Show accurate and proper functioning of the Medimate MiniLab system for professional and self test use.The objective of the studies is to show the performance of 10% or 0.1 mmmol/l @ 95% confidence interval.
ID
Bron
Verkorte titel
Aandoening
correlation
lithium
bipolar disorder
self test
correlatie
lithium
bipolaire stoornis
zelftest
Ondersteuning
Medisch Spectrum Twente, Enschede, The Netherlands
GO and EFRO funding the NIRION project
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
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.
Achtergrond van het onderzoek
N/A
Doel van het onderzoek
Show accurate and proper functioning of the Medimate MiniLab system for professional and self test use.The objective of the studies is to show the performance of 10% or 0.1 mmmol/l @ 95% confidence interval.
Onderzoeksopzet
N/A
Onderzoeksproduct en/of interventie
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 compared to the results of venous blood sample on the laboratory equipment. Both samples will be taken at the same instant.
The research will consists of three different phases, to be carried out after each other.
Phase 1: Show correlation between golden standard and Medimate system within artificial laboratorial setting based on precision and proven equivalence.
Phase 2: Validation of the system within daily clinical setting by laboratory professionals by method comparison based on accuracy.
Phase 3: Validation of the system in use by lay persons; physicians and patients.
Publiek
De Veldmaat 10
Marian Tellegen
Enschede 7522 NM
The Netherlands
marian.tellegen@medimate.com
Wetenschappelijk
De Veldmaat 10
Marian Tellegen
Enschede 7522 NM
The Netherlands
marian.tellegen@medimate.com
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
Bipolar patients > 18 years, using lithium and treated and selected by psychiatrists (clinic or outpatient) of MST Enschede or other medical centers.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Non-lithium users;
2. Not able to read or write dutch.
Opzet
Deelname
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Andere (mogelijk minder actuele) registraties in dit register
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL2846 |
| NTR-old | NTR2988 |
| CCMO | NL34961.044.10 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |