Introduction
Laboratories offer use of biochemical tests on body fluids that are clinically relev... more Introduction Laboratories offer use of biochemical tests on body fluids that are clinically relevant Body fluid biochemical tests provide valuable diagnostic information, guiding healthcare providers in making accurate diagnoses, monitoring disease progression, and evaluating treatment responses. Validating tests for off label use for unconventional fluids in chemistry poses challenges and requires thorough planning. Existing research on this topic offers partial guidance for clinical labs to create their own validations. This study aims to fill some of these gaps by providing evidences for performance specification using in house validation of these assays. Methods Unconventional types of body fluid were use such as pleural fluid, ascetic fluid (for glucose, albumin, protein, LDH, amylase, lipase, triglyceride, urea, creatinine, bilirubin total, cholesterol, ADA) where as cerebrospinal fluid was used for (albumin, LDH, ADA). A validation protocol was used to validate each analytical method for accuracy precision, linearity, sensitivity, specificity and interfering substances along with their acceptance criteria. Alternative calibrators having fixed assigned value were use to validated recovery. The equipment used was Beckman Coulter DxC 700 AU. Statistical analysis was done using Microsoft Excel (Version 2019, Microsoft, Seattle, WA) Results Precision for each assay and body fluid type had a CV <9%. Recovery for the various analytes in all fluid types was 93.5-108.6%. Biorad EQAS samples results comparisons were within 95.8 – 104.2%. Serial dilution with serum samples showed specificity of >95%. Sensitivity using specimen at lower limit of detection was confirmed with precision of less than 15% of CV. There were no interferences found for icterus, lipemia and haemolysis using spiked samples. The tests assays for various body fluids were found linear till the higher measurement range with and without dilutions Conclusions Beckman Coulter DxC 700 AU is validated for the off label use of biochemical analysis of various body fluids.
Auditing Internal Quality Control Practices in a Large Size Clinical Biochemistry Laboratory, 2024
Background: Auditing quality control practices is crucial for ensuring adherence to and complianc... more Background: Auditing quality control practices is crucial for ensuring adherence to and compliance with the standard operating procedures of quality assurance. This study examines the internal quality control (IQC) practices in clinical biochemistry laboratories, focusing on their effectiveness in ensuring accurate and reliable test results. Materials and methods: A comprehensive audit was conducted every month, and records were reviewed periodically in a high-volume clinical biochemistry lab, assessing compliance with established IQC protocols and identifying areas for improvement. Chi-square test was used to assess any significant deviations in the practices from the established protocols. Results: Overall compliance with IQC practices was 98.8%. The compliance rates of 100% were observed for LJ Chart, Monthly CV%, measurement uncertainty, mean SD calculation, IQC lot verification, accuracy testing records, and kit verification records. Lower compliance rates were noted for patient moving average records at 95.8%. Out-of-control events occurred in 0.12% of the IQC tests. The overall average audit score for six months stands at 94.3%. Conclusion: The findings reveal very minimal variations in IQC implementation as compared to standard operating procedures and provide recommendations for enhancing quality control processes
Analysis of Renal Stone Composition Using Fourier Transform Infrared Spectroscopy: A Cross-sectional Study of 3,789 Cases, 2024
Background: Renal stones, commonly known as kidney stones, are a significant urological condition... more Background: Renal stones, commonly known as kidney stones, are a significant urological condition caused by the crystallization of dietary minerals in the kidneys. Their composition varies and can include calcium oxalate, calcium phosphate, uric acid, cystine, and other minerals. Fourier transform infrared (FTIR) spectroscopy, a semi-quantitative and automated method, is an advanced technique for determining stone composition, aiding in personalized treatment and prevention of recurrence. Objectives: The study aims to: • Analyze the mineral composition of renal stones using FTIR spectroscopy. • Classify the mineral components of renal stones. • Study the trends and morphological characteristics of stones. Methods: This cross-sectional study analyzed 3,789 renal stones received from August 2019 to May 2024. The stones were prepared and analyzed using the Agilent Cary 630 FTIR Analyzer. Data on mineral composition and morphology were collected and processed to identify various mineral trends and stone compositions. Results: Demographics: 76.3% of stones were from male patients, with the highest incidence in the 31–40 age-group. Composition: 93.5% of stones were of mixed composition, with calcium oxalate monohydrate being the most prevalent (38.3%). Rare compositions: Stones with rare compositions, such as xanthine and 2, 8-dihydroxyadenine, were identified, providing insight into specific metabolic disorders. Conclusion: Fourier transform infrared spectroscopy provides reliable results for stone composition, enabling effective and individualized treatment plans. The predominance of mixed stones underscores the need for multifactorial treatment approaches addressing dietary, metabolic, and infectious factors. Further research, particularly using advanced techniques like genetic testing, may enhance understanding of stone formation. Keywords: Calcium oxalate, Fourier transform infrared spectroscopy, Nephrolithiasis, Renal stones, Stone composition, Urinary tract stones.
International Archives of Integrated Medicine, 2024
Background: Tests for hemostasis include prothrombin time (PT) and activated thromboplastin time ... more Background: Tests for hemostasis include prothrombin time (PT) and activated thromboplastin time (aPTT). Prothrombin time (PT) and activated partial thromboplastin time (APTT) are tests of hemostasis employed in the evaluation of coagulopathies and monitoring of anticoagulant drug therapy. These tests are supposed to be influences by many preanalytical factors. Objective: In this study, we have evaluated the stability of aliquoted plasma of blood sample collected in sodium citrate tubes for prothrombin time and activated partial thromboplastin time stored at-20 0C for a period of 7 days. Material and Methods: 67 Patients samples collected for PT and APTT were stored for 7 days at-20 0 C in different aliquots. One aliquot is taken out daily and tested for PT and aPTT. Results were compared with initial tests results. Results: It was found that there was no significant difference between initial test results and test results of the samples are stored at-20 0 C. Conclusion: Samples which are collected for coagulation studies in sodium citrate preservative, if are centrifuged immediately and plasma is stored at-20 0 C, result generated for PT and aPTT do not show any statistically significant difference compared to samples which are immediately processed.
