ABL90 FP MC Neonatal Arterial, Venous, Capillary Blood
United States612 participantsStarted 2023-03-17
Plain-language summary
The goal of this clinical trial is to validate performance claims for method comparison for ABL90 FLEX PLUS in heparinized neonatal arterial, venous, and capillary whole blood for ctBil and FHbF in a Point of Care (POC) setting.
Who can participate
Age range1 Day – 28 Days
SexALL
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Inclusion Criteria:
* The following are the inclusion criteria for the neonatal subjects:
* The age of the subject must be ≤28 days.
* Subject evaluated as suitable according to the protocol to enroll in the study by principal investigator or designee.
* Subjects having a sample drawn as part of standard of care that meets the requirements for samples in this study.
The following are the inclusion criteria for the subjects providing placenta for cord blood:
• Delivery ≥38 weeks of gestation.
Exclusion Criteria:
* The following are the exclusion criteria for the neonatal subjects:
* Subject who has already provided successful results from arterial, venous and mixed venous/arterial samples, to cover both syringe modes and the capillary mode and parameters.
* Subjects exposed to the substances listed in Appendix 1 with last dose within 72 hours, should be excluded due to risk of interference.
* Subjects with known infectious disease such as Hepatitis C and HIV (in order to ensure the operator safety).
The following are the exclusion criteria for the subjects providing placenta for cord blood:
• Subjects positive of HIV or Hepatitis C