Research on Biologic Limit of Detection and Functional Sensitivity of Chemiluminescence Immunoassay in the Detection of AFP

Objective To establish the biologic limit of detection and functional sensitivity of chemiluminescence immunoassay in detection of AFP.Methods Referring to pertinent literature, the RLUs of blank and a serial diluted samples detected by Bayer Centaur 240 chemiluminescense immunoassay system would be calculated to average value, standard deviations and coefficient of variance,which to establish the low limit of detection ,biologic limit of detection and functional sensitivity of AFP.Results The low limit of detection was 1.00 ng/ml and it was lower than the declaration of the manufacturer.The biologic limit of detection was between 2.65 ng/ml and 3.53 ng/ml.The functional sensitivity was 3.53 ng/ml.Conclusion The biologic limit of detection and functional sensitivity must be established in laboratories,which can provide more important information for the clinic.