International Journal of Research in Medical Sciences, 2024
Background: Blood glucose testing is performed to diagnose and monitor conditions such as diabete... more Background: Blood glucose testing is performed to diagnose and monitor conditions such as diabetes mellitus and gestational diabetes in pregnant women. Accurate measurement of plasma glucose concentration is an important component. Here, we have compared the glucose estimation in specimen collected in various collection tubes. Methods: The samples were stored at 2-4°C temperature and at 0, 4, 12 and 24 hrs aliquots were taken and were processed. Plasma glucose was determined using the glucose oxidase enzymatic methods on the Beckman coulter AU700. All the results at 0 hour were compared with results at 4 hours, 12 hours and 24 hours. Also results of fluoride tubes were compared with results of EDTA, heparin and plane tubes. Results: We have found no significant difference between results of glucose estimation obtained using samples collected in serum tubes, EDTA tubes, fluoride tube and lithium heparin tube even after 24 hours after separation of serum/plasma. Conclusions: From this study we have concluded that blood samples collected in plane serum tube, fluoride tubes, EDTA tubes and heparin tubes produce similar results for estimation of glucose if the collected samples are centrifuged immediately after collection for separation of plasma and serum.
Indian Journal of Medical Biochemistry, Dec 4, 2023
Introduction: Intelligent quality management (iQM) is an automated quality assurance system that ... more Introduction: Intelligent quality management (iQM) is an automated quality assurance system that monitors all testing processes and components and provides continuous error detection and correction. Here in this article, we have evaluated the performance of Gem Premier 4000 for iQM at Meenakshi Labs, Madurai, Tamil Nadu, India. Aim: To evaluate the quality control performance of GEM Premier 4000 using inbuilt iQM in terms of sigma matrices. Methodology: Solution B readings are taken every 30 seconds and documented every 30 minutes or on a specific schedule. Any change that exceeds the established statistical control limit leads to further assessment via iQM's failure pattern recognition (PR) software, including corrective actions based on pattern detection algorithms. Results: All the parameters performed on Gem Premier 4000 have shown world-class performance above the Six Sigma matrix on the sigma scale. Completely automated quality control (QC) system; Pattern recognition software; Automated corrective action. The advantages of iQM provide laboratories with key advantages, such as improved quality, decreased cost and workload, and improved patient safety.
Introduction: Intelligent quality management (iQM) is an automated quality assurance system that ... more Introduction: Intelligent quality management (iQM) is an automated quality assurance system that monitors all testing processes and components and provides continuous error detection and correction. Here in this article, we have evaluated the performance of Gem Premier 4000 for iQM
Multiple myeloma is a cancer of plasma cells, normally responsible for producing antibodies. It i... more Multiple myeloma is a cancer of plasma cells, normally responsible for producing antibodies. It is a group of B-cell disorders resulting in the secretion of a specific and unique monoclonal immunoglobulin (M-protein). Protein electrophoresis serves as a gold standard for the diagnosis of multiple myeloma. The protein fraction migrates under the influence of electric filed according to the mass of individual fraction. The M-protein usually migrates in the gamma or beta region of the normal protein pattern; very rarely it may appear in the beta region. Here we have given an atypical case presentation where the patient with multiple myeloma presented with two M-spike one each in beta and gamma -globulin region on agarose gel protein electrophoresis with hypoglobulinemia but with reversed A:G ratio.
International Journal of Management, IT, and Engineering, 2015
Point-of-care testing (POCT) has evolved as an important part of laboratory medicine by virtue of... more Point-of-care testing (POCT) has evolved as an important part of laboratory medicine by virtue of its compactness, portability, and the feasibility of operation by non laboratory personnel, where fast and accurate testing methods are a primary concern and, as a result, improving the patient care. To successfully achieve POCT quality in networks, a multidisciplinary organizational approach is required. A clearly defined organizational structure should be put in place for proper functioning and optimum utilization of each POCT unit. The POCT unit must include designated authority, responsibility, and accountability.
Chronic kidney failure is much more common than people realize, and often goes undetected and und... more Chronic kidney failure is much more common than people realize, and often goes undetected and undiagnosed until the disease is well advanced and k function decreases it affects many other systems of the body mainly the calcium phosphorous metabolism as the metabolism is mainly controlled by kidney in terms of absor of calcium phosphorus. Secondary hyperparathyroidism is usually found in patients with kidney failure and involves all four parathyroid glands. The kidney problems trigger the parathyroid glands into making excess parathyroid hormone (PTH). Here we have reconfirmed the fi of secondary hyperparathyroidism in chronic kidney disease patient
International Journal of Research in Medical Sciences, 2016
Prevalence studies of schizophrenia in India report prevalence rate between 1.5 per 1000 and 2.5 ... more Prevalence studies of schizophrenia in India report prevalence rate between 1.5 per 1000 and 2.5 per 1000. Annual incidence is 0.35 to 0.38 per 1000 in urban population and 0.44 per 1000 in the rural population. 2 Increased free radical mediated breakdown of phospholipids has been observed in schizophrenia. Oxidative neuronal injury in the brain has been known to be associated with abnormal neurodevelopment, neurodegeneration or neuronal membrane impairment. These mechanisms play a very important role in the pathogenesis of schizophrenia. 3 MDA is the most widely ABSTRACT Background: Schizophrenia is characterized by distortions in thinking, perception, emotions, language, sense of self and behaviour. It has been demonstrated that free radical-mediated damage has an important role in the pathophysiology of schizophrenia. The present study was undertaken to study malondialdehyde as an oxidative stress marker in first episode and chronic schizophrenic patients. Methods: 50 patients of first episode schizophrenia and 50 patients of chronic schizophrenia were included in the study. 50 numbers of age and sex matched healthy and apparently normal controls were also selected for study. Blood samples were drawn and analysed for malondialdehyde (MDA) from all participants. Results: The study shows significant increase in plasma malondialdehyde (MDA) levels in both first episode schizophrenics and chronic schizophrenic patients as compared to controls. When we compared levels of these parameters in first episode schizophrenics and chronic schizophrenics, we did not find significant difference. Conclusions: Findings in our study is suggesting that increase in the levels of plasma malondialdehyde (MDA) occurs due to increased lipid peroxidation in schizophrenics.
