Performance Evaluation of the LABGEO PT10 Point-of-care Chemistry Analyzer

Jeong, Tae Dong; Lee, Woochang; Chun, Sail; Min, Won Ki

Abstract

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 > or =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.