van de Schoor, F. R.
Baarsma, M. E.
Gauw, S. A.
Joosten, L. A. B.
Kullberg, B. J.
van den Wijngaard, C. C.
Hovius, J. W.
Funding for this research was provided by:
ZonMw (52205.0001)
Article History
Received: 6 June 2019
Accepted: 26 July 2019
First Online: 20 August 2019
Ethics approval and consent to participate
: This protocol, its amendments, and all associated documents (e.g., participant information form & informed consent form) have been reviewed and approved by the Medical Ethics Committee of the Amsterdam UMC / AMC. This study is registered with the Central Committee on Research Involving Human Subjects (CCMO) of the Netherlands under number NL63961.018.18. Should additional amendments arise, then these will be submitted to the aforementioned Medical Ethics Committee. Participants are all adults and all give written informed consent before enrolment. All study data are processed under a code, which is only accessible to researchers directly involved with the project or persons performing monitoring functions (e.g., the Medical Ethics Committee). Personal information is processed according to the provisions of the European Union’s General Data Protection Regulation. This research is conducted according to the principles of the Declaration of Helsinki.
: Not applicable.
: Radboudumc has developed the earliest version of the Spirofind as an in-house assay. The license was obtained by Boulder Diagnostics (Boulder, Colorado, USA), subsequently acquired by Oxford Immunotec (Oxford, UK). In 2018, the license was returned to Radboudumc; Oxford Immunotec is no longer involved in the development of the assay. Radboudumc has additionally received a grant from Boulder Diagnostics (later Oxford Immunotec) for an unrelated project. To secure the independence the study, the Amsterdam UMC functions as the Sponsor of the study, all samples are blinded prior to processing, including any information related to type (case or control) and time point. Samples are processed at two separate sites, and outcomes for all tests from both sites will be compared.