The objectives of this multicenter performance evaluation study comprise an assessment of the analytical performance, the reliability and robustness of the system to obtain a CE mark.
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
- Lipid metabolism disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- 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: <=0.500% HbA1c
-Pearson: r>=0.980
Bias on medical decision points:
On 5.0% HbA1c: <=6.0%
On 5.7% HbA1c: <=6.0%
On 6.5% HbA1c: <=6.0%
On 8.0% HbA1c: <=6.0%
On 12.0% HbA1c: <=6.0%
Method comparison for Lipid panel:
-Slope: 1.00±0.100
-Pearson: r>=0.975
Intercept:
Total Cholesterol: <11.7 mg/dL (0.3 mmol/L)
Triglycerides: <13.3 mg/dL (0.15 mmol/L)
HDL: <5.80 mg/dL (0.15 mmol/L)
Bias on medical decision points:
Total Cholesterol:
On 200 and 240 mg/dL: <=3.0%
Triglycerides:
On 150 and 200 mg/dL: <=5.0%
HDL:
On 40 and 60 mg/dL: <=5.0%
Secondary outcome
n/a
Background summary
HbA1c (glycated hemoglobin) can be determined by using samples from capillary
whole blood directly from the fingertip or from EDTA (K2/K3) venous whole
blood. Equal to the cobas b 101 HbA1c test, the new cobas HbaA1c test Gen. 2
uses a latex agglutination-inhibition immunoassay on a disc format with an
onboard dilution container.
The cobas Lipid Panel Gen. 2 measures total cholesterol, triglycerides, and
high density lipoprotein cholesterol from capillary blood from the fingertip or
from venous whole blood with EDTA (K2/K3) anticoagulant. Low density
lipoprotein is calculated using the Friedewald formula. The cobas click system
provides the lipid panel assay on a disc format with on onboard dilution
container.
Study objective
The objectives of this multicenter performance evaluation study comprise an
assessment of the analytical performance, the reliability and robustness of the
system to obtain a CE mark.
Study design
Method comparison HbA1c test and Lipid Panel: capillary whole blood and venous
whole blood (EDTA K2 and K3) on cobas click vs. reference instrument
measurements.
Method comparison HbA1c test and Lipid Panel: capillary whole blood and venous
whole blood (EDTA K2 and K3) on cobas b 101/software alpha vs. reference
instrument measurements.
Matrix comparison between HbA1c test and Lipid Panel test: EDTA (K2) whole
blood will be compared with EDTA (K3) whole blood and capillary whole blood on
cobas click system and cobas b 101 with alpha software.
Study burden and risks
The burden for subjects will consist of a maximum of 2 extra venapunctures and
a minimum of 2 (maximum of 4) capillary punctures without hospitalization. The
only risks for this study are the possible side effects for capillary and
venous blood draw.
Forrenstrasse 2
Rotkreuz 6343
CH
Forrenstrasse 2
Rotkreuz 6343
CH
Listed location countries
Age
Inclusion criteria
Informed consent signed.
Subject is >= 18 years old at the time of enrollment.
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
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL82547.000.22 |