Surgiscreen Registration

A Multi-center Clinical Study for Assessment of the Consistency of the Results of Human Irregular Antibody Screening With Surgiscreen and Serascan Diana 3

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01589133

Enrollment

3109

Registered

2012-05-01

Start date

2012-05-31

Completion date

2012-10-31

Last updated

2013-05-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Irregular Antibody Screening

Keywords

Irregular antibody screening

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

China

Outcome results