Acute Bacterial Infections Clinical Trial
— Antibody 300Official title:
Phase I Study for Positive IgM Antibody Detection in New Diagnostic Test Kit for for Acute Phase Infection
| Verified date | July 2012 |
| Source | The Plasma Source |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Institutional Review Board |
| Study type | Observational |
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.
| Status | Enrolling by invitation |
| Enrollment | 300 |
| Est. completion date | July 2013 |
| Est. primary completion date | December 2012 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 18 Years to 70 Years |
| Eligibility |
Inclusion Criteria: - current acute infection - age 18-70 - male or female - any race - currently active symptoms |
Observational Model: Case-Only, Time Perspective: Cross-Sectional
| Country | Name | City | State |
|---|---|---|---|
| United States | The Plasma Source | Southampton | Pennsylvania |
| Lead Sponsor | Collaborator |
|---|---|
| The Plasma Source | Plasma Services Group |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | IgM greater than 1xcut off value | 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. |
Antibody value measured within seven days of specimen collection. | No |