NT-proBNP Test

The LumiraDx NT-proBNP Test is the only direct fingerstick NT-proBNP test available today*.

An easy to use, fast microfluidic immunoassay designed to rapidly quantify NT-proBNP levels in whole blood and plasma, the LumiraDx NT-proBNP Test delivers reliable, quantitative results in only 12 minutes at the point of need.

Test benefits

The measurement of NT-proBNP aids in the diagnosis of individuals suspected of having congestive heart failure (also referred to as heart failure).

  • Sample types: Direct Fingerstick (or via Lithium Heparin transfer tube) venous (Lithium Heparin) or plasma (Lithium Heparin)
  • Sample size: 20 μL
  • Hematocrit determination for blood sample to ensure 15-55% range
  • Time to result: 12 minutes
  • Storage at room temperature

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.

Test Workflow

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.

NT-proBNP Workflow-EN

Test performance

Method comparison

A method comparison study was carried out in heparinised venous plasma on a protocol based on CLSI EP09c-ED3. The study was carried out using 3 Test Strip lots. 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. The analyses are summarised below:

NT-proBNP-Test-Performance-EN

Precision

A precision study was carried out in heparinised venous plasma on a protocol based on CLSI EP05-A3. The study was carried out at 2 concentrations of NT-proBNP, each 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:

*As stated at time of publication - 27th January 2023

Not all products are available in all countries and regions. Please check with your local LumiraDx sales representative or distributor for availability in specific markets. 

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