Examination of irregular antibody screening reagent 0.8% Cell Screen J -alba-

Abstract

The increased detection of clinically significant antibodies with the decreased detection of insignificant antibodies is ideal in an irregular antibody screening. Recently, it has been reported that the sensitivity to detect irregular antibodies was superior to low-ionic-strength solution-indirect antiglobulin test (LISS-IAT), including 0.8% Cell Screen J -alba-(0.8% CSJ) (also called 0.8% RCD method) rather than LISS-IAT + Ficin method. Here, we compared the two methods in terms of concordance rate, sensitivity, specificity, likelihood ratio, detection sensitivity, and cost per specimen. The polyethylene glycol-indirect antiglobulin test (PEG-IAT) was used as the control in this study. The number of specimens submitted to our laboratory was 1,254. The antibody positivity rates of the LISS-IAT + Ficin method and the 0.8% RCD method were 10.8% and 3.4%, respectively. The concordance rate and κ coefficient of the LISS-IAT + Ficin method for PEG-IAT were 33.2% and 0.086, respectively. The concordance rate and κ coefficient of the 0.8% RCD method for PEG-IAT were 82.1% and 0.705, respectively. The sensitivity, specificity, and likelihood ratio of the LISS-IAT + Ficin method were 82.6%, 90.5%, and 8.69, respectively. The sensitivity, specificity, and likelihood ratio of the 0.8% RCD method were 82.6%, 98.1%, and 42.37, respectively. Furthermore, the detection sensitivity of the 0.8% RCD method was equivalent to that of PEG-IAT, and the costs per specimen of the 0.8% RCD method and LISS-IAT + Ficin method were 717 and 1,234 yen, respectively. These results suggest that 0.8% CSJ is useful as a screening reagent.