Surgiscreen Registration
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ClinicalTrials.gov Identifier: NCT01589133 |
Recruitment Status
:
Completed
First Posted
: May 1, 2012
Last Update Posted
: May 30, 2013
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Condition or disease |
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Irregular Antibody Screening |
Study Type : | Observational |
Actual Enrollment : | 3109 participants |
Observational Model: | Case Control |
Time Perspective: | Prospective |
Official 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 |
Study Start Date : | May 2012 |
Actual Primary Completion Date : | October 2012 |
Actual Study Completion Date : | October 2012 |
- 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.
- 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.
Biospecimen Retention: Samples Without DNA

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Ages Eligible for Study: | Child, Adult, Senior |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01589133
China, Beijing | |
Cancer Institute & Hospital, Chinese Academy of Medical Science | |
Beijing, Beijing, China, 100021 | |
Peking University First Hospital | |
Beijing, Beijing, China, 100034 | |
China, Shanghai | |
Shanghai Changzheng Hospital | |
Shanghai, Shanghai, China, 200003 | |
Shanghai Blood Center | |
Shanghai, Shanghai, China, 200051 |
Responsible Party: | Johnson & Johnson Medical, China |
ClinicalTrials.gov Identifier: | NCT01589133 History of Changes |
Other Study ID Numbers: |
OCD-201108 |
First Posted: | May 1, 2012 Key Record Dates |
Last Update Posted: | May 30, 2013 |
Last Verified: | April 2012 |
Keywords provided by Johnson & Johnson Medical, China:
Irregular antibody screening |