Haemoglobin A1c: evaluation of a new HbA1c point-of-care analyser Bio-Rad in2it in comparison with the DCA 2000 and central laboratory analysers

2009 ◽  
Vol 46 (5) ◽  
pp. 373-376 ◽  
Author(s):  
Chin-Pin Yeo ◽  
Carol Hui-Chen Tan ◽  
Edward Jacob
Keyword(s):  
Point Of Care ◽  
Outpatient Setting ◽  
Haemoglobin A1c ◽  
Central Laboratory ◽  
Point Of Care Testing ◽  
Laboratory Methods ◽  
Deming Regression ◽  
Difference Test ◽  
Roche Cobas ◽  
Hba1c Levels

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.

scholarly journals Impact of point-of-care testing on patients' length of stay in a large emergency department

1996 ◽  
Vol 42 (5) ◽  
pp. 711-717 ◽  
Author(s):  
C A Parvin ◽  
S F Lo ◽  
S M Deuser ◽  
L G Weaver ◽  
L M Lewis ◽  
...  
Keyword(s):  
Emergency Department ◽  
Length Of Stay ◽  
Point Of Care ◽  
Control Period ◽  
Experimental Period ◽  
Central Laboratory ◽  
Point Of Care Testing ◽  
Acceptable Accuracy ◽  
Patient Interview ◽  
Combined Control

Abstract We prospectively investigated whether routine use of a point-of-care testing (POCT) device by nonlaboratory operators in the emergency department (ED) for all patients requiring the available tests could shorten patient length of stay (LOS) in the ED. ED patient LOS, defined as the length of time between triage (initial patient interview) and discharge (released to home or admitted to hospital), was examined during a 5-week experimental period in which ED personnel used a hand-held POCT device to perform Na, K, Cl, glucose (Gluc), and blood urea nitrogen (BUN) testing. Preliminary data demonstrated acceptable accuracy of the hand-held device. Patient LOS distribution during the experimental period was compared with the LOS distribution during a 5-week control period before institution of the POCT device and with a 3-week control period after its use. Among nearly 15 000 ED patient visits during the study period, 4985 patients (2067 during the experimental period and 2918 during the two control periods) had at least one Na, K, Cl, BUN, or Gluc test ordered from the ED. However, no decrease in ED LOS was observed in the tested patients during the experimental period. Median LOS during the experimental period was 209 min vs 201 min for the combined control periods. Stratifying patients by presenting condition (chest pain, trauma, etc.), discharge/admit status, or presence/absence of other central laboratory tests did not reveal a decrease in patient LOS for any patient subgroup during the experimental period. From these observations, we consider it unlikely that routine use of a hand-held POCT device in a large ED such as ours is sufficient by itself to impact ED patient LOS.

scholarly journals P295 Comparative Assessment of Infliximab Trough Levels between Point-of-Care Testing and current Standard of Care (enzyme linked immunosorbent assay) in patients with Inflammatory Bowel Disease

2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S325-S325
Author(s):  
D Maniero ◽  
G Lorenzon ◽  
I Marsilio ◽  
A Rigo ◽  
R Cardin ◽  
...  
Keyword(s):  
Inflammatory Bowel Disease ◽  
Bowel Disease ◽  
Whole Blood ◽  
Point Of Care ◽  
Enzyme Linked Immunosorbent Assay ◽  
Blood Collection ◽  
Point Of Care Testing ◽  
Deming Regression ◽  
Inflammatory Bowel ◽  
Trough Levels

