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Dahiya K, Ghalaut VS, Verma M, Kumari A, Dalal D. Hurdles Faced in Getting a Clinical Biochemistry Laboratory Accredited by NABL in Government Setup: Our Experience. Indian J Med Biochem 2020; 24 (1):1-3.
Diagnostic care is the heart of the healthcare management system. Clinical laboratories that are accredited by National Accreditation Board for Testing and Calibration Laboratories (NABL) get worldwide acceptance. Accreditation is an attempt to encourage diagnostic laboratories performing basic tests to adopt quality practices, thus improving healthcare system at grass root level in the country. A large number of laboratories are now accredited, but majority of them are in private sector. Very few clinical laboratories associated with government organization participate and are able to achieve accreditation by NABL. Fortunately, our laboratory is one of them. With the experience gained during the process of getting NABL accreditation, we feel competent enough to comment upon and summarize the areas that may present difficulty in the process. We hope that most of the laboratory personnel working in the government organization will identify with our experience and get prepared as well as motivated to get their laboratory accredited by NABL.
Pramila K Mishra,
Rasmita K Padhy
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Priyadarsini R, Mishra PK, Devi N, Padhy RK. Evaluating Blood Glucose-6-Phosphate Dehydrogenase Activity with Oxidative Stress: A Study in Uncomplicated Type 2 Diabetes Mellitus Patients. Indian J Med Biochem 2020; 24 (1):4-8.
Background: Diabetes mellitus (DM) is chronic hyperglycemia condition affecting multiple organs due to metabolic disorder. Insulin secretion, function, or both are affected for which one of the factors attributed is due to increased free radical activity. Nicotinamide adenine dinucleotide phosphate (NADPH) produced in HMP shunt pathway is regulated by the rate-limiting glucose-6-phosphate dehydrogenase (G6PD). When there is an imbalance between the production of reactive oxygen species and the antioxidant system that detoxifies, then it is called oxidative stress. This pathway is regulated by the reductant concentration of NADPH. Aims and objectives: The current study was taken up to evaluate and correlate oxidative stress and insulin resistance with G6PD activity in type 2 DM (T2DM) patients. Materials and methods: A total of 100 (76 males 24 females) T2DM patients with equal age- and sex-matched healthy controls were selected for the study. Glucose-6-phosphate dehydrogenase was measured by chemical method in semiauto analyzer. Total oxidative stress measured as ferrous oxidation in xylenol orange and total antioxidant capacity estimated as ferric-reducing ability of serum by spectrophotometer. Glucose was measured by glucose oxidase-peroxidase method in an autoanalyzer. SPSS Version 20 software was used for statistical analysis. Results and observations: Increased serum G6PD levels were found in DM patients which significantly correlates with the increase of oxidative stress and high glucose levels (p value < 0.01). Conclusion: Estimation of blood G6PD activity may be used as a test to know the extent of oxidative status in DM patients for its implications in further clinical complications.
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Indrayan A, Bhargava M, Shukla S. Utilization of Hospital Laboratory Data for Establishing Normal Reference Interval of Quantitative Medical Parameters: Double Filtration Method. Indian J Med Biochem 2020; 24 (1):9-11.
Background: India and other developing countries need their own reference intervals for various medical parameters because these populations differ from Western population for the genetic profile, anatomical structure, dietary habits, and lifestyle. Such reference intervals have not been worked out so far for most parameters because it is difficult to have a large database on healthy people in these countries. Aims and objectives: Large hospitals generally have a huge database of laboratory values but a substantial proportion of them belong to sick subjects whose values cannot be included for establishing normal reference intervals. Thus, the database remains unutilized. We propose a simple method to utilize these data for establishing reference intervals. Materials and methods: A simple double filtration method is used to exclude all outliers and abnormal values that could finally provide uncontaminated data on healthy values. This method is based on quartiles and interquartile range. The method is illustrated on a dataset from the laboratory of a large tertiary care hospital. Results: The filtered values have been seen to follow a smooth distribution pattern and can be used to establish our reference intervals using the usual 2.5th and 97.5th percentiles. The method is illustrated for A/G ratio in the data from our hospital, and the reference interval obtained. Conclusion: Double filtration method can be used on hospital laboratory data to establish reference intervals of medical parameters.
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Arora P, Datta SK, Upadhyay AD. Comparison between Serum Calcium Levels Measured Using Direct Ion-selective Electrodes and Photometric Method in Automated Analyzers. Indian J Med Biochem 2020; 24 (1):12-15.
