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INTENDED USE
The NT-proBNP Rapid Test Kit is intended for the qualitative
determination of NT-proBNP in human whole blood/Serum/Plasma.
Measurement of NT-proBNP values is useful in the diagnosis and
assessment of severity of heart failure.
INTRODUCTION
N-terminal pro-brain (or B-type) natriuretic peptide (NT-proBNP) is
produced predominately by the cardiac ventricular myocytes.[1] It
is released in response to volume expansion and filling pressure
and is involved in maintaining intravascular volume homeostasis.
After synthesis, the peptide is cleaved first to proBNP and
subsequently to BNP (active form) and NT-proBNP(inactive form).
Natriuretic peptide (NP) levels (BNP and NT-proBNP) are widely used
in clinical practice and cardiovascular research as a diagnotic
tool for the occurrence and severity of heart failure (HF) and
coronary syndrome.
Elevated plasma levels of BNP and NT-proBNP have been observed at
times of cardiac stress and damage. It has also been shown that
increased NP values in patients with renal dysfunction can suggest
the presence of cardiac disease. Low circulating NP levels have
been observed in obese people, however the prognostic capacity of
these biomarkers were not affected for those patients.
In summary, NP levels are quantitative plasma biomarkers of an
accurate diagnosis of heart failure. Measurements of NP levels may
help in risk stratification of patients suffering heart attacks in
emergency care and in accurate and rapid diagnosis of heart failure
in primary care.
PRINCIPLE
The NT-proBNP Rapid Test (Whole blood/Serum/Plasma) detects
NT-proBNP through visual interpretation of color development in the
internal strip. Anti-NT-proBNP antibodies are immobilized on the
test region of the membrane, and anti-mouse antibodies immobilized
on the control region. During testing, the specimen reacts with
anti-NT-proBNP antibodies conjugated to colored particles and
precoated onto the sample pad of the strip. The mixture then
migrates through the membrane by capillary action and interacts
with reagents on the membrane. If there is sufficient NT-proBNP in
the specimen, a colored band will form at the test region of the
membrane. The presence of this colored band indicates a positive
result, while its absence indicates a negative result. The
appearance of a colored band at the control region serves as a
procedural control, indicating that the proper volume of specimen
has been added and membrane wicking has occurred.
MAIN CONTENTS
• Rapid test Cassette with desiccant.
• Disposable pipettes.
• Buffer.
• Instructions for use.
STORAGE AND STABILITY
• Store at 2 ~ 30 º C in the sealed pouch for 18 months.
PRECAUTIONS
• For in vitro diagnostic use only.
• Do not use after expiration date.
• The test Cassette should remain in the sealed pouch until use.
• The used test Cassette should be discarded according to local
regulations.
SAMPLE COLLECTION
OPERATION
Bring tests, specimens, and/or controls to room temperature
(15-30°C) before use.
OR
Allow 3 hanging drops of fingerstick whole blood to fall into the
center of the specimen well (S) of the test device, and start the
timer.
Avoid trapping air bubbles in the specimen well (S), and do not add
any solution to the result area.
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.
PERFORMANCE
Sensitivity: The minimum detectable concentration of NT-proBNP Rapid Test Device
is 125 pg/ml.
Cross-Reactivity: Based on the specificity of the capture and detection antibodies,
the NT-proBNP Rapid Test assay detects the NT-proBNP only and does
not cross-react with proBNP and BNP.
For detailed information, please contact Dewei person for Manual
Instruction.