300 Antibody Diagnostic Test Kit

The Plasma Source300 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

300

Conditions

Acute Bacterial Infections Acute Viral Infections

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

The Plasma Source

Southampton, Pennsylvania, United States

Outcomes

Primary Outcomes

IgM greater than 1xcut off value

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.

Time frame: Antibody value measured within seven days of specimen collection.

Data from ClinicalTrials.gov

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