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Highly Accurate Flourescence Immunoassay Test Kits for Cardiac Troponin I

Brand Name:	ALLTEST Novatrend Plus
Model Number:	FI-CTI-402
MOQ:	N/A
Price:	negotiation

Detail Information

Product Description

Detail Information

Detection Method:

Flourescence Immunoassay

Sample:

Whole Blood/Serum/Plasma

Test Range:

0.1-40 Ng/mL

Accuracy:

High

Time To Results:

15 Minutes

Storage Temperature:

4-30℃

Shelf Time:

24 Months

Test Method:

Flourescence Immunoassay

Certifications:

Usage:

For Professional Use Only

Highlight:

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Product Description

The Cardiac Troponin I Test Cassette (Whole Blood/Serum/Plasma) is intended for in vitro

quantitative determination of human cardiac Troponin I in whole blood, serum or plasma as an

aid in the diagnosis of Myocardial Infarction (MI).

【SUMMARY】

Cardiac Troponin I (cTnI) is a protein found in cardiac muscle with a molecular weight of 22.5

kDa[1].Troponin I is part of a three subunit complex comprising of Troponin T and Troponin C.

Along with tropomyosin, this structural complex forms the main component that regulates the

calcium sensitive ATPase activity of actomyosin in striated skeletal and cardiac muscle[2].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[3].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[4].Because of its high specificity and sensitivity

in the myocardial tissue, Troponin I has recently become the most preferred biomarker for

myocardial infarction[5] .

The Cardiac Troponin I Test Cassette (Whole Blood/Serum/Plasma) is a simple test that

utilizes a combination of anti-cTnI antibody coated particles and capture reagent to detect cTnI

in whole blood, serum or plasma.

【PRINCIPLE】

The Cardiac Troponin I Test Cassette (Whole Blood/Serum/Plasma) detects cardiac Troponin I

(cTnI) based on Fluorescence Immunoassay. The sample moves through the strip from

sample pad to absorbent pad. If the specimen contains cTnI, it attaches to the fluorescent

microspheres-conjugated anti-cTnI antibodies. Then the complex will be captured by the

capture antibodies coated on the nitrocellulose membrane (Test line).The concentration of cTnI

in the sample correlates with the fluorescence signal intensity captured on the T line. According

to the fluorescence intensity of the test and product standard curve, the concentration of cTnI in

the sample can be calculated by Analyzer to show cTnI concentration in specimen.

【REAGENTS】

The test kit includes anti-cTnI antibody coated fluorophores and anti-cTnI antibody coated on

the membrane.

【PRECAUTIONS】

1. For professional in vitro diagnostic use only.

2. Do not use after the expiration date indicated on the package. Do not use the test if the foil

pouch is damaged. Do not reuse.

3. Avoid cross-contamination of specimens by using a new specimen collection container for

each specimen obtained.

4. Do not eat, drink or smoke in the area where the specimens and tests are handled. Handle

all specimens as if they contain infectious agents. Observe established precautions against

microbiological hazards throughout the procedure and follow standard procedures for proper

disposal of specimens. Wear protective clothing such as laboratory coats, disposable gloves

and eye protection when specimens are assayed.

5. Do not interchange or mix reagents from different lots.

6. Humidity and temperature can adversely affect results.

7. Used testing materials should be discarded in accordance with local regulations.

8. Read the entire procedure carefully prior to any testing.

9. The cTnI Test Cassette should only be used with the Analyzer by

approved medical professionals.

【STORAGE AND STABILITY】

1. The test should be stored at 4-30 °C until the expiry date printed on the sealed pouch.

2. The test must remain in the sealed pouch until use.

3. Do not freeze.

4. Care should be taken to protect the components of the kit from contamination.

5. Do not use if there is evidence of microbial contamination or precipitation. Biological

contamination of dispensing equipment, containers or reagents can lead to false results.

【SPECIMEN COLLECTION AND PREPARATION】

Preparation

1. Before performing the test, please make sure that all components are brought to room

temperature(15-30 ℃). Cold buffer solution or moisture condensation on the membrane can

lead to invalid test results.

2. Take a tube with buffer solution out of the kit. Document patients name or ID on it.

Sample Handling

1. Collect the specimen according to standard procedures.

2. Do not leave specimens at room temperature for prolonged periods. Serum and plasma

specimens may be stored at 2-8 °C for up to 1 day, for long term storage, specimens should

be kept below -20 °C. Whole blood collected by venipuncture should be stored at 2-8 °C if

the test is to be used within 1 day of collection. Do not freeze whole blood specimens. Whole

blood collected by finger stick should be tested immediately.

3. Bring specimens to room temperature prior to testing. Frozen specimens must be

completely thawed and mixed well prior to testing. Avoid repeated freezing and thawing of

specimens.

4. EDTA K2, Heparin sodium, Citrate sodium and Oxalate potassium can be used as the

anticoagulant tube for collecting the blood specimen.

Sample Dilution

1. The specimen (75 uL of serum/plasma/ whole blood) can be added directly with the micro

pipette into the buffer.

2. Close the tube and shake the sample by hand for approximately 10 seconds so sample and

dilution buffer mix well.

3. Let the diluted sample homogenize for approximately 1 minute.

4. It is best to place the diluted sample on an ice pack and leave the sample at room

temperature for no more than 2 hours.

【MATERIALS】

Materials Provided

• Test Cassettes

• Specimen Collection Tubes with Buffer

• ID Card

• Package Insert

Materials Required But Not Provided

• Timer • Centrifuge • Fluorescence Immunoassay Analyzer

• Pipette

【DIRECTIONS FOR USE】

Refer to Fluorescence Immunoassay Analyzer Operation Manual for the complete

instructions on use of the Test. The test should be conducted at room temperature.

Allow the test, specimen, buffer and/or controls to reach room temperature (15-30 °C)

prior to testing.

1. Turn on the Analyzer power. Then according to the need, select “standard test” or “Quick

test” mode.

2. Take out the ID card and insert it into the Analyzer port.

3. Serum/plasma: Transfer 75 μL serum/plasma into the buffer tube, mix the specimen and

the buffer well.

Whole blood: Transfer 75 μL whole blood into the buffer tube with pipette; mix the

specimen and the buffer well.

4. Add diluted specimen with a Pipette: Pipette 85 μL diluted specimen into the sample

well. Start the timer at the same time.

5. There are two test modes for Fluorescence Immunoassay Analyzer, Standard

Test mode and Quick Test mode. Please refer to the user manual of

Fluorescence Immunoassay Analyzer for details.

“Quick test” mode: Insert the test cassette into the Analyzer at 15 minutes after sample

application and click "New test ", the Analyzer will automatically give the test result after a

few seconds.

“Standard test” mode: Insert the test cassette into the Analyzer immediately after sample

application, click "New test" at the same time, the Analyzer will automatically count down

15 minutes. After the countdown, the Analyzer will give the result at once.

【INTERPRETATION OF RESULTS】

Results read by Fluorescence Immunoassay Analyzer.

The result of tests for cTnI is calculated by Fluorescence Immunoassay Analyzer

and display the result on the screen. For additional information, please refer to the user manual

of Fluorescence Immunoassay Analyzer.

Linearity range of cTnI Test is 0.1-40 ng/mL.

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products details

Highly Accurate Flourescence Immunoassay Test Kits for Cardiac Troponin I

Highly Accurate Flourescence Immunoassay Test Kits for Cardiac Troponin I

mab antibodies

hybridoma Monoclonal antibodies