Clinical Performance Evaluation Study of the Quotient MosaiQ'M Treponema pallidum/CMV Screening Test- MosaiQ Serological Oisease Screening (SOS) Magazines EU Study, Testing for Antibodies to Treponema pallidum and Cytomegalovirus in Blood Oonors (EU; SDS MACH 1)

Clinical Performance Evaluation Study of the Quotient MosaiQ'M Treponema pallidum/CMV Screening Test- MosaiQ Serological Oisease Screening (SOS) Magazines EU Study, Testing for Antibodies to Treponema pallidum and Cytomegalovirus in Blood Oonors (EU; SDS MACH 1) - MosaiQ

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00017023

Enrollment

4000

Registered

2019-03-26

Start date

2019-03-19

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

Infectioues disease serology syphilis B25

Interventions

Group 1: - The examinations are done with residual material that is part of the routine donor examination (the routine volume is sufficient for the tests) - There are no additional invasive or stressi

Eligibility

Sex/Gender

All

Age

18 Years to 72 Years

Inclusion criteria

Inclusion criteria: Not applicable – Performance Evaluation Study for a single use microarray for serological disease screening

Exclusion criteria

Exclusion criteria: Not applicable – Performance Evaluation Study for a single use microarray for serological disease screening

Design outcomes

Primary

Measure	Time frame
To compare the MosaiQ Platform to CE marked instruments/assays currently on the market. Instrument data will be entered into a central database using a printed copy of the instrument results - this will be the source document. Data will be entered on an excel spreadsheet - this will be the source document and subsequently entered into a central database. Site will be provided indepnedent laptops for data entry, and a USB sticks to remove data from the site and upload to the EDC system The test results will be evaluated after finishing the tests.	—

Measure

Time frame

To compare the MosaiQ Platform to CE marked instruments/assays currently on the market. Instrument data will be entered into a central database using a printed copy of the instrument results - this will be the source document. Data will be entered on an excel spreadsheet - this will be the source document and subsequently entered into a central database. Site will be provided indepnedent laptops for data entry, and a USB sticks to remove data from the site and upload to the EDC system The test results will be evaluated after finishing the tests.

—

Secondary

Measure	Time frame
To evaluate the user performance of the microarray for each tested category on the MosaiQ Platform.	—

Countries

Germany, Switzerland

Contacts

Public ContactFranz F. Wagner

DRK-Blutspendedienst NSTOB

franz.wagner@bsd-nstob.de05041 772 172

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026