NCT03238274

Sofia 2 Lyme FIA Whole Blood Clinical Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 597 (actual)
• Sponsor: Quidel Corporation · Industry
• Sex: All
• Age: 1 Year
• Healthy volunteers: Not accepted

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.

Detailed description

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. The finger-stick and venous whole blood specimens will be tested by CLIA waived test operators. The matched plasma (from the leftover whole blood) and serum specimens will be sent to a separate reference laboratory for testing to compare the matched specimen using the Comparator Method(s) and/or an FDA-cleared predicate test(s). The results of this study may be used to support a 510(k) and/or CLIA-Waiver submission for testing whole blood sample types.

Conditions

• Borrelia; Infection, Burgdorferi (Erythema Chronicum Migrans)

Interventions

Type	Name	Description
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

Timeline

• Start date: 2017-06-06
• Primary completion: 2017-12-15
• Completion: 2017-12-15
• First posted: 2017-08-03
• Last updated: 2018-03-20

Locations

11 sites across 1 country: United States

Regulatory

• FDA-regulated device study