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

• The product is available for professional use only.

Cardiovascular Markers Combined Rapid Test

The 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 in whole blood, serum or plasma. This test kit assists in the diagnosis of myocardial infarction (MI).

Myoglobin (MYO), creatine kinase MB (CK-MB) and cardiac-specific troponin I (cTnI) are proteins that are released into the bloodstream following cardiac injury. Myoglobin is a heme protein normally found in skeletal and cardiac muscle, with a molecular weight of 17.8 kDa. It accounts for approximately 2 percent of total muscle protein and is responsible for transporting oxygen within muscle cells. When muscle cells are damaged, myoglobin is rapidly released into the bloodstream due to its relatively small size.

Myoglobin levels rise measurably above baseline within 2-4 hours following an infarction, peak within 9-12 hours, and return to baseline within 24-36 hours. CK-MB is an enzyme also found in cardiac muscle, with a molecular weight of 87.0 kDa. Creatine kinase is a dimeric molecule consisting of two “M” and “B” subunits, which form three different isoenzymes: CK-MM, CK-BB and CK-MB. CK-MB is the creatine kinase isoenzyme that is most involved in the metabolism of cardiac muscle tissue.

CK-MB can be detected in the bloodstream 3-8 hours after the onset of symptoms following a myocardial infarction. It reaches its peak within 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 consisting of Troponin T and Troponin C. Together with tropomyosin, this structural complex forms the main component regulating the calcium-sensitive ATPase activity of actomyosin in striated skeletal and cardiac muscle.

Following cardiac injury, Troponin I is released into the bloodstream 4-6 hours after the onset of pain. The release pattern of Troponin I is similar to that of CK-MB, but while CK-MB levels normalize after 72 hours, Troponin I levels remain elevated for 6-10 days, providing a longer detection period for cardiac injury. The test kit is available for professional use only.

Cardiovascular markers rapid test specification

Product name: Cardiac Markers Combined Rapid Test Kit
Sample: whole blood/serum/plasma
Pack size: 1 pc/box
Format: Cassette test
Manufacturer: Assure Tech. (Hangzhou) Co., Ltd., 3RD FLOOR, BUILDING 4, NO. 1418 - ,MOGANSHAN ROAD, HANGZHOU, ZHEJIANG, 50 CHINA
EC REP: Lotus NL B.V. Koningin Julianaplein 10, le Verd, 2595AA,The Hague,Netherlands
Expiry date: 31/03/2028

Contents of the Cardiovascular markers rapid test kit

• 1 test cassette
• 1 disposable dropper
• 1 buffer solution
• 1 finger-prick lancet
• 1 alcohol wipe
• 1 instruction manual in English

How to use the finger-prick lancet

1. Remove the yellow single-use finger-prick lancet from the packaging. Remove the transparent cap.
2. Press it against your fingertip. The needle will automatically eject.
3. After use, dispose of the lancet in the trash.

Testing procedure

Read the Instructions for Use carefully before performing the test! Before testing, allow the test, sample and/or controls to reach room temperature (15-30°C).

1. Remove the test from the sealed pouch and use it as soon as possible. For best results, the test should be performed within one hour.

2.A Place the test device on a clean and level surface.

For serum or plasma samples:

Hold the dropper vertically and dispense 2 drops of serum or plasma (approximately 50 ml) into the sample well of the test device (S), then start the timer. Hold the test by the end where the product name is visible. To avoid contamination, do not touch the membrane of the test strip.

Avoid trapping air bubbles in the sample well (S), and do not allow solution to enter the result area.

2.B Place the test device on a clean and level surface.

For whole blood samples:

Dispense 3 drops of whole blood sample (approximately 75 μL) into the sample well of the device using the supplied disposable dropper, then add 1 drop of buffer and start the timer.

Avoid trapping air bubbles in the sample well (S), and do not allow solution to enter the result area.

2.C Place the test device on a clean and level surface.

For fingertip blood samples:

Allow 3 drops of whole blood collected from the fingertip to fall into the center of the sample well (S) of the test device, then add 1 drop of buffer and start the timer.

Avoid trapping air bubbles in the sample well (S), and do not allow solution to enter the result area.

3. Wait for the colored band(s) to appear. The result should be read after 10 minutes. Do not interpret the result after 20 minutes.

Performance of the Cardiovascular markers combined rapid test

For 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%)*
  *95% confidence interval

For 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%)*
  *95% confidence interval

For 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

The test may only be used by qualified professional personnel and healthcare professionals! Carbon Web Kft. assumes no responsibility for use for self-testing purposes.

ATTENTION!
Under Government Decree 45/2014. (II. 26.), for health protection or hygiene reasons, the product cannot be returned after delivery; therefore, the 14-day right of withdrawal does not apply to this product. Section 29 (1): The consumer may not exercise the right under Section 20 (the consumer's right of withdrawal) in the case of e) a product in sealed packaging which, for reasons of health protection or hygiene, cannot be returned after opening following delivery.

Carbon Web Kft. is not responsible for fulfilling the legal obligations related to the Buyer's procurement procedure, as this falls within the Buyer's responsibility; its liability is limited exclusively to information regarding proper use and to the goods delivered.