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: 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

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

Paratuberculosis (Johne's disease) is a chronic debilitating disease of domestic and wild ruminants. However, widespread point-of-care testing is infrequent due to the lack of a robust method. The isothermal recombinase polymerase amplification (RPA) technique has applied for rapid diagnosis. Herein, RPA combined with a lateral flow dipstick (LFD) assay was developed to estimate DNA from Mycobacterium avium subsp. paratuberculosis. First, analytical specificity and sensitivity of the RPA-nfo primer and probe sets were assessed. The assay successfully detected M. paratuberculosis DNA in 30 min at 39℃ with a detection limit of up to eight copies per reaction, which was equivalent to that of the real-time quantitative polymerase chain reaction (qPCR) assay. The assay was specific, as it did not amplify genomes from five other Mycobacterium spp. or five pathogenic enteric bacteria. Six hundred-twelve clinical samples (320 fecal and 292 serum) were assessed by RPA-LFD, qPCR, and enzyme-linked immunosorbent assay, respectively. The RPA-LFD assay yielded 100% sensitivity, 97.63% specificity, and 98.44% concordance rate with the qPCR results. This is the first report utilizing an RPA-LFD assay to visualize and rapidly detect M. paratuberculosis. Our results show this assay should be a useful method for the diagnosis of paratuberculosis in resource-constrained settings.
Animals ; Diagnosis ; DNA ; Enterobacteriaceae ; Enzyme-Linked Immunosorbent Assay ; Genome ; Limit of Detection ; Methods ; Mycobacterium avium subsp. paratuberculosis ; Mycobacterium avium ; Mycobacterium ; Paratuberculosis ; Point-of-Care Testing ; Polymerase Chain Reaction ; Recombinases ; Ruminants ; Sensitivity and Specificity

OBJECTIVETo develop a rapid, highly sensitive, and quantitative method for the detection of NT-proBNP levels based on a near-infrared point-of-care diagnostic (POCT) device with wide scope.

METHODSThe lateral flow assay (LFA) strip of NT-proBNP was first prepared to achieve rapid detection. Then, the antibody pairs for NT-proBNP were screened and labeled with the near-infrared fluorescent dye Dylight-800. The capture antibody was fixed on a nitrocellulose membrane by a scribing device. Serial dilutions of serum samples were prepared using NT-proBNP-free serum series. The prepared test strips, combined with a near-infrared POCT device, were validated by known concentrations of clinical samples. The POCT device gave the output of the ratio of the intensity of the fluorescence signal of the detection line to that of the quality control line. The relationship between the ratio value and the concentration of the specimen was plotted as a work curve. The results of 62 clinical specimens obtained from our method were compared in parallel with those obtained from the Roche E411 kit.

RESULTSBased on the log-log plot, the new method demonstrated that there was a good linear relationship between the ratio value and NT-proBNP concentrations ranging from 20 pg/mL to 10 ng/mL. The results of the 62 clinical specimens measured by our method showed a good linear correlation with those measured by the Roche E411 kit.

CONCLUSIONThe new LFA detection method of NT-proBNP levels based on the near-infrared POCT device was rapid and highly sensitive with wide scope and was thus suitable for rapid and early clinical diagnosis of cardiac impairment.

Antibodies ; Biomarkers ; Heart Diseases ; diagnosis ; Humans ; Immunoassay ; methods ; Infrared Rays ; Natriuretic Peptide, Brain ; blood ; Peptide Fragments ; blood ; Point-of-Care Testing ; Reagent Strips ; Sensitivity and Specificity

BACKGROUND: The amino-terminal pro-brain natriuretic peptide (NT-proBNP) is a useful biomarker for the diagnosis of acute congestive heart failure. A point-of-care test (POCT) could rapidly detect the presence of NT-proBNP during emergencies. We evaluated the analytical performance of the new Samsung LABGEO PA CHF Test (Samsung Electronics, Korea). METHODS: Based on the guidelines of the Clinical and Laboratory Standards Institute (CLSI), we compared the precision, linearity, and method with those of the E170 (Roche Diagnostics, Switzerland). Matrix comparison between the NT-proBNP values in whole blood and plasma was also performed, and the reference interval was determined using residual samples from healthy adults selected based on the evaluation criteria. RESULTS: The Samsung LABGEO PA CHF Test provided results in approximately 18 min. The coefficient of variation (CV) of within-laboratory precision was below 6.8%. A desirable linearity was observed in the range of 0–10,000 pg/mL, with R²=0.99. The correlation with E170 was also excellent (N=108, r=0.96). NT-proBNP values in the whole blood were correlated with those in the plasma (N=36, r=0.99). The reference interval for the circulating NT-proBNP concentration was determined in 118 plasma samples from healthy subjects (26-75 yr of age). The 97.5th percentile was found to be 58.3 pg/mL. CONCLUSIONS: The Samsung LABGEO PA CHF Test demonstrated a good analytical performance. It could be a powerful tool as a POCT for clinical practice, particularly during emergencies.
Adult ; Diagnosis ; Emergencies ; Healthy Volunteers ; Heart Failure ; Humans ; Methods ; Plasma ; Point-of-Care Systems* ; Point-of-Care Testing

BACKGROUND: The use of point-of-care (POC) devices for evaluating HbA1c is increasing; accordingly, comparisons between these devices and central laboratory methods are important. In the present study, we evaluated the analytical performance of the cobas b 101 analyzer for POC HbA1c testing. METHODS: The analytical quality of the cobas b 101 system was assessed based on repeatability, within-laboratory precision, linearity, and lot-to-lot reproducibility. Two specimen types, i.e., EDTA whole blood and capillary blood, were examined using the cobas b 101 system and the Variant II Turbo instrument. RESULTS: The coefficient of variation for within laboratory precision was 5.22% for a normal HbA1c level and 2.56% for a higher HbA1c level. The method showed good linearity, with a coefficient of correlation of 0.990. In a comparison of two different HbA1c disk lots, a strong correlation (r=0.986) and a mean %difference of −2.9% were observed. The cobas b 101 results using EDTA whole blood were strongly correlated with the Variant II Turbo results (r=0.958), with a mean %difference of 0.8%; the cobas b 101 results using capillary blood were strongly correlated with the Variant II Turbo results, using EDTA whole blood (r=0.976), with a mean %difference of 2.0%. A comparison between HbA1c levels in EDTA whole blood and capillary blood obtained using the cobas b 101 showed a strong correlation (r=0.985) and a mean %difference of 1.3%. CONCLUSIONS: The cobas b 101 analyzer is convenient for the measurement of HbA1c levels for diabetes management.
Capillaries ; Edetic Acid ; Methods ; Point-of-Care Systems* ; Point-of-Care Testing*