be stored at 2~8°C and should not exceed 48 hours. 3.

3. All specimens and used test materials are considered as potentially infectious.
For serum and plasma: Serum and plasma should be centrifuged immediately Appropriate protective measures should be taken, the blood collection,
Canine NT-proBNP (cNT-proBNP) after collection to avoid hemolysis. If the test cannot be performed within 2 disposal, storage, test devices and specimens must be handled carefully and
Rapid Quantitative Test hours after centrifugation, store the specimen at 2~8°C for no longer than 48 disposed of in accordance with local regulations and procedures.
hours. 4. The card must remain in its original sealed pouch until ready to use. Do not
use if the pouch, buffer, ID chip and the reagent card itself is damaged, torn
TESTING METHTOD or not fully sealed.
5. Lot Number of all the test components (reagent card, ID chip and buffer) must
PRODUCT NAME
1. Refer to Veterinary Immunofluorescence Analyzer Operation Manual for complete match each other. Do not mix components from different kit lots.
instructions for use of the reagent card. 6. This reagent card contains marking line. When the specimen climbs over this
Common Name：Canine NT-proBNP (cNT-proBNP) Rapid Quantitative Test
2. Take out the ID chip, make sure that the reagent card lot No. matches with ID line, it will be disappeared, indicating that the reagent card has been used.
Chip No. Insert ID Chip into the meter. Be aware not to touch the insertion tip 7. Never insert a test card whose surface is wet with blood or other liquids into
PACKAGE SPECIFICATION
of the ID chip. the reader, otherwise the device will be contaminated or damaged. Dispose
3. If removed from refrigerator, allow the test to attain room temperature before of used test cards properly and do not discard them randomly.
10 tests / kit
testing, and the test should be performed at room temperature. 8. It should be tested under the specific environment. The test card stored at low
4. Tear the pouch and take out the test card. Pipette 75µL of the sample, add the temperature needs to be attained to the room temperature before opening to
INTENDED USE
sample to the buffer, Upside-down 8-10 times until well mixed and pipette avoid moisture.
75µL then drop into the well of the test card. 9. The operation shall be conducted away from vibration and magnetic field.
Used for in vitro quantitative test of Canine NT-proBNP concentration in whole
5. “Quick Test” model: Start the timer right after adding the sample mixture to the Veterinary Immunofluorescence Analyzer may generate minute vibration
blood, serum or plasma. Clinically, it is mainly used for the assistant diagnosis
sample well. Leave the reagent card at room temperature for 10 minutes. during use, which should be regarded as normal. Do not remove the ID chip
of canine heart failure.
Once the reaction time is over insert reagent card immediately into the holder during the test.
of the meter and click “Test”. The device will read the reagent card automati- 10. It is recommended to use fresh samples. If there is obvious hemolysis or
TEST PRINCIPLE
cally and show the test result. blood clots in the specimen, it will interfere with the test and cause errors.
6. “Standard Test” model: insert the reagent card into the device holder right Please recollect the samples for testing.
This test employs a quantitative Immunofluorescence sandwich method
after adding the sample, click Test. The meter will start to countdown and 11. Inside the pouch desiccant, do not swallow, keep far away from the children.
technique to test the Canine NT-proBNP (cNT-proBNP) concentration in Canine
read the test result automatically. 12. Expired products will affect test results, please do not use.
whole blood, serum or plasma. Take the sample and add it into the buffer,
13. The final result should be issued by veterinarian after evaluation with all
mixture well, then drop the mixed sample into the well of the test card, the
INTERPRETATION OF RESULTS available clinical and laboratory data and clinical symptoms.
cNT-proBNP in the sample reacts with a fluorescently labeled antibody coated
14. If you have any questions or suggestions during using, please contact the
on the glass fiber to form a complex substance. Under the action of chromatog-
1. Right after correctly adding the specimen for 10 minutes the test result will be manufacture.
raphy, the complex substance and unreacted fluorescently labeled antibody
