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300 Antibody Diagnostic Test Kit

NCT01646411 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2012-07-20

No results posted yet for this study

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.

Conditions

  • Acute Bacterial Infections
  • Acute Viral Infections

Sponsors & Collaborators

  • Plasma Services Group

    collaborator INDUSTRY

  • The Plasma Source

    lead INDUSTRY

Principal Investigators

  • Jeffery Flieshman, M.S immunology

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2012-12-31
Completion
2013-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01646411 on ClinicalTrials.gov