Blood biochemical indicators are an important basis for the diagnosis and treatment by doctors. The performance of related instruments, the qualification of operators, the storage method and time of blood samples and other factors will affect the accuracy of test results. However, it is difficult to meet the clinical needs of rapid detection and early screening of diseases with currently available methods. Point-of-care testing (POCT) is a new diagnostic technology with the characteristics of instant, portability, accuracy and efficiency. Microfluidic chips can provide an ideal experimental reaction platform for POCT. This paper summarizes the existing detection methods for common biochemical indicators such as blood glucose, lactic acid, uric acid, dopamine and cholesterol, and focuses on the application status of POCT based on microfluidic technology in blood biochemistry. It also summarizes the advantages and challenges of existing methods and prospects for development. The purpose of this paper is to provide relevant basis for breaking through the technical barriers of microfluidic and POCT product development in China.
Humans ; Point-of-Care Testing ; Lactic Acid/blood* ; Microfluidic Analytical Techniques/methods* ; Blood Glucose/analysis* ; Point-of-Care Systems ; Blood Chemical Analysis/instrumentation* ; Uric Acid/blood* ; Cholesterol/blood* ; Dopamine/blood* ; Microfluidics/methods*

Point-of-care testing (POCT), as an emerging diagnostic technology, is gradually becoming an important part of the clinical diagnostic field due to its advantages, such as ease of operation, rapid response, and portability. This paper primarily introduces two mainstream technologies in POCT: lateral flow assays and nucleic acid amplification. It covers the basic principles, applications, and quality control points in design and development of the two mainstream technologies, aiming to provide a technical reference for device manufacturers, researchers, and regulatory agencies.
Point-of-Care Testing ; Point-of-Care Systems ; Quality Control ; Equipment Design ; Nucleic Acid Amplification Techniques ; Humans

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.
Humans ; Point-of-Care Testing ; Critical Care ; Blood Coagulation Tests/methods* ; Male ; Blood Coagulation ; Female ; Middle Aged ; Reproducibility of Results ; Prothrombin Time ; Aged ; Adult ; Point-of-Care Systems

Visual detection is a technique for evaluating the results through visual judgment without relying on complex optical detection systems. It obtains results quickly based on signals, such as visible light, changes in air pressure, and migration distance, that can be directly observed by naked eyes, being widely used in the in vitro diagnostics industry. The CRISPR-Cas system has the potential to be used in the development of point of care testing (POCT) technologies due to the advantages of mild reaction conditions, no need for thermal cycling or other control measures, and a robust signal amplification capability. In recent years, the combination of visual detection and CRISPR-Cas has significantly reduced the need for laboratory infrastructures, precision instruments, and specialized personnel for nucleic acid detection. This has promoted the development of POCT technology and methods for nucleic acids. This article summarizes the signal output modes and characteristics of the visual detection of nucleic acid by CRISPR-Cas and discusses the issues in the application. Finally, its future clinical translation is envisioned with a view to informing the development of CRISPR-Cas visualization assays.
CRISPR-Cas Systems ; Humans ; Nucleic Acids/analysis* ; Point-of-Care Testing