While quality in healthcare is an essential concept, the methodology to measure the quality is in... more While quality in healthcare is an essential concept, the methodology to measure the quality is in preliminary stage. Developing quality indicators seems to be inspiring concept in measuring quality in healthcare system. Clinical laboratory being the inseparable part of health care system, we have made an attempt to through a light on quality indicators in clinical laboratory. Developing key performance indicators and monitoring, auditing and improving those parameters is a dynamic process which requires standardization, improvement and innovationthe three arms of any improvement process, may it be in industry or in service scenario. While standardization means removing the outlier's i.e. reducing the standard deviation, improvement denotes gradual bettering of a parameter from the previous level with a degree of irreversible consistency. Innovation is however, sporadic and often it requires a thinking cap which, while maintaining the speed of standardization and improvement, quickly takes the parameters to a new level.
International Journal of Research in Medical Sciences, 2016
Background: Schizophrenia is one of the most debilitating psychiatric disorders. There is now sub... more Background: Schizophrenia is one of the most debilitating psychiatric disorders. There is now substantial evidence of increased free radical-mediated damage in schizophrenia. These mechanisms are critical role in etiopathogenesis of schizophrenia. The potential toxicity of reactive oxygen species (ROS) is counteracted by a large number of cytoprotective enzymes and nonenzymatic anti-oxidants. Endogenous substances like albumin, bilirubin and uric acid play very important defensive role against reactive oxygen species (ROS) produced in our body. The present study was undertaken to study nonenzymatic antioxidants i.e. serum albumin, bilirubin and uric acid in first episode and chronic schizophrenic patients. Methods: 50 patients of first episode schizophrenia and 50 patients of chronic schizophrenia were included in the study. 50 numbers of age and sex matched healthy and apparently normal controls were also selected for study. Blood samples were drawn and analysed for albumin, bilirubin and uric acid from all participants. Results: The study shows significant decrease in serum albumin, bilirubin and uric acid levels in both first episode schizophrenics and chronic schizophrenic patients as compared to controls. When we compared levels of these parameters in first episode schizophrenics and chronic schizophrenics, we did not find significant difference. Conclusions: Findings in our study is suggesting that decrease in the levels of nonenzymatic antioxidants occurs in attempting neutralization of ROS in schizophrenics. This study supports the defensive role of nonenzymatic antioxidants against ROS in our body.
Despite the increase in sensitivity and specificity of immunoassay technique over years, analytic... more Despite the increase in sensitivity and specificity of immunoassay technique over years, analytical interference remains to be major area of concern. The interfering substances are endogenous substances that are natural, polyreactive antibodies as heterophilic or auto antibodies, or human anti-animal antibodies together with other unsuspected binding proteins that are unique to the individual. Interfering substances can interfere with the reaction between analyte and reagent antibodies in immunoassay resulting in false positive or negative values. This ultimately results in misinterpretation of patients reports and finally to wrong course of treatment. In our study, we used a retrospective approach to find out the extent of interferences and type of interferences in some cases during our routine practice. The immunoassay reports which were clinically not correlating were retrospectively evaluated after discussion with the clinician. Over a period of six month a total of 42 samples w...
Point-of-care testing (POCT) has evolved as an important part of laboratory medicine by virtue of... more Point-of-care testing (POCT) has evolved as an important part of laboratory medicine by virtue of its compactness, portability, and the feasibility of operation by nonlaboratory personnel, where fast and accurate testing methods are a primary concern and, as a result, improving the patient care. To successfully achieve POCT quality in networks, a multidisciplinary organizational approach is required. A clearly defined organizational structure should be put in place for proper functioning and optimum utilization of each POCT unit. The POCT unit must include designated authority, responsibility, and accountability.
The sickle cell anemia and sickle cell trait are observed to occur in relatively high frequencies... more The sickle cell anemia and sickle cell trait are observed to occur in relatively high frequencies among the endogamous population of India. The highest of 22.2 % has been found in Lohars of
Introduction: The definitive diagnosis features can be demonstrated or mycobacteria can be isolat... more Introduction: The definitive diagnosis features can be demonstrated or mycobacteria can be isolated from the body fluids or from sputum or from gastric lavage. Various other methods, such as polymerase chain reaction are also available. It is wel and culture is difficult and time consuming and other tests are complex and technically more demanding. In this study, we correlated the results of QuantiFERON test and sputum positivity. Material and methods: Total 150 subjects were included in this study. The clinical features and detailed history of each case wa physical examination. Patients were tested for Results: The results obtained in this study showed patients may not be able to detect all methods for the diagnosis of tuberculosis patients is more tuberculosis patients. The combination of tuberculin skin test had yield 96.6% cases as positive in our study which is far better than using a single test. Conclusion: Use of QuantiFERON conventional methods of diagno tuberculin skin tes...
Background: The reference method for determining LDL-C is b-quantification. It requires ultracent... more Background: The reference method for determining LDL-C is b-quantification. It requires ultracentrifugation, uses large volumes of samples and is a time consuming and expensive technique. Therefore, this method is not suitable for routine laboratory testing. The Friedewald's formula use in routine practice for LDL has many limitation as it is not suitable for TG values >400 mg/dl. Also it tends to underestimate the LDL values. Aim: The aim of this study was to compare the results obtained by direct homogenous assay for LDL-C to those obtained by Friedewald's formulas with the assumption that the results obtained by direct assay are the most accurate. Materials and methods: Outpatient fasting complete lipid profile (including directly measured LDL) for patients >18 years of age performed between October 2014 and January 2015 was included in the study. A total of 1768 separate fasting lipid profiles were analyzed. Calculated LDL was derived using FF, and directly measure...
