300 Antibody Diagnostic Test Kit

• Conditions: Acute Bacterial Infections; Acute Viral Infections

• Registration Number: NCT01646411
• Lead Sponsor: The Plasma Source

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2012-07
• Study First Submitted: 2012-07-12
• Study First Submitted QC: 2012-07-19
• Last Update Submitted: 2012-07-19
• Study First Posted: 2012-07-20
• Last Update Posted: 2012-07-20
• Study Start: 2012-08
• Primary Completion: 2012-12
• Study Completion: 2013-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
IgM greater than 1xcut off value	Antibody value measured within seven days of specimen collection.	Elisa System positive results are greater than 1 times the cutoff. Negative less than 1x cutoff.; Prevalence of IGM in general mid-atlantic population is less than 10% of study population.

Trial Locations

Locations (1)

The Plasma Source; 🇺🇸 Southampton, Pennsylvania, United States