Clinical Precision and In-use Analyte Stability Study for Four (4) Parameters in Neonate Arterial Blood for PICO70 and SafePICO

Overview

The objective is to determine the total (within-lot and between lots) precision for four (4) parameters (pO2, tBil, ctHb and FHbF) in neonatal arterial blood. Furthermore, the objective is to determine the analyte in-use stability for each blood gas syringe in arterial blood for neonatal blood parameters. In-use analyte stability in neonatal arterial blood in PICO70 and safePICO for each parameter, measuring at four testing timepoints. It is expected that he precision performance of each parameter is equal to or within the acceptance criteria/performance claim. The in-use analyte stability measured at four testing timepoint is within the acceptance criteria.

The study is a Post-Market Clinical Follow-up (PMCF) randomized unblinded study, to be conducted across two sites in Denmark, using subject whole blood samples from Umbilical cord/placenta to determine the precision and stability for the PICO70/safePICO syringes when measuring four parameters using the RMED ABL90 FLEX PLUS analyzer. For PICO70 + safePICO: 40 + 40 completed arterial series of samples consisting of 5 syringes are needed: The syringes will be from three different lots (A,B,C) and analyzed at four different time points, T0 min., T15 min., T30 min., T45 min. to cover measurements completed within 0 - 45 minutes. Both PICO70 and safePICO arterial blood series of samples can be drawn from one subject/placenta, which brings a range of 40 - 80 completed subjects enrolled in total for the study. If subjects are enrolled but not completed according to the protocol such subject will need replacement. Whole blood will be collected from subject cord/placenta in a mother syringe and distributed when relevant into the five (5) PICO70 and five (5) safePICO syringes for measurments. It can be relevant to collect venous blood if sufficient volume of arterial blood is not available for the cord/placenta blood collection. The mother syringe will be heparinized. The amount of heparin in the mother syringe will be determined based on the total volume of the samples. Series of syringes will be randomized and provided to site in kits of 5 marked syringes prior to study start to get an unbiased precision result. Three different Lot numbers for both the PICO70 and safePICO syringes are to be analyzed during the conduct of the study. The order of the three Lots (ABC) to be analyzed are randomized and included in each Kit. Each kit will be marked with subject number and randomization number. Site has to use each kit for the next subject in subject number order (101, 102, 103 etc.). The 5 syringes will each be marked as follow; 1T0, 2T0, 3T15, 4T30 and 5T45 which indicates when and in what order the samples shall be measured after samples are drawn and contrived for specific level. T0 shall be measured within 10 min. after contriving is completed. The four (4) parameters pO2, tBil, ctHb and FHbF will be analysed for each syringe in the syringe series. Three parameters (pO2, tBil, FHbF) will be contrived according to guideline. The contriving procedure will be performed either by the site or lab technician. The contriving of the two parameters pO2 and tBil will be measured together with ctHb. FHbF will be analyzed in a separate sample after being contrived.