Introduction: Serum calcium is measured by photometric methods or ion-selective electrodes (ISEs). The ISEs measure free ionized calcium (FCa), which is not bound to proteins like albumin and is corrected using algorithms to calculate the total calcium, TCa (TCa_calc). The TCa obtained by photometry (TCa_meas) requires correction for albumin by several formulae to obtain the corrected Ca (TCa_corr). Aims and objectives: In this study, we aim to find the agreement between TCa levels calculated from direct ISE results (TCa_calc) and TCa levels obtained by spectrophotometric methods after correction using formulae given in the literature (TCa_corr) at different levels of serum albumin. Materials and methods: In this study, 332 serum samples were analyzed for TCa and albumin on Roche Modular P800 and FCa by direct ISE on XI-921 (Caretium) and converted to TCa_calc. The results of TCa_calc and TCa_corr were compared using paired t test. Results: Significant difference was observed between TCa_calc (2.45 ± 0.34 mmol/L) and TCa_meas (2.07 ± 0.27 mmol/L). The TCa_meas was corrected for albumin using several commonly used formulae. However, significant differences still existed between TCa_calc and TCa_corr. The cases were further subdivided into three groups on the basis of serum albumin; however, significant differences were observed between TCa_calc and TCa_corr values in all subgroups. Conclusion: Caution should be exercised while interchangeable usage and interpretation of serum calcium levels from direct ISE vis-à-vis photometric methods. Clinical significance: With the infiltration of point-of-care devices in casualties and intensive care units, awareness needs to be created among clinicians regarding the potential misinterpretations of the tests involved. Regulatory guidelines to the same effect may also be considered.
Shubha N Prakash,
Aim and objectives: To compare and evaluate the effect of sample type on vitamin D concentration in order to avoid multiple sample collection. Materials and methods: The study was conducted in a tertiary care hospital on 40 adult subjects whose samples were for both serum vitamin D and plasma parathyroid hormone (PTH). Leftover plasma sample was utilized for vitamin D analysis. Samples were analyzed on Advia Centaur XP from Siemens Healthineers. Bland–Altman analysis and regression equation were derived to evaluate the extent of agreement and conversion between sample types. Results and conclusion: Serum vitamin D is higher than plasma vitamin D (by 6.5 ng/mL), and it is more pronounced in samples with vitamin D greater than 20 ng/mL. Clinical significance: It is important that lab and clinicians should be aware of the comparably large preanalytical bias introduced by changing between serum and EDTA plasma sample for vitamin D analysis. This would impact patients who are serially monitored for vitamin D supplementation.
Introduction: Internal and external quality controls (QCs) used in the laboratory are effective in detecting analytical errors. However, they cannot quantify the number of errors. Six sigma can be used to objectively evaluate the performance of analytical methods. Hence, we have evaluated the analytical performance of 19 parameters using six sigma methodology. Materials and methods: Quality control data were collected over a period of 6 months—from January to June 2016—and sigma metric was calculated. Parameters showing sigma metrics of ≤3 were further analyzed between July and September 2016 by applying the suggested rules from Unity Real Time (URT) software. Results: Gamma-glutamyl transferase (GGT) Level (L) 2 showed the highest value of sigma (13.22). Total bilirubin was found to have the highest sigma values at both control levels (7.15 and 9.49 at L1 and L2, respectively). Sigma value of ≥4 was observed across all control levels for anti-TPO, CK-MB, potassium, PSA, and TSH. L1 of alpha feto protein (AFP) and L2 of Troponin I had sigma value of ≤3. We have obtained sigma value of ≤3 for all levels of remaining analytes. Among these, L1 of AFP showed a significant improvement in sigma after the application of suggested rules (2.5 to 9.3). Conclusion: The sigma value for a test is a good indication of its process capability because it considers both bias and imprecision. Unfortunately, most clinical laboratory tests are below six sigma processes. It is imperative to implement appropriate QC strategies for the judicious use of quality control.
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Pal PM. Comparison of Diagnostic Accuracy of Active B12 (Holotranscobalamin) and Total Vitamin B12 (Cobalamin) and Verification of Active B12 Test. Indian J Med Biochem 2020; 24 (1):25-31.
