Abstract
We compared performances of a new point-of-care testing (POCT) StatStripTM connectivity meter, a conventional POCT device, and three self-monitoring-of-blood-glucose (SMBG) devices using a laboratory routine as a reference.
StatStripTM was acceptable within-run precision whose coefficients of variation were less than 2.5% and differences from the reference 4-9%. Correlation statistics to the reference of r=0.994, slope=0.966 and intercept=1.66 mg/dl satisfied accuracy criteria (ISO 15197). StatStripTM was not affected by the 5 interfering substances used in this study or hematocrit, although another POCT device was adversely affected by hematocrit.
SMBG devices study showed significant device-to-device variation, with 1) 1 SMBG device showing very low values compared to the reference, 2) 2 SMBG devices not satisfying accuracy criteria, 3) SMBG devices adversely affected by interfering substances, such as ascorbic acid, maltose, and acetaminophen, and 4) low and high hematocrit interfering with glucose measurement by SMBG devices.
Hospital-use POCT devices must measure glucose to the accuracy level of the reference without interference from substances or hematocrit against SMBG devices.
Our findings suggest that StatStripTM is sufficiently reliable as a POCT device for glucose measurement in hospitals.
