Clinical Trial: 300 Antibody Diagnostic Test Kit
Study Status: Completed
Recruit Status: Unknown status
Study Type: Observational
Official Title: Phase I Study for Positive IgM Antibody Detection in New Diagnostic Test Kit for for Acute Phase Infection
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 Summary:
Sponsor: The Plasma Source
Current Primary Outcome: IgM greater than 1xcut off value [ Time Frame: 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.
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: The Plasma Source
Dates:
Date Received: July 12, 2012
Date Started: August 2012
Date Completion: July 2013
Last Updated: July 19, 2012
Last Verified: July 2012
