Coronavirus 2019 Rapid Ag Test Kit Neutralizing Rapid Antibody Test Validity Period
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:China
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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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Product Details
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Product Details
2019 Ag Rapid Test Kit Neutralizing Antibody Rapid Test Validity Period
Intended Use
The kit is used to qualitatively detect novel coronavirus
neutralizing antibodies in human serum, plasma and whole blood
samples.
Corona beer is a kind of novel coronavirus, belonging to long.com
coronavirus. Can cause viral pneumonia, the main clinical
manifestations are fever, fatigue and dry cough. A few patients
also have symptoms such as nasal congestion, runny nose, sore
throat and diarrhea. Critical illness usually develops dyspnea
and/or hypoxemia after one week, and rapidly develops into acute
respiratory distress syndrome, septic shock, refractory metabolic
acidosis and coagulation dysfunction.
Infection or vaccination in novel coronavirus in 2019 will trigger
an immune response and produce antibodies in the blood. Secreted
antibodies can prevent virus infection. After infection, they will
stay in the human circulatory system for months to years, where
they will quickly and firmly combine with pathogens to prevent
virus replication. These antibodies are called neutralizing
antibodies. Neutralizing antibody test can determine whether a
person has the ability to prevent virus infection.
Principle of Detection
Immunochromatography was used in the kit. The detection card
includes quality control line C, detection T, and reference line
r.Detection capillary sample (serum/plasma and whole blood) upward
diffusion loading, binding and S-RBD manufacturer plate combined
with immobilized ACE2 in NC membrane protein detection and signal
position line signal. If there is a neutralizing antibody in the
sample, it will combine with the labeled S-RBD antigen when it
flows through the labeled S-RBD antigen. Neutralizing antibody
prevents S-RBD from combining with ACE2, which leads to the
decrease of signal value, which is negatively correlated with
neutralizing antibody content. When neutralizing antibody
concentration is high enough, T-ray is colorless. Whether the
reference lines R and QC C are T-line coloring. Use quality control
line c
If there is no color display on the C line, the test is invalid and
the sample must be retested.
Main Components
The kit consists of a test card and a sample buffer.
Test card: It consists of aluminum foil bag, desiccant, test strip
and plastic card. The test paper consists of absorbent paper,
nitrocellulose membrane, sample pad, binding pad and rubber plate.
T-line (detection line) of nitrification membrane covers ACE2
protein, C-line (QC line) covers Ab on QC line, R-line (reference
line) covers reference AB, and the bonding pad contains the label
2019 nCoV Ab.
Sample buffer: phosphate, sodium azide, etc.
Storage Conditions and Validity
The storage temperature is 2℃~ 30℃ and the validity period is 12
months.
The validity period of aluminum foil bag is 1 hour.
Production batch number: see the label for details.
Expiry date: see the label for details.
Sample Requirements
1. Collect serum, plasma or whole blood samples.
2. The sediment and suspended matter in the sample will affect the
experimental results and should be removed by centrifugation.
3. Anticoagulant: heparin anticoagulant, EDTA anticoagulant and
sodium citrate anticoagulant are not obvious.
4. Blood collection should be conducted by professionals.
Serum/serum/plasma test is recommended. In emergency or special
cases, the whole blood samples of patients can also be used for
rapid detection.
5. The storage time of serum and plasma samples at room temperature
shall not exceed 8 hours.
It can be stored at 2-8℃ for 5 days and below -20℃ for 6 months,
but repeated freezing and thawing should be avoided. Whole blood
samples should not be frozen, and should be stored at 2 C to 8 C
for no more than 48 hours.
Test Method
Read the operating instructions carefully before testing. All
reagents should be returned to room temperature before testing, and
testing should be conducted at room temperature.
1. Take out the test card from the box and use it within 1 hour.
2. Add 20 L of sample (serum, plasma or whole blood) into the
filling hole of the test card, add 2 drops (~60 L) of sample
buffer, and then start timing.
3. React at room temperature for 10-15 minutes, and then read the
results. Invalid after 20 minutes.
Interpretation of Test Results
Explanation of test card:
1. invalid result: the quality control line (line c) is invalid and
needs to be re-tested.
2. Negative result: the appearance color of the detection line (T
line) is higher than or equal to that of the reference line (R
line), the quality control line (C line) and the reference line (R
line).
3. Positive results: The red band can't see that the test line (T
line), or the red color band, the test line (T line) is lower than
the reference line (R line) and the quality control (c) line and
reference line (R line) are colored.
Limitation of Test Method
This kit is used for qualitative analysis, only for in vitro
auxiliary diagnosis.
2. Make sure to add the right amount of samples for testing. Too
much or too little sample size may lead to inaccurate results.
3. Hemolysis, blood lipid, jaundice, sample contamination, etc. may
affect the test results and should be avoided as far as possible.
4. The test results of this reagent are for clinical reference
only, and should not be used as the only basis for clinical
diagnosis and treatment. Combine all clinical and laboratory
results to make a final diagnosis of the disease.
Precautions
1. This product is only used for in vitro diagnosis.
2. This product is disposable and cannot be recycled.
3. Read the instructions carefully before operation, and conduct
the experimental operation in strict accordance with the reagent
instructions.
4. Avoid conducting experiments under harsh environmental
conditions (including 84 disinfectant, sodium hypochlorite, acid,
alkali, acetaldehyde and other high-concentration corrosive gases,
dust, etc.). Laboratory disinfection should be carried out after
the experiment.
5. All samples and reagents used should be regarded as potentially
infectious substances and treated according to local regulations.
6. Reagents should be used within the validity period indicated on
the outer package. The test card should be taken out of the
aluminum foil bag as soon as possible after being taken out to
prevent moisture.
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 |
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Coronavirus 2019 Rapid Ag Test Kit Neutralizing Rapid Antibody Test Validity Period
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