COVID-19 Neutralizing Antibody Rapid Test Standard Q Antigen Test
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,China
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Location:
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 Standard Q Antigen Test
Intended Use
2019 nCoV Neutralization Technology Qualitative Test Kit
Antibodies in human serum, plasma and whole blood samples
The 2019-nCOV is a new machine, the β-COV. Viral pneumonia can be
caused and the main clinical symptoms are fever, lethargy and dry
cough. Many patients complain of stuffy nose, runny nose, sore
throat, and diarrhea. Severely ill patients usually develop dyspnea
and / or hypoxemia after one week, and severely ill patients
rapidly progress to acute respiratory distress syndrome, infectious
shock, refractory metabolic acidosis, and coagulopathy.
NCoV in 2019 has several structural proteins such as
spinoprotrusion proteins, enveloped proteins, enveloped proteins,
etc.
(m) Contact with the nucleus (n). The Peak protein contains one
receptor binding domain (RBD) and recognizes angiotensin converting
enzyme 2 (ACE2) on the cell surface receptor. In 2019, it was
revealed that the spike protein RBD in nCoV strongly interacts with
the human ACE2 receptor, causing intracellular reception and viral
replication in the lung host.
2019-n Cobalt virus infection or vaccination provokes an immune
response and produces antibodies in the blood. This antibody
prevents viral infection. Once infected, it remains in the
circulatory system for months to years and rapidly and tightly
binds to pathogens to prevent viral replication. These antibodies
are called neutralizing antibodies. Neutralizing antibody tests
determine whether a person can prevent a viral infection.
Principle of Detection
This kit uses immunochromatography. The test card contains quality
control line C, test line T and reference line R. The sample (serum
/ blood / whole blood) diffuses onto the loading well by
capillarity. The binding pad maker s-rbd binds to the ACE2 protein
immobilized on the NC membrane and detects the signal at the T-line
position. If the neutralizing antibody is present in the sample,
the neutralizing antibody binds to the labeled s-rbd antigen as it
flows through the labeled pad. Neutralizing antibodies block the
binding of s-rbd to ACE2, causing a decrease in signal values. The
T-ray signal value has a negative correlation with the content of
neutralizing antibody. If the antibody concentration is high enough
in the middle, there is no color in the T line. The reference line
r and the quality control line c must be colored regardless of
whether the t line is colored or not. 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 sample buffer.
Test card: Consists of aluminum foil bag, desiccant, test sheet and
plastic card. The test sheet consists of water-absorbent paper,
nitrocellulose membrane, sample pad, adhesive pad, and rubber
plate. The nitrocellulose membrane is coated with ACE2 protein on
the T line (test line), Ab on the C line (quality control line),
and standard Ab on the R line (reference line), and the label 2019
nCoVAb is affixed to the adhesive plate.
Sample buffer: Phosphate, sodium azide, etc.
Storage Conditions and Validity
Keep at 2 ° C to 30 ° C and the effective period is 12 months.The aluminum foil bag is valid for 1 hour.
Lot No .: See label for details.
Validity period: See label.
Sample Requirements
1. Collect serum, plasma or whole blood samples.
2. Sediments and suspended solids in the sample may affect the
experimental results and should be removed by centrifugation.
3. Anticoagulant: Heparin, EDTA, sodium citrate are ineffective.
4. Venipuncture is performed by a professional medical staff. We
recommend that you give priority to serum / plasma tests. In
emergencies and special cases, a patient's entire blood sample can
also be used for rapid testing.
5. The storage time of serum and plasma samples at room temperature
should not exceed 8 hours. They are
It can be stored at 2 ° C to 8 ° C for 5 days and below -20 ° C for
6 months, but avoid repeated freeze-thaw cycles. Whole blood
samples should not be stored frozen at 2 ° C-8 ° C within 48 hours.
Test Method
Please read the instructions carefully before testing. Allow all
reagents to cool to room temperature before testing. The test is
conducted at room temperature.
1. Remove the test card from the packaged reagent bag and use it
within 1 hour.
2. Add 20 μL of sample (whole serum and plasma), add 2 drops of
sample buffer (about 60 μL), and start the clock.
3. After reacting at room temperature for 10 to 15 minutes, read
the results. After 20 minutes, the result was invalid.
Interpretation of Test Results
Figure to judge the result of the test card:
1. Invalid result: Quality control line (c line) has no reaction
line, is invalid and needs to be retested.
2. Negative result: A red band appears on the test line (T line)
and the color is higher than or equal to the reference line (R
line), and the color is on the quality control line (C line) and
the reference line (R line). arrive.
3. Positive result: The test line (T line) has no red band and is
smaller than the reference line (R line), and the control line (C
line) and reference line (R line) are colored.
Limitation of Test Method
1. This kit is used for qualitative tests and is used only for
in-vitro assisted diagnosis.
2. Make sure to add the appropriate amount of sample and perform
the test. If the sample size is too large or too small, the results
may be incorrect.
3. Hemolysis, blood fats, jaundice, and contaminated samples should
be avoided as they can affect test results.
4. The test results of this reagent are for clinical reference only
and cannot be the sole basis for clinical diagnosis and treatment.
The final diagnosis should be a combination of evaluation and
laboratory results from all clinical trials.
Product Performance Indicators
1. Analysis of specificity
1.1 1.1 Cross-reactivity: As a result of evaluating the following
types of antibody interfering reagents, there was no
cross-reactivity.
| 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: The following substances are added to the sample at specific concentrations to assess potential interference in the 2019 nCoV and Ab test items. As a result, none of the interfering substances interfered with the detection of the 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 study: Using the above 2019 NCOVIGAB detection reagent (colloidal gold method) as a comparative reagent, 120 positive samples and 300 negative samples are selected and tested. The research results can be 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 used only for in vitro diagnosis.
2. This product is a disposable product and cannot be recycled.
3. Read the instructions carefully before starting work and perform
the experimental work according to the reagent instructions.
4. Avoid inspections under harsh environmental conditions
(including 84 disinfectants, sodium hypochlorite, alkali or
acetaldehyde, high concentration corrosive gases such as dust).
After the experiment is over, disinfect the laboratory.
5. All samples and reagents used are considered potential
contagious substances and should be disposed of in accordance with
local laws and regulations.
6. Reagents should be used within the shelf life indicated on the
package. Use a test card as soon as you remove it from the aluminum
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 |
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 Standard Q Antigen Test
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