Introduction
Laboratories offer use of biochemical tests on body fluids that are clinically relev... more Introduction Laboratories offer use of biochemical tests on body fluids that are clinically relevant Body fluid biochemical tests provide valuable diagnostic information, guiding healthcare providers in making accurate diagnoses, monitoring disease progression, and evaluating treatment responses. Validating tests for off label use for unconventional fluids in chemistry poses challenges and requires thorough planning. Existing research on this topic offers partial guidance for clinical labs to create their own validations. This study aims to fill some of these gaps by providing evidences for performance specification using in house validation of these assays. Methods Unconventional types of body fluid were use such as pleural fluid, ascetic fluid (for glucose, albumin, protein, LDH, amylase, lipase, triglyceride, urea, creatinine, bilirubin total, cholesterol, ADA) where as cerebrospinal fluid was used for (albumin, LDH, ADA). A validation protocol was used to validate each analytical method for accuracy precision, linearity, sensitivity, specificity and interfering substances along with their acceptance criteria. Alternative calibrators having fixed assigned value were use to validated recovery. The equipment used was Beckman Coulter DxC 700 AU. Statistical analysis was done using Microsoft Excel (Version 2019, Microsoft, Seattle, WA) Results Precision for each assay and body fluid type had a CV <9%. Recovery for the various analytes in all fluid types was 93.5-108.6%. Biorad EQAS samples results comparisons were within 95.8 – 104.2%. Serial dilution with serum samples showed specificity of >95%. Sensitivity using specimen at lower limit of detection was confirmed with precision of less than 15% of CV. There were no interferences found for icterus, lipemia and haemolysis using spiked samples. The tests assays for various body fluids were found linear till the higher measurement range with and without dilutions Conclusions Beckman Coulter DxC 700 AU is validated for the off label use of biochemical analysis of various body fluids.
Auditing Internal Quality Control Practices in a Large Size Clinical Biochemistry Laboratory, 2024
Background: Auditing quality control practices is crucial for ensuring adherence to and complianc... more Background: Auditing quality control practices is crucial for ensuring adherence to and compliance with the standard operating procedures of quality assurance. This study examines the internal quality control (IQC) practices in clinical biochemistry laboratories, focusing on their effectiveness in ensuring accurate and reliable test results. Materials and methods: A comprehensive audit was conducted every month, and records were reviewed periodically in a high-volume clinical biochemistry lab, assessing compliance with established IQC protocols and identifying areas for improvement. Chi-square test was used to assess any significant deviations in the practices from the established protocols. Results: Overall compliance with IQC practices was 98.8%. The compliance rates of 100% were observed for LJ Chart, Monthly CV%, measurement uncertainty, mean SD calculation, IQC lot verification, accuracy testing records, and kit verification records. Lower compliance rates were noted for patient moving average records at 95.8%. Out-of-control events occurred in 0.12% of the IQC tests. The overall average audit score for six months stands at 94.3%. Conclusion: The findings reveal very minimal variations in IQC implementation as compared to standard operating procedures and provide recommendations for enhancing quality control processes
Analysis of Renal Stone Composition Using Fourier Transform Infrared Spectroscopy: A Cross-sectional Study of 3,789 Cases, 2024
Background: Renal stones, commonly known as kidney stones, are a significant urological condition... more Background: Renal stones, commonly known as kidney stones, are a significant urological condition caused by the crystallization of dietary minerals in the kidneys. Their composition varies and can include calcium oxalate, calcium phosphate, uric acid, cystine, and other minerals. Fourier transform infrared (FTIR) spectroscopy, a semi-quantitative and automated method, is an advanced technique for determining stone composition, aiding in personalized treatment and prevention of recurrence. Objectives: The study aims to: • Analyze the mineral composition of renal stones using FTIR spectroscopy. • Classify the mineral components of renal stones. • Study the trends and morphological characteristics of stones. Methods: This cross-sectional study analyzed 3,789 renal stones received from August 2019 to May 2024. The stones were prepared and analyzed using the Agilent Cary 630 FTIR Analyzer. Data on mineral composition and morphology were collected and processed to identify various mineral trends and stone compositions. Results: Demographics: 76.3% of stones were from male patients, with the highest incidence in the 31–40 age-group. Composition: 93.5% of stones were of mixed composition, with calcium oxalate monohydrate being the most prevalent (38.3%). Rare compositions: Stones with rare compositions, such as xanthine and 2, 8-dihydroxyadenine, were identified, providing insight into specific metabolic disorders. Conclusion: Fourier transform infrared spectroscopy provides reliable results for stone composition, enabling effective and individualized treatment plans. The predominance of mixed stones underscores the need for multifactorial treatment approaches addressing dietary, metabolic, and infectious factors. Further research, particularly using advanced techniques like genetic testing, may enhance understanding of stone formation. Keywords: Calcium oxalate, Fourier transform infrared spectroscopy, Nephrolithiasis, Renal stones, Stone composition, Urinary tract stones.
International Archives of Integrated Medicine, 2024
Background: Tests for hemostasis include prothrombin time (PT) and activated thromboplastin time ... more Background: Tests for hemostasis include prothrombin time (PT) and activated thromboplastin time (aPTT). Prothrombin time (PT) and activated partial thromboplastin time (APTT) are tests of hemostasis employed in the evaluation of coagulopathies and monitoring of anticoagulant drug therapy. These tests are supposed to be influences by many preanalytical factors. Objective: In this study, we have evaluated the stability of aliquoted plasma of blood sample collected in sodium citrate tubes for prothrombin time and activated partial thromboplastin time stored at-20 0C for a period of 7 days. Material and Methods: 67 Patients samples collected for PT and APTT were stored for 7 days at-20 0 C in different aliquots. One aliquot is taken out daily and tested for PT and aPTT. Results were compared with initial tests results. Results: It was found that there was no significant difference between initial test results and test results of the samples are stored at-20 0 C. Conclusion: Samples which are collected for coagulation studies in sodium citrate preservative, if are centrifuged immediately and plasma is stored at-20 0 C, result generated for PT and aPTT do not show any statistically significant difference compared to samples which are immediately processed.
