Method Comparison for ABL90 FLEX PLUS in Neonatal Subjects
Conditions
Keywords
Blood Gas, Method Comparison, Capillary, Neonates
Brief summary
The study is intended to validate performance claims for method comparison for ABL90 FLEX PLUS in heparinized neonatal capillary whole blood for ctBil and FHbF in a POC setting
Detailed description
The objective is to perform a method comparison study to quantify the relationship using comparison measurement from the same sample between ABL90 FLEX PLUS and the predicate device within the reportable range for ctBil and FHbF in heparinized capillary whole blood samples in capillary measuring mode (C65). This study will together with a method comparison study performed with surrogate capillary samples contribute to the overall validation of the performance of ABL90 FLEX for capillary whole blood with regards to the parameters ctBil and FHbF measured using the capillary mode. This study is anticipated to run for approximately 6-12 months from site initiation visit till close-out visit depending on patient enrollment.
Interventions
DEVICEMethod Comparison
Quantifying the relationship using comparison measurement from the same sample between ABL90 FLEX PLUS and the predicate device within the reportable range for ctBil and FHbF in heparinized capillary whole blood samples in capillary measuring mode (C65).
Sponsors
Radiometer Medical ApS
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 28 Days
Healthy volunteers
No
Inclusion criteria
* Informed consent collected from legal representative able to understand information given and willing and able to voluntary give their consent to participate in this study. * The age of the subject must be ≤28 days. * Subject evaluated as suitable according to the protocol to enrol in the study by principal investigator or designee
Exclusion criteria
* Subject where sample collection is evaluated by principal investigator or designee to impose an unnecessary risk. * Subject, who has an invalid written informed consent or has withdrawn consent. * Subject who has already provided successful results from capillary samples, to cover both parameters. * Subjects exposed to the substances listed in Appendix 1 with last dose within 72 hours, should be excluded due to risk of interference.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Endpoints | 12 months | Bias between device under investigation and comparative device at medical decision level across sites; (unit is mg/dL) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary Endpoints | 12 months | Bias between device under investigation and comparative device at a medical decision point in native capillary samples per site; (unit is mg/dL) |
Countries
United States
Outcome results
None listed