Evaluation of Precision and Accuracy of INR Measurements in a Point of Care Device (OPTIMAL)

June 9, 2026 updated by: LumiraDx UK Limited

Evaluation of the Precision and Accuracy of International Normalised Ratio (INR) Measurements as Assessed by the LumiraDx Instrument in a Professional Point of Care Setting With Multiple Operators

Comparison of capillary whole blood INR determined by LumiraDx Instrument to venous plasma INR determined by laboratory reference method (IL ACL ELITE PRO) for method comparison and assessment of accuracy and bias by regression analysis and other analytical methods.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A performance evaluation study designed to assess the precision and accuracy of the LumiraDx Instrument, a point of care in vitro diagnostic system employing a portable diagnostic meter in conjunction with single use analyte test strips, for the quantitative determination of Prothrombin Time expressed as International Normalised Ratio (INR), as sampled from individuals evaluated for INR at the point of care (POC).

The accuracy of the LumiraDx Instrument INR results will be assessed by, in the first instance, comparison to the INR results obtained from the same individuals as analysed by trained laboratory professionals using the paired venous plasma samples in the reference device IL ACL ELITE PRO Coagulation Analyzer. The accuracy of INR measurements of capillary whole blood across the range of haematocrit (25% - 55%) will be assessed using paired haematocrit results obtained from the HemoCue Hb 201+ on venous whole blood. The results of these evaluations are intended to be used for regulatory filings for the LumiraDx Instrument and LumiraDx INR test as an in vitro diagnostic test in the European Union (EU) and other relevant geographies. For information only, the accuracy of the LumiraDx Instrument INR Test will also be assessed by comparison to INR results from an alternative point of care instrument, the Roche Coaguchek PRO II.

Adult males and females currently in receipt of vitamin K antagonist therapy will be included on the study. Approximately 500 subjects will be recruited to ensure that sufficient suitable subjects are enrolled and to allow for a small level of exclusions. The power calculation as well as recommendations of the FDA CLIA Waiver Guidance document (1) requires a minimum of 360 valid subjects in total (inclusive of non-therapy subset). A subsection of the subject population (~50 subjects) will consist of adult males and females who fulfil all other study inclusion criteria but are not in receipt of vitamin K antagonist therapy. This will be done in order to test the lower measurement limit of the LumiraDx Instrument INR test. At the end of the study the Healthcare Professional will be asked to complete a User Acceptability Questionnaire which is intended to assess the acceptability of the LumiraDx INR system in terms of ease of use.

Study Type

Observational

Enrollment (Actual)

420

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Glasgow, United Kingdom, G81 4DY
        • Golden Jubilee National Hospital
      • Glasgow, United Kingdom, G4 0SF
        • Glasgow Royal Infirmary Clinical Research Facility
      • Wishaw, United Kingdom, ML2 0DP
        • Wishaw General Hospital, NHS Lanarkshire

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Capillary and venous whole blood samples were collected and analyzed from adult males and females who are receiving current vitamin K antagonist therapy and fulfil all other study inclusion and exclusion criteria. A subsection of the subject population (~50 subjects) consisted of adult males and females who fulfil all other study inclusion criteria but are not in receipt of vitamin K antagonist therapy. This was done in order to test the lower measurement range of the LumiraDx Instrument.

Description

Inclusion Criteria - VKA Therapy Subjects:

  • Persons >18 years of age
  • Willing and able to provide written informed consent and comply with study procedures
  • Currently prescribed vitamin K antagonist therapy
  • Deemed medically appropriate for study participation by the Investigator

Exclusion Criteria - VKA Therapy Subjects:

  • Persons <18 years of age
  • Subject has previously participated in this study
  • Subject is within 4 weeks of first prescription of vitamin K antagonist therapy
  • Confirmed or suspected pregnancy
  • Unwilling or unable to provide written informed consent and comply with study procedures
  • Vulnerable populations deemed inappropriate for study by the Investigator
  • Deemed medically inappropriate for study by the Investigator (i.e. patients with a known inherited [e.g. haemophilia or von Willebrand's disease] or acquired [e.g. liver cirrhosis] condition likely to be associated with a coagulopathy; or patients receiving non-VKA anticoagulant medications)

Inclusion Criteria - Non-VKA Therapy Subjects:

  • Persons >18 years of age
  • Willing and able to provide written informed consent and comply with study procedures
  • Deemed medically appropriate for study participation by the Investigator

Exclusion Criteria - Non-VKA Therapy Subjects:

  • Persons <18 years of age
  • Subject has previously participated in this study
  • Confirmed or suspected pregnancy
  • Unwilling or unable to provide written informed consent and comply with study procedures
  • Vulnerable populations deemed inappropriate for study by the Investigator
  • Any persons deemed medically inappropriate for study by the Investigator

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
VKA Patients
Single Arm - blood collection by venepuncture and fingerstick in patients undergoing Warfarin Therapy
Procedure: VKA Patients
Venepuncture and capillary blood collection from Patients receiving Warfarin Therapy
Other Names:
  • Fingerstick to collect blood samples from Patients
  • Venepuncture to collect blood samples from Patients
Procedure: Non-VKA Patients
Venepuncture and capillary blood collection from Patients not receiving Warfarin Therapy
Other Names:
  • Fingerstick to collect blood samples from Patients
  • Venepuncture to collect blood samples from Patients
non-Vka Patients
Single Arm - blood collection by venepuncture and fingerstick in patients not undergoing Warfarin Therapy
Procedure: VKA Patients
Venepuncture and capillary blood collection from Patients receiving Warfarin Therapy
Other Names:
  • Fingerstick to collect blood samples from Patients
  • Venepuncture to collect blood samples from Patients
Procedure: Non-VKA Patients
Venepuncture and capillary blood collection from Patients not receiving Warfarin Therapy
Other Names:
  • Fingerstick to collect blood samples from Patients
  • Venepuncture to collect blood samples from Patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To determine the clinical performance of the LumiraDx instrument
Time Frame: 8 weeks
Measurement of INR using Capillary & Venous blood samples
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To determine the accuracy of the LumiraDx instrument
Time Frame: 8 weeks
Measurement of INR & Haematocrit using Capillary & Venous blood samples
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

LumiraDx UK Limited

Investigators

  • Principal Investigator: Robert C Tait, BSc (Hons), Consultant Haematologist

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 17, 2018

Primary Completion (Actual)

November 23, 2018

Study Completion (Actual)

November 23, 2018

Study Registration Dates

First Submitted

September 19, 2018

First Submitted That Met QC Criteria

September 21, 2018

First Posted (Actual)

September 24, 2018

Study Record Updates

Last Update Posted (Actual)

June 11, 2026

Last Update Submitted That Met QC Criteria

June 9, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D-CLIN-PROT-00001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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