Evaluation of the CoaguChek XS PT Masterlot 15
Research type
Research Study
Full title
Post Launch Study Evaluation of the CoaguChek XS PT Masterlot 15 CIM RD006261
IRAS ID
312245
Contact name
Joanne Howard
Contact email
Sponsor organisation
Roche Diagnostics GmbH
Duration of Study in the UK
0 years, 3 months, days
Research summary
Summary of Research
CoaguChek XS is a handheld device with teststrips manufactured by Roche. Physicians/Patients use it for monitoring of prothrombine time (clotting time) in bleeding disorders.
Before releasing any batch of test strips, the quality and performance of this new batch must be assessed by using real blood samples.
In this study, we evaluate a new batch of test strips (Masterlot).
In order to demonstrate the quality of the Masterlot, we compare the results from the study to other laboratory reference methods.There is no direct benefit for the participants. The study does not replace the routine care. The study results won’t be used for medical decisions (non interventional study). Nevertheless, the study is important because it helps maintaining high quality diagnostic methods available to the physicians/patients in the future. This study is conducted at two hospitals & will last 3 months.
Study design:
Familiarization (before any participants are enrolled): simulation where the study team familiarises with the use of the device/test strips by measuring Quality Control material as if it was a sample: this is NOT blood material, it is a solution manufactured by Roche
Main trial:
- patient cohort:
The clinical team involved in the patient’s care will identify potential participants who meet the eligibility criteria and ask them if they would be interested in finding out more about the study by discussing it with a member of the local research study team. If they agree they will be offered to take part on the study during their routine appointments.
- healthy cohort: they will be volunteers from the hospital staff.Participants will dedicate 60 min to the study (no follow up visits) They can decline participation at any time.
Within this time, the participant undergoes:
-The research nurse will go through the “patient information sheet” that details all the procedures involved, participant’s rights, and consequences of taking part on the study. They will answer any questions the participant might have.
-The research nurse will obtain written informed consent from the participant to take part in the study procedures.
-The research nurse will collect 9mL of blood from the participant (¾ teaspoon).
-The research nurse will test a portion of the blood sample on the devices and annotate the results in an anonymized fashion.The below procedures happen once the participant has left:
-Another portion of the blood sample will be sent to the onsite laboratory for testing
-The remaining of sample will be passed on to Roche Diagnostics in Germany for testing
-Leftover blood will be stored and destroyed at the end of the study
No personal data will be stored by Roche, and this will only be kept by the clinical team in line with current regulations (GDPR)Summary of Results
The execution of the post launch study “Evaluation of the CoaguChek XS PT Masterlot 15 CIM RD006261” was performed as planned from June to November 2022 in in- and outpatient clinics in Spain (Hospital Sant Pau in Barcelona) and in the United Kingdom (NHS teaching hospital in Blackpool). Ethics and authority approvals were received prior to the study start and only subjects agreeing to the study’s informed consent were included. INR, HKT and PT values were determined for all eligible specimen.314 subjects (163 in Spain and 151 in UK) were screened and citrated venous blood samples and CoaguChek XS and ACL top data sets from 290 subjects were collected following an agreed BIN distribution (characterization according to MLot14 measurement results).
Exclusion of 24 subjects were done due to violation against inclusion criteria (1xsuffer from Lupus disease) and unable to bleed (5x) as well as technical problems (problematic citrate concentration (12x), less sample volume (4x) out of measuring range (1x) and hemolytic sample (1x) resulting in a final amount of 290 samples and corresponding data sets.
The collected citrated venous blood samples were provided to the System Testing Coagulation Monitoring department at Roche Diagnostics GmbH in Mannheim, Germany for the laboratory reference measurements and data sets after validation by the PoC Biostatistics & Mathematics department at Roche Diagnostics GmbH in Mannheim were used for the calculation of the Masterlot 15 code function.
The collected blood samples and data sets in this study fully met the requirements stated in the study protocol. In addition, the estimated recruitment targets in terms of amounts and BIN distributions have been complied. The resulting data set therefore secured a successful Masterlot 15 code calculation.
REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
22/YH/0086
Date of REC Opinion
14 Apr 2022
REC opinion
Further Information Favourable Opinion