International Sensitivity Index Calibration of the Near-Patient Testing Prothrombin Time Monitor, ProTime
Why the study?
Can the ProTime near-patient testing monitor be calibrated according to the WHO international sensitivity index (ISI) model?
Population
Blood samples for prothrombin time measurement
Comparison
ProTime monitor for near-patient prothrombin… vs International reference preparation for…
Design
Other
Authors
Discussion
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Member takes
Implication
Supports ProTime calibration per WHO model; leaves open clinical adoption for self-testing pending outcome studies.
Structured PICO
Can the ProTime near-patient testing monitor be calibrated according to the WHO international sensitivity index (ISI) model?
P
Population
Blood samples for prothrombin time measurement (device calibration study for patients receiving oral anticoagulants)
I
Intervention
ProTime monitor (International Technidyne) for near-patient prothrombin time testing
C
Comparator
International reference preparation for thromboplastin
O
Outcome
Conformity to the international sensitivity index (ISI) calibration model and agreement of INR valuessurrogate
The ProTime near-patient monitor for prothrombin time testing demonstrates acceptable ISI calibration and INR agreement with reference standards, supporting its potential for patient self-testing.
Limitations
- Requires confirmation in a large multicenter study
Cite This Study
Bressi et al. (2003) studied this question.