NT-proBNP Rapid Test (1 pc/box)

NT-proBNP Rapid Test Kit for Cardiovascular Disease Diagnosis

The NT-proBNP Rapid Test Kit (whole blood/serum/plasma) is a qualitative immunochromatographic assay designed for the detection of NT-proBNP levels in human whole blood, serum, or plasma samples. NT-proBNP (N-terminal pro-brain natriuretic peptide) is a biomarker released primarily from the left ventricular myocardium in response to cardiac stress and is widely used in the clinical assessment of heart-related conditions.

Clinical Significance

NT-proBNP is produced alongside B-type natriuretic peptide (BNP) from the cleavage of proBNP. Elevated NT-proBNP levels are associated with:

• Heart Failure: Increased ventricular wall stress results in elevated NT-proBNP levels, aiding diagnosis and monitoring of heart failure progression.

• Myocardial Infarction: Cardiac muscle injury triggers increased NT-proBNP secretion as part of the stress response.

• Myocarditis: Inflammatory damage to the myocardium can raise NT-proBNP concentrations.

• Valvular Heart Disease: Structural valve abnormalities can elevate cardiac stress markers, including NT-proBNP.

• Hypertension: Especially when affecting left ventricular function, hypertension can cause elevated NT-proBNP levels.

Measurement of NT-proBNP is crucial for diagnosing heart failure, assessing disease severity, and evaluating therapeutic efficacy. Interpretation should always be conducted by qualified medical professionals considering patient clinical context, as levels may be influenced by age, sex, renal function, and certain medications.

Specifications

Test Name: NT-proBNP Rapid Test Kit

Sample Type: Whole blood, serum, plasma

Packaging: 1 test/box

Format: Cassette

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd., 3RD FLOOR, BUILDING 4, NO. 1418 - MOGANSHAN ROAD, HANGZHOU, ZHEJIANG, 50 CHINA, imd.assuretech@diareagent.com

EC REP: Lotus NL B.V., Koningin Julianaplein 10, le Verd, 2595AA, The Hague, Netherlands, peter@lotusnl.com

Expiration Date: May 2026

Contents of the NT-proBNP Rapid Test Kit

• 1 test cassette

• 1 disposable pipette

• 1 buffer solution

• 1 lancet

• 1 alcohol swab
  

• 1 instruction manual in English

Instructions for Using the Lancet

1. Remove the yellow single-use lancet from its packaging.

2. Remove the transparent cap.

3. Press it firmly against the fingertip. The lancet will automatically release.

4. After use, dispose of the lancet in a sharps container or trash.

Test Procedure

Please read the user manual carefully before performing the test. Collect the sample according to the instructions. Before use, ensure that all devices, reagents, samples, and/or controls have reached room temperature (15°C-30°C).

1. Remove the test from the sealed pouch and place it on a clean, flat surface. Label the test with the patient’s name or control ID. For best results, perform the test within one hour after opening.

2.A Using the provided disposable pipette, add 3 drops of whole blood/serum/plasma into the sample well (S) of the device, then start the timer.

Avoid trapping air bubbles in the sample well (S), and do not allow any liquid into the result window.

2.B Alternatively, allow 3 hanging drops of fingertip whole blood to fall directly into the center of the sample well (S) of the device, then start the timer.

Avoid trapping air bubbles in the sample well (S), and do not allow any liquid into the result window.

3. If the sample does not begin to migrate across the membrane within 1 minute, add 1 drop of buffer into the sample well (S).

4. Wait for the colored line(s) to appear. Read the result at 10 minutes. Do not interpret the result after 20 minutes.

Performance

• Relative Sensitivity: 98% (95% CI: 91.7%-98.2%)

• Relative Specificity: 98.2% (95% CI: 97.4%-99.7%)

• Overall Agreement: 98.2% (95% CI: 96.5%-99.0%)

Legal Notices

Professional Use

This product is an in vitro diagnostic (IVD) and intended exclusively for professional use by medical personnel. Use for self-testing is not permitted. The manufacturer/distributor accepts no liability for damages resulting from improper or unauthorized use.

Right of Withdrawal

In accordance with § 312g (2) No. 3 of the German Civil Code (BGB), there is no right of withdrawal for sealed goods which, for reasons of health protection or hygiene, are not suitable for return if their seal has been removed after delivery.

Disclaimer

The seller assumes no responsibility for compliance with legal regulations within the buyer’s procurement process. The seller’s responsibility is limited solely to the delivery of the ordered goods and the provision of information regarding their proper use.