300 Antibody Diagnostic Test Kit (Antibody 300)
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.
Acute Bacterial Infections
Acute Viral Infections
|Study Design:||Observational Model: Case-Only
Time Perspective: Cross-Sectional
|Official Title:||Phase I Study for Positive IgM Antibody Detection in New Diagnostic Test Kit for for Acute Phase Infection|
- IgM greater than 1xcut off value [ Time Frame: Antibody value measured within seven days of specimen collection. ] [ Designated as safety issue: No ]
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.
Biospecimen Retention: Samples Without DNA
Serum collected in two 10ml sst and two 8ml edta venipuncture tubes.
|Study Start Date:||August 2012|
|Estimated Study Completion Date:||July 2013|
|Estimated Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
assorted acute infection
300 patients diagnosed with assorted acute infection.
|United States, Pennsylvania|
|The Plasma Source|
|Southampton, Pennsylvania, United States, 18966|
|Study Director:||Jeffery Flieshman, M.S immunology|