Comparison of the Performance of Point-of-Care and Device Analyzers to Hospital Laboratory Instruments

2003 ◽  
Vol 2 (3) ◽  
pp. 172-178 ◽  
Author(s):  
Wanvisa Boonlert ◽  
Porntip H. Lolekha ◽  
Gerald J. Kost ◽  
Somsak Lolekha
Keyword(s):  
Point Of Care ◽  
Hospital Laboratory

The Reliability of Point-of-Care (POC) Prothrombin Time Testing - A Comparison of CoaguChek XS® INR Measurements with Hospital Laboratory Monitoring.

Blood ◽  
2007 ◽  
Vol 110 (11) ◽  
pp. 973-973 ◽  
Author(s):  
Fiona Ryan ◽  
Susan O’Shea ◽  
Thomas L. Ortel ◽  
Stephen Byrne
Keyword(s):  
Clinical Laboratory ◽  
Point Of Care ◽  
Venous Blood ◽  
Anticoagulation Therapy ◽  
University Hospital ◽  
External Quality ◽  
Hospital Laboratory ◽  
Laboratory Values ◽  
Venous Sample ◽  
Coaguchek Xs

Abstract Background The development of Point of Care (POC) testing devices enables patients to test their own International Normalised Ratio (INR) at home, and has lead to the development of patient self- testing (PST) programmes. This facilitates more frequent testing of anticoagulation levels which in turn improves time in therapeutic range (TTR) and reduces bleeding and thrombotic complications in patients on oral anticoagulation therapy (OAT).1 External quality control of POC devices is essential to ensure that results are robust. One approach is to collect a venous sample at the same time as POC testing, which is analysed using an appropriate hospital laboratory analyzer. It has been recommended that INR results should be within 0.5 of each other when measured by each method2. However, previous studies have shown that when compared with clinical laboratory values, POC devices may show statistically significant differences between the INR values.3 Aim The aim of this study is primarily to compare TTR and adverse events between two different approaches to OAT management and more specifically in this presentation to examine the intra patient variability of INR measurements performed by two different techniques. Methods 160 patients routinely attending the anticoagulant clinic of Cork University Hospital (CUH) were enrolled to take part in a prospective randomized controlled, cross-over design trial of supervised PST of warfarin therapy using an internet based expert system (Coagcare®, ZyCare, Inc) and POC testing device (CoaguChek XS®, Roche, UK) vs. rountine medical care in CUH. During the 6 months PST arm of the study a venous blood sample was taken from each patient for laboratory determination of the INR on 3 occasions; at enrolment, 2 months and 4 months. This measurement was then compared with the INR measured on the Coaguchek XS® machine using capillary blood from the patient’s fingertip. Results 88 patients have being enrolled in the PST arm of the study to date and 454 POC measurements have been compared with laboratory values. Good correlation has been shown between the two methods of INR determination (r2 = 0.8314), however, statistically significant differences did occur (p < 0.005). A Bland and Altman plot showed good agreement between the dual measurements at values between 2.0–3.5 INR units. However there seemed to be increasing disagreement between the two methods as the INR rose above 3.5. Four patients were excluded from the study because the differences in the INR measurements were greater than 0.5 INR units. Conclusion POC testing devices for OAT are reliable and safe. External quality assessment should be inherent to any programme involving these devices. Clinicians involved in the use of POC anticoagulation monitoring should be aware that POC and laboratory values may differ and intervene if there is not adequate correlation between the two INR measurements.

