AllergyNCT04401631
Analytical Validation of the abioSCOPE Device With an IgE Test Panel: Point-of-Care Precision, Sample Type Comparison and Method Correlation
An observational study of Allergy and Allergic Asthma, run by Abionic SA at 3 sites in United States.
Trial summary
This is a multicenter, prospective, observational study to evaluate the analytical performance of the Abionic IgE Multi-Allergen Test Panel on the abioSCOPE® device in a U.S. point-of-care environment within a clinical laboratory operating under a CLIA certificate for tests of moderate complexity. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Allergy, Allergic Asthma, Allergy to Cats
- What is being tested?
- Blood Collection
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 3 sitesUnited States
- Study dates
- Nov 2020to Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: * A minimum of 20 subjects with targeted levels of total IgE are needed to participate in the Operator-to-Operator whole blood study. * A minimum of 20 subjects with targeted levels of allergen-specific and total IgE are needed to participate in the capillary whole blood between-run imprecision study in the POL environment. * A minimum of 40 subjects with targeted levels of Fel d 1-specific IgE and total IgE are needed to participate in the sample type comparison study. These subjects will be recruited, and their samples analyzed at 1 POL. * A minimum of 300 subjects (approximately 100 subjects enrolled and evaluated at each of three sites) and with targeted levels of total IgE are needed to participate in the method comparison study.
Who may be able to join
- Provision and understanding of signed and dated written informed consent by the subject prior to any mandatory study-specific procedures, sample collection, or analysis.
- Male or female, 18 years of age or older.
Who cannot join
- Subject participating in another study that may influence test results.
- Subject taking any of the following medications: systemic steroids (inhaled or nasal steroids are allowed), anti-cytokines or cytokines, systemic interferon (injection local interferon α for the treatment of HPV is allowed), anti-IgE therapy (approved or investigational) or treated with systemic chemotherapy.
- History of cancer, autoimmune, or immune deficiency disease.
- Suffering from a hematological pathology (coagulation disorder, severe anemia) that could interfere with the blood draw procedure.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Johns Hopkins University, Baltimore
Baltimore, Maryland, 21215
The Bernstein Clinical Research Center Cincinnati
Cincinnati, Ohio, 45231
George Washington University, Washington DC
Washington D.C., District of Columbia, 20037
About this study
This is a multicenter, prospective, observational study to evaluate the analytical performance of the Abionic IgE Multi-Allergen Test Panel on the abioSCOPE® device in a U.S. point-of-care environment within a clinical laboratory operating under a CLIA certificate for tests of moderate complexity. The study will assess point-of-care ('external') precision, sample type comparison and correlation with a reference method (Phadia Laboratory System, ThermoFisher Scientific).
- Conditions
- Allergy, Allergic Asthma, Allergy to Cats, Allergy to House Dust, Allergy to Dog Dander (Finding), Allergy Mold
- Being tested
- Blood Collection
- Keywords
- Allergy, Asthma, Point-of-Care, Immunoassay, In vitro Diagnostic, Total IgE, Specific allergy
- Medical subject headings
- Hypersensitivity, Signs and Symptoms, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood CollectionDevice
Between-Run Reproducibility K3-EDTA venous whole blood 3 mL 1 venous draw
Operator-to-operator imprecision (abioSCOPE) K3-EDTA capillary whole blood 0.05 mL/draw; 0.15 mL total 3 finger sticks (3 different fingers)
Sample type comparison (abioSCOPE) K3-EDTA capillary whole blood, venous serum, venous K3-EDTA plasma 0.35 mL (finger stick), 9 mL of whole blood to get a minimum of 3 mL of serum and 9 mL of whole blood K3-EDTA to get a minimum of 3 mL of plasma 1 finger stick; 1 venous draw into serum tube (9 mL) and 1 venous draw into K3-EDTA plasma tube (9 mL), in total 18 mL
Method comparison (abioSCOPE and ImmunoCAP/Phadia) K3-EDTA capillary whole blood, venous K3-EDTA plasma 0.05 mL (finger stick), 9 mL of whole blood to get a minimum of 3 ml of plasma 1 finger stick; 1 venous draw into K3-EDTA plasma tube (9 mL tube)
| Study group | Role | What they receive |
|---|---|---|
| Interventions | * A minimum of 20 subjects with targeted levels of total IgE are needed to participate in the Operator-to-Operator whole blood study.
