Surgiscreen Registration

Johnson & Johnson (J&J)

Status: Completed

Conditions: Irregular Antibody Screening

Study type: Observational

Funder types: Industry

Identifiers

NCT01589133

OCD-201108

Details and patient eligibility

About

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.

Enrollment: 3,109 patients

Sex: All

Volunteers: No 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.