THẨM ĐỊNH PHƯƠNG PHÁP CỦA MÁY XÉT NGHIỆM THEO DÕI ĐƯỜNG HUYẾT POCT THEO CLSI POCT12-A3

Abstract

Objective: To validate common blood glucose monitors used in hospitals by calculate the accuracy and precision and compare them to CLSI POCT12-A3 standards and assess the effect of hematocrit on monitors’ accuracy. Methods: 135 pregnant women, who underwent a 75g oral glucose tolerance test, consented to participate in the study at an obstetrics clinic in a single center at Hung Vuong hospital. Each patient’s blood was drawn three times when fasting, 1 hour after 75g glucose intake and 2 hours after 75g glucose intake. 45 fasting samples, 45 samples after 1 hour and 45 samples after 2 hours are taken from different pregnant women to ensure a wide range of hematocrit. Blood samples are collected into Ethylenediaminetetraacetic acid (EDTA). Hematocrit is analyzed by hematology analyzer, Alinity hq. After which, blood sample was tested with each meter system in duplicate using six different BGM. Within 5 minutes after being tested by blood glucose monitors, glucose levels are then measured twice in a row by Cobas c502 analyzer, which is a reference method. Result: Out of six evaluated monitors, two were disqualified due to lack of precision according to CLSI POCT12-A3. Three out of four remaining monitors satisfied the accuracy qualification. In three monitors qualifying the accuracy and precision criteria, two machines with the same technology show an inverse correlation between bias and hct, and the other showed no effect of hct on bias. Conclusion: Most blood glucose monitors circulating the market are manufactured after ISO 15197 standard, which is intended for self-measurement. To ensure patients’ safety, medical organizations need to verify blood glucose monitors if they are designed for prescription point-of-care use or validate blood glucose monitors if they are designed for over-the-counter use. Users need to pay attention to the effect of hematocrit on results.