Integration between the Tele-Cardiology Unit and the central laboratory: methodological and clinical evaluation of point-of-care testing cardiac marker in the ambulance

Author(s):  
Francesca Di Serio ◽  
Roberto Lovero ◽  
Massimo Leone ◽  
Rosalia De Sario ◽  
Vincenzo Ruggieri ◽  
...  

AbstractThe aim of this study was to identify patients with myocardial necrosis in pre-hospital phase during transport by ambulance, without ST-segment elevation (NSTE) on the ambulance ECG. The analytical performance of the i-STAT

2000 ◽  
Vol 46 (10) ◽  
pp. 1604-1609 ◽  
Author(s):  
Fred S Apple ◽  
F Philip Anderson ◽  
Paul Collinson ◽  
Robert L Jesse ◽  
Michael C Kontos ◽  
...  

Abstract Background: Validation of whole blood, point-of-care testing devices for monitoring cardiac markers to aid clinicians in ruling in and ruling out myocardial infarction (MI) is necessary for both laboratory and clinical acceptance. Methods: This study evaluated the clinical diagnostic sensitivity and specificity of the First Medical Cardiac Test device operated by nursing and laboratory personnel that simultaneously measures cardiac troponin I (cTnI), creatine kinase (CK) MB, myoglobin, and total CK on the Alpha Dx analyzer in whole blood for detection of MI. Over a 6-month period, 369 patients initially presenting to the emergency department with chest pain were evaluated for MI using modified WHO criteria. Eighty-nine patients (24%) were diagnosed with MI. Results: In whole blood samples collected at admission and at 3- to 6-h intervals over 24 h, ROC curve-determined MI decision limits were as follows: cTnI, 0.4 μg/L; CKMB, 7.0 μg/L; myoglobin, 180 μg/L; total CK, 190 μg/L. Based on peak concentrations within 24 h after presentation, the following sensitivities (± 95% confidence intervals) were found: cTnI, 93% ± 5.5%; myoglobin, 81% ± 9.7%; CKMB, 90% ± 6.3%; total CK, 86% ± 7.5%. Sensitivities were maximal at >90% for both cTnI and CKMB at >12 h in MI patients, without differences between ST-segment elevation and non-ST-segment elevation MI patients. Conclusions: The First Medical point-of-care device provides cardiac marker assays that can be used by laboratories and clinicians in a variety of hospital settings for ruling in and ruling out MI.


Author(s):  
Francesca Di Serio ◽  
Gianfranco Amodio ◽  
Lucia Varraso ◽  
Maurizio Campaniello ◽  
Paola Coluccia ◽  
...  

AbstractTo achieve rapid assessment of chest pain in emergency/cardiology departments, a short turnaround time for cardiac marker testing is necessary. Nevertheless, Total Quality Management principles must be incorporated into the management of point-of-care testing (POCT); in this setting we implemented the Stratus CS


Author(s):  
Chin-Pin Yeo ◽  
Carol Hui-Chen Tan ◽  
Edward Jacob

Background Point-of-care-testing (POCT) of haemoglobin Alc (HbA1c) is popular due to its fast turnaround of results in the outpatient setting. The aim of this project was to evaluate the performance of a new HbA1c POCT analyser, the Bio-Rad in2it, and compare it with the Siemens DCA 2000, Bio-Rad Variant II and Roche Tina-quant HbA1c Gen 2 assay on the cobas c501. Methods Imprecision of the four methods were compared by computing total imprecision from within-run and between-run data. A total of 80 samples were also compared and analysed by Deming regression and Altman–Bland difference test. Results Study of total imprecision of the in2it at HBA1c levels of 6.0% and 10.4% produced a coefficient of variation (%CV) of 3.8% and 3.7%, respectively. These results were more favourable as compared with the DCA 2000 but did not match the low imprecision of the central laboratory methods, the Bio-Rad Variant II and the Roche cobas c501. Comparison between the in2it and the central laboratory analysers, Bio-Rad variant II and cobas c501, revealed positive bias of 12% and 10%, respectively, supported by corresponding Deming regression equation slopes of +1.18 and +1.14. Comparison between the DCA 2000 and the central laboratory analysers revealed a bias that became increasingly positive with rising HbA1c concentrations with Deming regression analysis also revealing proportional and constant differences. Conclusions The in2it is a suitable POCT analyser for HbA1c but its less than ideal precision performance and differences with the central laboratory analysers must be communicated to and noted by the users.


