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KMID : 0387720140250020105
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Korean Journal of Blood Transfusion
2014 Volume.25 No. 2 p.105 ~ p.112
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Evaluation of Point-of-Care Testing Devices for Pre-donation Alanine Aminotransferase Test
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양진혁:Yang Jin-hyuk
김재현:Kim Jae-Hyun/이주연:Lee Ju-Yeon/최경영:Choi Kyoung-Young/이상운:Lee Sang-Woon/이영순:Lee Young-Soon/이은자:Lee Eun-Ja/이미정:Lee Mi-Jung/김철용:Kim Chul-Yong/조남선:Cho Nam-Sun/권소영:Kwon So-Yong
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Abstract
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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 ≥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.
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KEYWORD
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Blood donation, Point-of-care test, Pre-donation ALT screening
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