Product Overview

Human whole blood (from venipuncture or fingerstick), serum, or plasma. It is designed for professional in vitro diagnostic use as an aid in the timely diagnosis of myocardial infarction (MI), providing clear, visual results in just 10 minutes.

Disease Background

Myocardial infarction (MI), or heart attack, occurs when blood flow to the heart is blocked, causing damage to the heart muscle. Creatine Kinase-MB (CK-MB) is an isoenzyme found primarily in heart muscle. When the heart is damaged, CK-MB is released into the bloodstream, making it a specific and crucial biomarker for confirming acute myocardial injury and diagnosing MI.

Ordering Information

Product Name	Catalog No.	Specimen	Format	Certification
CK-MB Rapid Test Device	CKMB-4012	Whole Blood/Serum/Plasma	Cassette	CE

Product Advantages

Rapid Results: Provides visual results in 10 minutes, enabling fast clinical decision-making in critical situations.

Multi-Sample Flexibility: Unique capability to test whole blood from a fingerstick or venipuncture, in addition to serum and plasma, offering unparalleled convenience at the point-of-care.

Simple and User-Friendly: The procedure involves minimal steps-just add the sample and one drop of buffer-requiring little training.

Room Temperature Storage: Stable at 4-30°C, eliminating the need for refrigeration and simplifying storage and logistics.

Operation Steps

Bring the test device, specimen, and buffer to room temperature (15-30°C).

Remove the test device from its sealed pouch and place it on a clean, level surface.

For Venous Whole Blood, Serum, or Plasma:Using the provided dropper, transfer 2 drops of the specimen into the specimen well (S).

For Fingerstick Whole Blood: Use a capillary tube (not provided) to collect and transfer 2 drops of blood to the specimen well (S).

Immediately add 1 drop of buffer to the specimen well (S) and start the timer.

Read the result at 10 minutes. Do not interpret results after 20 minutes.

Result Interpretation

POSITIVE

Two distinct colored lines appear. One line in the control region (C) and another line in the test region (T). Any shade of color in the (T) line is positive.

NEGATIVE

Only one colored line appears in the control region (C). No line appears in the test region (T).

INVALID

If the control band (C) does not appear. The test is invalid and must be repeated with a new device.

FAQ

Q: How accurate is this test?

A: Our clinical evaluation shows the test has 100% sensitivity and 99.8% specificity compared to a standard laboratory EIA method, with an overall accuracy of 99.8%.

Q: What does a positive result mean?

A: POSITIVE: Two distinct colored lines appear, One colored line should be in the control region (C) and another colored line should be in the test region (T).

NEGATIVE: One colored line appears in the control region (C).

No apparent colored line appears in the test region (T).

INVALID: Control line fails to appear, Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure , Review the procedure and repeat the test with a new test device, If the problem persists,discontinue using the test kit immediately and contact your local distributor.

Q: The test is negative, but I still suspect a heart issue. What now?

A: A negative result means that the level of CK-MB in the sample is below the test's detection limit (5 ng/mL). However, a negative result does not at any time rule out myocardial infarction.If clinical symptoms persist, further testing and clinical evaluation are imperative.

Q: Can this test give a numerical value for the CK-MB level?

A: No.This is a qualitative test, meaning it indicates the presence or absence of the biomarker above a certain threshold. It does not measure the precise concentration.

Q: Can I use a blood sample from a fingerstick?

A: Yes.A key advantage of this test is its compatibility with fingerstick whole blood, making it ideal for near-patient testing settings.

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