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

July 12, 2012
July 19, 2012
August 2012
December 2012   (final data collection date for primary outcome measure)
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.

Same as current
Complete list of historical versions of study NCT01646411 on ClinicalTrials.gov Archive Site
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300 Antibody Diagnostic Test Kit
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.

Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Not Provided
Retention:   Samples Without DNA
Description:

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

Non-Probability Sample

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

  • Acute Bacterial Infections
  • Acute Viral Infections
Not Provided
assorted acute infection
300 patients diagnosed with assorted acute infection.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
300
July 2013
December 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • current acute infection
  • age 18-70
  • male or female
  • any race
  • currently active symptoms
Both
18 Years to 70 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01646411
300831
Yes
The Plasma Source
The Plasma Source
Plasma Services Group
Study Director: Jeffery Flieshman, M.S immunology
The Plasma Source
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP