Accuracy and precision of point-of-care testing for glucose and prothrombin time at the critical care units

Abstract

The use of point-of-care testing (POCT) in critical care patient units has continued to increase since the 1980s. This increase is due to the need for prompt therapeutic interventions that may impact mortality and morbidity, and reduce the overall cost of healthcare for critically ill patients. The diagnostic manufacturing industry has risen to this challenge by introducing portable and/or handheld analyzers for use at the point-of-care. In order to ensure the public safety in the USA, the Food and Drug Administration (FDA) must approve the use of each POCT analyzer. The FDA approval is based on established performance criteria that includes relative accuracy and precision documentation. This study evaluated the precision and accuracy of the POCT prothrombin time and glucose analyzers relative to the manufacturers' specifications, to the internal QC in the main laboratory, and to the results of the external proficiency-testing program. The QC for the prothrombin time had a precision that ranged from 2.84% to 3.45% (POCT) and from 1.27–1.66% (main laboratory). The precision for the glucose QC ranged from 5% to 5.2% (POCT) and 0.9–2.7% (main laboratory). Using the results of the external proficiency testing, the inter-laboratory CV% for the POCT prothrombin time ranged from 3.5% to 5.0% and the main laboratory had a range of 2.5–2.9%. The inter-laboratory CV% ranges for glucose POCT and the main laboratory were 4.9–10.6% and 1.8–3.5%, respectively. The main laboratory analyzers proved to be more accurate than the POCT analyzers as indicated by comparison to the mean prothrombin time and glucose results of all participating laboratories in the proficiency testing program.