Abstract: The accurate and timely detection of biochemical coagulation indicators is pivotal in pulmonary and critical care medicine. Despite their reliability, traditional laboratories often lag in terms of rapid diagnosis. Point-of-care testing (POCT) has emerged as a promising alternative, which is awaiting rigorous validation. We assessed 226 samples from patients at the First Affiliated Hospital of Guangzhou Medical University using a Beckman Coulter AU5821 and a PUSHKANG POCT Biochemistry Analyzer MS100. Furthermore, 350 samples were evaluated with a Stago coagulation analyzer STAR MAX and a PUSHKANG POCT Coagulation Analyzer MC100. Metrics included thirteen biochemical indexes, such as albumin, and five coagulation indices, such as prothrombin time. Comparisons were drawn against the PUSHKANG POCT analyzer. Bland-Altman plots (MS100: 0.8206‒0.9995; MC100: 0.8318‒0.9911) evinced significant consistency between methodologies. Spearman correlation pinpointed a potent linear association between conventional devices and the PUSHKANG POCT analyzer, further underscored by a robust correlation coefficient (MS100: 0.713‒0.949; MC100: 0.593‒0.950). The PUSHKANG POCT was validated as a dependable tool for serum and whole blood biochemical and coagulation diagnostics. This emphasizes its prospective clinical efficacy, offering clinicians a swift diagnostic tool and heralding a new era of enhanced patient care outcomes.

床旁即时检测分析仪在血清生化十三项指标与全血凝血五项指标的应用：评估呼吸与危重症疾病的理想工具

[1]AthaleUH, ChanAKC, 2003. Thrombosis in children with acute lymphoblastic leukemia: Part II. Pathogenesis of thrombosis in children with acute lymphoblastic leukemia: effects of the disease and therapy. Thromb Res, 111(4-5):199-212.

[2]BriggsC, KimberS, GreenL, 2012. Where are we at with point‐of‍‐‍care testing in haematology?Br J Haematol, 158(6):679-690.

[3]ChaseJG, PreiserJC, DicksonJL, et al., 2018. Next-generation, personalised, model-based critical care medicine: a state-of-the art review of in silico virtual patient models, methods, and cohorts, and how to validation them. Biomed Eng Online, 17:24.

[4]China Food and Drug Administration, 2014. Notice of the State Food and Drug Administration in China on Issuing Technical Guidelines for Clinical Trials of In Vitro Diagnostic Reagents. https://www.nmpa.gov.cn/directory/web/nmpa//xxgk/ggtg/ylqxggtg/ylqxqtggtg/20140911120001840.html

[5]Clinical and Laboratory Standards Institute, 2012. Verification of Comparability of Patient Results Within One Health Care System; Approved Guideline. CLSI Document C54-A, Clinical and Laboratory Standards Institute, Wayne.

[6]Clinical and Laboratory Standards Institute, 2013. Measurement Procedure Comparison and Bias Estimation Using Patient Samples; Approved Guideline. Third Edition. CLSI Document EP09-A3, Clinical and Laboratory Standards Institute, Wayne.

[7]CuiP, WangSC, 2019. Application of microfluidic chip technology in pharmaceutical analysis: a review. J Pharm Anal, 9(4):238-247.

[8]EbnerM, BirschmannI, PeterA, et al., 2017. Point-of-care testing for emergency assessment of coagulation in patients treated with direct oral anticoagulants. Crit Care, 21:32.

[9]FlorkowskiC, Don-WauchopeA, GimenezN, et al., 2017. Point-of-care testing (POCT) and evidence-based laboratory medicine (EBLM)‒does it leverage any advantage in clinical decision making? Crit Rev Clin Lab Sci, 54(7-8):471-494.

[10]FragosoCAV, 2017. Epidemiology of lung disease in older persons. Clin Geriatr Med, 33(4):491-501.

[11]GervaisL, de RooijN, DelamarcheE, 2011. Microfluidic chips for point‐of‐care immunodiagnostics. Adv Mater, 23(24):H151-H176.

[12]GreenhalghT, KnightM, A'CourtC, et al., 2020. Management of post-acute COVID-19 in primary care. BMJ, 370:m3026.

[13]HerrmannJ, NotzQ, SchlesingerT, et al., 2021. Point of care diagnostic of hypercoagulability and platelet function in COVID-19 induced acute respiratory distress syndrome: a retrospective observational study. Thromb J, 19:39.

[14]IchkawaY, WadaH, EzakiM, et al., 2020. Elevated d-dimer levels predict a poor outcome in critically ill patients. Clin Appl Thromb Hemost, 26:1076029620973084.

[15]LinJ, YanH, ChenHC, et al., 2021. COVID‐19 and coagulation dysfunction in adults: a systematic review and meta‐analysis. J Med Virol, 93(2):934-944.

