scholarly journals Method comparison of beta‐hydroxybutyrate point‐of‐care testing to serum in healthy children

JIMD Reports ◽  
2021 ◽  
Author(s):  
Komalben Parmar ◽  
Maua Mosha ◽  
David A. Weinstein ◽  
Rebecca Riba‐Wolman
Keyword(s):  
Point Of Care ◽  
Method Comparison ◽  
Healthy Children ◽  
Point Of Care Testing ◽  
Beta Hydroxybutyrate

Performance Evaluation and Multicenter Consistency Study of Smartphone-based Hipee S2 Point-of-care Testing Urine Dipstick Analyser: Evaluation Study (Preprint)

2021 ◽  
Author(s):  
Qiang Zhang ◽  
Guoqing Wang ◽  
Xiaolong Zong ◽  
Jinghua Sun
Keyword(s):  
Health Management ◽  
Clinical Performance ◽  
Point Of Care ◽  
Method Comparison ◽  
Evaluation Study ◽  
Analytical Performance ◽  
Point Of Care Testing ◽  
Urine Dipstick ◽  
Quantitative Results ◽  
Carry Over

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.

Lot variation and inter-device differences contribute to poor analytical performance of the DCA Vantage™ HbA1c POCT instrument in a true clinical setting

2021 ◽  
Vol 0 (0) ◽  
Author(s):  
Anders Abildgaard ◽  
Cindy Søndersø Knudsen ◽  
Lise Nørkjær Bjerg ◽  
Sten Lund ◽  
Julie Støy
Keyword(s):  
Clinical Setting ◽  
Clinical Laboratory ◽  
Point Of Care ◽  
Method Comparison ◽  
Glycated Haemoglobin ◽  
Analytical Performance ◽  
Point Of Care Testing ◽  
Performance Specifications ◽  
Ion Exchange Hplc ◽  
Analytical Imprecision

Abstract Objectives The glycated haemoglobin fraction A1c (HbA1c) is widely used in the management of diabetes mellitus, and the Siemens DCA Vantage™ point-of-care testing (POCT) instrument offers rapid HbA1c results even far from a clinical laboratory. However, the analytical performance has been questioned, and not much is known about effects of changing reagent lot, instrument and operator. We therefore compared the analytical performance of the DCA Vantage™ with established routine methods (Tosoh G8/G11 ion exchange HPLC) in a true clinical setting at two Danish hospitals. Methods We extracted all routine clinical HbA1c results incidentally drawn from the same patient within 48 h (n=960 pairs) and evaluated the effect of reagent lot, operator and instrument. We also performed a prospective method comparison in our diabetes out-patient clinic (n=97). Results The critical difference (CD) between two POCT results varied between 5.14 and 6.61 mmol/mol (0.47–0.55%), and the analytical imprecision of the DCA Vantage™ (CVA) was >3%. Significant effect of reagent lot and inter-instrument differences were found, whereas no effect of operator was seen. Conclusions The DCA Vantage™ HbA1c analysis does not fulfil the prevailing analytical performance specifications, but rigorous validation of new reagent lots and continuous recalibration of instruments may potentially improve the precision substantially. Our findings, therefore, clearly emphasise the necessity of a close collaboration between clinicians and laboratory professionals in the POCT field. Finally, POCT HbA1c results should always be interpreted together with other measures of glycaemic control to avoid inappropriate change of patient treatments due to measurement uncertainty.

Magnetic Digital Microfluidics for Point-of-Care Testing: Where Are We Now?

2020 ◽  
Vol 27 ◽  
Author(s):  
Yi Zhang
Keyword(s):  
System Integration ◽  
Diagnostic Tests ◽  
Point Of Care ◽  
Digital Microfluidics ◽  
Controlled Environment ◽  
Point Of Care Testing ◽  
Microfluidic Platforms ◽  
Interface System ◽  
Technical Issues ◽  
Sample System

: Point-of-care (POC) testing decentralizes the diagnostic tests to the sites near the patient. Many POC tests rely microfluidic platforms for sample-to-answer analysis. Compared to other microfluidic systems, magnetic digital microfluidics demonstrate compelling advantages for POC diagnostics. In this review, we have examined the capability of magnetic digital microfluidics-based POC diagnostic platforms. More importantly, we have categorized POC settings into three classes based on “where is the point”, “who to care” and “how to test”, and evaluated the suitability of magnetic digital microfluidics in various POC settings. Furthermore, we have addressed other technical issues associated with POC testing such as controlled environment, sample-system interface, system integration and information connectivity. We hope this review would provide a guideline for the future development of magnetic digital microfluidics-based platforms for POC testing.

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