2021 ◽  
Author(s):  
Qiang Zhang ◽  
Guoqing Wang ◽  
Xiaolong Zong ◽  
Jinghua Sun

BACKGROUND With advances in mobile technology, smartphone-based point-of-care testing (POCT) urinalysis hold great potential for disease screening and health management for clinicians and individual users. The POCT devices need to have good analytical and clinical performance, but data are lacking. OBJECTIVE The purpose of this study is to evaluate the analytical performance of smartphone-based Hipee S2 POCT urine dipstick analyser. METHODS A total of 1,603 urine samples from three hospitals were collected. Precision, drift, carry-over, interference, and method comparison of Hipee S2 were evaluated. RESULTS The precision for each parameter, assessed by control materials, was acceptable. No sample carry-over or drift was observed. Ascorbate solution with 1 g/L had an inhibitory effect for the haemoglobin test. Agreement for specific gravity (SG) varied between moderate to substantial, for pondus hydrogenii (pH) was moderate, and for other parameters varied between substantial to excellent, on comparing the results obtained by Hipee S2 with those measured by laboratory reference analysers. The semi-quantitative results of microalbumin and creatinine were highly correlated with the quantitative results. CONCLUSIONS Hipee S2 POCT urine analyser showed acceptable analytical performance as a semi-quantitative method. It serves as a convenient alternate device for clinicians and individual users for urinalysis and health management.


SLEEP ◽  
2020 ◽  
Vol 43 (Supplement_1) ◽  
pp. A385-A385
Author(s):  
C S Cheong ◽  
A T Aung ◽  
S Chan ◽  
C Lee

Abstract Introduction Obstructive sleep apnea (OSA) is prevalent and carries prognostic implication in patients with acute coronary syndrome (ACS). The relative contribution of pathophysiological mechanisms in ACS towards OSA is not well-studied. We examined the correlation between severity of OSA and myocardial necrosis, inflammation, wall stress, and fibrosis. Methods A total of 89 patients admitted with ACS underwent an overnight sleep study during index admission. Plasma levels of peak troponin I, high-sensitivity C-reactive protein (hs-CRP), N-terminal pro-brain natriuretic peptide (NT-proBNP), and suppression of tumorigenicity 2 (ST2) were prospectively analyzed. Two patients diagnosed with central sleep apnea were excluded. Results The recruited patients were divided into no (AHI <5 events/hour, 9.2%), mild (5-<15, 27.6%), moderate (15-<30, 21.8%), and severe (≥30, 41.4%) OSA. The respective Epworth Sleepiness Scale scores were 3.8±3.7, 5.3±4.9, 4.0±2.8, and 5.5±4.5 (p=0.734). Compared to the no, mild and moderate OSA groups, the severe OSA group had a higher body mass index (p=0.005). They were also more likely to present with ST-segment elevation ACS (vs non-ST-segment elevation ACS) (p=0.041), have undergone previous coronary artery bypass grafting (p=0.013), demonstrate complete coronary occlusion during baseline coronary angiography (p=0.049), and have a larger left atrium diameter measured on echocardiography (p=0.029). Likewise, the severe OSA group had higher plasma levels of troponin I (10584±13078, 11699±20130, 19280±30670, 37571±31269 µg/L; p=0.017), hs-CRP (8.1±9.2, 23.1±52.3, 9.3±17.1, 39.4±44.7 mg/L; p=0.004), and NT-proBNP (667±604, 765±856, 636±728, 1395±1220 pg/mL; p=0.004), but not ST2 (p=0.10). After adjusting for the effects of the confounding variables, severe OSA was independently associated with troponin I (i.e., myocardial necrosis; OR 1.00003, 95% CI 1.000013-1.000048; p=0.001) and NT-proBNP (i.e., myocardial wall stress; OR 1.00081, 95% CI 1.00021-1.00141; p=0.008). Conclusion Severe OSA during the acute phase of ACS was associated with extensive myocardial necrosis and myocardial wall stress, but not with inflammation and myocardial fibrosis. Support Nil


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