Antibody 300: 300 Antibody Diagnostic Test Kit

Sponsor

The Plasma Source (Industry)

Overall Status

Unknown status

CT.gov ID

NCT01646411

Collaborator

Plasma Services Group (Industry)

300

Enrollment

Location

Duration (Months)

27.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Bacterial Infections Acute Viral Infections

Study Design

Study Type:

Observational

Anticipated Enrollment :

300 participants

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

Study Start Date :

Aug 1, 2012

Anticipated Primary Completion Date :

Dec 1, 2012

Anticipated Study Completion Date :

Jul 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
assorted acute infection 300 patients diagnosed with assorted acute infection.

Outcome Measures

Primary Outcome Measures

IgM greater than 1xcut off value [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.