displayed on the main screen.
diffuse forward along the nitrocellulose membrane, are captured by the
2. If the sample is insufficient or the specimen is not completely crawled across INTERPRETATION
cNT-proBNP monoclonal antibody coated on the nitrocellulose membrane test
the test line, the device will prompt “No sample or the volume of sample is
line. The more cNT-proBNP in the sample, the more complexes accumulate on
insufficient”. In this case recommends a new test. 1. Reference range of cNT-proBNP in canine blood:
the detection line, and the signal intensity of the fluorescent antibody reflects the
3. There is the possibility that factors such as technical limits or operational errors. Detection range : 150- 6000 pmol/L
amount of cNT-proBNP captured. The cNT-proBNP concentration is expressed
It should be evaluated with all clinical and laboratory data available if not Reference: < 800 pmol/L
pmol/L as the unit.
agree with the clinical evaluation, additional tests also should be performed -- The reference range of this product is recommended. Each laboratory should
accordingly establish its own reference range.
MATERIAL PROVIDED
2. There must be a final decision by the veterinarian.
LIMITATIONS OF TESEING METHODS 3. If in any case can not be confirmed using a diagnostic method. Please make
Each kit contains test card, buffer, ID chip and instructions use.
a comprehensive evaluation based on clinical symptoms, diagnostic records,
(1) The test card consists of strip, plastic shell. The strip consists of sample pad,
1. The test is developed for testing canine whole blood, serum or plasma specimen. and testing results.
nitrocellulose film, absorbent paper, PVC board and other testing auxiliaries.
2. The test results of the reagent can only be used as a doctors’ or other diagno-
(2) The main ingredient of the sample dilution is PBS buffer.
sis. The result should be evaluated with all clinical and laboratory data BASIC INFORMATION
available if test results do not agree with the clinical evaluation, additional
STORAGE AND STABILITY
tests also should be performed accordingly. Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
3. There may be several reasons for false positive result: Some non-specific Address: No. 8 Lizhishan Rd., Science City, Luogang District, 510663,
Store the test kit at 4~30°C up to the expiration date, the shelf life is 24 months.
components in the sample have similar epitopes to capture fluorescently Guangzhou, P.R. China
Once the pouch is opened, the test should be performed within an hour.
labeled antibodies as cNT-proBNP; the presence of non-specific binding to Distributed by: Guangzhou Wondko Technology Co., Ltd.
Production Date：See the Label.
the coated antibody in the sample affects the capture of fluorescently labeled Tel: +86 20-32293661
Expiration date：See the Label
antibodies by the coating line. Fax: +86 20-32022032
4. There may be several reasons for false negative result：Some unknown E-mail: wondfo-vet@wondfo.com.cn
APPLICABLE DEVICE
components shield the epitope from binding to the antibody; the unstable Web: www.wondko.com
cNT-proBNP antigen, which gradually degrades over time and temperature,
Testing with the series of fluorescence devices produced by Guangzhou
cannot be recognized by the antibody. Effective test results depend on a good
Wondfo Biotech Co., Ltd.
reagent and sample storage environment.
5. Other factors may also cause incorrect cNT-proBNP test results. These factors
SPECIMEN REQUIREMENTS
include technical reasons, operational errors, and other sample factors such
as severe hemolysis, severe jaundice, and high lipid content.
The test can be performed with either serum, plasma or whole blood (Recom-
mend the use of serum or plasma)
PRECAUTIONS
For whole blood：Collect whole blood specimen containing anticoagulants or
add anticoagulant into the blood collection tube (EDTA is recommended), shake
1. This kit is for canine use only.
well after the collection. It is recommended that specimens should be tested
2. This product is a single-use in vitro diagnostic reagent. Do not reuse. Rev. A1
immediately. If blood cannot be tested within 2 hours after collection, it should
Rel.: 2020/08/13
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物料编码：13009361 项目名称：兽用cNT-proBNP检测试剂盒说明书(210*285mm)英文V01

尺寸(长*宽*高)：210X285mm 颜色： C100M40 材质：80g双铜 工艺：/

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改稿前编码：/ 申请人：何浩 设计师：宋银 设计时间：2020.10.21

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