Accurate Flourescence Immunoassay Test cassette for Cardiovascular Diseases Screening cardiac troponin i

The Troponin I/D-Dimer/NT-proBNP (3 in 1) Test Cassette (Whole Blood/Serum/Plasma) is intended for in vitro quantitative determination of human cardiac Troponin I, D-Dimer and NT-proBNP in whole blood, serum or plasma as an aid in the diagnosis of Myocardial Infarction (MI), heart failure, DVT and PE.

【SUMMARY】

D-dimer (or D dimer) is a fibrin degradation product (or FDP), a small protein fragment present in the blood after a blood clot is degraded by fibrinolysis. Its formation or increase reflects the activation of coagulation and fibrinolysis system, and its plasma level can represent the production of thrombin active agent fibrin in vivo. It can be used as an indicator of thrombosis in the body. The D-dimer content in patients with thrombosis is significantly elevated^[1].

In addition, studies have shown that low levels of D-Dimer (100-500 ng/ml) are closely related to the occurrence of cardiovascular diseases, and high levels of D-Dimer may be early exclusion diagnostic indicators for DVT and PE^[2].

The N-terminal of the prohormone brain natriuretic peptide (NT-proBNP) is a 76 amino acid N-terminal inactive protein that is cleaved from proBNP to release brain natriuretic peptide.Both BNP and NT-proBNP levels in the blood are used for screening, diagnosis of acute congestive heart failure (CHF) and may be useful to establish prognosis in heart failure, as both markers are typically higher in patients with worse outcome. ^[3]The plasma concentrations of both BNP and NT-proBNP are also typically increased in patients with asymptomatic or symptomatic left ventricular dysfunction and is associated with coronary artery disease and myocardial ischemia.^[4][5]

Cardiac Troponin I is a protein found in cardiac muscle, with a molecular weight of 22.5 kDa.^[6] Troponin I is part of a three subunit complex comprised 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.^[7] After cardiac injury occurs, Troponin I is released into the blood 4-6 hours after the onset of pain. The release pattern of Troponin I 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 Troponin I/D-Dimer/NT-proBNP (3 in 1) Test Cassette (Whole Blood/Serum/Plasma) is a simple test that utilizes a combination of antibody coated particles and capture reagent to detect cardiac Troponin I, D-Dimer and NT-proBNP in whole blood, serum or plasma.

【PRINCIPLE】

The Troponin I/D-Dimer/NT-proBNP (3 in 1) Test Cassette (Whole Blood/Serum/Plasma) detects cardiac Troponin I, D-Dimer and NT-proBNP based on Fluorescence Immunoassay. The sample moves through the strip from sample pad to absorbent pad. If the specimen contains cTnI, D-Dimer or NT-proBNP, it attaches to the fluorescent microspheres-conjugated specific antibodies. Then the complex will be captured by the capture antibodies coated on the nitrocellulose membrane (Test line). The concentration of cTnI, D-Dimer and NT-proBNP in the sample correlates with the fluorescence signal intensity captured on the Test line. According to the fluorescence intensity of the test and product standard curve, the concentration of cTnI, D-Dimer and NT-proBNP in the sample can be calculated by Analyzer to show cTnI, D-Dimer and NT-proBNP concentration in specimen.

【REAGENTS】

The test kit includes cTnI antibody coated fluorophores, D-Dimer antibody coated fluorophores, NT-proBNP antibody conjugated fluorophores and capture reagents coated on the membrane.

【PRECAUTIONS】

• For professional in vitro diagnostic use only.
• 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.
• Avoid cross-contamination of specimens by using a new specimen collection container for each specimen obtained.
• 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.
• Do not interchange or mix reagents from different lots.
• Humidity and temperature can adversely affect results.
• Used testing materials should be discarded in accordance with local regulations.
• Read the entire procedure carefully prior to any testing.
• The Troponin I/D-Dimer/NT-proBNP(3 in 1)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.

• The test must remain in the sealed pouch until use.
• Do not freeze.
• Care should be taken to protect the components of the kit from contamination.
• 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

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

Sample Handling

• Collect the specimen according to standard procedures.
• 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.
• 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.
• EDTA K2, Heparin sodium, Citrate sodium and Oxalate potassium can be used as the anticoagulant tube for collecting the blood specimen.

Sample Dilution

• The specimen (75 uL of serum/plasma/ whole blood) can be added directly with the micro pipette into the buffer.
• Close the tube and shake the sample by hand for approximately 10 seconds so sample and dilution buffer mix well.
• Let the diluted sample homogenize for approximately 1 minute.
• 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.

• Turn on the Analyzer power. Then according to the need, select “standard test” or “Quick test” mode.
• Take out the ID card and insert it into the Analyzer port.
• 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.

• Add diluted specimen with a Pipette: Pipette 75 μL diluted specimen into the sample well. Start the timer at the same time.
• 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, D-Dimer and NT-proBNP 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.

Linearity range of D-Dimer Test is 100-10000 ng/ml.

Linearity range of NT-proBNP is 0.3-22 ng/ml.