Heart and Cardiovascular Markers Combined Rapid Test Kit (1 pc/box)

Heart and Cardiovascular Markers Combined Rapid Test

The Heart and Cardiovascular Markers Combined Rapid Test Kit (whole blood/serum/plasma) is intended for the qualitative presumptive detection of human myoglobin, CK-MB, and cardiac-specific Troponin I from whole blood, serum, or plasma. This test kit aids in the diagnosis of myocardial infarction (MI).

Myoglobin (MYO), creatine kinase MB (CK-MB), and cardiac-specific troponin I (cTnI) are proteins released into the bloodstream following cardiac injury. Myoglobin is a heme protein primarily found in skeletal and cardiac muscles with a molecular weight of 17.8 kDa. It constitutes about 2% of total muscle protein and is responsible for oxygen transport within muscle cells. Due to its small size, myoglobin is rapidly released into the blood upon muscle cell damage.

Myoglobin levels rise above baseline within 2-4 hours after infarction, peak within 9-12 hours, and return to baseline within 24-36 hours. CK-MB is an enzyme also present in cardiac muscle, with a molecular weight of 87.0 kDa. Creatine kinase is a dimeric enzyme composed of M and B subunits, forming three isoenzymes: CK-MM, CK-BB, and CK-MB. CK-MB is the isoenzyme predominantly involved in cardiac muscle metabolism.

CK-MB appears in blood within 3-8 hours after the onset of symptoms of myocardial infarction, peaks at 9-30 hours, and returns to baseline within 48-72 hours. Cardiac-specific troponin I is a protein found in cardiac muscle with a molecular weight of 22.5 kDa. Troponin I is part of a three-subunit complex with Troponin T and Troponin C, which together with tropomyosin regulate calcium-sensitive ATPase activity in striated skeletal and cardiac muscles.

Following cardiac injury, Troponin I is released into the bloodstream 4-6 hours after symptom onset. Its release pattern resembles CK-MB, but while CK-MB normalizes within 72 hours, Troponin I remains elevated for 6-10 days, allowing for a longer detection window for cardiac injuries. This test kit is intended for professional use only.

Specifications of the Heart and Cardiovascular Markers Rapid Test

Product name: Cardiac Markers Combined 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

Expiry date: 2026.02.

Kit Contents

• 1 test cassette

• 1 disposable pipette

• 1 buffer solution

• 1 lancet for fingertip sampling

• 1 alcohol swab

• 1 instruction leaflet 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).

After sample collection:

1. Remove the test from the sealed pouch and place it on a clean, flat surface. Label the test with the patient or control identifier. For best results, conduct the test within one hour of opening the pouch.

2.A For serum or plasma samples:
Hold the pipette vertically and dispense 2 drops of serum or plasma (approx. 50μL) into the sample well (S) on the test cassette, then start the timer. Avoid air bubbles in the sample well (S) and prevent buffer from entering the result window.

2.B For whole blood samples:
Hold the pipette vertically and dispense 3 drops of blood (approx. 75μL) into the sample well (S), then add 1 drop of buffer solution (approx. 40μL) and start the timer. Avoid air bubbles entering the sample well (S), and do not apply any solution onto the result area. During the process, color will migrate along the membrane.

3. Wait for the colored lines to appear. Read the result after 10 minutes. Results after 20 minutes are invalid.

Performance Characteristics

Myoglobin:

• Relative Sensitivity: >100.0% (94.0%-100.0%)*

• Relative Specificity: >97.7% (95.6%-98.9%)*

• Overall Agreement: >98.0% (99.7%-99.9%)*

CK-MB:

• Relative Sensitivity: >100.0% (93.4%-100.0%)*

• Relative Specificity: >99.8% (98.7%-99.9%)*

• Overall Agreement: >99.8% (98.8%-99.9%)*

Troponin I:

• Relative Sensitivity: >98.7% (96.2%-99.7%)*

• Relative Specificity: >98.4% (97.0%-99.3%)*

• Overall Agreement: >98.5% (97.4%-99.3%)*

* 95% Confidence Interval

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.

Instructions