A Multi-center Clinical Study for Assessment of the Consistency of the Results of Human Irregular Antibody Screening With Surgiscreen and Serascan Diana 3
N/A
N/A
N/A
N/A
N/A
Not Enrolling
Both
Irregular Antibody Screening
Both
Irregular Antibody Screening
Trial Information
A Multi-center Clinical Study for Assessment of the Consistency of the Results of Human Irregular Antibody Screening With Surgiscreen and Serascan Diana 3
Inclusion Criteria:
- 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
after collection.
Exclusion Criteria:
- 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
Study Design:
Observational Model: Case Control, Time Perspective: Prospective
Outcome Measure:
The consistency of the results of irregular antibody screening of investigational reagent and control reagent.
Outcome Description:
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:
baseline
Safety Issue:
No
Authority:
China: Food and Drug Administration
Study ID:
OCD-201108
NCT ID:
NCT01589133
Start Date:
May 2012
Completion Date:
October 2012
Related Keywords:
- Irregular Antibody Screening
- Irregular antibody screening
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