헌혈 전 ALT 사전검사를 위한 현장검사 장비 평가 (Evaluation of Point-of-Care Testing Devices for Pre-donation Alanine Aminotransferase Test)

서지정보

· 발행기관 : 대한수혈학회
· 수록지 정보 : 대한수혈학회지 / 25권 / 2호 / 105 ~ 112페이지
· 저자명 : 양진혁, 권소영, 김재현, 최경영, 이상운, 이영순, 이은자, 이미정, 김철용, 조남선

초록

Background: In Korea, since 1990, in an effort to reduce the transmission of non-A, non-B hepatitis, all blooddonations with alanine aminotransferase (ALT) levels above 65 IU/L are discarded. In 2012, 64.8% of the disposedblood units at the Korean Red Cross blood centers were due to high ALT levels. Pre-donation ALT testing mightprevent 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 ≥65IU/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, ReflotronPlus, 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. Thespecificity 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 couldbe useful for pre-donation ALT screening. However, before implementing ALT POCT devices, cost-effectivenessanalyses should be performed.

영어초록

Background: In Korea, since 1990, in an effort to reduce the transmission of non-A, non-B hepatitis, all blooddonations with alanine aminotransferase (ALT) levels above 65 IU/L are discarded. In 2012, 64.8% of the disposedblood units at the Korean Red Cross blood centers were due to high ALT levels. Pre-donation ALT testing mightprevent 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 ≥65IU/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, ReflotronPlus, 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. Thespecificity 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 couldbe useful for pre-donation ALT screening. However, before implementing ALT POCT devices, cost-effectivenessanalyses should be performed.

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