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KMID : 1100820130030030138
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Laboratory Medicine Online
2013 Volume.3 No. 3 p.138 ~ p.144
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Evaluation of the Performance of LABGEO PT Hepatic Test 9
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Jeong Tae-Dong
Kang Hyun-Jung
Kim Min-Sook
Kim So-Young
Lee Woo-Chang
Chun Sa-Il
Min Won-Ki
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Abstract
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Background: The Samsung LABGEO PT Hepatic Test 9 (Samsung electronics, Korea) was developed as a point-of-care (POC) testing device. The levels of 9 analytes, namely, albumin, AST, ALT, alkaline phosphatase, gamma-glutamyl transferase, glucose, total bilirubin, direct bilirubin, and total protein, could be evaluated simultaneously by using 70 μL of whole blood, plasma, or serum samples. In this study, we assessed the performance of the Samsung LABGEO PT Hepatic Test 9.
Methods: The precision and linearity of the test were evaluated according to the CLSI EP5-A2 and CLSI EP6-A guidelines, respectively. Correlational analyses between Samsung LABGEO PT Hepatic Test 9 and Cobas 8000 modular analyzer (Roche, Switzerland) were carried out as per the CLSI EP9-A2 guidelines. Additionally, the results between 3 different specimen types, whole blood, plasma, and serum samples obtained from the same individual were compared to evaluate the matrix effect.
Results: The total imprecision at both low and high levels of the 9 analytes was within 10% and in the clinically important concentration range for all test items, all obtained results were linear. We compared the above results with those obtained using Cobas 8000 and a good correlation was observed with a correlation coefficient of more than 0.975 for all 9 analytes. Simple linear regression analyses between the 3 different specimen types indicated that there was no statistically significant difference (P<0.001).
Conclusions: The Samsung LABGEO PT Hepatic Test 9 showed good precision and linearity when compared to established assays for 9 clinical test items and could be useful in cases where the POC testing is required.
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KEYWORD
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Samsung LABGEO PT Hepatic Test 9, Precision, Linearity, Method comparison, Specimen type
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