300 Antibody Diagnostic Test Kit

Status unconfirmed

Conditions studied: Acute Bacterial Infections, Acute Viral Infections

In brief

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.

Key facts

Study ID

NCT01646411

Run by

The Plasma Source

People needed

300

Starts

2012-08-01

Expected to finish

2013-07-01

Last updated by the study team

2012-07-20

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• current acute infection
• age 18-70
• male or female
• any race
• currently active symptoms

Where it is running

• The Plasma Source — Southampton, Pennsylvania, United States

Full record on ClinicalTrials.gov

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