Coronavirus 2019 Ag Rapid Test Kit Neutralizing Production Batch Number
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
Coronavirus 2019 Ag Rapid Test Kit Neutralizing Antibody Rapid Test Kit Production Batch Number
Intended Use
The kit is used for qualitative detection of 2019 nCoV neutralizing
antibodies in human serum, plasma, and whole blood samples.
Corona beer is Novel Coronavirus, belonging to Elong. Com
coronavirus. Can cause viral pneumonia, the main clinical
manifestations are fever, fatigue and dry cough. A small number of
patients also experience nasal congestion, runny nose, sore throat,
diarrhea and other symptoms. Critical cases usually develop dyspnea
and/or hypoxemia one week later, and critical cases rapidly
progress to acute respiratory distress syndrome, septic shock,
refractory metabolic acidosis, and cotting disorders.
2019 nCoV infection or vaccination triggers an immune response that
produces antibodies in the blood. Secreting antibodies protects
against viral infection. After infection, they stay in the body's
circulatory system for months to years, where they bind quickly and
firmly to pathogens to prevent virus replication. These antibodies
are called neutralizing antibodies. Neutralizing antibody tests
determine whether a person is able to protect against viral
infection.
Principle of Detection
The kit was performed by immunochromatography. The test card
includes quality control line C, test line T and reference line R.
Capillary action of samples (serum/plasma and whole blood) for
upward diffusion loading, binding, and immobilization of ACE2 in
S-RBD manufacturer plate binding NC membrane protein to detect and
signal localization line signals. If neutralizing antibodies are
present in the sample, they bind to the labeled S-RBD antigen as
they flow through the labeled disk. Neutralizing antibody prevents
S-RBD from binding to ACE2, resulting in a decrease in the signal
value, which is negatively correlated with the content of
neutralizing antibody. When the concentration of neutralizing
antibody is high enough, T-ray is colorless. Whether reference
lines R and QC C are colored for T lines. Use quality control line
C
Quality control If there is no color display for line C, the test
is invalid and the sample must be retested.
Main Components
The kit consisted of a test card and a sample buffer.
Test card: composed of aluminum foil bag, desiccant, test strip and
plastic card.Among them, the test paper consists of water
absorption paper, nitrocellulose film, sample pad, binding pad, and
rubber plate.Nitrification membrane T line (detection line) covers
ACE2 protein, C line (QC line) covers Ab on QC line, R line
(reference line) covers reference Ab, and the binding pad contains
tag 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 bag is one hour.
Production number: please refer to the label for details.
Validity period: please refer to the label for details.
Sample Requirements
1. Collection of serum, plasma, or whole blood samples.
2. Precipitates and suspended objects in the sample may 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 carried out by professionals.Serum /
serum / plasma testing is recommended.Whole blood samples of
patients can also be used for rapid detection in emergency or
special cases.
5. Serum and plasma samples shall not be stored for time at room
temperature than 8 hours.
The 2-8°C can be kept for 5 days and below the-20°C for 6 months,
but repeated freeze and thawing should be avoided.Whole blood
specimens should not be frozen and should be kept 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 put back to room temperature before testing, and
the testing should be performed at room temperature.
1. Remove the test card from the package kit and use it within one
hour.
2. Add 20 L samples (serum, plasma, or whole blood) to the test
card filling hole, add 2 drops (~60 L) of the sample buffer, and
then start the timing.
3. Reaction at room temperature for 10-15 minutes and read the
results.Invalid after 20 minutes.
Interpretation of Test Results
Test card interpretation:
1. Invalid result: Quality control line (C line) is invalid and
needs to be re-tested.
2. Negative result: the color appearance of test line (T line) is
higher than or equal to the color of reference line (R line),
quality control line (C line) and reference line (R line).
3. Positive results: No red band can be seen on the test line (T
line), or the color of the red band on the test line (T line) is
lower than the reference line (R line), and the quality control
line (C line) and reference line (R line) are colored.
Limitation of Test Method
This kit is used for qualitative analysis and in vitro auxiliary
diagnosis only.
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 lipids, jaundice and sample contamination may
affect test results and should be avoided as far as possible.
4. The test results of this reagent are only for clinical reference
and shall not be used as the sole basis for clinical diagnosis and
treatment. The final diagnosis of the disease was made after
combining all clinical and laboratory results.
Precautions
1. This product is only used for in vitro diagnosis.
2. This product is a disposable product and cannot be recycled.
3. Read the instruction carefully before operation, and carry out
experimental operation strictly according to the instruction of
reagent.
4. Avoid performing experiments under harsh environmental
conditions (including 84 disinfectant, sodium hypochlorite, acid,
alkali, acetaldehyde and other corrosive gases with high
concentration, dust, etc.). Laboratory disinfection should be
carried out after the experiment.
5. All samples and reagents used should be treated as potentially
infectious substances and handled in accordance with local
regulations.
6. The reagent should be used within the expiry date indicated on
the outer package. The test card should be used as soon as possible
after removal from the foil bag 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 Ag Rapid Test Kit Neutralizing Production Batch Number
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