* A minimum of 20 subjects with targeted levels of allergen-specific and total IgE are needed to participate in the capillary whole blood between-run imprecision study in the POL environment.
* A minimum of 40 subjects with targeted levels of Fel d 1-specific IgE and total IgE are needed to participate in the sample type comparison study. These subjects will be recruited, and their samples analyzed at 1 POL.
* A minimum of 300 subjects (approximately 100 subjects enrolled and evaluated at each of three sites) and with targeted levels of total IgE are needed to participate in the method comparison study. Receives: Device: Blood Collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
POC variance components (in a POL environment):
- External Precision Study ('reproducibility study' 'site-to-site precision study'): Demonstrate that the imprecision of K3-EDTA venous plasma using the IVD CAPSULE Allergic Asthma panel on the abioSCOPE device (all 5 allergens/allergen mixes and total IgE) in the hands of trained Healthcare Professionals in a Physician Office Laboratory (POL) is within the expected range of the imprecision established in the clinical laboratory by Laboratory Scientists.
- Operator-to-Operator imprecision on whole blood: Demonstrate that the between-Operator reproducibility of the total IgE of the IVD CAPSULE Allergic Asthma panel on the abioSCOPE device test results is within the expected range of variability.
- Between-run reproducibility: Demonstrate that the between-run reproducibility of venous whole blood samples measured with the IVD CAPSULE Allergic Asthma panel on the abioSCOPE device (all 5 allergens/allergen mixes and total IgE) is within the expected range of variability.
Measured: Day 1
Sample type comparison:
Demonstrate that the IVD CAPSULE Allergic Asthma panel on the abioSCOPE device test results obtained from capillary whole blood correlates well with values obtained from K3-EDTA anticoagulated venous plasma and serum samples.
Measured: Day 1
Method comparison
Demonstrate that test results obtained with the total IgE test of the IVD CAPSULE Allergic Asthma panel on the abioSCOPE device correlates with total IgE test results from the reference method (Phadia Laboratory System, ThermoFisher Scientific).
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2020
- Study startNov 2020 (estimated)
- Primary completionNov 2020 (estimated)
- Study completionDec 2020 (estimated)
Why it stopped: Sponsor financial has been stopped
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AllergyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abionic SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- NAMSA, Johns Hopkins University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04401631
- Sponsor's protocol ID
- AB-ALL-3.1
- Status last verified
- Oct 2020
- First submitted
- 20 May 2020
- Last updated
- 5 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analytical Validation of the abioSCOPE Device With an IgE Test Panel: Point-of-Care Precision, Sample Type Comparison and Method Correlation
- ClinicalTrials.gov ID
- NCT04401631
- Acronym / sponsor ID
- AB-ALL-3.1
- Conditions
- Allergy, Allergic Asthma, Allergy to Cats, Allergy to House Dust, Allergy to Dog Dander (Finding), Allergy Mold
- Keywords
- Allergy, Asthma, Point-of-Care, Immunoassay, In vitro Diagnostic, Total IgE, Specific allergy
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Sponsor financial has been stopped
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Abionic SAIndustry (pharma, biotech, devices)
- Collaborators
- NAMSA, Johns Hopkins University
- Study start
- Nov 2020 (estimated)
- Primary completion
- Nov 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 26 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multicenter, prospective, observational study to evaluate the analytical performance of the Abionic IgE Multi-Allergen Test Panel on the abioSCOPE® device in a U.S. point-of-care environment within a clinical laboratory operating under a CLIA certificate for tests of moderate complexity. The study will assess point-of-care ('external') precision, sample type comparison and correlation with a reference method (Phadia Laboratory System, ThermoFisher Scientific).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Interventions | – | Device: Blood Collection* A minimum of 20 subjects with targeted levels of total IgE are needed to participate in the Operator-to-Operator whole blood study. * A minimum of 20 subjects with targeted levels of allergen-specific and total IgE are needed to participate in the capillary whole blood between-run imprecision study in the POL environment. * A minimum of 40 subjects with targeted levels of Fel d 1-specific IgE and total IgE are needed to participate in the sample type comparison study. These subjects will be recruited, and their samples analyzed at 1 POL. * A minimum of 300 subjects (approximately 100 subjects enrolled and evaluated at each of three sites) and with targeted levels of total IgE are needed to participate in the method comparison study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- * A minimum of 20 subjects with targeted levels of total IgE are needed to participate in the Operator-to-Operator whole blood study. * A minimum of 20 subjects with targeted levels of allergen-specific and total IgE are needed to participate in the capillary whole blood between-run imprecision study in the POL environment. * A minimum of 40 subjects with targeted levels of Fel d 1-specific IgE and total IgE are needed to participate in the sample type comparison study. These subjects will be recruited, and their samples analyzed at 1 POL. * A minimum of 300 subjects (approximately 100 subjects enrolled and evaluated at each of three sites) and with targeted levels of total IgE are needed to participate in the method comparison study.
