1.Design of the Intelligent POCT Network Architecture.
Chinese Journal of Medical Instrumentation 2018;42(6):428-430
A new concept and solution of architecture of the intelligent POCT network, based on Internet of Things and intelligent POCT devices, is proposed. This network's topology structure and components with basic requirements are introduced. Through the experience of clinical application scenario, the main characteristics of the network and superiority over traditional POCT device have been analyzed.
Internet
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Point-of-Care Systems
2.Determinants Used to Justify the Strength of Recommendations among Korean Clinical Practice Guidelines
Ein Soon SHIN ; Ji Eun JANG ; Ji Yun YEON ; Da sol KIM ; Sung Goo CHANG ; Yoon Seong LEE
Journal of Korean Medical Science 2018;33(8):e79-
BACKGROUND: A standardized systematic approach to grade evidence and the strength of recommendations is important for guideline users to minimize bias and help interpret the most suitable decisions at the point of care. The study aims to identify and classify determinants used to make judgement for the strength of recommendations among 56 Korean clinical practice guidelines (CPGs), and explore strong recommendations based on low quality of evidence. METHODS: Determinants used in the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach among 34 CPGs which have reported both strength of recommendations and level of evidence were reviewed. RESULTS: Five of 34 CPGs (14.7%) considered quality of evidence, benefits and harms, patients' values and preferences, and costs. And 24 of 34 CPGs (70.6%) considered both magnitude of effect and feasibility as additional determinants. Judgement table was not widely provided for use to translate evidence into recommendations. Eighty-two of 121 recommendations (67.8%, ranged 20.0% to 100.0%) among 11 CPGs using the same judgement scheme showed ‘strong’ strength of recommendations based on low or very low quality of evidence. Among 5 paradigmatic situations that justify strong recommendations based on low or very low evidence, situation classified as ‘potential equivalence, one option clearly less risky or costly’ was 87.8% for 82 strong recommendations. Situation classified as ‘uncertain benefit, certain harm’ was 4.9%. CONCLUSION: There is a need to introduce and systematize an evidence-based grading system. Using judgement table to justify the strength of recommendations and applying the 5 paradigmatic situations mentioned above is also recommended in the near future.
Bias (Epidemiology)
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Point-of-Care Systems
3.Point-of-Care Diagnostics for Infectious Diseases: Present and Future.
Korean Journal of Medicine 2018;93(2):181-187
No abstract available.
Communicable Diseases*
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Point-of-Care Systems*
4.Evaluation of Cobas b 101 HbA1c Analyzer Performance for Point-of-Care Testing.
Hui Jin YU ; Sangeun LIM ; Min Jung KWON ; Hee Yeon WOO ; Hyosoon PARK
Laboratory Medicine Online 2017;7(4):182-188
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
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Edetic Acid
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Methods
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Point-of-Care Systems*
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Point-of-Care Testing*
5.Application of POCT in Community Health Institutions.
Chinese Journal of Medical Instrumentation 2015;39(2):149-152
In this paper, POCT detection technology which has been carried out in community health institutions is summarized and introduced. The paper has made the research on the existing resistance and urgent problem of POCT in the community. At the same time, the paper described the prospect of the development of POCT detection technology in community health institutions in view of the future.
Humans
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Point-of-Care Systems
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Public Health
6.Performance Evaluation of a Point-of-care Test, ‘Samsung LABGEO PA CHF Test’, for the Amino-terminal Pro-brain Natriuretic Peptide.
Man Jin KIM ; Kyunghoon LEE ; Sun Hee JUN ; Sang Hoon SONG ; Woon Heung SONG ; Junghan SONG
Laboratory Medicine Online 2017;7(3):135-140
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
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Diagnosis
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Emergencies
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Healthy Volunteers
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Heart Failure
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Humans
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Methods
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Plasma
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Point-of-Care Systems*
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Point-of-Care Testing
7.Comparing the Efficacy of Samsung LABGEO PT10 and Bio-Rad Variant II Turbo for HbA1c Measurement in Three Types of Blood Samples.
