A Multi-center Clinical Study for Assessment of the Consistency of the Results of Human Irregular Antibody Screening With Surgiscreen and Serascan Diana 3
- Serum or plasma samples left after routine clinical testing;
- Blood sample of the same day, or blood samples stored at 2-8°C for 3 days after
collection, or serum or plasma samples stored at -20°C for those separated 3 days
- Samples with severe hemolysis, jaundice or chyle-like samples;
- Small sample size insufficient for completing the testing;
- Samples not collected and processed upon the requirements of the instructions.
Type of Study:
Observational Model: Case Control, Time Perspective: Prospective
The consistency of the results of irregular antibody screening of investigational reagent and control reagent.
The positive coincidence rate, the negative coincidence rate and the overall coincidence rate, as well as their respective 95% confidence interval of the irregular antibody screening results of two reagents.
Outcome Time Frame:
China: Food and Drug Administration
- Irregular Antibody Screening
- Irregular antibody screening