300 Antibody Diagnostic Test Kit — Antibody 300  

Acute Bacterial Infections Clinical Trial

Official title: Phase I Study for Positive IgM Antibody Detection in New Diagnostic Test Kit for for Acute Phase Infection

Status Enrolling by invitation

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Acute Bacterial Infections
• Acute Viral Infections
• Bacterial Infections
• Communicable Diseases
• Infection
• Virus Diseases

• NCT number: NCT01646411
• Study type: Observational
• Source: The Plasma Source
• Status: Enrolling by invitation
• Phase: N/A
• Start date: August 2012
• Completion date: July 2013