300 Antibody Diagnostic Test Kit (Antibody 300)

The Plasma Source

Status: Unknown

Conditions: Acute Viral Infections; Acute Bacterial Infections

Study type: Observational

Funder types: Industry

Identifiers

NCT01646411

300831

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

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

Trial design

300 participants in 1 patient group

assorted acute infection

Description:

300 patients diagnosed with assorted acute infection.