Evaluation of Point-of-Care Testing Devices for Pre-donation Alanine Aminotransferase Test

Yang, Jin Hyuk; Kim, Jae Hyun; Lee, Ju Yeon; Choi, Kyoung Young; Lee, Sang Woon; Lee, Young Soon; Lee, Eun Ja; Lee, Mi Jung; Kim, Chul Yong; Cho, Nam Sun; Kwon, So Yong

Abstract

BACKGROUND
In Korea, since 1990, in an effort to reduce the transmission of non-A, non-B hepatitis, all blood donations with alanine aminotransferase (ALT) levels above 65 IU/L are discarded. In 2012, 64.8% of the disposed blood units at the Korean Red Cross blood centers were due to high ALT levels. Pre-donation ALT testing might prevent unnecessary blood donation and save related expenses. We evaluated performance of point-of-care test (POCT) devices for pre-donation ALT screening.
METHODS
ALT levels by four ALT POCT devices (Mission C100, Acon; Reflotron Plus, Roche; Labgeo PT10, Samsung; and FDC NX500, Fujifilm) were compared with venous blood results using laboratory chemistry analyzers (AU series, Beckman Coulter Inc.). Intraclass correlation coefficients (ICCs), sensitivity (ability to detect ALT > or =65 IU/L), and specificity (ability to detect <65 IU/L) for each method were calculated.
RESULTS
Compared with the laboratory analyzers, the ICCs of ALT measurements by Mission C-100, Reflotron Plus, Labgeo PT10, and FDC NX500 were 0.96 (95% confidence interval (CI): 0.95~0.97), 0.99 (95% CI: 0.99~0.99), 0.98 (95% CI: 0.98~0.98), and 0.94 (95% CI: 0.91~0.96), respectively. The sensitivity was 80.95% for Mission C-100, 83.33% for Reflotron Plus, 78.57% for Labgeo PT10, and 97.62% for FDC NX500. The specificity was 99.13% for Mission C-100, 100.00% for Reflotron Plus, 99.78% for Labgeo PT10, and 98.26% for FDC NX500.
CONCLUSION
The ALT POCT devices showed almost perfect agreement with the laboratory analyzers and could be useful for pre-donation ALT screening. However, before implementing ALT POCT devices, cost-effectiveness analyses should be performed.