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

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 - Sofia 2 Lyme+ testing in finger-stick whole blood

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON49820

Enrollment

300

Registered

2019-11-01

Start date

2020-01-20

Completion date

Unknown

Last updated

2024-04-15

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

Conditions

Borrelia infection Lyme disease

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
Cut-off values and incubation time needed for the WB assay, performance of the WB assay including sensitivity and specificity.	—

Countries

Netherlands

Outcome results