J Lab Med Qual Assur 2013; 35(2): 70-80
Published online December 31, 2013
Copyright © Korean Association of External Quality Assessment Service.
Tae-Dong Jeong, Woochang Lee, Sail Chun, and Won-Ki Min
Department of Laboratory Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
Correspondence to:Won-Ki Min
Department of Laboratory Medicine, Asan Medical Center, University of Ulsan College of Medicine, 88 Olympic-ro 43-gil, Songpa-gu, Seoul 138-736, Korea Tel: +82-2-3010-4503 Fax: +82-2-478-0884 E-mail: email@example.com
Background: The Samsung LABGEO PT10 (Samsung Electronics, Korea) has been developed as a point-of-care testing (POCT) chemistry analyzer. We evaluated the performance of the Samsung LABGEO PT Biochemistry Test 15 (Samsung Electronics) and the HbA1c Test (Samsung Electronics), which are dedicated cartridges for the LABGEO PT10.
Methods: Based on the Clinical and Laboratory Standards Institute guidelines, the precision, linearity, and methodology were evaluated for seven chemistry analytes (cholesterol, triglycerides, HDL cholesterol, blood urea nitrogen, creatinine, amylase, and hemoglobin A1c). All the analytes, except for hemoglobin A1c, were obtained from three different types of samples: whole blood, plasma, and serum, to evaluate matrix effects.
Results: In the precision analysis, both within-run and total-run coefficients of variation were less than 10% for the seven analytes. Dose curves for the seven analytes were linear in the clinically relevant concentration ranges. The methodology study yielded correlation coefficients ≥0.98 for the seven comparisons of the LABGEO PT10 cartridge tests with other methods. Except for HDL cholesterol, the percentage differences between test results obtained from whole blood, plasma, and serum, were within ±10%. The concentrations of HDL cholesterol measured in whole blood samples were 0.9 mg/dL and 5.6 mg/dL higher than those measured in plasma and serum specimens, respectively.
Conclusions: The LABGEO PT10 showed suitable analytical performance with respect to precision and linearity and demonstrated a good correlation with automated chemistry analyzer. With the additional benefits of a short turnaround time and ease of use, the LABGEO PT10 is an acceptable POCT chemistry analyzer. (J Lab Med Qual Assur 2013;35:70-80)
Keywords: Samsung LABGEO PT10, Evaluation, Point-of-care systems
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