NT-proBNP on Cobas h 232 in point-of-care testing: Performance in the primary health care versus in the hospital laboratory

2015 ◽  
Vol 75 (7) ◽  
pp. 602-609 ◽  
Author(s):  
Charlotte Gils ◽  
Ramshanker Ramanathan ◽  
Torben Breindahl ◽  
Mette Brokner ◽  
Anne L. Christiansen ◽  
...  
Keyword(s):  
Health Care ◽  
Primary Health Care ◽  
Point Of Care ◽  
Point Of Care Testing ◽  
Hospital Laboratory ◽  
Primary Health ◽  
Testing Performance

scholarly journals Diagnosing Diabetes Mellitus: Performance of Hemoglobin A1c Point-of-Care Instruments in General Practice Offices

2013 ◽  
Vol 59 (12) ◽  
pp. 1790-1801 ◽  
Author(s):  
Una Ørvim Sølvik ◽  
Thomas Røraas ◽  
Nina Gade Christensen ◽  
Sverre Sandberg
Keyword(s):  
Diabetes Mellitus ◽  
General Practice ◽  
Quality Assurance ◽  
Hemoglobin A1c ◽  
Point Of Care ◽  
Quality Assurance Program ◽  
Analytical Quality ◽  
Hospital Laboratory ◽  
Hb A1c ◽  
Quality Specifications

BACKGROUND Hemoglobin A1c (Hb A1c) measurement by hospital laboratory instruments, but not by point-of-care (POC) instruments, has been recommended for use to diagnose diabetes mellitus. We evaluated results from 13 Hb A1c external quality assurance (EQA) surveys over a 6-year period in Norway, from both POC instruments used in general practice (GP) offices and instruments in hospital laboratories, against the analytical quality specifications recommended for use of Hb A1c to diagnose diabetes mellitus. METHODS All GP offices (n = 1288) and hospital laboratories (n = 52) measuring Hb A1c in Norway participated in the EQA survey. The percentage of participants that performed measurements within the quality specifications was calculated. Pooled within-laboratory CVs were estimated for the Afinion, DCA 2000, DCA 2000+, DCA VantageTM, and Nycocard Hb A1c Reader instruments and for hospital laboratory instruments. RESULTS Between 60% to 90% of Afinion and DCA users and hospital laboratories performed Hb A1c measurements within the quality specifications for both trueness (6.0%) and imprecision (CV ≤2.0%) at 2 levels in each EQA survey. The pooled within-laboratory CVs for the Afinion and DCA instruments and hospital laboratories were below the recommended limit of 2.0% for most of the surveys. CONCLUSIONS A large proportion of GP offices using Afinion and DCA POC instruments to measure Hb A1c fulfill the analytical quality specifications for diagnosing diabetes mellitus, and these instruments demonstrate analytical quality comparable to that of hospital laboratory instruments. When GP offices participate in a stringent quality assurance program and generate Hb A1c measurements that meet analytical quality specifications, these measurements can be recommended for use to diagnose diabetes mellitus.

Accuracy of the AvoSure PT Pro System Compared with a Hospital Laboratory Standard

2002 ◽  
Vol 36 (3) ◽  
pp. 380-385 ◽  
Author(s):  
Janene M Rigelsky ◽  
Hae Mi Choe ◽  
Dawn M Curtis ◽  
Marcia J Brosnan ◽  
Sonya Mitrovich ◽  
...  
Keyword(s):  
Prediction Error ◽  
Point Of Care ◽  
International Normalized Ratio ◽  
Laboratory Method ◽  
Standard Laboratory ◽  
Altman Analysis ◽  
Bland Altman Analysis ◽  
Hospital Laboratory ◽  
Squared Prediction Error ◽  
Clinical Accuracy

