COVID-19 Neutralizing Antibody Rapid Test Immunochromatography Storage Conditions
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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Zhengzhou Henan China
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Office Address: Building 4, No. 51 Jingbei 3rd Road, Jingkai Zone, Zhengzhou City. Henan Province,China.
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Product Details
(COVID-19) Neutralizing Antibody Rapid Test (Immunochromatography) Storage Conditions And Validity
Intended Use
The kit is used for qualitative detection of 2019-nCoV neutralization technology
Antibodies in human serum, plasma and whole blood samples.
As a new machine, 2019-nCOV is a kind of β-COV. It can cause viral pneumonia, and its main clinical manifestations are fever, fatigue and dry cough. A few patients have nasal congestion, runny nose, sore throat, diarrhea and other symptoms. Severe cases usually have dyspnea and/or hypoxemia one week later, and severe cases will rapidly develop into acute respiratory distress syndrome, septic shock, intractable metabolic acidosis and coagulation dysfunction.
NCoV in 2019 has several structural proteins, including spike (S),
envelope (E) and membrane
(m) and nuclear contact (n). Peak protein contains a receptor
binding domain (RBD), which is responsible for recognizing
angiotensin converting enzyme 2(ACE2) on cell surface receptor. It
is found that RBD of spike protein in 2019-nCoV interacts strongly
with human ACE2 receptor, which leads to endocytosis of lung host
cells and virus replication.
2019-n cobaltous acid virus infection or vaccination will trigger an immune response and produce antibodies in blood. These secreted antibodies can prevent virus infection. They will exist in human circulatory system for several months to several years after infection, and will combine with pathogens quickly and firmly 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
The kit uses immunochromatography. The test card includes quality
control line C, test line T and reference line R. The sample to be
tested (serum/blood/whole blood) diffuses upward at the loading
well through capillary action. The S-RBD of the binding pad
manufacturer binds with ACE2 protein fixed on NC membrane, and
detects the signal at the position of T line. If the neutralizing
antibody exists in the sample, it will bind to the labeled S-RBD
antigen when flowing through the labeled pad. Neutralizing antibody
can prevent S-RBD from binding to ACE2, which leads to the decrease
of signal value. The signal value of T line is negatively
correlated with the content of neutralizing antibody. When the
concentration of neutralizing antibody is high enough, there is no
color on T line. The reference line r and the quality control line
c should be colored, whether the t line is colored or not. The
quality control line c is used for quality control. If there is no
color display on line C, 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 strip consists of absorbent paper,
nitrocellulose membrane, sample pad, adhesive pad and rubber sheet.
T-line (test line) of nitrocellulose membrane is coated with ACE2
protein, C-line (quality control line) is coated with Ab, R-line
(reference line) is coated with reference Ab, and the bonding plate
contains the label 2019-nCoVAb.
Sample buffer: phosphate, sodium azide, etc.
Storage Conditions and Validity
Keep it at 2℃~30℃ and set the validity period to 12 months.
The validity period of the aluminum foil bag is one hour.
LotNo.: for details, see the label.
Expiry date: see the label for details.
Sample Requirements
1. Collect serum, plasma or whole blood samples.
2. Sediments and suspended solids in samples may affect the
experimental results and should be removed by centrifugation.
3. Anticoagulants: heparin, EDTA and sodium citrate had no
significant effect.
4. Blood collection should be carried out by professional medical
personnel. It is recommended to give priority to serum/plasma test.
In case of emergency or special circumstances, the whole blood
sample 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. They ..
It can be stored at 2℃ to 8℃ for 5 days and below -20℃ for 6
months, but repeated freeze-thaw cycles should be avoided. Whole
blood samples should not be frozen and stored at 2℃~8℃ for no more
than 48 hours.
Test Method
Please read the instructions carefully before testing. Please
reduce all reagents to room temperature before the test, and the
test should be carried out at room temperature.
1. Take out the test card from the packaged reagent bag and use it
within one hour.
2. Add 20μL sample (whole serum and plasma), then add 2 drops
(about 60μL) of sample buffer, and then start timing.
3. Please read the results when reacting for 10-15 minutes at room
temperature. After 20 minutes, the result is invalid.
Interpretation of Test Results
Figure for judging test card results:
1. invalid result: there is no reaction line on the quality control
line (line c), which is invalid, and the test should be carried out
again.
