The measurement of NT-proBNP aids in the diagnosis of individuals suspected of having congestive heart failure (also referred to as heart failure).
The LumiraDx NT-proBNP test is a smart, automated, highly portable solution designed to improve access and ease of use in community-based healthcare settings, without the need for phlebotomy.
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 12 minutes from sample application.
A method comparison study was carried out in heparinised venous plasma using 3 Test Strip lots and 659 samples. Each sample tested on the LumiraDx Platform was compared to plasma tested on the Roche Cobas Elecsys® proBNP II assay. The data was analysed by Passing Bablok regression.
A precision study was carried out in heparinised venous plasma using 2 concentrations of NT-proBNP. Each concentration was tested in 1 run of 5 replicates per day, for 5 days across 3 sites using 3 Test Strip lots. The results of the precision study are summarised below:
|NT-proBNP Concentration (pg/mL & ng/L)||Within Day Precision (%CV)||Between Day Precision (%CV)||Between Site Precision (%CV)||Total Precision (%CV)||n|
*As stated at time of publication - 10th March 2023
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