Product Overview

The Cardiac Troponin I Rapid Test Device is a rapid, qualitative immunoassay for the presumptive detection of cardiac Troponin I (cTnI) in human whole blood, serum, or plasma. It is designed as a professional in vitro diagnostic tool to aid in the diagnosis of myocardial infarction (MI), providing visual results within 10 minutes.

Disease Background

Myocardial infarction (MI), commonly known as a heart attack, is a life-threatening medical emergency caused by a blockage of blood flow to the heart muscle. Cardiac Troponin I is a highly specific and sensitive biomarker released into the bloodstream following heart muscle damage. Rapid detection of cTnI is critical for the timely diagnosis and management of MI.

Ordering Information

Product Name	Catalog No.	Specimen	Format	Certification
Cardiac Troponin I Rapid Test Device	CTNI-4012	Whole Blood/Serum/Plasma	Cassette	CE

Product Advantages

Rapid Results: Provides visual results in just 10 minutes, enabling quick clinical decision-making.

High Accuracy: Demonstrates a 99.3% accuracy rate compared to standard EIA tests.

Versatile Sample Compatibility: Works with three sample types: whole blood, serum, and plasma, offering flexibility in various clinical settings.

Ease of Use: Simple procedure requires minimal training; involves adding a sample and one drop of buffer.

Room Temperature Storage:The kit is stable at 4-30°C, eliminating the need for refrigeration and simplifying storage.

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.

Using the provided dropper, transfer 2 drops of the specimen into the specimen well (S).

Immediately add 1 drop of buffer into the same 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 bands appear. One band in the control region (C) and another band in the test region (T). Any shade of color in the (T) line is positive.

NEGATIVE

Only one colored band appears in the control region (C). No apparent band 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: What does a positive result mean?

A: A positive result indicates the presence of cardiac Troponin I in the specimen, suggesting heart muscle damage. It is an aid in diagnosis and should be evaluated by a physician alongside clinical symptoms and other findings.

Q: What does a negative result mean?

A: A negative result means that the level of cTnI in the sample is below the detection limit of the test. However, if clinical symptoms of MI persist, further testing using other clinical methods is strongly recommended, as a negative result does not completely rule out myocardial infarction.

Q: Can the test tell me the concentration of Troponin?

A: No.This is a qualitative test, meaning it indicates the presence or absence of the biomarker, not its exact concentration. The intensity of the test line should not be used to infer concentration.

Q: How should I store the test kits?

A: Store the unopened kits at 4-30°C in a dry place. Do not freeze. The test must remain in its sealed pouch until immediately before use.

Q: What are common reasons for an invalid test?

A: An invalid test (no control line) is typically caused by insufficient specimen volume, incorrect procedural technique, or using an expired test device.

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