Indian Journal of Medical Biochemistry

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VOLUME 27 , ISSUE 1 ( January-April, 2023 ) > List of Articles

ORIGINAL RESEARCH ARTICLE

A Comparative Analysis between HaemurEx (Clinical Chemistry Analyzer) and Standard Methodologies for Determining Its Efficacy for Estimation of Various Blood Parameters Like Glucose, Cholesterol, Triglyceride, Creatinine, Direct Bilirubin, and Total Bilirubin

Kusuma Kasapura Shivashankar, Swetha Nagarahalli Kempegowda, Abhijith Devaraju, Akila Prashant, Suma Maduvanahalli Nataraj, Partha Chakraborty, Amrita Mukherjee

Keywords : Blood analysis, Clinical chemistry analyzer, HaemurEx, Noncommunicable disease, Remote healthcare

Citation Information : Shivashankar KK, Kempegowda SN, Devaraju A, Prashant A, Nataraj SM, Chakraborty P, Mukherjee A. A Comparative Analysis between HaemurEx (Clinical Chemistry Analyzer) and Standard Methodologies for Determining Its Efficacy for Estimation of Various Blood Parameters Like Glucose, Cholesterol, Triglyceride, Creatinine, Direct Bilirubin, and Total Bilirubin. Indian J Med Biochem 2023; 27 (1):1-8.

DOI: 10.5005/jp-journals-10054-0216

License: CC BY-NC 4.0

Published Online: 05-12-2023

Copyright Statement:  Copyright © 2023; The Author(s).


Abstract

Background: The rapidly increasing cases of noncommunicable diseases (NCDs) are required to be managed to maintain the sustainable development of society. HaemurEx, developed by Arogyam Medisoft Solution, is a battery-operated, lightweight, photometric clinical chemistry analyzer with the ability to transmit data to a remote health platform. It can evaluate different blood and urine biomarkers related to various NCDs and women's health at the community level. This novel device can advance universal access to healthcare by enhancing the availability, accessibility, and affordability of testing the blood and urine biomarkers in primary health setup and thus can improve screening and monitoring of NCD conditions. The present study compares the results obtained from HaemurEx with the standard methodologies for patient care to determine its efficacy and accuracy. Materials and methods: The amount of glucose, total cholesterol, triglyceride, total bilirubin, direct bilirubin, and creatinine were estimated in 40 blood samples collected from the inpatient and outpatient facilities at JSS Medical College, Mysuru, Karnataka, India using the standard methodologies. The same samples were analyzed on the same day using HaemurEx. The results obtained from both methods were compared to validate the performance characteristics of HaemurEx for its operation. Results: The comparison between the results revealed the accuracy of HaemurEx for the above-mentioned parameters to be in the range of 85–97%. Conclusion: HaemurEx as a screening tool has the potential to significantly impact the diagnosis and treatment of different NCDs and diseases related to women in low-resource areas.


