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Trial record 71 of 74 for:    lyme

300 Antibody Diagnostic Test Kit (Antibody 300)

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ClinicalTrials.gov Identifier: NCT01646411
Recruitment Status : Unknown
Verified July 2012 by The Plasma Source.
Recruitment status was:  Enrolling by invitation
First Posted : July 20, 2012
Last Update Posted : July 20, 2012
Sponsor:
Collaborator:
Plasma Services Group
Information provided by (Responsible Party):
The Plasma Source

Brief 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.

Condition or disease
Acute Bacterial Infections Acute Viral Infections

Study Type : Observational
Estimated Enrollment : 300 participants
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
Study Start Date : August 2012
Estimated Primary Completion Date : December 2012
Estimated Study Completion Date : July 2013

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. 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.



Biospecimen Retention:   Samples Without DNA
Serum collected in two 10ml sst and two 8ml edta venipuncture tubes.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: The Plasma Source
ClinicalTrials.gov Identifier: NCT01646411     History of Changes
Other Study ID Numbers: 300831
First Posted: July 20, 2012    Key Record Dates
Last Update Posted: July 20, 2012
Last Verified: July 2012

Keywords provided by The Plasma Source:
Lyme
cytomegalovirus (CMV) IgM &IgG
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:
Infection
Communicable Diseases
Bacterial Infections
Virus Diseases
Antibodies
Immunoglobulins
Immunologic Factors
Physiological Effects of Drugs