Objective: This study is based on the comparison of the diagnostic accuracy of active B12 (holotranscobalamin) to total vitamin B12 (cobalamin) and verification of the active B12 test for clinical use. Materials and methods: We have considered 310 individuals (total, mean age 48 ± 15years) that includes 233 individuals with serum active B12 levels within the biological reference interval of 20.6–196.7 pmol/L (controls, mean age 47 ± 15 years) and 54 individuals with serum active B12 levels below 20.6 pmol/L (cases, mean age 46 ± 13 years). Results: Based on the study, we have found that the diagnostic accuracy of active B12 (holotranscobalamin) was found to be better than that of total vitamin B12 (cobalamin). The precision of active B12 testing was found to be comparable to the manufacturer\'s claim. The reference interval for active B12 was also found to be comparable to the manufacturer\'s claim. Conclusion: From the above study, active B12 assay was found to be a better means for detecting vitamin B12 deficiency in individuals, and also, this assay was found to be a better one to follow-up the vitamin B12 levels in the patients who are already vitamin B12-deficient. Clinical significance: Active B12 (holotranscobalamin) testing can be used as a secondary choice of test for the patients with total B12 levels within the gray-zone (100–400 pg/mL) or can be used as a primary choice of test for the diagnosis of vitamin B12 deficiency and the follow-up during its treatment.
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Mane KB, Asegaonkar S. Evaluation of High-sensitivity C-reactive Protein and Lipid Profile in Nondiabetic Siblings and Offspring of Type 2 Diabetes Mellitus Patients. Indian J Med Biochem 2020; 24 (1):32-36.
Introduction: Onset of type 2 diabetes mellitus (T2DM) at early age heralds many years of disease and an increased risk that the full range of both microvascular and macrovascular complications will occur when affected individuals are still relatively young. Thus, further generations may be burdened with morbidity and mortality at the height of their productivity, potentially affecting workface, and healthcare systems of countries across the world. Materials and methods: The present study carried out at Department of Biochemistry at tertiary care hospital; total 100 nondiabetic siblings and offspring of T2DM patients between the age group 20 and 50 years selected on outpatient department (OPD) basis and compared with 100 age- and sex-matched healthy controls. Serum tested for plasma glucose level, serum high-sensitivity C-reactive protein (hs-CRP), serum cholesterol, serum triglycerides (TGs), and high-density lipoprotein (HDL) levels. Results: The mean value of blood sugar level did not show significant difference between the cases and controls (92.02 ± 9.23 vs 91.77 ± 7.99, p ≥ 0.05). The mean values of hs-CRP (2.4 ± 1.98 vs 1.0 ± 0.38), TG (167.35 ± 17.35 vs 124.63 ± 13.55), total cholesterol (TC) (176.99 ± 12.45 vs 147.59 ± 9.72), low-density lipoprotein (LDL) (106.41 ± 12.99 vs 71.65 ± 11.24), and very high-density lipoprotein (VHDL) (33.47 ± 3.47 vs 24.93 ± 2.71) (all p < 0.001) were increased, however mean value of HDL (37.11 ± 3.99 vs 51.01 ± 3.93) was decreased in the cases as compared to controls. High-sensitivity C-reactive protein shows positive correlation with TG, TC, LDL, and very low-density lipoprotein and has negative correlation with HDL. Conclusion: Timely screening and early detection of the increased hs-CRP in the first-degree relatives of T2DM subjects may help clinicians enable to intervene early in the course of disease and to prevent further complications and outcomes. Therefore, primary prevention by target screening among high-risk individuals to prevent transition to overt T2DM by therapeutic lifestyle changes is a feasible and attractive alternative to reduce diabetes-related morbidity and mortality.
Srinivas N Chakravarthy,
Aim: To explore the interference of a hemoglobin E on glycated hemoglobin (HbA1c) measurement on two methodologies including high performance liquid chromatography (HPLC) and immunoassay. Background: HbA1c is an invincible analyte in modern laboratory medicine era. The role of HbA1c in diabetes mellitus has expanded from prognosis to diagnosis of diabetes. Hence, it becomes an essential responsibility of the medical testing laboratories to deliver quality results to the patients. The quality of a result is determined by several factors. One essential determinant of the quality of an analyte in a clinical laboratory is the choice of method of testing. HbA1c has various standardized methods of measurement, each of it having its own advantages and limitations. One significant limitation is interference from abnormal hemoglobins. Case description: In our case report, we have tried to explore the interference of hemoglobin E on HbA1c measurement on two methodologies including HPLC and immunoassay. In our case scenario, HbA1c immunoassay could produce a reliable HbA1c result, while HPLC was significantly being interfered by the hemoglobin variant. Conclusion: With respect to HbA1c, each method has its own advantages and limitations. It is the responsibility of the laboratories to understand, adopt, and optimally utilize these methods based on the needs. Clinical significance: HbA1c is the gold standard investigation for monitoring patients with diabetes mellitus. National Glycohemoglobin Standardization Program (NGSP) provides traceability and improvement in standardization of methods used for A1C measurement. Each method has its own limitations; the most significant from the clinical significance point of view is being interfered by the abnormal hemoglobins. Hence, each laboratory must understand the strengths and limitations of the available methods in their premises and hold the responsibility for reporting clinically relevant results to its patients.