25010 - ABL90 FLEX PLUS - Precision Capillary Adult - Clinical Study Protocol

Conducting the ABL90 FLEX PLUS Clinical Precision Study for 15 Parameters in Adult Whole Blood is to validate performance claims for precision in heparinized whole blood for 15 parameters: pH, pCO2, pO2, cCa2+, cCl-, cK+, cNa+, cGlu, cLac, ctHb, sO2, FO2Hb, FMetHb, FCOHb, and FHHb, while being influenced by testing environment that is representative of intended use environment, site variability, and operator variability in a point-of-care (POC) setting.

The investigational device is the ABL90 FLEX PLUS incl. consumables, running SW3.5 MR2, manufactured by Radiometer Medical ApS The study is being conducted in Denmark and in total, a minimum of 30 subjects are to be enrolled to provide successful measurement values from 2 sites.

Study Overview

• Status: Completed
• Conditions: Diagnostic Tests
• Intervention / Treatment: Diagnostic test: ABL90 FLEX PLUS analyser running SW3.5 MR2.

Detailed Description

Adult Whole Blood is to validate performance claims for precision in heparinized whole blood for 15 parameters: pH, pCO2, pO2, cCa2+, cCl-, cK+, cNa+, cGlu, cLac, ctHb, sO2, FO2Hb, FMetHb, FCOHb, and FHHb, while being influenced by testing environment that is representative of intended use environment, site variability, and operator variability in a point-of-care (POC) setting.

Capillary blood collected into 2 capillary tubes from 2 distinct finger sticks will be measured on ABL90 FLEX PLUS in the Capillary mode (C65).

The study is designed to collect approximately 30 pairs of samples combined across sites.

• Study Type: Observational
• Enrollment (Actual): 39

Contacts and Locations

Study Locations

• Denmark
  • Hvidovre, Denmark, 2650
    • Hvidovre Hospital
  • Køge, Denmark, 4600
    • Sjællands Universitets Hospital Køge

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Adult patients (≥18 years old ) admitted to the hospital with low (moderate hypo), normal, or elevated (moderate hyper) concentrations of the 15 parameters covering the reportable range as much as possible.

Description

Inclusion Criteria:

• The subject must be 18 years or older.
• Subjects must be able to understand given information and demonstrate willingness and ability to voluntarily give a signed, valid written informed consent to participate in the study.
• Subject evaluated as suitable according to the protocol to enroll in the study by the principal investigator or designee

Exclusion Criteria:

• Subject where sample collection is evaluated by principal investigator or designee to impose an unnecessary risk.
• Subject, with known pregnancy or breastfeeding.
• Subject, who has an invalid written informed consent or has withdrawn consent.
• Subjects who have been previously enrolled in the study.

• Subjects exposed to following substances within the last 72 hours:

  • Acetylsalicylic Acid Sodium Salt at dose equal or above 1 gram/day
  • N-acetylcysteine o Fluorescein dye o Patent Blue dye -

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Within sample precision for each parameter measured in capillary mode pooled across sites.	Within sample precision of each parameter (pH, pCO2, pO2, cCa2+, cCl-, cK+, cNa+, cGlu, cLac, ctHb, sO2, FO2Hb, FMetHb, FCOHb and FHHb) using replicate measurements from heparinized whole blood samples measured by intended users in a POC setting.	1 hour

Secondary Outcome Measures

Outcome Measure	Time Frame
Within sample precision for each parameter measured in capillary mode per site, if applicable (at least 15 degrees of freedom shall be obtained for the estimate to be statistically meaningful).	1 hour

Collaborators and Investigators

• Sponsor: Radiometer Medical ApS
• Investigators: Principal Investigator: Klaus T Kristiansen, MD, Hvidovre Hospital, ICU; Principal Investigator: Lars Peter k Andersen, MD, Sjællands Universitetshospital Køge, Centre for Anaesthesiology

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2026
• Primary Completion (Actual): January 30, 2026
• Study Completion (Actual): January 30, 2026

Study Registration Dates

• First Submitted: December 15, 2025
• First Submitted That Met QC Criteria: December 15, 2025
• First Posted (Actual): December 29, 2025

Study Record Updates

• Last Update Posted (Actual): March 4, 2026
• Last Update Submitted That Met QC Criteria: March 2, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: ABL90
• Other Study ID Numbers: 25010

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The clinical study results will be submitted to clinical trial.gov after study completion.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No