Jong Eun PARK ; Hyung Doo PARK
Laboratory Medicine Online 2016;6(3):152-158
BACKGROUND: Hemoglobin A1c (HbA1c) is a good marker for monitoring glycemic control. The Samsung LABGEO PT10 HbA1c test (Samsung Electronics, Korea) was developed as a point-of-care testing approach. This study evaluated the levels of HbA1c in three different types of blood specimens using two different methods. METHODS: We used correlation analyses to compare the results obtained using Samsung LABGEO PT10 and Bio-Rad Variant II Turbo (Bio-Rad Laboratories, USA) to determine the levels of HbA1c in three different types of blood samples: capillary blood, EDTA whole blood, and lithium (Li)-heparin whole blood. RESULTS: The correlation coefficient for the level of HbA1c in capillary blood based on LABGEO PT10 vs. that in EDTA whole blood based on the Variant II Turbo was r=0.9619; that in capillary blood based on LABGEO PT10 vs. that in Li-heparin whole blood based on the Variant II Turbo was r=0.9619; that in capillary blood vs. that in EDTA whole blood based on the LABGEO PT10 was r=0.9697; that in capillary blood vs. that in Li-heparin whole blood based on the LABGEO PT10 was r=0.9724; and that in EDTA whole blood vs. that in Li-heparin whole blood based on the LABGEO PT10 was r=0.9730. CONCLUSIONS: The LABGEO PT10 was suitable for analyzing HbA1c. The results for the measurement of HbA1c levels in capillary blood were comparable to that in the whole blood samples. Additionally, LABGEO PT10 can be used for patients who are unable to take venipuncture.
Capillaries
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Edetic Acid
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Humans
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Lithium
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Phlebotomy
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Point-of-Care Systems
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Point-of-Care Testing
8.Downward bias of conductivity based point-of-care hemoglobin measurement compared with optical methods.
Min Hee HEO ; Jun Hyun KIM ; Kyung Woo KIM ; Ho Jae CHO ; Won Joo CHOE ; Kyung Tae KIM ; Ji Yeon KIM ; Sang Il LEE ; Jang Su PARK ; Jung Won KIM
Anesthesia and Pain Medicine 2018;13(3):323-328
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)*
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Blood Gas Analysis
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Linear Models
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Methods*
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Point-of-Care Systems*
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Point-of-Care Testing
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Retrospective Studies
10.Evaluation of the i-Smart 30 Point-of-Care Analyzer for Use in Clinical Laboratory Settings.
Yoonmi SEOK ; Woonhyoung LEE ; Seoyoung YOON ; Youngchul WON ; Oh Hun KWON
Journal of Laboratory Medicine and Quality Assurance 2011;33(1):25-30
BACKGROUND: The i-Smart 30 point-of-care (POC) analyzer (i-SENS, Korea) is a compact and portable system used for the analysis of electrolytes (sodium, potassium, chloride) and hematocrit in whole blood samples. In this study, we evaluated the analytical performance of the i-Smart 30 analyzer. METHODS: Precision and sample-related percent carry-over were determined using the quality control materials. Comparison study was performed with the Stat Profile Critical Care Xpress (STP CCX; Nova Biomedical, USA) analyzer using venous whole blood samples. RESULTS: In the precision study, imprecision studies demonstrated within-run and total-run coefficients of variation within 0.5-3.9% and 0.7-4.4%, respectively, for all analytes. A good correlation was found between the i-Smart 30 analyzer and the STP CCX analyzer, except for chloride that showed high intercept. In the study of carry-over, sample-related carry-over for Na+, K+, Cl- and Hct were demonstrated as 0.84%, 0%, 0.86% and 1.56%, respectively. CONCLUSIONS: We conclude that the i-Smart 30 analyzer is suitable for routine use in clinical laboratories, especially where rapid test results are required such as emergency departments, intensive care units, and dialysis units. However, for Cl-, it is necessary that a significant correlation between this analyzer and a reference method should be demonstrated.
Critical Care
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Dialysis
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Electrolytes
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Emergencies
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Hematocrit
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Intensive Care Units
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Point-of-Care Systems
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Potassium
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Quality Control