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KMID : 0387720170280010058
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Korean Journal of Blood Transfusion
2017 Volume.28 No. 1 p.58 ~ p.66
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Evaluation of DiaCell ABO Red Blood Cell Reagents as a Reverse Typing for ABO Blood Group
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Lim Young-Ae
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Abstract
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Background: Because ABO reverse typing reagents approved by the Ministry of Food and Drug Safety (MFDS) for manual typing are rare in Korea, 3% DiaCell ABO A1 red blood cell (RBC) reagents (DiaCell A1, BioRad, DiaMed, Cressier, Switzerland) and DiaCell ABO B RBC reagents (DiaCell B) for a manual technique were compared with already approved RBC reagents for the acquisition of an import permit.
Methods: Residual plasmas or sera were collected after routine ABO grouping or other tests. The reverse typing tests were performed by a manual tube technique with DiaCell A1 & B as the test reagents and 0.8% ID-DiaCell ABO A1 & B RBC reagents, ID-Card for NaCl, and an IH-1000 autoanalyzer from the same manufacturer of DiaCell A1 & B as the control reagents. Agreements, clinical sensitivities and clinical specificities between test and control reagents were calculated.
Results: Comparison tests were performed in 1000 samples, and agreements were 99.9% for DiaCell A1 and 100.0% for DiaCell B. Clinical sensitivities and clinical specificities were 99.9% and 100.0% for DiaCell A1 and all 100.0% for DiaCell B, respectively.
Conclusion: Because the evaluation results of DiaCell A1 and B were all satisfied with more than 99% as the evaluation criteria of MFDS, they were concluded to be suitable for use as ABO reverse typing reagents for manual typing. The results of this study are also expected to be useful in the design of clinical trials for approval of future in vitro medical devices.
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KEYWORD
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ABO blood group, Reverse typing, In vitro medical device
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