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  1. Banerjee A, Deaton A, Duflo E. Health care delivery in rural Rajasthan. Econ Polit Weekly 2004;39(09):944–949. Available from: https://www.jstor.org/stable/4414706.
  2. World Health Organization. Non-communicable diseases. Available at: https://www.who.int/news-room/fact-sheets/detail/noncommunicable-diseases. Accessed on: July 2022.
  3. Gubala V, Harris LF, Ricco AJ, et al. Point of care diagnostics: Status and future. Anal Chem 2012;84(2):487–515. DOI: 10.1021/ac2030199.
  4. Altinier S, Zaninotto M, Mion M, et al. Point-of-care testing of cardiac markers: Results from an experience in an emergency department. Clin Chim Acta 2001;311(1):67–72. DOI: 10.1016/s0009-8981(01)00562-9.
  5. Louie RF, Tang Z, Shelby DG, et al. Point-of-care testing: Millennium technology for critical care. Lab Med 2000;31(7):402–408. DOI: 10.1309/0Y5F-B7NP-5Y67-GW7T.
  6. St-Louis P. Status of point-of-care testing: Promise, realities, and possibilities. Clin Biochem 2000;33(6):427–440. DOI: 10.1016/s0009-9120(00)00138-7.
  7. Kuwa K, Nakayama T, Hoshino T, et al. Relationships of glucose concentrations in capillary whole blood, venous whole blood and venous plasma. Clin Chim Acta 2001;307(1–2):187–192. DOI: 10.1016/s0009-8981(01)00426-0.
  8. Klonoff DC. Continuous glucose monitoring: Roadmap for 21st century diabetes therapy. Diabetes Care 2005;28(5):1231–1239. DOI: 10.2337/diacare.28.5.1231.
  9. Shephard MDS, Mazzachi BC, Shephard AK. Comparative performance of two point-of-care analysers for lipid testing. Clin Lab 2007;53(9–12):561–566. PMID: 18257461.
  10. The European Parliament and the Council of the European Union. Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (Text with EEA relevance), Official Journal of the European Union 2016. Available at: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32016R0679. Accessed on: November 2020.
  11. Google Cloud Platform. HIPAA compliance on Google Cloud platform. Available at: https://cloud.google.com/security/compliance/hipaa. Accessed on: July 2022.
  12. Sen S, Chakraborty P, Mukherjee A. Analysis of glucose, cholesterol, and triglyceride in blood by a novel point-of care device: Validation and interim analysis. Indian J Med Biochem 2021;25(1):14–18. DOI: 10.5005/jp-journals-10054-0177.
  13. Naing NN. Determination of sample size. Mal J Med Sci 2003;10:84–86.
  14. www.surveymonkey.com. Sample size calculator. Availabt at: https://www.surveymonkey.com/mp/sample-size-calculator/. Accessed on: July 2022.
  15. The US Department of Health and Human Services; Food and Drug Administration Center for Drug Evaluation and Research (CDER); Center for Veterinary Medicine (CVM). Bioanalytical method validation, guidance for industry. 2018. Available at: https://www.fda.gov/files/drugs/published/Bioanalytical-Method-Validation-Guidance-for-Industry.pdf. Accessed on: July 2022.
  16. Bondar JL, Mead DC. Evaluation of glucose-6-phosphate dehydrogenase from Leuconostoc mesenteroides in the hexokinase method for determining glucose in serum. Clin Chem 1974;20(5):586–590. PMID: 4363766.
  17. Neese JW, Duncan P, Bayse D, et al. Development and evaluation of a hexokinase/glucose-6-phosphate dehydrogenase procedure for use as a national glucose reference method. Center for Disease Control DHEW Publication No. (CDC) 77–8330. Public Health Service, Atlanta, GA; 1976.
  18. Meiattini F, Prencipe L, Bardelli F, et al. The 4-hydroxybenzoate/4-aminophenazone chromogenic system used in the enzymic determination of serum cholesterol. Clin Chem 1978;24(12):2161–2165. PMID: 719864.
  19. Abhijit KR, Kusuma KS, Vasudha KC, et al. Estimation of total cholesterol from a single dried blood spot: New application for an age old technique. Ind J Appl Res 2016;6(2):130–135. DOI: 10.36106/ijar.
  20. Heather M, Barbour HM. Enzymatic determination of cholesterol and triglyceride with the Abbott bichromatic analyser. Ann din Biochem 1977;14(1):22–28. DOI: 10.1177/000456327701400104.
  21. Myers GL, Miller WG, Coresh J, et al. Recommendations for improving serum creatinine measurement: A report from the Laboratory Working Group of the National Kidney Disease Education Program. Clin Chem 2006;52(1):5–18. DOI: 10.1373/clinchem.2005.0525144.
  22. Suzuki Y, Sakagishi Y. Determination of Serum Bilirubin by the Diazo Method Using the Diazotized 3-Nitroaniline Reacting Readily with the Photoproducts of Bilirubin. Jpn J Clin Chem 1994;23:158–163. DOI: https://doi.org/10.14921/jscc1971b.23.2_158.
  23. Doğan NÖ. Bland–Altman analysis: A paradigm to understand correlation and agreement, Turk J Emergency Med 2018;18(4):139–141. DOI: 10.1016/j.tjem.2018.09.001.
  24. Rao M, Rao KD, Kumar AKS, et al. Human resources for health in India. Lancet 2011;377(9765):587–598. DOI: 10.1016/S0140-6736(10)61888-0.
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