Objective: To evaluate the performance of point-of-care testing for cervical cancer and precancerous lesions screening. Methods: In September 2020, 197 and 273 women were selected by using simple random sampling method from "self-sampling" cohort and "physician-sampling" cohort established in Xiangyuan county, Shanxi Province, China, respectively. Cervical exfoliated cells were collected by women themselves or gynecologists. All samples were detected by POCT and women with positive result were directly referred for colposcopy. Subsequently, all the samples were detected by careHPV and PCR test. Colposcopy and punch biopsy were performed for women with POCT negative but careHPV or PCR test positive at another visit. Using histopathological diagnosis as the gold standard, we calculated sensitivity, specificity and drew the receiver operating characteristic (ROC) curves. The accuracy of POCT was analyzed and compared to that of careHPV and conventional PCR test in cervical cancer and precancerous lesions screening. Results: The median (Q₁ , Q₃) age of 470 women was 51 (45, 57) years old. Based on self-sampling, the sensitivity and specificity of POCT for CIN2+ were 100.00% (95%CI: 56.56%-100.00%) and 28.95% (95%CI: 22.97%-35.76%), respectively. Compared with POCT, POCT HPV16/18 test had similar sensitivity and higher specificity of 89.47% (95%CI: 84.30%-93.08%). Self-sampling POCT HPV16/18 test had an AUC of 0.947 (95%CI:0.910-0.985), which was higher than that of careHPV and PCR test. Physician-sampling POCT test had 100.00% sensitivity (95%CI: 64.57%-100.00%) and 55.85% specificity (95%CI: 49.83%-61.70%) for detecting CIN2+. POCT HPV16/18 test had lower sensitivity (71.43%, 95%CI: 35.90%-91.76%) and higher specificity (92.45%, 95%CI: 88.63%-95.06%). POCT HPV16/18 test generally showed similar AUC on both self-collected samples and clinician-collected samples (0.947 vs 0.819, P=0.217). Conclusion: POCT HPV16/18 test is an effective method with relatively high sensitivity and specificity for cervical cancer screening.
Cervical Intraepithelial Neoplasia/diagnosis* ; Colposcopy ; Early Detection of Cancer/methods* ; Female ; Human papillomavirus 16/genetics* ; Human papillomavirus 18 ; Humans ; Mass Screening/methods* ; Papillomaviridae ; Papillomavirus Infections/diagnosis* ; Point-of-Care Testing ; Pregnancy ; Sensitivity and Specificity ; Uterine Cervical Neoplasms

Point-of-care testing (POCT) is a test method performed on the sampling site or patient bedside. Accurate results can be achieved rapidly by the application of portable analytical instruments and compatible reagents. It has been widely used in the field of in vitro diagnosis (IVD). Paper-based microfluidics technology has great potential in developing POCT due to its advantages in low cost, simple operation, rapid detection, portable equipment, and unrestricted application conditions. In recent years, the development of paper-based microfluidic technology and its integration with various new technologies and methods have promoted the substantial development of POCT technology and methods. The classification and characteristic of the paper are summarized in this review. Paper-based microfluidic sample pretreatment methods, the flow control in the process of reaction and the signal detecting and analyzing methods for the testing results are introduced. The research progress of various kinds of microfluidic paper-based analytical devices (μPADs) toward POCT in recent years is reviewed. Finally, remaining problems and the future prospects in POCT application of paper-based microfluidics are discussed.
Diagnostic Tests, Routine ; methods ; Humans ; Microfluidic Analytical Techniques ; instrumentation ; Paper ; Point-of-Care Testing

BACKGROUND: C-reactive protein (CRP) is an acute-phase protein whose level increases in response to tissue injury, infection, or other inflammation. It is used in clinical and forensic settings. Point-of-care (POC) testing has recently become available, and it is considered to be useful during postmortem examinations. However, laboratory testing of postmortem blood samples is difficult due to hemolysis and postmortem clotting. METHODS: The utility of POC testing for CRP during postmortem examination was evaluated using cardiac blood from the inferior vena cava. The whole blood sample was immediately tested using the POC instrument. Subsequently, the same sample was processed to obtain the serum, which was tested using common laboratory instruments. RESULTS: The postmortem POC test had a high positive predictive value and specificity, and the results strongly correlated with the laboratory test results. CONCLUSION: POC CRP testing is valid in postmortem examination and can be used in forensic medicine (postmortem inspection and autopsy).
Acute-Phase Proteins ; Autopsy ; C-Reactive Protein ; Forensic Medicine ; Forensic Sciences ; Hemolysis ; Inflammation ; Point-of-Care Systems ; Point-of-Care Testing ; Sensitivity and Specificity ; Vena Cava, Inferior