OBJECTIVE: To compare international normalized ratio (INR) values obtained using the AvoSure PT Pro point-of-care (POC) system with those obtained using a standard laboratory method. METHODS: Forty-one INR values obtained from the POC system were compared with those obtained from a standard laboratory method. The POC method was evaluated for both laboratory and clinical agreement. To evaluate laboratory agreement, various analyses were used, including mean-squared prediction error (MSE) and mean prediction error (ME), Bland—Altman analysis, correlation, and paired t-test comparing group INR means. For clinical accuracy, discrepant pairs were identified and evaluated to determine whether dosage adjustments would have been needed based on values obtained. RESULTS: The POC system demonstrated modest precision (MSE = 0.147, 95% CI 0.065 to 0.228) and relatively little bias (ME = 0.090, 95% CI–0.025 to 0.205). Bland—Altman analysis also suggested good agreement at average INRs from 2.0 to 3.0. At average INR values >3.0, the POC system consistently overestimated INR. Values obtained with the POC system were significantly correlated with those obtained from the hospital laboratory (r = 0.77; p < 0.001). Similarly, mean ± SD POC INR did not differ significantly from the laboratory-determined INR (2.45 ± 0.59 vs. 2.37 ± 0.48, respectively; p = 0.176). Regarding clinical accuracy, the values clinically agreed in 85.4% of the cases. CONCLUSIONS: The AvoSure PT Pro POC system appears to be useful for INR values within the 2.0–3.0 range, but values outside of this range should probably be confirmed with a standard laboratory method.

Reproducibility of thrombelastometry (ROTEM®): Point-of-care versus hospital laboratory performance

2012 ◽  
Vol 72 (4) ◽  
pp. 313-317 ◽  
Author(s):  
Thorsten Haas ◽  
Nelly Spielmann ◽  
Jacqueline Mauch ◽  
Oliver Speer ◽  
Markus Schmugge ◽  
...  
Keyword(s):  
Point Of Care ◽  
Laboratory Performance ◽  
Hospital Laboratory

Positive Predictive Value of a Point-of-Care Testing Strategy on First-Draw Specimens for the Emergency Department–Based Detection of Acute Coronary Syndromes

2002 ◽  
Vol 126 (12) ◽  
pp. 1487-1493
Author(s):  
Alexander Kratz ◽  
James L. Januzzi ◽  
Kent B. Lewandrowski ◽  
Elizabeth Lee-Lewandrowski
Keyword(s):  
Acute Coronary Syndrome ◽  
Creatine Kinase ◽  
Positive Predictive Value ◽  
Predictive Value ◽  
Cardiac Troponin ◽  
Point Of Care ◽  
Cardiac Markers ◽  
Hospital Laboratory ◽  
Coronary Syndrome ◽  
Creatine Kinase Mb

Abstract Context.—The rapid and accurate diagnosis of the etiology of chest pain is of central importance in the triage of patients presenting to emergency departments. The “first-draw” sensitivity of serum cardiac markers is known to be low on initial presentation; however, less is understood regarding the predictive value of a positive test in this situation. Objective.—To determine the ability of a critical pathway combining medical history and physical examination, electrocardiographic findings, point-of-care testing, and central laboratory data to accurately predict the presence of acute coronary ischemia. Methods.—We investigated the positive predictive value of a testing algorithm for first-draw specimens in clinical practice, combining a qualitative, point-of-care, triple-screen testing panel for cardiac markers, including myoglobin, creatine kinase–MB, and cardiac troponin I, with confirmation of the rapid assay in the central hospital laboratory by quantitative assays for creatine kinase–MB and cardiac troponin T. Results.—While a positive result on any of the individual cardiac markers of the point-of-care test had a positive predictive value for the acute coronary syndrome of only 36% (creatine kinase–MB, 41%; myoglobin, 36%; and troponin I, 65%), the positive predictive value for the diagnosis of acute coronary syndrome increased to 76% if all 3 point-of-care markers were simultaneously positive. The positive predictive value for acute coronary syndrome for a positive confirmatory result in the hospital laboratory for either creatine kinase–MB or cardiac troponin T was 61%. Among those patients with a positive marker on both the point-of-care test and the laboratory test, a careful retrospective review of the clinical history (with exclusion of patients with nonischemic cardiac pathologies and renal insufficiency) increased the positive predictive value of this algorithm to 98%. Conclusions.—Our data suggest that qualitative, point-of-care, triple-screen cardiac marker testing of patients with chest pain at initial presentation may exhibit relatively low positive predictive values. Positive predictive value can be significantly improved by rapid confirmation in the hospital laboratory and careful review of clinical findings.

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