Advancing Point-of-Care Diagnostics in Community Medicine: Evaluation of the Portable ENNOLIFE HCA-TC-200 Analyzer for Hepatorenal and Urinary Testing

Portable Analyzer for Hepatorenal and Urinary Testing

DOI: https://doi.org/10.5937/jomb0-58353
Keywords: point-of-care diagnostics, portable analyzer, clinical chemistry, hepatorenal diagnostics, urinary biomarkers, community medicine

Abstract


Background: Accurate and efficient chemical analyzers play a critical role in modern healthcare, particularly in community medicine where early diagnosis and intervention can significantly improve patient outcomes. This study evaluated the diagnostic performance of the novel portable ENNOLIFE HCA-TC-200 analyzer compared to the established Beckman UniCel DxC 880i analyzer, emphasizing its application for point-of-care testing in community settings.

Methods: A total of 600 healthy subjects were recruited from Shuang Ho Hospital, Taiwan. The diagnostic accuracy of ENNOLIFE HCA-TC-200 was validated using clinical chemistry assays, specifically assessing hepatic, renal, and urinary biomarkers. The analyzers were compared based on linearity, inter-method agreement, accuracy, and precision.

Results: The ENNOLIFE HCA-TC-200 analyzer demonstrated diagnostic accuracy and precision comparable to the Beckman UniCel DxC 880i. High linear correlations (R > 0.97) were found for most hepatic, renal, and urinary markers, with minor deviations observed for albumin (R = 0.92) and urine creatinine (R = 0.80), which remained within clinically acceptable diagnostic ranges. Accuracy assessments showed >97% inter-method agreement across all analytes after excluding extreme outliers, with 100% agreement for hepatic and renal markers.

Conclusions: Chronic liver and kidney diseases remain significant public health challenges, especially within community healthcare contexts. The portable ENNOLIFE HCA-TC-200 analyzer effectively addresses these challenges by facilitating rapid, accurate point-of-care diagnostics in community-based settings. This device supports timely disease detection, enhances preventive medicine practices, and promotes personalized healthcare, ultimately contributing to improved community health outcomes.

Author Biographies

Ping-Jen Hu, Shuang-Ho Hospital

I am Ping-Jen Hu, MD, MS, a gastroenterologist at Shuang Ho Hospital in Taiwan, specializing in endoscopic ultrasound (EUS), endoscopic retrograde cholangiopancreatography (ERCP), and advanced biliary-pancreatic interventions. I earned my MD from Chung Shan Medical University in 2010 and completed internal medicine and gastroenterology fellowship training at Shuang Ho Hospital. In 2018, I served at Mackay Memorial Hospital in Taitung, gaining experience in managing gastrointestinal diseases in underserved areas. In 2019, I trained in EUS and cholangioscopy at Kitasato University Endoscopy Center in Japan, focusing on minimally invasive techniques. I obtained my Master’s in Biomedical Sciences from Taitung University in 2021 and received lecturer certification from the Ministry of Education. Returning to Shuang Ho Hospital, I was appointed Director of the Endoscopy Center, leading advancements in biliary-pancreatic endoscopy and training programs. I later became Deputy Director of the Department of Community Medicine, integrating clinical expertise with public health initiatives. My research focuses on chronic kidney disease, biliary-pancreatic diseases, hepatitis, and community medicine, utilizing big data analytics to improve patient outcomes. I have been invited as a speaker and live demonstration expert at national and international conferences, contributing to advancements in endoscopic techniques and gastroenterological healthcare.

