No abstract

The reference intervals (RIs) of serum aminotransferases and Gamma-glutamyl transferase (GGT) have been established many years ago. Recent RIs are not available. The prospective study was conducted to re-evaluate the RIs of liver enzymes and the effect of demographic and anthropometric variables on them in western Indian population. A total of 1059 blood donors comprised the study population. Anthropometry and serum liver enzymes levels were measured. Subjects were categorized into normal weight and overweight by using body mass index (BMI) and waist circumference (WC). For RI determination, non-parametric methodology recommended by IFCC/CLSI was adopted. Mann-Whitney test and Spearman's rank correlation were used for statistical analysis. Upper limit of normal reference value of liver enzymes were lower in female compared to male. (ALT-23.55 F vs 36.00 M, GGT-34.58 F vs 36.20 M) When RI of liver enzymes were calculated according to body mass index, the upper limit of normal of ALT and GGT were higher in overweight group compared to normal weight group. (ALT-38.00 vs 27.00 IU/L and GGT-37.59 vs 35.26 IU/L). In both male and female, liver enzymes correlated significantly with age. WC and BMI were positively correlated with AST, ALT and GGT in both subgroups and the correlation was stronger in male. Demographic factors should be considered for making liver enzyme tests more clinically relevant. Gender based partitioning should be adopted for serum alanine aminotransferase (ALT) and GGT reference values for Western Indian population.

Background: The physicochemical properties of Red Blood Cell membranes (RBC) are altered in liver diseases. Langmuir monolayers offer an excellent model system to study biological membrane surface properties. The aim of this study was to evaluate surface properties of erythrocyte membranes in liver diseases. Methods: Sixty-one patients with various liver diseases and fifteen controls were enrolled. Surface properties of RBC membrane were evaluated using Langmuir monolayers. Surface pressure area isotherms were recorded at body temperature using RBC membrane lipid extract. Student"s t-test and Analysis of variance tests were performed. Results: Mean maximum surface pressure and hysteresis area were significantly higher in cirrhotic and non-cirrhotic liver disease groups compared to controls. Within cirrhotics, mean maximum surface pressure and lift off area was significantly lower in the Child C group as compared to the Child A, B and A-B groups. The mean hysteresis area was significantly lower in the Child C group as compared to the Child B and A-B groups. Conclusion: The results of our study confirmed high rigidity of RBC membrane in mild and moderate liver cirrhosis and high fluidity in severe liver cirrhosis. This study may pave the way to the development of a surface activity based biophysical tool for therapeutic implication in liver diseases.

Introduction: Any error in the laboratory testing processes can affect the diagnosis and patient management. Six Sigma is a data driven quality management system for identifying and reducing errors and variations in clinical laboratory processes. Aim: This study was carried out to estimate Sigma metrics of various biochemical analytes in order to evaluate performance of quality control and implement optimum quality control strategy for each analyte. Quality goal index (QGI) was also calculated to identify the problems of inaccuracy and imprecision for parameters having lower sigma values. Materials and Methods: This retrospective, observational study was conducted at the Central Clinical Biochemistry Laboratory of Seth GS Medical College and KEM hospital in Mumbai for a period of six months (July 2019 to December 2019). Sigma metrics for 20 analytes was calculated by using internal quality control and external quality control data. Further, QGI was calculated for analytes having sigma value of <4 to identify imprecision or inaccuracy. Statistical analysis was performed using Microsoft office excel 2010 software. Results: Total protein, Glucose, Urea, Triglyceride (TAG), High Density Lipoprotein (HDL), and Low Density Lipoprotein (LDL) for normal (L1) and pathological (L2) controls achieved excellent performance (>6 sigma). Westgard rule (13s) with two control measurement (N2) per QC event and run size (R1000) i.e. 1000 patient samples between consecutive QC events was adopted for these analytes. For analytes with sigma value of 4-6, more rules (sigma 4-5: Westgardrules-13s/22s/R4s/41s, N4 and R200 and for sigma value 5-6: 13S/22s/R4s, N2 and R450) were adopted. The sigma values of six analytes (Creatinine, Sodium, Potassium, Calcium, Chloride, Inorganic phosphate) were <4 at one or more QC levels. For these analytes, strict QC procedures (Westgard rules-13s/22s/R4s/41s/6x, N4 and R45) were incorporated. QGI of these analytes was <0.8 which indicated the problem of imprecision. Staff training programs and review of standard operating procedures were done for these analytes to improve method performance. Conclusion: Sigma Metrics estimation helps in designing optimum QC protocols, minimising unnecessary QC runs and reducing the cost for analytes having high sigma metrics. Focused and effective QC strategy for analytes having low sigma helps in improving the performance of those analytes.

Introduction: Novel coronavirus disease 2019 (COVID-19) has become a global public health calamity since its outbreak in Wuhan, China in December 2019, and there is a lack of diagnostic biochemical data related to the disease. This study aimed to investigate routine biochemical parameters in COVID-19 positive Indian patients and check their predictive value for the detection of this novel disease. Materials and Methods: This observational study was conducted retrospectively with the participation of 166 patients referred to King Edward Memorial (KEM) Hospital, Mumbai, India during May 2020. The baseline characteristics (age and gender) and biochemical data of individuals with COVID-19-related symptoms but negative for COVID-19 were collected and classified into two groups of real-time reverse transcriptase polymerase chain reaction (RT-PCR) and COVID-19 positive. The value of organ function tests (blood urea nitrogen [BUN], creatinine, and levels of serum electrolytes, alanine aminotransferase [ALT], aspartate aminotransferase (AST), bilirubin total, bilirubin direct, total protein, and albumin) were noted and analyzed. The groups were compared using unpaired t test, and predictive value of these parameters for COVID-19 was evaluated by calculating the area under the ROC curve (AUC). Results: There was a significant rise in the serum AST ALT, bilirubin direct, BUN, and creatinine levels of COVID-19 subjects compared to non-COVID-19 ones (P < 0.001). AST (AUC=0.826, CI: 0.76 to 0.89, P < 0.001), ALT (AUC=0.8525, 95% CI: 0.79 to 0.90, P < 0.001), and BUN (AUC=0.8097, 95% CI: 0.74 to 0.87, P < 0.001) showed very good accuracy and serum creatinine (AUC=0.7971, 95% CI: 0.73 to 0.86, P < 0.001) showed good accuracy in predicting COVID- 19 positivity. Conclusion: Serum levels of ALT, AST, BUN, and creatinine can be the reliable predictors of COVID-19 test and identify infected patients.