Diabetes mellitus (person with high glucose level) and dyslipidemia (imbalance of lipids)
Conditions
Interventions
None listed
Sponsors
Roche Diagnostics International Ltd
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Informed consent signed. Subject is >= 18 years old at the time of enrollment.
Exclusion criteria
Exclusion criteria: Subjects for whom informed consent is not signed before sample collection. Subjects whom the attending physician has determined that the health status of the subject is at risk and/or may be compromised if a blood draw is performed. Subjects who have received an intravenous lipid emulsion injection within 5 days of the study blood draw. Pregnant subjects.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Method comparison between HbA1c and Lipid panel test: capillary vs venous whole blood (EDTA K2 and K3) on cobas click system vs. laboratory reference equipment. - Method comparison between HbA1c and Lipid panel test: capillary vs venous whole blood (EDTA K2 and K3) on cobas b 101/alpha software vs. laboratory reference equipment. Method comparison acceptance criteria for HbA1c: -Slope: 1.000±0.060 -Intercept: =0.980 Bias on medical decision points: On 5.0% HbA1c: =0.975 Intercept: Total Cholesterol: | — |
Countries
Netherlands
Outcome results
None listed