No registrations found.
ID
Source
Brief title
Health condition
manic deppresive illness, total parenteral nutrition
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary result will be a validated Medimate Minilab 2017 with a defined Total Error in mmol/l with a confidence interval of 95%..
Secondary outcome
Specific validation results per patient group.
Interference test results.
Selftest performance results.
Method Comparison results.
Limit of quantification results.
Background summary
This 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.
Study objective
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
Study design
not applicable
Intervention
Validation of a selftest in finger prick whole blood, venous whole blood, plasma and urine.
Inclusion criteria
1. > 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 criteria
1. Under 18
2. No speaking and writing capabilities in Dutch
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL6629 |
| NTR-old | NTR6806 |
| CCMO | NL62392.044.17 |
| OMON | NL-OMON48752 |
Summary results
ELECTROPHORESIS, 2015, 36: 712–721. doi: 10.1002/elps.201400428