300 Antibody Diagnostic Test Kit (Antibody 300)

July 19, 2012 updated by: The Plasma Source

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

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.

Study Overview

Study Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Pennsylvania
      • Southampton, Pennsylvania, United States, 18966
        • The Plasma Source

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with acute infection between the age of 18 and 70. Sex and race are random.

Description

Inclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
assorted acute infection
300 patients diagnosed with assorted acute infection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
IgM greater than 1xcut off value
Time Frame: 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.

Antibody value measured within seven days of specimen collection.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Study Director: Jeffery Flieshman, M.S immunology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (Anticipated)

December 1, 2012

Study Completion (Anticipated)

July 1, 2013

Study Registration Dates

First Submitted

July 12, 2012

First Submitted That Met QC Criteria

July 19, 2012

First Posted (Estimate)

July 20, 2012

Study Record Updates

Last Update Posted (Estimate)

July 20, 2012

Last Update Submitted That Met QC Criteria

July 19, 2012

Last Verified

July 1, 2012

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Acute Bacterial Infections

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