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300 Antibody Diagnostic Test Kit (Antibody 300)

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Plasma Services Group
Information provided by (Responsible Party):
The Plasma Source
ClinicalTrials.gov Identifier:
NCT01646411
First received: July 12, 2012
Last updated: July 19, 2012
Last verified: July 2012
History of Changes
  Purpose

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
Acute Bacterial Infections
Acute Viral Infections

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by The Plasma Source:

Primary Outcome Measures:
  • IgM greater than 1xcut off value [ Time Frame: Antibody value measured within seven days of specimen collection. ] [ Designated as safety issue: No ]

    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.



Biospecimen Retention:   Samples Without DNA

Serum collected in two 10ml sst and two 8ml edta venipuncture tubes.


Estimated Enrollment: 300
Study Start Date: August 2012
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
assorted acute infection
300 patients diagnosed with assorted acute infection.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

Inclusion Criteria:

  • current acute infection
  • age 18-70
  • male or female
  • any race
  • currently active symptoms
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01646411

Locations
United States, Pennsylvania
The Plasma Source
Southampton, Pennsylvania, United States, 18966
Sponsors and Collaborators
The Plasma Source
Plasma Services Group
Investigators
Study Director: Jeffery Flieshman, M.S immunology
  More Information

No publications provided

Responsible Party: The Plasma Source
ClinicalTrials.gov Identifier: NCT01646411     History of Changes
Other Study ID Numbers: 300831
Study First Received: July 12, 2012
Last Updated: July 19, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by The Plasma Source:
cytomegalovirus (CMV) IgM &IgG
Lyme
Toxoplasma
Rubella
Rubeola IgM
Rocky mountain Spotted Fever IgM
Ebv IgM
Herpes
Babesia
Measles
Tetanus
 Mumps
Mycoplasma
Legionella
Giardia
Syphilis
Bordetella Pertussis
H Pylori
Antibody Titre
Elevated IgG
Abnormal IgM
SLE

Additional relevant MeSH terms:
Bacterial Infections
Virus Diseases
Antibodies
 Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013