[16]LiuMT, ChengZJ, XueMS, et al., 2023a. The application of metabolomics toward idiopathic pulmonary fibrosis and potential metabolomic value of diverse samples in interstitial lung diseases. Precis Med Sci, 12(3):134-143.

[17]LiuMT, LyuJ, ZhengXH, et al., 2023b. Evolution of the newest diagnostic methods for COVID-19: a Chinese perspective. J Zhejiang Univ-Sci B (Biomed & Biotechnol), 24(6):463-484.

[18]LiuMT, LiangZM, ChengZK, et al., 2023c. SARS-CoV-2 neutralising antibody therapies: recent advances and future challenges. Rev Med Virol, 33(5):e2464.

[19]LuppaPB, MüllerC, SchlichtigerA, et al., 2011. Point-of-care testing (POCT): current techniques and future perspectives. TrAC Trends Anal Chem, 30(6):887-898.

[20]LuppaPB, BietenbeckA, BeaudoinC, et al., 2016. Clinically relevant analytical techniques, organizational concepts for application and future perspectives of point-of-care testing. Biotechnol Adv, 34(3):139-160.

[21]MansourSA, MossaATH, 2010. Oxidative damage, biochemical and histopathological alterations in rats exposed to chlorpyrifos and the antioxidant role of zinc. Pestic Biochem Physiol, 96(1):14-23.

[22]ParikhCR, 2009. A point-of-care device for acute kidney injury: a fantastic, futuristic, or frivolous ‘measure’? Kidney Int, 76(1):8-10.

[23]ParshallMB, SchwartzsteinRM, AdamsL, et al., 2012. An official american thoracic society statement: update on the mechanisms, assessment, and management of dyspnea. Am J Respir Crit Care Med, 185(4):435-452.

[24]SherM, ZhuangR, DemirciU, et al., 2017. Paper-based analytical devices for clinical diagnosis: recent advances in the fabrication techniques and sensing mechanisms. Expert Rev Mol Diagn, 17(4):351-366.

[25]SolerM, EstevezMC, Cardenosa-RubioM, et al., 2020. How nanophotonic label-free biosensors can contribute to rapid and massive diagnostics of respiratory virus infections: COVID-19 case. ACS Sens, 5(9):2663-2678.

[26]SongJC, WangG, ZhangW, et al., 2020. Chinese expert consensus on diagnosis and treatment of coagulation dysfunction in COVID-19. Military Med Res, 7:19.

[27]St-LouisP, 2000. Status of point-of-care testing: promise, realities, and possibilities. Clin Biochem, 33(6):427-440.

[28]StootLJ, CairnsNA, CullF, et al., 2014. Use of portable blood physiology point-of-care devices for basic and applied research on vertebrates: a review. Conserv Physiol, 2:cou011.

[29]TanejaR, BatraP, 2021. Biomarkers as point of care tests (POCT) in neonatal sepsis: a state of science review. J Neonat-Perinat Med, 14(3):331-338.

[30]TorresN, Torre-VillalvazoI, TovarAR, 2006. Regulation of lipid metabolism by soy protein and its implication in diseases mediated by lipid disorders. J Nutr Biochem, 17(6):365-373.

[31]VesperHW, MyersGL, MillerWG, 2016. Current practices and challenges in the standardization and harmonization of clinical laboratory tests. Am J Clin Nutr, 104(S3):907S-912S.

[32]VolpicelliG, ElbarbaryM, BlaivasM, et al., 2012. International evidence-based recommendations for point-of-care lung ultrasound. Intens Care Med, 38(4):577-591.

[33]XiaoM, TianF, LiuX, et al., 2022. Virus detection: from state‐of‐the‐art laboratories to smartphone‐based point‐of‐care testing. Adv Sci, 9(17):2105904.

[34]XueMS, ZhangT, ChengZJ, et al., 2022. Effect of a functional phospholipid metabolome-protein association pathway on the mechanism of COVID-19 disease progression. Int J Biol Sci, 18(12):4618-4628.

[35]Zaczek-MoczydlowskaMA, BeizaeiA, DillonM, et al., 2021. Current state-of-the-art diagnostics for norovirus detection: model approaches for point-of-care analysis. Trends Food Sci Technol, 114:684-695.

[36]ZhangYT, ZhouND, 2022. Electrochemical biosensors based on micro‍‐‍fabricated devices for point‍‐‍of‍‐‍care testing: a review. Electroanalysis, 34(2):168-183.

[37]ZhuHL, ZhangHQ, NiS, et al., 2020. The vision of point-of-care PCR tests for the COVID-19 pandemic and beyond. TrAC Trends Anal Chem, 130:115984.

[38]ZhuHQ, HuangZF, HuangHM, et al., 2022. Evaluation of a point-of-care testing analyzer for measuring peripheral blood leukocytes. J Vis Exp, (181):e63364.