Performance evaluation study of the DiaSys Procalcitonin FS Assay on seven different clinical chemistry analyzers

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00031322

Enrollment

400

Registered

2023-03-09

Start date

2023-03-15

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

A49 A41

Interventions

Group 1: Serum samples from sepsis patients with elevated procalcitonin levels as residual samples evaluated on seven different analyzers. Performance comparison to CLIA reference reagents as well as

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: not applicable

Exclusion criteria

Exclusion criteria: not applicable

Design outcomes

Primary

Measure	Time frame
Through the planned study, in accordance with EP protocols, the performance and high comparability of PCT FS on the different platforms against a LC-MS/MS reference measurement and a reference reagent will be demonstrated. The comparability of the different reagents and analyzers will be determined by the degree of agreement/correlation coefficient.	—

Secondary

Measure	Time frame
not defined	—

Countries

Germany

Contacts

Public ContactMatthias Grimmler

DiaSys Diagnostic Systems GmbH

matthias.grimmler@diasys.de+49 6432 9146 486

Outcome results

None listed

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