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300 Antibody Diagnostic Test Kit (Antibody 300)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
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

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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

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.

Information from the National Library of Medicine

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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.

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 identifier (NCT number): NCT01646411

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

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Responsible Party: The Plasma Source 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:
cytomegalovirus (CMV) IgM &IgG
Rubeola IgM
Rocky mountain Spotted Fever IgM
Ebv IgM
Bordetella Pertussis
H Pylori
Antibody Titre
Elevated IgG
Abnormal IgM
Additional relevant MeSH terms:
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Communicable Diseases
Bacterial Infections
Virus Diseases
Immunologic Factors
Physiological Effects of Drugs