Evaluation of Point-of-Care Testing Devices for Pre-donation Alanine Aminotransferase Test.
- Author:
Jin Hyuk YANG
1
;
Jae Hyun KIM
;
Ju Yeon LEE
;
Kyoung Young CHOI
;
Sang Woon LEE
;
Young Soon LEE
;
Eun Ja LEE
;
Mi Jung LEE
;
Chul Yong KIM
;
Nam Sun CHO
;
So Yong KWON
Author Information
1. Blood Transfusion Research Institute, Korean Red Cross, Wonju, Korea. sykwon@redcross.or.kr
- Publication Type:Original Article
- Keywords:
Blood donation;
Point-of-care test;
Pre-donation ALT screening
- MeSH:
Alanine Transaminase*;
Blood Donors;
Chemistry;
Hepatitis;
Humans;
Korea;
Mass Screening;
Missions and Missionaries;
Red Cross;
Sensitivity and Specificity
- From:Korean Journal of Blood Transfusion
2014;25(2):105-112
- CountryRepublic of Korea
- Language:Korean
-
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.