International Journal of Research in Medical Sciences, 2024
Background: Blood glucose testing is performed to diagnose and monitor conditions such as diabete... more Background: Blood glucose testing is performed to diagnose and monitor conditions such as diabetes mellitus and gestational diabetes in pregnant women. Accurate measurement of plasma glucose concentration is an important component. Here, we have compared the glucose estimation in specimen collected in various collection tubes. Methods: The samples were stored at 2-4°C temperature and at 0, 4, 12 and 24 hrs aliquots were taken and were processed. Plasma glucose was determined using the glucose oxidase enzymatic methods on the Beckman coulter AU700. All the results at 0 hour were compared with results at 4 hours, 12 hours and 24 hours. Also results of fluoride tubes were compared with results of EDTA, heparin and plane tubes. Results: We have found no significant difference between results of glucose estimation obtained using samples collected in serum tubes, EDTA tubes, fluoride tube and lithium heparin tube even after 24 hours after separation of serum/plasma. Conclusions: From this study we have concluded that blood samples collected in plane serum tube, fluoride tubes, EDTA tubes and heparin tubes produce similar results for estimation of glucose if the collected samples are centrifuged immediately after collection for separation of plasma and serum.
Indian Journal of Medical Biochemistry, Dec 4, 2023
Introduction: Intelligent quality management (iQM) is an automated quality assurance system that ... more Introduction: Intelligent quality management (iQM) is an automated quality assurance system that monitors all testing processes and components and provides continuous error detection and correction. Here in this article, we have evaluated the performance of Gem Premier 4000 for iQM at Meenakshi Labs, Madurai, Tamil Nadu, India. Aim: To evaluate the quality control performance of GEM Premier 4000 using inbuilt iQM in terms of sigma matrices. Methodology: Solution B readings are taken every 30 seconds and documented every 30 minutes or on a specific schedule. Any change that exceeds the established statistical control limit leads to further assessment via iQM's failure pattern recognition (PR) software, including corrective actions based on pattern detection algorithms. Results: All the parameters performed on Gem Premier 4000 have shown world-class performance above the Six Sigma matrix on the sigma scale. Completely automated quality control (QC) system; Pattern recognition software; Automated corrective action. The advantages of iQM provide laboratories with key advantages, such as improved quality, decreased cost and workload, and improved patient safety.
Introduction: Intelligent quality management (iQM) is an automated quality assurance system that ... more Introduction: Intelligent quality management (iQM) is an automated quality assurance system that monitors all testing processes and components and provides continuous error detection and correction. Here in this article, we have evaluated the performance of Gem Premier 4000 for iQM
Multiple myeloma is a cancer of plasma cells, normally responsible for producing antibodies. It i... more Multiple myeloma is a cancer of plasma cells, normally responsible for producing antibodies. It is a group of B-cell disorders resulting in the secretion of a specific and unique monoclonal immunoglobulin (M-protein). Protein electrophoresis serves as a gold standard for the diagnosis of multiple myeloma. The protein fraction migrates under the influence of electric filed according to the mass of individual fraction. The M-protein usually migrates in the gamma or beta region of the normal protein pattern; very rarely it may appear in the beta region. Here we have given an atypical case presentation where the patient with multiple myeloma presented with two M-spike one each in beta and gamma -globulin region on agarose gel protein electrophoresis with hypoglobulinemia but with reversed A:G ratio.
International Journal of Management, IT, and Engineering, 2015
Point-of-care testing (POCT) has evolved as an important part of laboratory medicine by virtue of... more Point-of-care testing (POCT) has evolved as an important part of laboratory medicine by virtue of its compactness, portability, and the feasibility of operation by non laboratory personnel, where fast and accurate testing methods are a primary concern and, as a result, improving the patient care. To successfully achieve POCT quality in networks, a multidisciplinary organizational approach is required. A clearly defined organizational structure should be put in place for proper functioning and optimum utilization of each POCT unit. The POCT unit must include designated authority, responsibility, and accountability.
Chronic kidney failure is much more common than people realize, and often goes undetected and und... more Chronic kidney failure is much more common than people realize, and often goes undetected and undiagnosed until the disease is well advanced and k function decreases it affects many other systems of the body mainly the calcium phosphorous metabolism as the metabolism is mainly controlled by kidney in terms of absor of calcium phosphorus. Secondary hyperparathyroidism is usually found in patients with kidney failure and involves all four parathyroid glands. The kidney problems trigger the parathyroid glands into making excess parathyroid hormone (PTH). Here we have reconfirmed the fi of secondary hyperparathyroidism in chronic kidney disease patient
International Journal of Research in Medical Sciences, 2016
Prevalence studies of schizophrenia in India report prevalence rate between 1.5 per 1000 and 2.5 ... more Prevalence studies of schizophrenia in India report prevalence rate between 1.5 per 1000 and 2.5 per 1000. Annual incidence is 0.35 to 0.38 per 1000 in urban population and 0.44 per 1000 in the rural population. 2 Increased free radical mediated breakdown of phospholipids has been observed in schizophrenia. Oxidative neuronal injury in the brain has been known to be associated with abnormal neurodevelopment, neurodegeneration or neuronal membrane impairment. These mechanisms play a very important role in the pathogenesis of schizophrenia. 3 MDA is the most widely ABSTRACT Background: Schizophrenia is characterized by distortions in thinking, perception, emotions, language, sense of self and behaviour. It has been demonstrated that free radical-mediated damage has an important role in the pathophysiology of schizophrenia. The present study was undertaken to study malondialdehyde as an oxidative stress marker in first episode and chronic schizophrenic patients. Methods: 50 patients of first episode schizophrenia and 50 patients of chronic schizophrenia were included in the study. 50 numbers of age and sex matched healthy and apparently normal controls were also selected for study. Blood samples were drawn and analysed for malondialdehyde (MDA) from all participants. Results: The study shows significant increase in plasma malondialdehyde (MDA) levels in both first episode schizophrenics and chronic schizophrenic patients as compared to controls. When we compared levels of these parameters in first episode schizophrenics and chronic schizophrenics, we did not find significant difference. Conclusions: Findings in our study is suggesting that increase in the levels of plasma malondialdehyde (MDA) occurs due to increased lipid peroxidation in schizophrenics.
