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.