Ctni Cardiac Marker in-Vitro Diagnostic Test

• Type: IVD Reagent
• Test Parameter: Troponin I
• Result Time: 15 Mins
• Accuracy: 98.5%
• Shelf Life: 24 Months
• Format: Cassette
• Model NO.: TNI-DW02
• Method: Colloidal Gold
• Specimen: Whole Blood/Serum/Plasma
• Content: Rapid Test+Buffer+Pippette
• Transport Package: Cartons
• Specification: 25 tests/box, 40tests/box
• Trademark: Dewei
• Origin: China
• HS Code: 3822190090
• Production Capacity: 100, 000 Tests/Day

Product Description

Product Description

INTENDED USE

The Troponin I (cTnI) Rapid Test (Whole Blood/Serum/Plasma) is a rapid visual immunoassay for the qualitative presumptive detection of cardiac Troponin I in human whole blood, serum or plasma specimens. It is intended for use as an aid in the diagnosis of myocardial infarction (MI).

 

INTRODUCTION

Cardiac Troponin I (cTnI) is a protein found in cardiac muscle with a molecular weight of 22.5 kDa. After cardiac injury occurs, Troponin I is released into the blood 4 - 6 hours after the onset of pain. The release pattern of cTnI is similar to CK-MB, but while CK-MB levels return to normal after 72 hours, Troponin I remains elevated for 6 - 10 days, thus providing for a longer window of detection for cardiac injury. The high specificity of cTnI measurements for the identification of myocardial damage has been demonstrated in conditions such as the perioperative period, after marathon runs, and blunt chest trauma. cTnI release has also been documented in cardiac conditions other than acute myocardial infarction (AMI) such as unstable angina, congestive heart failure, and ischemic damage due to coronary artery bypass surgery.

 

MAIN CONTENTS

Test Cassette

Disposable Pipettes

Buffer

Instructions for use

 

STORAGE AND STABILITY

Store at 2 ~ 30 º C in the sealed pouch for 24 months.

Keep away from direct sunlight, moisture and heat.

Do not freeze.

TEST PROCEDURE
1. Remove the test from its sealed pouch, and place it on a clean, level surface. For best results, the assay should be performed within one hour.
2. Using the provided disposable pipette, transfer 3 drops of the specimen (approximately 75 µL) to each specimen well (S) of the device, then add one drop of buffer and start the timer.
3. Wait for the colored band(s) to appear. The result should be read at 15 minutes. Do not interpret the result after 20 minutes.

INTERPRETATION

POSITIVE: Two colored bands appear on the membrane. One band appears in the control region (C) and another band appears in the test region (T).

NEGATIVE: Only one colored band appears, in the control region (C). No apparent colored band appears in the test region (T).

INVALID: Control band fails to appear. Results from any test which has not produced a control band at the specified read time must be discarded. Please review the procedure and repeat with a new test. If the problem persists, discontinue using the kit immediately and contact your local distributor.

Detailed Photos

Product Line	Product Name	Cat#	Specimen Used	Test Format
Cardiac Marker	CK-MB	CKMB-DW02	Whole Blood/Serum/Plasma	Cassette
	Myoglobin	MYO-DW02	Whole Blood/Serum/Plasma	Cassette
	Troponin I (cTnI)	TNI-DW02	Whole Blood/Serum/Plasma	Cassette
	Cardiac Markers 3 in 1 Combo	CMC-DW32	Whole Blood/Serum/Plasma	Cassette
	C Reactive Protein (CRP)	CRP-DW02	Whole Blood/Serum/Plasma	Cassette
	High Sensitive C Reactive Protein (HS-CRP)	HCRP-DW02	Whole Blood/Serum/Plasma	Cassette
	h-FABP	FABP-DW02	Whole Blood/Serum/Plasma	Cassette
	NT-proBNP	BNP-DW02	Whole Blood/Serum/Plasma	Cassette

 

Company Profile

About Us
 

DEWEI Medical Equipment Co., Ltd is a leading and professional manufacturer of IVD products, it is a high-tech enterprise specialized in developing, manufacturing and marketing IVD products.
DEWEI products are widely used in hospital clinics, disease control centers, blood banks, veterinary clinics, scientific research centers, and college laboratories. Quality is the primary concern, DEWEI team is strict on quality control systems thus our products have CE, ISO, CFDA, and other international standards certificates.
The view of DEWEI is to be the most professional and respected enterprise in the IVD field, DEWEI will go on to provide the best service to you with outstanding R&D and cost-effective products.


 

R&D Team
 

15% of annual sales amount is devoted R&D department. With a professional R&D team, Dewei is continuously making new achievements in innovation, gaining numbers of national invention patents and professional technical awards. Meanwhile, Dewei focuses on the improvement of technology to guarantee product quality and pursue product performance.

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Production Workshop
 

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