300 Antibody Diagnostic Test Kit (Antibody 300)
|ClinicalTrials.gov Identifier: NCT01646411|
Recruitment Status : Unknown
Verified July 2012 by The Plasma Source.
Recruitment status was: Enrolling by invitation
First Posted : July 20, 2012
Last Update Posted : July 20, 2012
|Condition or disease|
|Acute Bacterial Infections Acute Viral Infections|
|Study Type :||Observational|
|Estimated Enrollment :||300 participants|
|Official Title:||Phase I Study for Positive IgM Antibody Detection in New Diagnostic Test Kit for for Acute Phase Infection|
|Study Start Date :||August 2012|
|Estimated Primary Completion Date :||December 2012|
|Estimated Study Completion Date :||July 2013|
assorted acute infection
300 patients diagnosed with assorted acute infection.
- 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.
Biospecimen Retention: Samples Without DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01646411
|United States, Pennsylvania|
|The Plasma Source|
|Southampton, Pennsylvania, United States, 18966|
|Study Director:||Jeffery Flieshman, M.S immunology|