Abstract Background Infliximab (IFX) is a monoclonal antibody that targets cytokine tumor necrosis factor; it is used for the treatment of patients with active inflammatory bowel disease (IBD), including Crohn’s disease (CD) and ulcerative colitis (UC). IFX induces and maintains remission and mucosal healing in patients with IBD. Measurement of trough levels (TL) of IFX is important to assess if the drug is within its therapeutic concentrationand to explain lack/loss of response. Standard laboratory tests to assess IFX trough levels (enzyme linked immunosorbent assays, ELISA) present some downsides, related to the long turnaround (about 3 hours), and the need of specialized equipment and laboratory personnel. For this reason, point-of care testing (POCT) was developed to provide results within a few minutes from blood collection, leading to a decision-making approach. Aim To determine the degree of analytical correlation between a recently developed POCT (ProciseDx) IFX assay which analyze capillary whole blood and the comparative ELISA from serum. Methods From October 2020 to January 2021, patients (aged≥18 years) taking IFX were recruited at Gastroenterology Unit, Padua University Hospital. In each patient, IFX levels from capillary whole blood collected by finger stick were performed using the ProciseDx IFX assay with reportable range between 1.7-77.2 µg/mL; at the same time, a serum sample from venous blood was collected to carry out Grifols’ Promonitor ELISA test (range 0.035–14.4 µg/mL). A Deming regression test was used to identify the correlation between the two methods. Results Eighty-seven patients were enrolled (63% males; mean age of 44±16), with 52% of them having CD, 45% UC and 3% an undetermined-Inflammatory Bowel Disease. The assessment with ProciseDx POCT was feasible in each patient and only in three cases blood collection from finger prick was repeated. Moreover, from blood collection to results we needed about 3±0.5 minutes, while serum ELISA analysis required the collection of at least 40 samples (around three weeks at our centre) and 3 hours to be performed. 39 patients (59% males; mean age of 44±16) had TL as assessed by ProciseDx IFX assay lower than 1.7 or greater than 14.4 µg/mL, in accordance with ELISA assessment. Among the remaining 48 patients (67% males with mean age of 45±17), The correlation between the two tests was high (the total results showed an R squared of 0.691 (95% CI 0.717-0.902). Conclusion The ProciseDx POCT has good accuracy but was more rapid and easy to be performed in providing the results of Therapeutic Drug Monitoring in outpatients taking IFX. This could lead to a more effective optimization of the biological drug, thus avoiding treatment failure.

scholarly journals Point-of-care coagulation testing for reducing in-hospital delay in thrombolysis

2018 ◽  
Vol 26 (4) ◽  
pp. 218-224 ◽  
Author(s):  
Jung Hee Han ◽  
Seongsoo Jang ◽  
Mi-Ok Choi ◽  
Mi-Jeong Yoon ◽  
Seung-Bok Lim ◽  
...  
Keyword(s):  
Ischemic Stroke ◽  
Prothrombin Time ◽  
Laboratory Testing ◽  
Point Of Care ◽  
Intravenous Thrombolysis ◽  
International Normalized Ratio ◽  
Interquartile Range ◽  
Time Interval ◽  
Central Laboratory ◽  
Point Of Care Testing

Background: The confirmation of prothrombin time international normalized ratio by a central laboratory often delays intravenous thrombolysis in patients with acute ischemic stroke. Objectives: We investigated the feasibility, reliability, and usefulness of point-of-care determination of prothrombin time international normalized ratio for stroke thrombolysis. Methods: Among 312 patients with ischemic stroke, 202 who arrived at the emergency room within 4.5 h of stroke onset were enrolled in the study. Patients with lost orders for point-of-care testing for the prothrombin time international normalized ratio or central laboratory testing for the prothrombin time international normalized ratio (n = 47) were excluded. We compared international normalized ratio values and the time interval from arrival to the report of test results (door-to-international normalized ratio time) between point-of-care testing for the prothrombin time international normalized ratio and central laboratory testing for the prothrombin time international normalized ratio. In patients who underwent thrombolysis, we compared the time interval from arrival to thrombolysis (door-to-needle time) between the current study population and historic cohort at our center. Results: In the 155 patients included in the study, the median door-to-international normalized ratio time was 9.0 min (interquartile range, 5.0–12.0 min) for point-of-care testing for the prothrombin time international normalized ratio and 46.0 min (interquartile range, 38.0–55.0 min) for central laboratory testing for the prothrombin time international normalized ratio (p < 0.001). The intraclass correlation coefficient between point-of-care testing for the prothrombin time international normalized ratio and central laboratory testing for the prothrombin time international normalized ratio was 0.975 (95% confidence interval: 0.966–0.982). Forty-nine of the 155 patients underwent intravenous thrombolysis. The door-to-needle time was significantly decreased after implementation of point-of-care testing for the prothrombin time international normalized ratio (median, 23.0 min; interquartile range, 16.0–29.8 vs median, 46.0 min; interquartile range, 33.5–50.5 min). Conclusion: Utilization of point-of-care testing for the prothrombin time international normalized ratio was feasible in the management of patients with acute ischemic stroke. Point-of-care testing for the prothrombin time international normalized ratio was quick and reliable and had a pivotal role in expediting thrombolysis.

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