300 Antibody Diagnostic Test Kit

NCT ID: NCT01646411

Last Updated: 2012-07-20

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-08-31
• Study Completion Date: 2013-07-31

Brief Summary

For the development of a Point of Care IVD test kit for acute phase disease detection against a variety of bacterial and viral infections. Phase one includes 100 clinical diagnosed positive and 200 clinically "normal" serum and whole blood matched specimens for specificity and sensitivity determination for each marker. The positive samples must be IgM positive using any FDA cleared ELISA test kit. The negatives samples must be negative for IgM.

Conditions

Acute Bacterial Infections; Acute Viral Infections

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

assorted acute infection

300 patients diagnosed with assorted acute infection.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• current acute infection
• age 18-70
• male or female
• any race
• currently active symptoms

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Plasma Services Group

INDUSTRY

Sponsor Role: collaborator

The Plasma Source

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jeffery Flieshman, M.S immunology

Role: STUDY_DIRECTOR

Locations

The Plasma Source

Southampton, Pennsylvania, United States

Countries

United States

Other Identifiers

300831

Identifier Type: -

Identifier Source: org_study_id