Surgiscreen Registration

Completed

• Conditions: Irregular Antibody Screening

• Registration Number: NCT01589133
• Lead Sponsor: Johnson & Johnson Medical, China

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2012-04
• Study First Submitted: 2012-04-26
• Study First Submitted QC: 2012-04-28
• Study Start: 2012-05
• Study First Posted: 2012-05-01
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Last Update Submitted: 2013-05-29
• Last Update Posted: 2013-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3109

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The consistency of the results of irregular antibody screening of investigational reagent and control reagent.	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 Outcome Measures

Name	Time	Method
The consistency of the results of irregular antibody screening with investigational reagent on different types of samples (serum and plasma).	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.

Trial Locations

Locations (4)

Shanghai Changzheng Hospital; 🇨🇳 Shanghai, Shanghai, China

Cancer Institute & Hospital, Chinese Academy of Medical Science; 🇨🇳 Beijing, Beijing, China

Shanghai Blood Center; 🇨🇳 Shanghai, Shanghai, China

Peking University First Hospital; 🇨🇳 Beijing, Beijing, China