Indian Journal of Medical Biochemistry

Register      Login

VOLUME 25 , ISSUE 1 ( January-April, 2021 ) > List of Articles

Original Article

Analysis of Glucose, Cholesterol, and Triglyceride in Blood by a Novel Point-of-care Device: Validation and Interim Analysis

Sumalya Sen, Partha Chakraborty, Amrita Mukherjee

Keywords : Blood analysis, Digital health, Point of care testing, Remote healthcare, Rural healthcare, Telemedicine, Urine analysis

Citation Information : 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

License: CC BY-NC 4.0

Published Online: 00-00-0000

Copyright Statement:  Copyright © 2021; The Author(s).


Abstract

HaemurEx is a novel point-of-care (POC) battery-operated photo analyzer device designed for the potential clinical purpose(s). This novel device, if deployed in all primary health centers and subcenters and outreach clinics in combination with provisioning of physician consultation and essential medicine, can advance universal access to healthcare in countries like India. This device weighs approximately 500 g. It can analyze routine clinical chemistry parameters of blood and urine and transmitting them to a remote health platform which further needs validation by future studies. The validation study of this device is initiated to assess the comparability of HaemurEx with gold standards and determine the margin of error and the correction factor required to calibrate the analyzer further. In this study, glucose, total cholesterol, and triglyceride estimations were performed using HaemurEx by low-skill healthcare professionals, and the accuracy of these tests was done by comparison with the gold standard which was found to be in the range of 82–91%. HaemurEx as a screening tool has the potential to significantly impact the diagnosis and treatment of different diseases at the POC.


PDF Share
  1. Iyengar S, Dholakia RH, Access of the Rural Poor to Primary Healthcare in India, (working paper no. 2011-05-03), IIM-Ahmedabad. 2011; (http://www.iimahd.ernet.in/assets/snippets/workingpaperpdf/3937368102011-05-3.pdf).
  2. Banerjee A, Deaton A, Duflo E. Health care delivery in rural Rajasthan. Econ Polit Weekly 2004;XXXIX(09):944–949. (http://www.epw.in/special-articles/health-care-delivery-rural-rajasthan.html).
  3. Kumar A, Gupta S, Health Infrastructure in India: Critical Analysis of Policy Gaps in the Indian Healthcare Delivery (Occasional paper), Vivekananda International Foundation. 2012; (http://www.vifindia.org/sites/default/files/health-infrastructure-in-india-critical-analysis-of-policy-gaps-in-the-indian-healthcare-delivery.pdf).
  4. Shephard MD. Point-of-care testing and creatinine measurement. Clin Biochem Rev 2011;32(2):109–114.
  5. Yang X, Kanter J, Piety NZ, et al. A simple, rapid, low-cost diagnostic test for sickle cell disease. Lab Chip 2013;13(8):1464–1467. DOI: 10.1039/C3LC41302K.
  6. St John A, Price CP. Existing and emerging technologies for point-of care testing. Clin Biochem Rev 2014;35(3):155–167.
  7. Nichols JH. Blood glucose testing in the hospital: error sources and risk management. J Diabetes Sci Techol 2011;5(1):173–177. DOI: 10.1177/193229681100500124.
  8. Mecozzi DM, Brock K, Tran NK, et al. Evidence-based point-of-care device design for emergency and disaster care. Point Care 2010;9(2):65–69. DOI: 10.1097/POC.0b013e3181d9d47a.
  9. Plebani M. Does POCT reduce the risk of error in laboratory testing? ClimChim Acta 2009;404(1):59–64. DOI: 10.1016/j.cca.2009.03.014.
  10. HaemurEx (https://www.arogyammedisoft.com).
  11. 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.
  12. Altinier S, Zaninotto M, Mion M, et al. Point-of-care testing of cariac 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.
  13. 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.
  14. 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.
  15. 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(9):187–192. DOI: 10.1111/j.1464-5491.2005.01491.x.
  16. 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.
  17. Mazzachi BC, Shephard AK. Comparative performance of two point-of-care analysers for lipid testing. Clin Lab 2007;53(9-12):561–566.
  18. CDSCO NOC.
  19. Anamol Laboratories Private Limited, India. (https://anamollabs.com/rapidtestkits.html).
  20. European Union Regulation 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), 2016; (https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32016R0679).
  21. HIPAA compliance on Google cloud platform. (https://cloud.google.com/security/compliance/hipaa)..
  22. Dan S, Ghosh B, Gorain B, et al. Mandatory registration of the research ethics committees in India. App Clin Res, Clin Trials Regulat Aff 2014;1(2):88–92. DOI: 10.2174/2213476X01999140818112854.
  23. US Food and Drug Administration. (2000) Guidance for Industry: Bioavailability and Bioequivalence Studies for Orally Administered Drug Products. (www.fda.gov/downloads/Drugs/…/Guidance's/ucm070124.pdf).
  24. https://ncss-wpengine.netdna-ssl.com/wp-content/themes/ncss/pdf/Procedures/NCSS/Bland-Altman_Plot_and_Analysis.pdf.
  25. Davide Giavarina. Understanding bland altman analysis. Biochem Med 2015;25(2):141–151. DOI: 10.11613/BM.2015.015.
  26. https://www.medcalc.org/.
PDF Share
PDF Share

© Jaypee Brothers Medical Publishers (P) LTD.