Yung-Han Lai, Department of Education, Taipei Municipal Wanfang Hospital, Taipei, Taiwan

I am Yung-Han Lai, M.D., a Postgraduate Year (PGY) physician at Wanfang Municipal Hospital in Taiwan, where I focus on clinical training and research. My passion lies in improving patient care through data-driven insights, evidence-based medicine, and preventive healthcare strategies. I believe that integrating research with clinical practice enhances medical decision-making and leads to better long-term health outcomes for individuals and communities. I earned my Doctor of Medicine (M.D.) from Poznan University of Medical Sciences in 2021, after completing a Bachelor of Arts (B.A.) in Biochemistry at the University of Washington in 2016. My academic background provides a strong foundation in biological sciences and analytical research methodologies, which I actively apply in my medical and scientific work. Building on my passion for family medicine, my research focuses on preventive medicine and community healthcare services, particularly integrating point-of-care (POC) solutions to enhance early disease detection and timely interventions. I am interested in big data and epidemiological research to identify risk factors for chronic diseases and develop effective screening and prevention strategies. By combining critical thinking, data analysis, and evidence synthesis, I aim to advance disease prevention, health promotion, and community-based healthcare. My expertise in research design, biostatistics, and systematic literature review allows me to critically evaluate medical data and translate findings into meaningful clinical applications. Beyond research, I am committed to lifelong learning and interdisciplinary collaboration. My ultimate goal is to become a leading expert in preventive and community medicine, helping to shape healthcare policies and strategies that promote disease prevention and improved quality of life.

