The NT-proBNP Test Cassette (Whole Blood/Serum/Plasma) is intended for in vitro quantitative determination of human NT-proBNP in whole blood, serum or plasma as an
aid in the diagnosis of heart failure.
【SUMMARY】
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. [1] 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.[2][3][4]
The NT-proBNP Test Cassette (Whole Blood/Serum/Plasma) is a simple test that utilizes
a combination of anti-NT-proBNP antibody coated particles and capture reagents to
quantitatively detect NT-proBNP in whole blood, serum or plasma. The minimum
detection level is 0.3 ng/mL.
【PRINCIPLE】
The NT-proBNP Test Cassette (Whole Blood/Serum/Plasma) is based on Fluorescence
Immunoassay for the detection of NT-proBNP in whole blood, serum or plasma. The
sample moves through the strip from sample pad to absorbent pad. If the specimen
contains NT-proBNP, it attaches to the fluorescent microspheres-conjugated anti- NT
proBNP antibodies. Then the complex will be captured by the capture antibodies coated
on the nitrocellulose membrane (Test line). The concentration of NT-proBNP in the
sample correlates linearly with the fluorescence signal intensity captured on the T line.
According to the fluorescence intensity of the test and standard curve, the concentration
of NT-proBNP in the sample can be calculated by
Analyzer to show NT
proBNP concentration in specimen.
【REAGENTS】
The test contains anti-NT-proBNP antibody conjugated fluorophores and capture
reagents 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 FIATEST GO NT-proBNP Test Cassette should only be used with the
Analyzer by approved medical professionals.
【STORAGE AND STABILITY】
1. The kit 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. 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 °C). Cold buffer solution or moisture condensation on the membrane
can lead to invalid test results.
Sample Handling
Collect the specimen according to standard procedures.
To collect Fingerstick Whole blood specimens:
Wash the patient’s hand with soap and warm water or clean with an alcohol
swab. Allow to dry. Massage the hand without touching the puncture site by rubbing down the hand
towards the fingertip of the middle or ring finger.
Puncture the skin with a sterile lancet. Wipe away the first sign of blood.
Gently rub the hand from wrist to palm to finger to form a rounded drop of blood
over the puncture site.
Add the Fingerstick
Whole blood specimen to the tube with buffer by using
pipette.
Separate serum or plasma from blood as soon as possible to avoid hemolysis. Use only
clear non
-hemolyzed specimens.
Testing should be performed immediately after the specimens have been collected. Do
not leave the specimens at room temperature for prolonged periods. Serum and plasma
specimens may be stored at 2-8°C for up to 2 days. 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 run within 2 days of collection. Do not freeze whole blood
specimens. Whole blood collected by fingerstick should be tested immediately.
Bring specimens to room temperature prior to testing. Frozen specimens must be
completely thawed and mixed well prior to testing. Specimens should not be frozen and
thawed repeatedly. If specimens are to be shipped, they should be packed in compliance with local
regulations covering the transportation of etiologic agents.
Sample Dilution / Sample Stability
1. The specimen (50ul of Whole Blood/Serum/Plasma) can be added directly with the
micro pipette into the tube with buffer.
2. Close the tube and shake the sample by hand vigorously for approximately 10 seconds
to mix the sample and dilution buffer.
3. 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 8 hours.
【MATERIALS】
Materials Provided
• Test Cassettes
• Specimen Collection Tubes with Extraction Buffer
• ID Card
• Package Insert
Materials Required But Not Provided
• Timer
• Pipette • Specimen Collection Containers
【DIRECTIONS FOR USE】
Refer to FIATEST GO Fluorescence Immunoassay Analyzer Operation Manual for the
complete instructions on use of the Test. The test should be conducted in room
temperature.
Allow the test, specimen, buffer and/or controls to reach room temperature (15-30°C)
prior to testing.
2. Turn on the Analyzer power. Then according to the need, select “Standard Test” or
“Quick Test” mode.
3. Take out the ID card and insert it into the Analyzer ID Card Slot.
4. Pipette 50μl whole blood/serum/plasma into the buffer tube; mix the specimen and
the buffer well.
5. Add diluted specimen with a Pipette: Pipette 85μl diluted specimen into the sample
well of the test cassette. Start the timer at the same time.
6. 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: After 15 minutes of adding sample, Insert the test cassette into the
Analyzer, click “QUICK TEST”, fill the test information and click "NEW TEST" immediately.
The Analyzer will automatically give the test result after a few seconds.
“Standard Test” mode: Insert the test cassette into the Analyzer immediately after adding
specimen, click “STANDARD TEST”, fill the test information and click "NEW TEST" at the
same time, The Analyzer will automatically countdown 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 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 Analyze.
Linearity range of NT-proBNP Test is 0.3-22 ng/mL.