BACKGROUND: Point-of-care (POC) arterial blood gas analysis (ABGA) is widely used for checking hemoglobin (Hb) level. However, there is the tendency of downward bias of conductivity-based POC ABGA Hb measurement compared with optical methods. Authors tried to correct that bias by linear regression equation. METHODS: We retrospectively collected a total of 86 Hb result pairs during surgeries. Hb measured by the Sysmex XE-2100 in the laboratory was set as the gold standard and was compared with that measured by the GEM Premier 3500. Data were compared using the Bland-Altman analysis, the reliability of transfusion decision was assessed using three-zone error grid. The linear regression analysis was performed to find out the relation between the Hb results of POC ABGA and those of laboratory based test. RESULTS: The bias of the Hb measured between Sysmex XE-2100 and GEM Premier 3500 was −0.9 g/dl (P < 0.001, 95% confidence interval, −1.038 to −0.665 g/dl). The percentage error was 16.4%. According to error grid methodology, zone A, B and C encompassed 89.5%, 10.5% and 0% of data pairs. After adjusting the POC ABGA Hb values, the bias of the Hb measured by two methods was 0 g/dl (P = 0.991). The percentage error was 18.2%. The zone A, B and C encompassed 91.9%, 8.1% and 0% of data pairs. CONCLUSIONS: Hb measurements obtained with reference to conductivity via a POC ABGA were significantly lower than those obtained via optical methods. This bias may deserve attention of anesthesiologists when POC ABGA Hb level is used as a transfusion guideline.
Bias (Epidemiology)* ; Blood Gas Analysis ; Linear Models ; Methods* ; Point-of-Care Systems* ; Point-of-Care Testing ; Retrospective Studies

BACKGROUND: Conventional IgG assays require costly equipment and skilled experts. Semiquantitative measurement of total IgG using point-of-care testing devices may be the solution for these limitations. This study evaluated the reproducibility of the ImmuneCheck™ IgG assay (ProteomeTech Inc., Korea) and the correlation of its results with conventional laboratory IgG results in the serum and whole blood. METHODS: Both the serum and whole blood samples from 120 patients were used. To evaluate the intra-test reproducibility and inter-test correlation, intraclass correlation coefficient (ICC) analysis was used. RESULTS: The concentration of serum total IgG measured by cobas® 6000 (Roche Diagnostics, Switzland) ranged from 690.4 to 2,756.4 mg/dL. The intra-test reproducibility of ImmuneCheck™ IgG was high (Serum ICC=0.724, P < 0.001; Whole blood ICC=0.843, P < 0.001). The inter-test correlation between the ImmuneCheck™ IgG and cobas® 6000 results was very good (Serum ICC=0.805, P < 0.001; Whole blood ICC=0.842, P < 0.001). Because there were no samples with a total IgG level lower than 600 mg/dL, the pre-existing serum samples were diluted and then the linearity tests were conducted. The intra-test reproducibility for the diluted serum samples was almost perfect (ICC=0.995, P < 0.001), and the inter-test correlation between the ImmuneCheck™ IgG and cobas® 6000 results was also strong (ICC=0.992, P < 0.001). CONCLUSIONS: The ImmuneCheck™ IgG assay is reproducible and highly correlated with the conventional IgG assay for the serum and whole blood. It could be applied for the rapid detection of total IgG.
Humans ; Immunoglobulin G* ; Point-of-Care Testing

In the 2016 and 2017 programs for blood gas analysis (BGA) in central laboratory and by point-of-care testing (POCT), and glucose analysis by POCT, external quality assessment of 9, 3, and 1 analytes, respectively, was performed each year. The materials used were commercially available quality control materials, and three levels were used per trial. Based on the information and results from each participating laboratory, statistical analysis was carried out. Results were provided to each laboratory through individual and comprehensive reports. The mean response rates were 96.6%, 96.5%, and 95.6% for BGA in central laboratory, BGA (POCT), and glucose (POCT), respectively. The number of participating laboratories in BGA (central laboratory and POCT) in 2017 was not significantly different from that in 2016. However, in the glucose (POCT) program, the number of registered instruments sharply increased in 2017 as the allowable number of registered instruments was increased from 5 to 30. The coefficient of variation (CV) did not show any significant differences in pH, sodium, chloride, and ionized calcium of BGA. However, the differences of CV were found to be relative large between instruments in other analytes of BGA and glucose POCT.
Blood Gas Analysis ; Calcium ; Glucose* ; Hydrogen-Ion Concentration ; Korea* ; Point-of-Care Systems* ; Point-of-Care Testing ; Quality Control ; Sodium