The measurement of CRP provides information for the detection and evaluation of infection, tissue injury, inflammation disorders, and associated disease.
The Instrument and Test Strips are integrated with several quality control checks to ensure the Instrument and Test are functioning correctly for every test run.
The workflow process is comprised of a simple sample collection with a fingerstick lancet followed by step-by-step guidance of the Instrument to report a patient result in 4 minutes from sample application.
The method comparison was performed using 2 Test Strip lots with plasma samples (Lithium Heparin) sourced from patients presenting with symptoms of respiratory illness, inflammation, or injury, at hospital Emergency Departments (ED), acute medical units or out-patient clinics. A comparison of 205 CRP measurements with the LumiraDx CRP Test to the RCRP Flex® assay on the Siemens Dimension® Xpand® Plus Integrated Chemistry System analysed by Passing Bablok regression yielded the following statistics: Slope = 1.00, Intercept = -0.48, r = 0.99.
A precision study was carried out in heparinised venous plasma on a protocol based on CLSI EP5-A34. The study was carried out at 3 concentrations of CRP, each was tested in 1 run of 5 replicates per day, for five days across 3 sites. The results of the precision study are summarised below:
|CRP Concentration (mg/L)||Within Day Precision (%CV)||Between Day Precision (%CV)||Between Site Precision (%CV)||Total Precision (%CV)||n|
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