References

1. Leitner-Ferenc V, Atamaniuk J, Jansen-Skoupy S, Stöckelmeier B, Grohs K, Födinger M. CLSI-based validation of manufacturer-derived reference intervals on the Cobas 8000 platform. Lab Med 2017; 48: e30-5.
2. Genc S, Dervisoglu E, Erdem S, Arslan O, Aktan M, Omer B. Comparison of performance and abnormal cell flagging of two automated haematology analyzers: Sysmex XN 3000 and Beckman Coulter DxH 800. Int J Lab Hematol 2017; 39: 633-40.
3. Lippi G, Plebani M, Favaloro EJ. Technological advances in the hemostasis laboratory. Semin Thromb Hemost 2014; 40: 178.
4. Clinical and Laboratory Standards Institute (CLSI). CLSI guideline. 2nd ed. Wayne, PA, USA: Clinical and Laboratory Standards Institute; 2020.
5. Markin RS, Whalen SA. Laboratory automation: trajectory, technology, and tactics. Clin Chem 2000; 46: 764-71.
6. Park HW, Ko D, Kim JQ, Song SH. Performance evaluation of the Piccolo xpress point-of-care chemistry analyzer. Korean J Lab Med 2009; 29: 430-8.
7. Zimmerman MK, Friesen LR, Nice A, et al. Multi-center evaluation of analytical performance of the Beckman Coulter AU5822 chemistry analyzer. Clin Biochem 2015; 48: 881-5.
8. Choi YJ, Kang H, Cho CI, Rim JH, Lee SG, Lim JB. Performance evaluation of the DxC 700 AU chemistry analyzer in hemoglobin A1c measurement. Ann Lab Med 2022; 43: 167-73.
9. Bush VJ, Smola C, Schmitt P. Evaluation of the Beckman Coulter DxC 700 AU chemistry analyzer. Pract Lab Med 2020; 18: e00148.
10. Sicard DA, Taylor JR. Comparison of point-of-care HbA1c test versus standardized laboratory testing. Ann Pharmacother 2005; 39: 1024-8.
11. Yonel Z, Kuningas K, Sharma P, Dutton M, Jalal Z, Cockwell P, Webber J, Narendran P, Dietrich T, Chapple ILC. Concordance of three point of care testing devices with clinical chemistry laboratory standard assays and patient-reported outcomes of blood sampling methods. BMC Med Inform Decis Mak 2022; 22: 248.
12. Clinical and Laboratory Standards Institute (CLSI). Measurement procedure comparison and bias estimation using patient samples. 3rd ed. CLSI Guideline EP09c. Wayne, PA, USA: Clinical and Laboratory Standards Institute; 2018.
13. Mark D, Haeberle S, Roth G, von Stetten F, Zengerle R. Microfluidic lab-on-a-chip platforms: requirements, characteristics and applications. Chem Soc Rev 2010;39:1153-82.
14. Yang Y, Chen Y, Tang H, Zong N, Jiang X. Microfluidics for biomedical analysis. Small Methods 2019; 4: 1900451.
15. Wang L, Li PCH. Microfluidic DNA microarray analysis: a review. Anal Chim Acta 2011; 687: 12-27.
16. Nolan JP, Condello D. Spectral flow cytometry. Curr Protoc Cytom 2013; 63: 1.27.1-1.27.13.
17. Paik J, Golabi P, Younossi Y, Mishra A, Younossi ZM. Changes in the global burden of chronic liver diseases from 2012 to 2017: the growing impact of NAFLD. Hepatology 2020; 72: 1605-16.
18. World Health Organization. Global health sector strategy on viral hepatitis, 2016–2021. Geneva, Switzerland: World Health Organization; 2016. p. 56.
19. Akbar SMF, Al-Mahtab M, Khan S, Yoshida O, Hiasa Y. “Elimination of hepatitis by 2030”: present realities and future projections. Infect Dis Immun 2021; 2: 3-8.
20. Marcellin P, Kutala B. Liver diseases: a major, neglected global public health problem requiring urgent actions and large-scale screening. Liver Int 2018; 38: 2-6.
21. Jha V, Garcia-Garcia G, Iseki K, et al. Chronic kidney disease: global dimension and perspectives. Lancet 2013; 382: 260-72.
22. Liyanage T, et al. Worldwide access to treatment for end-stage kidney disease: a systematic review. Lancet 2015; 385: 1975-82.
23. Wen CP, Cheng TY, Tsai MK, et al. All-cause mortality attributable to chronic kidney disease: a prospective cohort study based on 462,293 adults in Taiwan. Lancet 2008; 371: 2173-82.
24. Chen TK, Knicely DH, Grams ME. Chronic kidney disease diagnosis and management. JAMA 2019; 322: 1294-304.
25. Thipsawat S. Early detection of diabetic nephropathy in patients with type 2 diabetes mellitus: a review of the literature. Diab Vasc Dis Res 2021; 18: 14791641211058856.
26. Ene-Iordache B, Perico N, Bikbov B, et al. Chronic kidney disease and cardiovascular risk in six regions of the world (ISN-KDDC): a cross-sectional study. Lancet Glob Health 2016; 4: e307-19.
27. Badve SV, Pascoe EM, Tiku A, et al. Effects of allopurinol on the progression of chronic kidney disease. N Engl J Med 2020; 382: 2504-13.
28. United States Renal Data System. 2021 USRDS annual data report: epidemiology of kidney disease in the United States. Bethesda, MD, USA: National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases; 2021.
29. Bodington R, Kassianides X, Bhandari S. Point-of-care testing technologies for the home in chronic kidney disease: a narrative review. NDT Plus 2021; 14: 2316-31.
30. Zarei M. Advances in point-of-care technologies for molecular diagnostics. Biosens Bioelectron 2017; 98: 494-506.
31. Sang J, Cheng J, Hu H, Liu K, Guo J, Guo J. Portable dual-channel blood enzyme analyzer for point-of-care liver function detection. Analyst 2023; 148: 6020-7.
32. Kosack CS, de Kieviet W, Bayrak K, Milovic A, Page AL. Evaluation of the Nova StatSensor® Xpress™ Creatinine point-of-care handheld analyzer. PLoS One 2015; 10: e0122433.
33. Current and emerging trends in point-of-care urinalysis tests. Expert Rev Mol Diagn 2019; 20: 69-84.
34. Currin SD, Gondwe MS, Mayindi NB, et al. Diagnostic accuracy of semiquantitative point-of-care urine albumin to creatinine ratio and urine dipstick analysis in a primary care resource-limited setting in South Africa. BMC Nephrol 2021; 22: 1.
Published
2025/12/27
Issue
Ahead of print
Section
Original paper

Copyright (c) 2025 Ping-Jen Hu, Yung-Han Lai, Cai-Mei Zheng, Hsin-Ting Lin, Pei-Yu Wang, Chi-Chen Yang, Yu-Ann Fang, Tian-Jong Chang, Chia-Wei Lin, Yuh-Feng Lin, Ming-Yao Chen, Hsiao-Chung Tsai, Huai-Chih Chiang

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