【Product name】NT.pdf
N-terminal prohormone of brain natriuretic peptide (NT-proBNP)
Rapid Quantitative Test(Fluorescence immunoassay)
【Intended use】
This kit is used for quantitative determination of N-terminal
prohormone of brain natriuretic peptide (NT-proBNP) in human whole
blood and plasma,serum.
【Inspection principle】
The principle of immunofluorescence chromatography was applied to
the kit. The NT-proBNP antigen in the sample was first bound with
the conjugated compound of fluorescent labeled NT-proBNP monoclonal
antibody, then moved and combined with another NT-proBNP monoclonal
antibody fixed on the nitrocellulose membrane, and the double
antibody sandwich complex was formed at the detection line of the
cellulose nitrate membrane. The quantitative detection results were
obtained by NIR-1000 dry fluoroimmunoassay analyser.
【Main components】
| Name | Quantity | Component |
| Test card | 25 | It is composed of fluorescent pad (coated with fluorescent labeled
N-terminal prohormone of brain natriuretic peptide (NT-proBNP)
monoclonal mouse antibody), nitrocellulose membrane (coated with
N-terminal prohormone of brain natriuretic peptide (NT-proBNP)
monoclonal mouse antibody and Goat anti mouse IgG antibody),
absorbent paper and backing |
| Sample buffer | 25(300μL/tube) | Phosphate buffer |
| ID card | 1 | Record the standard curve information of this kit |
The components in different batches of kits cannot be used
interchangeably.
【Procedure】
1. Before the test, please read the instructions completely. If the
test card and sample are stored in cold storage, they should be
balanced at room temperature (15-30)℃ for not less than 30min
before use.
2. Start NIR-1000 dry fluoroimmunoassay analyzer according to the
instruction manual of the instrument, and carry out quality control
verification according to the instruction manual of the
instrument(Note: the reagent has been calibrated in advance, and
the calibration curve parameters of each batch of reagent have been
stored in the information card. The information card is inserted
before use, so it is not necessary to calibrate again, and the test
can be carried out only after the quality control is passed;
Otherwise, the cause should be found out before testing.)
3. Remove the test card from the aluminum foil bag and use it
within 15 minutes.
4. Place the test card on a clean horizontal table and mark it
horizontally.
5. Mix 100µL of patient sample with 300µL of sample diluent. Apply
100µL of diluted samples to the well of the test card.
6. Insert the test card into NIR-1000 dry fluoroimmunoassay
analyzer, press the [timing detection] key, automatically time for
10 minutes, automatically judge the test results, and display the
quantitative results on the screen. Or insert the test card into
the analyzer after timing for 10 minutes, and press the [real time
detection] key, and the instrument will automatically interpret the
test results.
【Reference interval】
Healthy subjects under 75 years old have assay values below
347pg/mL. Healthy subjects over 75 years old have assay values
below 449pg/mL.
【Interpretation of results】
This reagent is only used for auxiliary detection. If the test
results are abnormal, it should be reviewed in time and judged in
combination with clinical symptoms.
【Performance】
1. Analysis sensitivity
No more than 18pg/mL.
2. Accuracy
The relative deviation from the target value is within ±10%.
3. Precision
The within and between assay coefficient of variations are within
15%.
4. Linear range
Within the linear range (20-35000pg/mL), the linear correlation
coefficient R≥0.990.
| Assay list | | | | | |
| Cardiac | | | | | |
| cat#. | Product Item | Specimen | Reaction Time | Measure Range | Clinical Range | Intended Use |
| 1 | cTnI | WB/Serum/Plasma | 12min. | 0.1-40ng/ml | <0.3ng/ml | several heart diseases including myocardial infarction and heart
failure. |
| 2 | Myo | WB/Serum/Plasma | 12min. | 5-400ng/ml | <58ng/ml | acute myocardial infarction (AMI) in early stage. |
| 3 | CK-MB | WB/Serum/Plasma | 12min. | 1-200ng/ml | <5ng/ml | acute myocardial infarction (AMI) in early stage. |
| 4 | NT-proBNP | WB/Serum/Plasma | 10min. | 20-35000pg/ml | Under 75:0~347pg/mL,
Over 75:0~449pg/mL | heart failure . |
| 5 | D-Dimer | WB/Plasma | 10min. | 40-10000ng/ml | <500ng/ml | disseminated intravascular coagulation (DIC),deep vein thrombosis
(DVT),pulmonary embolism (PE), myocardial infarction, cerebral
infarction, etc. |
| 6 | cTnI+Myo+CKMB | WB/Serum/Plasma | 12min. | same with single item | same with single item | Triple marker of myocardial infarction. |
| 7 | ST2 | WB/Serum/Plasma | 10min. | 10-400ng/ml | <35ng/ml | heart failure . |
| 8 | Lp-PLA2 | WB/Serum/Plasma | 10min. | 10-900ng/ml | <175ng/ml | Risk evaluation of ACS and atherosclerotic ischemic stroke
patients. |
| 9 | S100-β | WB/Serum/Plasma | 10min. | 0.05-10ng/ml | <0.2ng/ml | Cerebral infarction, cerebral injury. |
