Hemolysis
Conditions
Keywords
IVDR, Blood Gas Analyser, In vitro diagnostic, hemolysis detection
Brief summary
This feasibility performance study evaluates the ABL90 FLEX PLUS HEM device for its analytical performance in a clinical setting. The study aims to evaluate the performance of the hemolysis detection feature.
Detailed description
The study is designed to assess the feasibility and performance of the ABL90 FLEX PLUS HEM device in a clinical environment. It will involve testing whole blood samples using the device and comparing results against established reference method. The primary focus is on validating the device's performance of the hemolysis detection function. The study will be conducted at one selected clinical site with trained personnel and will follow a predefined protocol to ensure consistency and reliability of data collection. The outcomes will inform future clinical studies aimed at supporting regulatory submissions and clinical adoption.
Interventions
DIAGNOSTIC_TESTThe purpose of this study is to investigate the performance of the hemolysis detection function on the ABL90 FLEX PLUS HEM using arterial or venous whole blood
The hemolysis detection function is a newly developed sample quality feature on the ABL90 FLEX PLUS HEM intended to detect hemolyzed samples and to improve the reliability of the results provided by blood gas analyzer.
Sponsors
Bispebjerg Hospital
Radiometer Medical ApS
Study design
Observational model
ECOLOGIC_OR_COMMUNITY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject must be 18 years of age or older * Informed consent is obtained: * Directly from the subject, if they are competent and able to understand the provided information and voluntarily agree to participate, or * If the subject is temporarily incapacitated and unable to provide informed consent at the time of sample collection, written informed consent will be obtained from the subject's legally designated representative (LDR). when the subject regains capacity after enrollment, they will be informed of study inclusion and given the opportunity to withdraw consent. * Subject evaluated as suitable according to the protocol and for the study by the principal investigator or designee.
Exclusion criteria
* Subject where sample collection is evaluated by PI or designee to impose unnecessary risk. * Subject with an invalid written informed consent or who has withdrawn consent. * Subject with known pregnancy or who is breastfeeding.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent of samples correctly classified into hemolysis bins (0-4) using ABL90 FLEX PLUS HEM hemolysis flag | At time of sample analysis (single session per sample; Day 1) | Whole blood samples (native and contrived) are classified into five hemolysis bins based on reference ccfHb (mg/dL): bin 0 (0-100), bin 1 (101-200), bin 2 (201-400), bin 3 (401-1000), bin 4 (\>1000). Correct classification is the proportion of samples where the ABL90 FLEX PLUS HEM hemolysis flag matches the reference bin assignment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Slope of change in ccfHb concentration over 0-45 minutes (mg/dL per minute) | 0-45 minutes after t=0 measurement (within one sample session; Day 1) | For each sample, ccfHb is measured on ABL90 FLEX PLUS HEM at t=0, 15, 30, and 45 minutes (±5 minutes). The outcome is the slope (mg/dL/min) from linear regression of ccfHb versus time over 0-45 minutes. |
| Pearson correlation coefficient (r) between ABL90 ccfHb (mg/dL) and Cobas 8000 Hemolysis Index (HI) | At time of paired analysis per sample (Day 1) | Paired measurements are obtained from the same sample: ABL90 FLEX PLUS HEM measures ccfHb (mg/dL) in S65 mode, and Roche cobas 8000 reports Hemolysis Index (HI) using the hemolysis index assay. The outcome is the Pearson correlation coefficient (r) across paired ABL90 ccfHb and Cobas HI values (unitless r). |
| Pearson correlation coefficient (r) between ccfHb and potassium concentration (cK+, mmol/L) after RMED aspiration manipulation | During RMED manipulation session (baseline to after 2 aspiration rounds; Day 1) | For each sample, ABL90 FLEX PLUS HEM measures ccfHb and potassium (cK+) at baseline (no manipulation), after 1 round of RMED aspiration manipulation, and after 2 rounds. The outcome is Pearson correlation coefficient (r) between ccfHb and potassium values pooled across the three measurements (unitless r). |
| Percentage of native whole blood samples with hemolysis (ccfHb > 20 mg/dL) | At time of native sample analysis (Day 1) | Among native (non-contrived) leftover arterial and venous whole blood samples, the outcome is the percentage of samples with ccfHb \> 20 mg/dL as measured on ABL90 FLEX PLUS HEM. |
Countries
Denmark
Contacts
Primary ContactVadim Fedulov
Outcome results
None listed