Clinical study of the MosaiQ™ Platform, comprised of a fully automated instrument and MosaiQ™ Microarray IH (Immunohaematology), (EU: MACH 1 Study)

Clinical study of the MosaiQ™ Platform, comprised of a fully automated instrument and MosaiQ™ Microarray IH (Immunohaematology), (EU: MACH 1 Study) - MosaiQ

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00014656

Enrollment

1000

Registered

2018-04-24

Start date

2018-05-24

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

Blood Group serology

Interventions

Group 1: Samples from donors (donor sites) who have made a blood donation to transfusion services and whose redundant, anonymous blood samples will be tested for Research purposes. Test Parameters are

Eligibility

Sex/Gender

All

Age

18 Years to 72 Years

Inclusion criteria

Inclusion criteria: Not applicable. This is a Performance Evaluation of an in-vitro diagnostic. Samples from donors (donor sites) who have made a blood donation to transfusion services and whose redundant, anonymous blood samples can be used for research purposes will be tested. Only samples from healthy donors who fulfill the donation criteria of DRK-Blutspendedienst NSTOB will be accepted (see also Guidelines Hemotherapy)

Exclusion criteria

Exclusion criteria: Not applicable. This is a Performance Evaluation of an in-vitro diagnostic. Samples from donors (donor sites) who have made a blood donation to transfusion services and whose redundant, anonymous blood samples can be used for research purposes will be tested. Samples from donors who do not fulfill the donation criteria of DRK-Blutspendedienst NSTOB will not be accepted (see also Guidelines Hemotherapy)

Design outcomes

Primary

Measure	Time frame
Immunohaematology (IH): 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. Comparator Data will be entered on an excel spreadsheet – this will be the source document and subsequently entered into a central database. Sites will be provided independent 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

Immunohaematology (IH): 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. Comparator Data will be entered on an excel spreadsheet – this will be the source document and subsequently entered into a central database. Sites will be provided independent 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, United Kingdom

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