (n = 33), ischemia (n = 38), and infarction (42) of either sex with an age group of 70 were included. The cardiac parameters, ischemia-modified albumin (IMA), creatine kinase-MB (CK-MB), creatine kinase (CK), high sensitive cardiac troponin I (hscTnI), N-terminal pro brain natriuretic peptide (NTpro-BNP), myoglobin, and heart type fatty acid binding protein (H-FABP) analyses were carried out for their sensitivity and specificity. Results: All the parameters in infarction were significantly raised when compared with the control group. In ischemia, the markers NTproBNP, hscTnI, and IMA and in infarction, the NTproBNP, hscTnI, and H-FABP showed more area under the curve. Conclusion: The markers exhibited different pattern shift in ischemia and infarction. The combination of hscTnI, NTproBNP, and IMA would increase the sensitivity in the detection of ischemia. In case of AMI, the H-FABP in the early stages, and NTproBNP, hscTnI, IMA, and CKMB in the later stages of ACS contribute immensely for the diagnosis.

Introduction: Arterial blood gas (ABG) analysis plays an important role in the treatment of intensive care patients, especially for critically ill patients but are often difficult to understand, interpret, and sometimes confusing if both the metabolic and respiratory disturbances are found. There are only few graphical tools available depicting the respiratory and metabolic acid–base disturbances but are rarely used in clinical setting. Aim: The aim of the current research study is to develop a newer graphical tool for ABG interpretation. Materials and methods: A total of 120 arterial blood samples were collected and analyzed using ABG analyzer. The ABG parameters like pH, pCO₂, HCO₃, and standard HCO₃ values were noted. Standard base excess was calculated from the obtained data. Arterial blood gas interpretation was done and all the 120 samples were classified into various acid–base disorders. The difference in value between bicarbonate and standard bicarbonate (HCO₃ – standard HCO₃) was calculated. Carbonic acid was derived from pCO₂ values and the ratio (HCO₃ – standard HCO₃)/H2CO₃ was found. The relationship between pCO₂, difference between bicarbonate and standard bicarbonate values, and the ratio (HCO₃ – standard HCO₃)/H2CO₃ were graphically analyzed. A novel four-quadrant graph method was developed using standard base excess in the x-axis and the ratio (HCO₃ – standard HCO₃)/H2CO₃ values in the y-axis. Results: Each acid–base disorders will occupy any of the four quadrants and the normal cases with no acid–base disturbances will be seen around the center of the graph. Conclusion: This newer graphical tool may help in easier and quicker interpretation of ABG reports compared with the other existing graphical tools. Clinical significance: This simple four-quadrant graph method may provide a rough guide for ABG interpretation, which, when applied at the appropriate time, results in timely management.

Aim: To determine whether vitamin D deficiency is related to the degree of physical activity or not. Materials and methods: A total of 113 Bachelor of Medicine and Bachelor of Surgery (MBBS) students of the same batch aged 17 to 21 years (59 boys and 54 girls) were included in this case–control study. Levels of physical activity were determined using a self-prepared questionnaire. Results: According to vitamin D grading, only 19 (16.8%) students were in normal category, rest of them were either in deficient (69.9%) or in insufficiency (13.3%) category. Age-matched comparisons between case group and control group revealed that those physically active had higher levels of vitamin D as compared with those with lower physical activity. Conclusion: Plasma vitamin D deficiency was prevalent even in apparently healthy young individuals. In the case group (who are physically active), the mean of serum vitamin D level was significantly higher (23 ng/dL) than the control group (10.5 ng/dL). Serum vitamin D deficiency was more prevalent in females. Clinical significance: This study clearly shows that the increased physical activity, especially in sunlight, among individuals should be encouraged not only at home but also at their school and workplace to promote a more active lifestyle that will counteract not only vitamin D deficiency but other benefits as well.

Introduction: As we know, endothelial dysfunction (ED) is an initial stage of vascular complications in type II diabetes mellitus. Hypoglycemic drugs have shown beneficial effect on endothelial function. Insulin is a regulatory hormone for endothelial function in vessels. But, there was a controversial report on the effect of exogenous insulin on endothelial function in type II diabetes subjects. Aim and objective: The study has been designed to observe the effect of insulin therapy on ED in type II diabetic subjects without any complications. Result: Significantly high level of body mass index (BMI) was identified in insulin-treated subjects than subjects with hypoglycemic drugs and healthy controls. Nitric oxide (NO) has been shown to be significantly lower in insulin-treated subjects compared to subjects with hypoglycemic drugs and healthy controls. There was no significant change in the levels of lipid profile and oxidative stress between two treatment groups. Conclusion: Significant effect of insulin therapy was observed on ED in type II diabetes mellitus. Exogenous insulin itself may cause ED by hyperinsulinemia due to high-fat diet or high dosage of insulin.