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Method comparison and bias estimation of point of care creatinine test

Method comparison and bias estimation of point of care creatinine tests against standard of care laboratory testing by enzymatic method

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN18805212
Enrollment
300
Registered
2017-08-21
Start date
2016-09-07
Completion date
Unknown
Last updated
2018-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Specialty: Renal disorders, Primary sub-specialty: Renal disorders

Interventions

Additional blood tests are performed utilising POCT devices on outpatients routinely referred to phlebotomy for blood (U&E) testing as part of their standard pathway. Patients will be identified as a

Sponsors

Mid Yorkshire Hospitals NHS Trust
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients who are already having a blood test for U&Es (other assays will be excluded from the results) 2. The inclusion of non-English speaking patients will be made on a case-by-case basis 3. Those participants who are able to provide consent but are unable to read or write will be offered the opportunity for a witness to sign the participant consent sheet on their behalf 4. Over 18 years of age

Exclusion criteria

Exclusion criteria: 1. Under 18 years of age 2. Pregnant patients 3. Those unable to provide consent

Design outcomes

Primary

MeasureTime frame
Renal function concordance measured as the difference between Estimated Glomerular Filtration Rate (eGFR) measurements calculated from serum creatinine measurements recorded by the standard pathology test and each point of care device (not POCT vs POCT); Timepoint(s): Day 1 only

Secondary

MeasureTime frame
1. Failure rates, recorded as the number of test analyses which do not produce a result from PoCT and laboratory tests at day 1 2. Appropriateness of the modified Choyke screening questionnaire to identify patients with reduced renal function, measured as the number of patients with no risk factors who have a reduced renal function identified (eGFR<40) at day 1

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026