2. Negative result: the red band appears on the test line (T line),
the color is higher than or equal to the reference line (R line),
and the quality control line (C line) and reference line (R line)
are colored.
3. Positive results: the test line (T line) has no red band, which
is smaller than the reference line (R line), and the quality
control line (C line) and reference line (R line) are colored.
Limitation of Test Method
1. This kit is used for qualitative detection, only for in vitro
auxiliary diagnosis.
2. Make sure to add an appropriate number of samples for testing.
Too much or too little sample size may lead to inaccurate results.
3. Hemolysis, lipidemia, jaundice and contaminated samples may
affect the test results, so these samples should be avoided.
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. The final diagnosis should be made after
comprehensive evaluation and laboratory results of all clinical
practices.
Product Performance Indicators
1. Analysis of specificity
1.1 1.1 Cross-reaction: The following types of antibody
interference reagents were evaluated, and the results showed that
there was no cross-reaction.
| SN | Item | Cross reaction | SN | Item | Cross reaction |
| 1 | Endemic human coronavirus OC43 | No | 10 | Enterovirus | No |
| 2 | Endemic human coronavirus HKUI | No | 11 | EB virus | No |
| 3 | Endemic human coronavirus NL63 | No | 12 | Measles virus | No |
| 4 | Endemic human coronavirus 229E | No | 13 | Human cytomegalovirus | No |
| 5 | Influenza A virus | No | 14 | Rotavirus | No |
| 6 | Influenza B virus | No | 15 | Norovirus | No |
| 7 | Respiratory syncytial virus | No | 16 | Mumps virus | No |
| 8 | Adenovirus | No | 17 | Varicella-zoster virus | No |
| 9 | Rhinovirus | No | 18 | Mycoplasma pneumoniae | No |
1.2 Interfering substances: Add the following substances to the samples at specific concentrations to evaluate their potential interference in 2019-nCoV and Ab test projects. The results showed that all kinds of interfering substances did not interfere with the test results of this reagent.
| Interfering substances | Concentration | Interfering substances | Concentration |
| Bilirubin | ≤50mg/dL | Triglycerides | ≤15mmol/mL |
| Hemoglobin | ≤5g/L | Cholesterol L | ≤500mg/d |
| Rheumatoid factor | ≤500IU/mL | Human total IgG | ≤14mg/mL |
| Ribavirin | 0.4mg/mL | Fluticasone | 0.5mg/mL |
| Oxymetazoline | 10mg/mL | Dexamethasone | 5 mg/mL |
| Histamine hydrochloride | 10mg/mL | Triamcinolone acetonide | 5mg /mL |
| Tobramycin | 1mg/mL | Levofloxacin | 0.2 mg/mL |
| Oseltamivir | 1mg/mL | Azithromycin | 0.1 mg/mL |
| Zanamivir | 1mg/mL | Ceftriaxone | 0.4 mg/mL |
| Arbidol | 0.5mg/mL | Meropenem | 0.2 mg/mL |
2. Clinical research: 120 positive samples and 300 negative samples were selected for detection with the listed 2019-nCoVIgGAb detection reagent (colloidal gold method) as the comparative reagent. The research results are summarized as follows:
2019-nCoV IgG Ab detection reagent (colloidal goldmethod) | Sum | |||
| Positive | Negative | |||
| Positive | 115 | 5 | 120 | |
| Negtive | 5 | 295 | 300 | |
| Sum | 120 | 300 | 420 | |
| Sensitivity | 95.83%, (95%CI: 90.62%～98.21%) | |||
| Specificity | 98.33%, (95%CI: 96.16%～99.29%) | |||
Precautions
1. This product is only used for in vitro diagnosis.
2. This product is disposable and cannot be recycled and reused.
3. Read the instructions carefully before operation, and carry out
experimental operation in strict accordance with the reagent
instructions.
4. Avoid testing under severe environmental conditions (including
84 kinds of disinfectants, sodium hypochlorite, high concentration
corrosive gases such as acid and alkali or acetaldehyde and dust).
After the experiment, the laboratory should be disinfected.
5. All samples and reagents used should be regarded as potentially
infectious substances and disposed of according to local laws and
regulations.
6. Reagents should be used within the validity period marked on the
outer packaging. After taking it out of the aluminum foil bag, use
the test card as soon as possible 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 |
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.
COVID-19 Neutralizing Antibody Rapid Test Immunochromatography Storage Conditions
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