Key inclusion criteria (2 listed)
- Provision and understanding of signed and dated written informed consent by the subject prior to any mandatory study-specific procedures, sample collection, or analysis.
- Male or female, 18 years of age or older.
Key exclusion criteria (4 listed)
- Subject participating in another study that may influence test results.
- Subject taking any of the following medications: systemic steroids (inhaled or nasal steroids are allowed), anti-cytokines or cytokines, systemic interferon (injection local interferon α for the treatment of HPV is allowed), anti-IgE therapy (approved or investigational) or treated with systemic chemotherapy.
- History of cancer, autoimmune, or immune deficiency disease.
- Suffering from a hematological pathology (coagulation disorder, severe anemia) that could interfere with the blood draw procedure.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood CollectionBetween-Run Reproducibility K3-EDTA venous whole blood 3 mL 1 venous draw Operator-to-operator imprecision (abioSCOPE) K3-EDTA capillary whole blood 0.05 mL/draw; 0.15 mL total 3 finger sticks (3 different fingers) Sample type comparison (abioSCOPE) K3-EDTA capillary whole blood, venous serum, venous K3-EDTA plasma 0.35 mL (finger stick), 9 mL of whole blood to get a minimum of 3 mL of serum and 9 mL of whole blood K3-EDTA to get a minimum of 3 mL of plasma 1 finger stick; 1 venous draw into serum tube (9 mL) and 1 venous draw into K3-EDTA plasma tube (9 mL), in total 18 mL Method comparison (abioSCOPE and ImmunoCAP/Phadia) K3-EDTA capillary whole blood, venous K3-EDTA plasma 0.05 mL (finger stick), 9 mL of whole blood to get a minimum of 3 ml of plasma 1 finger stick; 1 venous draw into K3-EDTA plasma tube (9 mL tube) | Device | Interventions |
Primary outcome
POC variance components (in a POL environment):
Time frame: Day 1
* External Precision Study ('reproducibility study' 'site-to-site precision study'): Demonstrate that the imprecision of K3-EDTA venous plasma using the IVD CAPSULE Allergic Asthma panel on the abioSCOPE device (all 5 allergens/allergen mixes and total IgE) in the hands of trained Healthcare Professionals in a Physician Office Laboratory (POL) is within the expected range of the imprecision established in the clinical laboratory by Laboratory Scientists. * Operator-to-Operator imprecision on whole blood: Demonstrate that the between-Operator reproducibility of the total IgE of the IVD CAPSULE Allergic Asthma panel on the abioSCOPE device test results is within the expected range of variability. * Between-run reproducibility: Demonstrate that the between-run reproducibility of venous whole blood samples measured with the IVD CAPSULE Allergic Asthma panel on the abioSCOPE device (all 5 allergens/allergen mixes and total IgE) is within the expected range of variability.
Sample type comparison:
Time frame: Day 1
Demonstrate that the IVD CAPSULE Allergic Asthma panel on the abioSCOPE device test results obtained from capillary whole blood correlates well with values obtained from K3-EDTA anticoagulated venous plasma and serum samples.
Method comparison
Time frame: Day 1
Demonstrate that test results obtained with the total IgE test of the IVD CAPSULE Allergic Asthma panel on the abioSCOPE device correlates with total IgE test results from the reference method (Phadia Laboratory System, ThermoFisher Scientific).
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Allergy and Allergic Asthma, run by Abionic SA at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 5 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
POC variance components (in a POL environment): (time frame: Day 1). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2020.