2019 Coronavirus Disease Neutralizing Antibody Rapid Test Kit Card Efficient
Brand Name:ZOSBIO
Certification:CE BfArm
Model Number:2019-NCoV Neutralizing Antibody
Minimum Order Quantity:To be negotiated
Delivery Time:To be negotiated
Place of Origin:Henan
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Location:
Zhengzhou Henan China
Address:
Office Address: Building 4, No. 51 Jingbei 3rd Road, Jingkai Zone, Zhengzhou City. Henan Province,China.
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within 47 hours
Product Details
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Product Details
2019 Coronavirus Disease Neutralizing Antibody Rapid Test Kit Card Efficient
Intended Use
This kit is used for qualitative detection of 2019-NCOV
neutralizing antibodies in human serum, plasma and whole blood
samples.
Corona beer 2019 Is Elong. A novel corona virus belonging to corona
virus. May cause viral pneumonia, the main clinical symptoms are
fever, tiredness, dry cough. A small number of patients also show
symptoms such as stuffy nose, runny nose, sore throat and diarrhea.
Dyspnea and/or hypoxemia usually develop after one week in severe
cases. Examples of severe cases are acute dyspnea syndrome, septic
shock, refractory metabolic adoxis, and coagulation disorder.
19 NCOV infection or vaccination causes an immune response that
produces antibodies in the blood. Secreted antibodies protect
against viral infection. After infection, they stay in the body's
circulatory system for months to years, rapidly binding to the
pathogen to prevent the virus from replicating. These antibodies
are called neutralizing antibodies. Neutralization antibody test
can determine whether a person has the ability to prevent viral
infection.
Principle of Detection
The accessory components were implemented using IMO chromaticity.
The test card contains quality control line C, test line T and
reference line R. Updiffusion load, binding, and capillary action
of S in test samples (serum/plasma and whole blood) The S-RBD
manufacturer's pad combines ACE2, which is fixed to the NC membrane
protein, to detect position line signals and send signals. In the
presence of neutralizing antibodies in the sample, the neutralizing
antibodies bind to labeled S-RBD antigens as they flow through the
labeling plate. Neutralizing antibodies prevent S-. When S-RBD
binds to ACE2, the signal value decreases, and the neutralizing
antibody content is negatively correlated. When the concentration
of neutralizing antibody is high enough, the T-line becomes
colorless. Reference line R and quality control line C will be
colored regardless of whether T is colored or not. Whether to use
quality control line C
If there is no color display on quality control line C, the test is
invalid and the sample needs to be tested again.
Main Components
The kit consists of test cards and sample buffers.
Test card: aluminum foil bag, desiccant, test strip, plastic card
composition. The test paper consists of absorbent paper,
nitrocellulose film, sample pad, binding pad and rubber plate.
Nitrifying membrane T line (test line) covers ACE2 protein, C line
(QC line) covers QC line Ab, R line (reference line) covers
reference Ab, and binding pad contains label 2019nCoVAb.
Sample buffer: phosphoric acid, sodium nitrite, etc.
Storage Conditions and Validity
Storage temperature is 2℃ ~ 30℃, effective for 12 months.
Aluminum foil bags are valid for 1 hour.
Production Lot Number: Refer to the label for details.
Expiry date: Refer to the label for details.
Sample Requirements
1. Collection of serum, plasma or whole blood samples.
2. Sediment or plankton in the sample may affect the experimental
results, so it needs to be removed by centrifugation.
3. Anti-coagulant: luffa anti-coagulant, EDA anti-coagulant, sodium
citrate anti-coagulant effect is not obvious.
4. Blood collection by a medical expert is required.
Serum/serum/plasma tests are recommended. Whole blood samples from
patients can also be used for rapid testing in emergency or special
situations.
5. Serum and plasma samples should not be kept at room temperature
for more than 8 hours.
Can be stored for 5 days from 2 °C to 8°C, less than -20°C can be
stored for 6 months, but please avoid repeated freezing melting.
Blood samples are ice-free and must be kept at 2°C ~ 8°. C within
48 hours.
Test Method
Please read the instructions carefully before the test. All
reagents should be returned to room temperature prior to test,
which must be carried out at room temperature.
1. Remove the test card from the package and use it within 1 hour.
2. Add 20L sample (serum, plasma or whole blood) to the filling
hole of the test card, add 2 drops (~ 60L) of sample buffer memory
and start timing.
3. Reaction at room temperature for 10 to 15 minutes, read the
results. Invalid after 20 minutes.
Interpretation of Test Results
Test card explanation:
1. Invalid result: The response line of quality management line
(Line C) is not invalid and needs to be tested again.
2. Negative result: the test line (T line), color appearance is
greater than the reference line (R line), quality management line
(C line) and reference line (R line) color.
3. Positive results: There is no red band on the test line (T
line), the red band on the test line (T line) is lower than the
reference line (R line), and the quality management line (C line)
and the reference line (R line) are colors.
Limitation of Test Method
This kit is for qualitative testing and Invitro assisted diagnosis
only.
2. Confirm that the appropriate number of test samples has been
added. If the sample size is too large or too small, the result may
be incorrect.
3. Hemolysis, lipids, jaundice, and contaminated samples may affect
the results and must be avoided.
4. The test results of the reagent are for clinical reference only,
and cannot be used as the sole basis for clinical diagnosis and
treatment. A final diagnosis of the disease must be made after a
comprehensive evaluation of all clinical and examination results.
Precautions
1. This product is only used for Invitro diagnosis.
This product is disposable and can't be reused.
3. Please read the instructions carefully before operation, and
strictly follow the instructions of reagent for experimental
operation.
4. Do not perform the experiment under harsh environmental
conditions (84 disinfectant, sodium hypochlorite, acid, alkali,
acetaldehyde, other highly corrosive gases, dust, etc.). Please
disinfect in laboratory after experiment.
5. All samples and reagents used are treated as potentially
infectious substances and are disposed of in accordance with
regional regulations.
6. The reagent must be used within the expiry date stated on the
package. To prevent moisture, the test card must be used as soon as
possible after it is removed from the foil bag.
Logo interpretation
| Do not re-use | Store at 2℃～30℃ | ||
| Consult instructions for use | In vitro diagnostic medical device | ||
| Batch code | Use-by date | ||
| Keep dry | Keep away from sunlight | ||
Authorized representative in the European Community | Manufacturer |
Basic Information
ZHONGXIU SCIENCE AND TECHNOLOGY CO.,LTD
Dingluan industrial zone ,Changyuan City,453400,P.R.CHINA
Tel:+86-371-55016575
Email:zosbio@zosbio.com
Web:www.zosbio.com
SUNGO Europe B.V.
Olympisch Stadion 24, 1076DE Amsterdam, Netherlands
Company profile
Zhongxiu Science And Technology Co.,Ltd., is a high-tech enterprise
engaged in the research and development, production and operation
of in vitro diagnostic products. The in vitro diagnostic products
developed by the company cover POCT series, microbial series,
biochemical series and immune series reagents and supporting
instruments.
The company has always adhered to the core concept of "fast and accurate, living up to life", committed to providing society with excellent products and services, and contributing to the cause of human health.
The company has always adhered to the core concept of "fast and accurate, living up to life", committed to providing society with excellent products and services, and contributing to the cause of human health.
2019 Coronavirus Disease Neutralizing Antibody Rapid Test Kit Card Efficient
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