Phase I Study for Positive IgM Antibody Detection in New Diagnostic Test Kit for for Acute Phase Infection
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- The Plasma Source
- Enrollment
- 300
- Locations
- 1
- Primary Endpoint
- IgM greater than 1xcut off value
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •current acute infection
- •age 18-70
- •male or female
- •currently active symptoms
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
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.
Secondary Outcomes
No secondary outcomes reported