Point-of-care detection of Borrelia antibodies using Sofia 2 Lyme+ FIA: Comparison of finger-prick whole blood assay versus testing in serum or plasma

Recruiting

• Conditions: Borrelia infection; Lyme disease; 10004018

• Registration Number: NL-OMON49820
• Lead Sponsor: Quidel Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 300

Inclusion Criteria

- At least 18 years old;
- Previous Borrelia antibody testing performed at Innatoss, with known results;
- Able and willing to sign the informed consent form.

Exclusion Criteria

There are no specific criteria for subjects to be excluded from participation
in this study, as long as they adhere to the inclusion criteria mentioned
above.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Cut-off values and incubation time needed for the WB assay, performance of the<br /><br>WB assay including sensitivity and specificity.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>N/A</p><br>