NCT Number: NCT01589133
Surgiscreen Registration
The purpose of this study is to assess the consistency of the results of irregular antibody screening with Surgiscreen （investigational reagent) and Serascan Diana 3 (control reagent), and the consistency of the results of irregular antibody screening with investigational reagent on serum and plasma from same patients.
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Notify MeKey information
Conditions
Sex eligibility
All sexes
Study type
Observational
Primary location
Cancer Institute & Hospital, Chinese Academy of Medical Science, Beijing, Beijing Municipality, China
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Primary outcomes
-
The consistency of the results of irregular antibody screening of investigational reagent and control reagent.
Time frame: baseline
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.
Secondary outcomes
-
The consistency of the results of irregular antibody screening with investigational reagent on different types of samples (serum and plasma).
Time frame: baseline
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 investigational reagent on serum and plasma from same patient.
Sponsors and collaborators
Lead sponsor
Johnson & Johnson Medical, China
Industry
Registry information
Official study title
A Multi-center Clinical Study for Assessment of the Consistency of the Results of Human Irregular Antibody Screening With Surgiscreen and Serascan Diana 3
Important dates
- Study start
- 2012
- Primary completion
- 2012
- Study completion
- 2012
- First posted
- May 1, 2012
- Registry last updated
- May 30, 2013
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.