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Validation Reseach of Medimate Minilab, Multi Lab-chip 2017


- candidate number28165
- NTR NumberNTR6806
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR8-nov-2017
- Secondary IDsNL62392.044.17 Medisch Ethische Toetsingscommissie Twente
- Public TitleValidation Reseach of Medimate Minilab, Multi Lab-chip 2017
- Scientific TitleValidation Reseach of Medimate Minilab, Multi Lab-chip 2017
- ACRONYMVRMMML2017
- hypothesisTo validate the Total Error of the Medimate Minilab for Sodium, Potassium,Lithium and Creatinine analysis in blood and for Sodium, Potassium, Creatinine and Magnesium analysis in Urine
- Healt Condition(s) or Problem(s) studiedParenteral nutrition, Manic depressive illness
- Inclusion criteria1. > 18 years;
2. The participant has to be able to speak and read Dutch;
3. Healthy volunteers
4. The participant has to be part of the targeted patient group
- Exclusion criteria1. Under 18
2. No speaking and writing capabilities in Dutch
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeobservational
- planned startdate 15-nov-2017
- planned closingdate31-dec-2022
- Target number of participants1185
- InterventionsValidation of a selftest in finger prick whole blood, venous whole blood, plasma and urine.
- Primary outcomeThe primary result will be a validated Medimate Minilab 2017 with a defined Total Error in mmol/l with a confidence interval of 95%..
- Secondary outcomeSpecific validation results per patient group.
Interference test results.
Selftest performance results.
Method Comparison results.
Limit of quantification results.
- Timepointsnot applicable
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIES Steven Staal
- CONTACT for SCIENTIFIC QUERIES Steven Staal
- Sponsor/Initiator Radboud University Medical Center Nijmegen, CE-Mate BV, Diagnostiek voor U
- Funding
(Source(s) of Monetary or Material Support)
CE-Mate BV
- PublicationsStaal, S. et al., A versatile electrophoresis-based self-test platform.
ELECTROPHORESIS, 2015, 36: 712721. doi: 10.1002/elps.201400428
- Brief summaryThis study is to validate the Total Error of the Medimate Minilab for Sodium, Potassium, Lithium and Creatinine analysis in blood and for Sodium, Potassium, Creatinine and Magnesium analysis in Urine

These validation studies will provide statistical information concerning the accuracy, precision and reliability of the measurement under varying circumstances.

During this validation study the precision, accuracy and reliability are validated for the different parameters. These evaluations are designed to prove the Minilab 2017 performance under normal and extreme conditions.
- Main changes (audit trail)
- RECORD8-nov-2017 - 30-nov-2017


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