While quality in healthcare is an essential concept, the methodology to measure the quality is in... more While quality in healthcare is an essential concept, the methodology to measure the quality is in preliminary stage. Developing quality indicators seems to be inspiring concept in measuring quality in healthcare system. Clinical laboratory being the inseparable part of health care system, we have made an attempt to through a light on quality indicators in clinical laboratory. Developing key performance indicators and monitoring, auditing and improving those parameters is a dynamic process which requires standardization, improvement and innovationthe three arms of any improvement process, may it be in industry or in service scenario. While standardization means removing the outlier's i.e. reducing the standard deviation, improvement denotes gradual bettering of a parameter from the previous level with a degree of irreversible consistency. Innovation is however, sporadic and often it requires a thinking cap which, while maintaining the speed of standardization and improvement, quickly takes the parameters to a new level.
International Journal of Research in Medical Sciences, 2016
Background: Schizophrenia is one of the most debilitating psychiatric disorders. There is now sub... more Background: Schizophrenia is one of the most debilitating psychiatric disorders. There is now substantial evidence of increased free radical-mediated damage in schizophrenia. These mechanisms are critical role in etiopathogenesis of schizophrenia. The potential toxicity of reactive oxygen species (ROS) is counteracted by a large number of cytoprotective enzymes and nonenzymatic anti-oxidants. Endogenous substances like albumin, bilirubin and uric acid play very important defensive role against reactive oxygen species (ROS) produced in our body. The present study was undertaken to study nonenzymatic antioxidants i.e. serum albumin, bilirubin and uric acid in first episode and chronic schizophrenic patients. Methods: 50 patients of first episode schizophrenia and 50 patients of chronic schizophrenia were included in the study. 50 numbers of age and sex matched healthy and apparently normal controls were also selected for study. Blood samples were drawn and analysed for albumin, bilirubin and uric acid from all participants. Results: The study shows significant decrease in serum albumin, bilirubin and uric acid levels in both first episode schizophrenics and chronic schizophrenic patients as compared to controls. When we compared levels of these parameters in first episode schizophrenics and chronic schizophrenics, we did not find significant difference. Conclusions: Findings in our study is suggesting that decrease in the levels of nonenzymatic antioxidants occurs in attempting neutralization of ROS in schizophrenics. This study supports the defensive role of nonenzymatic antioxidants against ROS in our body.
Despite the increase in sensitivity and specificity of immunoassay technique over years, analytic... more Despite the increase in sensitivity and specificity of immunoassay technique over years, analytical interference remains to be major area of concern. The interfering substances are endogenous substances that are natural, polyreactive antibodies as heterophilic or auto antibodies, or human anti-animal antibodies together with other unsuspected binding proteins that are unique to the individual. Interfering substances can interfere with the reaction between analyte and reagent antibodies in immunoassay resulting in false positive or negative values. This ultimately results in misinterpretation of patients reports and finally to wrong course of treatment. In our study, we used a retrospective approach to find out the extent of interferences and type of interferences in some cases during our routine practice. The immunoassay reports which were clinically not correlating were retrospectively evaluated after discussion with the clinician. Over a period of six month a total of 42 samples w...
Point-of-care testing (POCT) has evolved as an important part of laboratory medicine by virtue of... more Point-of-care testing (POCT) has evolved as an important part of laboratory medicine by virtue of its compactness, portability, and the feasibility of operation by nonlaboratory personnel, where fast and accurate testing methods are a primary concern and, as a result, improving the patient care. To successfully achieve POCT quality in networks, a multidisciplinary organizational approach is required. A clearly defined organizational structure should be put in place for proper functioning and optimum utilization of each POCT unit. The POCT unit must include designated authority, responsibility, and accountability.
The sickle cell anemia and sickle cell trait are observed to occur in relatively high frequencies... more The sickle cell anemia and sickle cell trait are observed to occur in relatively high frequencies among the endogamous population of India. The highest of 22.2 % has been found in Lohars of
Introduction: The definitive diagnosis features can be demonstrated or mycobacteria can be isolat... more Introduction: The definitive diagnosis features can be demonstrated or mycobacteria can be isolated from the body fluids or from sputum or from gastric lavage. Various other methods, such as polymerase chain reaction are also available. It is wel and culture is difficult and time consuming and other tests are complex and technically more demanding. In this study, we correlated the results of QuantiFERON test and sputum positivity. Material and methods: Total 150 subjects were included in this study. The clinical features and detailed history of each case wa physical examination. Patients were tested for Results: The results obtained in this study showed patients may not be able to detect all methods for the diagnosis of tuberculosis patients is more tuberculosis patients. The combination of tuberculin skin test had yield 96.6% cases as positive in our study which is far better than using a single test. Conclusion: Use of QuantiFERON conventional methods of diagno tuberculin skin tes...
Background: The reference method for determining LDL-C is b-quantification. It requires ultracent... more Background: The reference method for determining LDL-C is b-quantification. It requires ultracentrifugation, uses large volumes of samples and is a time consuming and expensive technique. Therefore, this method is not suitable for routine laboratory testing. The Friedewald's formula use in routine practice for LDL has many limitation as it is not suitable for TG values >400 mg/dl. Also it tends to underestimate the LDL values. Aim: The aim of this study was to compare the results obtained by direct homogenous assay for LDL-C to those obtained by Friedewald's formulas with the assumption that the results obtained by direct assay are the most accurate. Materials and methods: Outpatient fasting complete lipid profile (including directly measured LDL) for patients >18 years of age performed between October 2014 and January 2015 was included in the study. A total of 1768 separate fasting lipid profiles were analyzed. Calculated LDL was derived using FF, and directly measure...
