Current principles for the establishment of the virological "cutoff points" in transfusion science and medicine: A short concise overview.

ABSTRACT

Establishing the virological cutoff point, during epidemics, such as the COVID-19 Pandemic, is crucially important as inadequate standardization and the false qualitative results, have enormous clinical and economic consequences when screening for SARS-CoV-2. Moreover, a cutoff point is a crucial step in ensuring a minimal risk of clinical misclassification. Therefore complying with such statutory requirements is an essential part of obligatory good laboratory and clinical practices. In this concise report, we propose a novel methodology for establishing cutoff points for all samples exhibiting detectable levels of the measured parameter, even those from the disease-free group. Based on target specificity and sensitivity levels of 100 % and 95 %, a value of 1209 A is identified as the "best cutoff". In fact, the ROC decision matrixes play a crucial role in determining optimal cutoff points. The most effective discriminators are those that meet specified accuracy criteria. The selection process is influenced by finding the right clinical sensitivity/specificity trade-off.