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Validation of Medimate MiniLab, lithium lab-chip.

Validation of Medimate MiniLab with lithium lab-chip.

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON25707
Enrollment
94
Registered
2011-07-14
Start date
2011-08-15
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

correlation lithium bipolar disorder self test correlatie lithium bipolaire stoornis zelftest

Interventions

Correlation study between standard validated laboratory equipment for lithium and the Medimate MiniLab. The lithium results of whole blood finger prick sample measured on the Medimate device are to be
physicians and patients.

Sponsors

Medimate BV, Enschede The Netherlands Medisch Spectrum Twente, Enschede, The Netherlands
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Bipolar patients > 18 years, using lithium and treated and selected by psychiatrists (clinic or outpatient) of MST Enschede or other medical centers.

Exclusion criteria

Exclusion criteria: 1. Non-lithium users; 2. Not able to read or write dutch.

Design outcomes

Primary

MeasureTime frame
From the measurements the correlation between the measurement systems, the accuracy and liability are calculated and analyzed using Bland & Altman statistics and CLSI EP-9 Method Comparison. Precision analysis is done by standard deviation on residual, equivalence is shown by Anova analysis.

Secondary

MeasureTime frame
Information on user friendlyness of the Medimate Minilab system.

Contacts

Public ContactMarian Tellegen

Medimate BV De Veldmaat 10

marian.tellegen@medimate.com

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)