Objectives of the study: To evaluate clinical impact on interaoperative intact PTH estimation in ... more Objectives of the study: To evaluate clinical impact on interaoperative intact PTH estimation in patient of undergoing parathyroidectomy Brief methodology: This prospective study included 17 patients of parathyroid adenoma, 2 blood samples were taken from patients undergoing parathyroidectomy. Among the samples, one were pre-excision, one samples were taken at 10 min after the excision of the parathyroid glands. The criterion for evaluation of results in primary hyperparathyroidism is based on a cut off of 50% of the decrease of PTH in plasma levels, while the evaluation of the results in secondary hyperparathyroidism is based on a cut off of 70% of the decrease of PTH levels in plasma after 10 min from the resection of the last gland. Serum PTH levels were analyzed. Summary of Results: The mean pre-excision PTH level was 201.5 ± 18.5 pg/mL. At and 10-minute post tumour resection, PTH levels were 42.7 ± 2.3 pg/mL. In all cases, IOPTH levels fell by at least 50% after removing all suspected abnormal glands. All patients had a successful return to normocalcemia after surgery Conclusions: The interaoperative intact PTH estimation in patient of undergoing parathyroidectomy has significant clinical impact and helps surgeons to assess success of parathyroidectomy in real time, minimizing complications, customizing surgical extent, higher success rates, shorter hospital stays, reduced recurrence, and improved patient outcomes.
Introduction: The DxC 700 AU clinical chemistry analyzer is reliable chemistry systems for the mi... more Introduction: The DxC 700 AU clinical chemistry analyzer is reliable chemistry systems for the mid- to high-volume laboratory. The DxC 700 AU combines the best-loved (and time-tested) features of the popular DxC and AU series of clinical chemistry analyzers. This combination delivers maximal uptime, high reliability and precise performance. In this study, we have evaluated the stability of measurement system of Beckman Coulter AU 700 Methods: This is a retrospective observational study. The measurement system stability of AU 700 was evaluated with respect to reagents on board stability, calibration frequency, and scheduled maintenance using sigma matrix calculation using internal quality control performance for over a period of six months. (May 2023 to Oct 2023). Data is collected for reagents contamination, reagent evaporation, carryover, cuvette blank absorption, syringe pressure, calibration recovery, equipment breakdown and daily internal quality control. Results: The study shows the stability of 99.89% on sigma scale above industry standard (> 4.5 sigma) for AU 700 measurement system during the study period. This includes 0.75% reagent evaporation, 0.95 % carryover, 1.7% outlier in cuvette blank absorption, 0.7% outlier in calibration recovery, 0.25% outlier in syringe pressure and 6.25% outlier at 99.87% confidence interval (4.5 sigma) with 0% reagent contamination and equipment downtime. Conclusions: Beckman Coulter AU 700 Measurement System delivers a very strong stable performance on sigma scale above industry standard (> 4.5 sigma) in a large size laboratory performing over 7000 tests per day. The results generated are precise and can be reliably consumed for clinical decision making. This data can also help in planning of quality control plan with less frequent IQCs and reducing the overall burden of cost spent on internal quality control.
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Papers by jayesh warade
Laboratories offer use of biochemical tests on body fluids that are clinically relevant Body fluid biochemical tests provide valuable diagnostic information, guiding healthcare providers in making accurate diagnoses, monitoring disease progression, and evaluating treatment responses. Validating tests for off label use for unconventional fluids in chemistry poses challenges and requires thorough planning. Existing research on this topic offers partial guidance for clinical labs to create their own validations. This study aims to fill some of these gaps by providing evidences for performance specification using in house validation of these assays.
Methods
Unconventional types of body fluid were use such as pleural fluid, ascetic fluid (for glucose, albumin, protein, LDH, amylase, lipase, triglyceride, urea, creatinine, bilirubin total, cholesterol, ADA) where as cerebrospinal fluid was used for (albumin, LDH, ADA). A validation protocol was used to validate each analytical method for accuracy precision, linearity, sensitivity, specificity and interfering substances along with their acceptance criteria. Alternative calibrators having fixed assigned value were use to validated recovery. The equipment used was Beckman Coulter DxC 700 AU. Statistical analysis was done using Microsoft Excel (Version 2019, Microsoft, Seattle, WA)
Results
Precision for each assay and body fluid type had a CV <9%. Recovery for the various analytes in all fluid types was 93.5-108.6%. Biorad EQAS samples results comparisons were within 95.8 – 104.2%. Serial dilution with serum samples showed specificity of >95%. Sensitivity using specimen at lower limit of detection was confirmed with precision of less than 15% of CV. There were no interferences found for icterus, lipemia and haemolysis using spiked samples. The tests assays for various body fluids were found linear till the higher measurement range with and without dilutions
Conclusions
Beckman Coulter DxC 700 AU is validated for the off label use of biochemical analysis of various body fluids.
Objectives:
The study aims to:
• Analyze the mineral composition of renal stones using FTIR spectroscopy.
• Classify the mineral components of renal stones.
• Study the trends and morphological characteristics of stones.
Methods: This cross-sectional study analyzed 3,789 renal stones received from August 2019 to May 2024. The stones were prepared and analyzed using the Agilent Cary 630 FTIR Analyzer. Data on mineral composition and morphology were collected and processed to identify various mineral trends and stone compositions.
Results: Demographics: 76.3% of stones were from male patients, with the highest incidence in the 31–40 age-group.
Composition: 93.5% of stones were of mixed composition, with calcium oxalate monohydrate being the most prevalent (38.3%).
Rare compositions: Stones with rare compositions, such as xanthine and 2, 8-dihydroxyadenine, were identified, providing insight into specific metabolic disorders.
