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Sofia 2 Lyme FIA Whole Blood Clinical Study

NCT03238274 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 597

Last updated 2018-03-20

No results posted yet for this study

Summary

The objective of this study is to demonstrate the clinical performance of the Sofia® 2 analyzer and Sofia Lyme FIA test in the CLIA waived test environment in comparison to Comparator Method(s) and/or an FDA cleared predicate test(s) using matched finger-stick, whole blood and serum from symptomatic subjects.

Conditions

  • Borrelia; Infection, Burgdorferi (Erythema Chronicum Migrans)

Interventions

DEVICE

Sofia 2 Lyme FIA testing

IVD testing of whole blood or serum/plasma to aid in the detection of anti-B. burgdorferi IgG / IgM antibody

Sponsors & Collaborators

  • Quidel Corporation

    lead INDUSTRY

Principal Investigators

  • Tom Clement · Quidel Corporation

Eligibility

Min Age
1 Year
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-06
Primary Completion
2017-12-15
Completion
2017-12-15
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03238274 on ClinicalTrials.gov