300 Antibody Diagnostic Test Kit

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01646411

Acronym

Antibody 300

Enrollment

300

Registered

2012-07-20

Start date

2012-08-31

Completion date

2013-07-31

Last updated

2012-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Bacterial Infections, Acute Viral Infections

Keywords

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

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Yes

Inclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
IgM greater than 1xcut off value	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.

Countries

United States

Outcome results