Conclusion: Fourier transform infrared spectroscopy provides reliable results for stone composition, enabling effective and individualized treatment plans. The predominance of mixed stones underscores the need for multifactorial treatment approaches addressing dietary, metabolic, and infectious factors. Further research, particularly using advanced techniques like genetic testing, may enhance understanding of stone formation.
Keywords: Calcium oxalate, Fourier transform infrared spectroscopy, Nephrolithiasis, Renal stones, Stone composition, Urinary tract stones.
Laboratories offer use of biochemical tests on body fluids that are clinically relevant Body fluid biochemical tests provide valuable diagnostic information, guiding healthcare providers in making accurate diagnoses, monitoring disease progression, and evaluating treatment responses. Validating tests for off label use for unconventional fluids in chemistry poses challenges and requires thorough planning. Existing research on this topic offers partial guidance for clinical labs to create their own validations. This study aims to fill some of these gaps by providing evidences for performance specification using in house validation of these assays.
Methods
Unconventional types of body fluid were use such as pleural fluid, ascetic fluid (for glucose, albumin, protein, LDH, amylase, lipase, triglyceride, urea, creatinine, bilirubin total, cholesterol, ADA) where as cerebrospinal fluid was used for (albumin, LDH, ADA). A validation protocol was used to validate each analytical method for accuracy precision, linearity, sensitivity, specificity and interfering substances along with their acceptance criteria. Alternative calibrators having fixed assigned value were use to validated recovery. The equipment used was Beckman Coulter DxC 700 AU. Statistical analysis was done using Microsoft Excel (Version 2019, Microsoft, Seattle, WA)
Results
Precision for each assay and body fluid type had a CV <9%. Recovery for the various analytes in all fluid types was 93.5-108.6%. Biorad EQAS samples results comparisons were within 95.8 – 104.2%. Serial dilution with serum samples showed specificity of >95%. Sensitivity using specimen at lower limit of detection was confirmed with precision of less than 15% of CV. There were no interferences found for icterus, lipemia and haemolysis using spiked samples. The tests assays for various body fluids were found linear till the higher measurement range with and without dilutions
Conclusions
Beckman Coulter DxC 700 AU is validated for the off label use of biochemical analysis of various body fluids.
Objectives:
The study aims to:
• Analyze the mineral composition of renal stones using FTIR spectroscopy.
• Classify the mineral components of renal stones.
• Study the trends and morphological characteristics of stones.
Methods: This cross-sectional study analyzed 3,789 renal stones received from August 2019 to May 2024. The stones were prepared and analyzed using the Agilent Cary 630 FTIR Analyzer. Data on mineral composition and morphology were collected and processed to identify various mineral trends and stone compositions.
Results: Demographics: 76.3% of stones were from male patients, with the highest incidence in the 31–40 age-group.
Composition: 93.5% of stones were of mixed composition, with calcium oxalate monohydrate being the most prevalent (38.3%).
Rare compositions: Stones with rare compositions, such as xanthine and 2, 8-dihydroxyadenine, were identified, providing insight into specific metabolic disorders.
Conclusion: Fourier transform infrared spectroscopy provides reliable results for stone composition, enabling effective and individualized treatment plans. The predominance of mixed stones underscores the need for multifactorial treatment approaches addressing dietary, metabolic, and infectious factors. Further research, particularly using advanced techniques like genetic testing, may enhance understanding of stone formation.
Keywords: Calcium oxalate, Fourier transform infrared spectroscopy, Nephrolithiasis, Renal stones, Stone composition, Urinary tract stones.
Brief methodology: This prospective study included 17 patients of parathyroid adenoma, 2 blood samples were taken from patients undergoing parathyroidectomy. Among the samples, one were pre-excision, one samples were taken at 10 min after the excision of the parathyroid glands. The criterion for evaluation of results in primary hyperparathyroidism is based on a cut off of 50% of the decrease of PTH in plasma levels, while the evaluation of the results in secondary hyperparathyroidism is based on a cut off of 70% of the decrease of PTH levels in plasma after 10 min from the resection of the last gland. Serum PTH levels were analyzed.
Summary of Results: The mean pre-excision PTH level was 201.5 ± 18.5 pg/mL. At and 10-minute post tumour resection, PTH levels were 42.7 ± 2.3 pg/mL. In all cases, IOPTH levels fell by at least 50% after removing all suspected abnormal glands. All patients had a successful return to normocalcemia after surgery
Conclusions: The interaoperative intact PTH estimation in patient of undergoing parathyroidectomy has significant clinical impact and helps surgeons to assess success of parathyroidectomy in real time, minimizing complications, customizing surgical extent, higher success rates, shorter hospital stays, reduced recurrence, and improved patient outcomes.
Methods: This is a retrospective observational study. The measurement system stability of AU 700 was evaluated with respect to reagents on board stability, calibration frequency, and scheduled maintenance using sigma matrix calculation using internal quality control performance for over a period of six months. (May 2023 to Oct 2023). Data is collected for reagents contamination, reagent evaporation, carryover, cuvette blank absorption, syringe pressure, calibration recovery, equipment breakdown and daily internal quality control.
Results: The study shows the stability of 99.89% on sigma scale above industry standard (> 4.5 sigma) for AU 700 measurement system during the study period. This includes 0.75% reagent evaporation, 0.95 % carryover, 1.7% outlier in cuvette blank absorption, 0.7% outlier in calibration recovery, 0.25% outlier in syringe pressure and 6.25% outlier at 99.87% confidence interval (4.5 sigma) with 0% reagent contamination and equipment downtime.
Conclusions: Beckman Coulter AU 700 Measurement System delivers a very strong stable performance on sigma scale above industry standard (> 4.5 sigma) in a large size laboratory performing over 7000 tests per day. The results generated are precise and can be reliably consumed for clinical decision making. This data can also help in planning of quality control plan with less frequent IQCs and reducing the overall burden of cost spent on internal quality control.