NT-proBNP Test
an easy to use, fast microfluidic immunoassay designed to rapidly quantify NT-proBNP levels in whole blood and plasma. The only quantitative direct fingerstick NT-proBNP test available today*. Delivering reliable results in only 12 minutes at the point of care without the need for phlebotomy.
*As stated at time of publication - 04/03/2024
Quantitative NT-proBNP test
The LumiraDx NT-proBNP test is an in vitro diagnostic test for the quantitative determination of N-terminal pro-Brain Natriuretic Peptide (NTproBNP) in human capillary and venous whole blood and plasma samples.
Near-patient testing
As an automated in vitro diagnostic test, it is made for near-patient testing with the LumiraDx Instrument.
Purpose
The test can be used as an aid in the diagnosis of individuals suspected of having congestive heart failure (also referred to as heart failure).
Benefits
The only* direct fingerstick NT-proBNP test available at the point of care
Rapidly quantify NT-proBNP levels in only 12 minutes without needing a phlebotomist. Used to aid in the diagnosis of congestive heart failure wherever symptomatic patients present:
- Sample types: direct fingerstick (or via lithium heparin transfer tube), venous (lithium heparin), or plasma (lithium heparin)
- Sample size: 20 μL
- Hematocrit determination for whole blood sample to ensure 15 - 55% range
- Reportable range 50 - 9,000 pg/mL (ng/L)
- Time to result: 12 minutes
- Storage at room temperature (2°C to 30°C)
*As stated at time of publication - 04/03/2024
Workflow
The workflow process is comprised of a fingerstick sample collection, followed by step-by-step guidance of the Instrument to report a patient result in 12 minutes from sample application.
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.
HOW TO USE VIDEOTest performance
Method comparison
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 giving a slope of 0.86, an intercept of -4.12 and an r value of 0.97.
Test precision
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 gave a total precision of 9.4% CV and 12.0% CV across the two concentrations. Click above for more details.
Product Documentation
NT-proBNP Test:
NT-proBNP Test