Evaluation of DiaCell ABO Red Blood Cell Reagents as a Reverse Typing for ABO Blood Group

Abstract

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.

배경: 국내에는 식품의약품안전처(이하 식약처)로부터 허가 받은 수기용 ABO 혈청형 검사 적혈구 시약은 드문 실정이므로, 수기용 3% DiaCell ABO A1 적혈구 시약과(DiaCell A1 Biorad, DiaMed, Cressier, Switzerland) DiaCell ABO B 적혈구 시약을(DiaCell B) 기허가 제품과 비교하여 식약처 수입 허가를 받고자 하였다. 방법: 통상 ABO 혈액형 혹은 다른 검사 후 잔여 혈장이나 혈청을 수집하여 시험용 시약인 DiaCell ABO A1 및 B으로 시험관법을, 대조용 시약으로는 DiaCell ABO A1 및 B과 동일제조사 제품인 0.8% ID-DiaCell ABO A1 및 B 적혈구 시약, NaCl용 ID-Card, 그리고 IH-1000 자동화장비를 이용하여 혈청형 검사를 시행하였다. 시험용과 대조용 시약간의 일치도, 임상적 민감도와 임상적 특이도를 산정하였다. 결과: 비교검사는 1000개 검체에서 시행되었는데, 일치도는 DiaCell A1 99.9%, DiaCell B 100.0%였다. 임상적 민감도와 임상적 특이도는 각각 DiaCell A1는 99.9%와 100.0%, DiaCell B은 모두 100.0%였다. 결론: DiaCell ABO A1 및 B 평가 결과는 식약처 평가기준인 99% 이상을 모두 만족하였으므로, 수기로 시행하는 ABO 혈청형 검사 시약으로 사용 가능하다고 판단한다. 또한 이 연구는 향후 체외진단기기 승인을 위한 임상시험의 연구 설계 시 도움을 줄 것이다.