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

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.

Analysis of neonatal blood testing / 国际检验医学杂志

Objective To understand the neonatal ABO type positive and reverse typing consistent rate and to improve the accu-racy of the methods of neonatal blood.Methods The traditional tube method was used to detect the local neonatal ABO blood.The method of micro gel cards,improved tube method,enhancer and traditional tube method,paper,micro-plate,polybrene method to de-tect anti A,anti B,anti D titer,and neonatal blood detection comparator.Results Neonatal ABO positive and negative stereo types compliance rate was 83% (913/1 100);Detecting 15 copies of anti A,B,D titer,the highest sensitivity was improved intensifier tube method and the worst is the method of paper.The method of neonatal specimens was with the similar results.Conclusion ABO positive and negative stereo types should be increased by plasma (serum)levels and extending the incubation time,or using theen-hancerof this study,thereby improving the accuracy of the newborn blood testing.