Serum Phosphoric Acid COVID-19 Neutralizing Ag Rapid Test Kit Sample Buffer
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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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 Ag Rapid Test Kit Sample Buffer
Intended Use
This kit is used for 2019 neutralization qualitative testing-nCoV.
Antibodies in human serum, plasma and whole blood samples.
2019-nCOV is a new type of nCOV.
Can cause viral pneumonia, the main clinical symptoms are fever,
tiredness and dry cough.
Some patients have stuffy nose, runny nose, sore throat, diarrhea
and other symptoms.
Severe cases usually develop dyspnea and / or hypoxemia one week
later. Severe cases rapidly develop into acute respiratory distress
syndrome, septic shock, difficult to correct metabolic acidosis and
coagulation dysfunction.
2019-nCoV contains some structural proteins, such as spike protein,
envelope protein and membrane protein.
(M) and riboside (N).
Among them, the spike protein contains the receptor binding domain
(RBD) related to the identification of angiotensin converting
enzyme 2 (ACE2) on the cell surface.
The RBD of spie of 2019-nCoV has a strong interaction with human
ACE2 receptor, which causes endocytosis and virus replication in
lung host cells.
2019-nCoV infection or vaccination can cause an immune response
that produces antibodies in the bloodstream.
Secreted antibodies can prevent virus infection.
They exist in the human circulation for months or years after
infection and bind quickly and firmly to the pathogen to prevent
the virus from replicating.
These antibodies are called neutralizing antibodies.
Neutralizing antibody tests can determine whether a person has the
ability to prevent viral infection.
Principle of Detection
The kit uses immunochromatography.
The test card, quality control line c, test line t, and reference line r, including the tested sample (serum / plasma / whole blood) spread upward according to the capillarity on the s-rbd nc film in the pad, and the position signal of the test line was detected.
The neutralizing antibody in the sample binds to the labeled S-RBD antigen as it flows through the labeled pad.
Neutralizing antibody prevents S-RBD from binding to ACE2, the signal value decreases, T-line signal value is negatively correlated with the content of neutralizing antibody, and the color disappears when the concentration of neutralizing antibody is high enough.
T-line is T-line with color.
Quality management line is used for quality management.
If the C line is not displayed in color, the test is invalid and the sample needs to be retested.
The test card, quality control line c, test line t, and reference line r, including the tested sample (serum / plasma / whole blood) spread upward according to the capillarity on the s-rbd nc film in the pad, and the position signal of the test line was detected.
The neutralizing antibody in the sample binds to the labeled S-RBD antigen as it flows through the labeled pad.
Neutralizing antibody prevents S-RBD from binding to ACE2, the signal value decreases, T-line signal value is negatively correlated with the content of neutralizing antibody, and the color disappears when the concentration of neutralizing antibody is high enough.
T-line is T-line with color.
Quality management line is used for quality management.
If the C line is not displayed in color, the test is invalid and the sample needs to be retested.
Main Components
The kit consists of a test card and a sample package.
Test card: composed of aluminum foil packaging, desiccant, test
strip and plastic card.
Among them, the test paper is composed of absorbent paper,
nitrocellulose film, sample pad, bonding pad and rubber plate.
Nitrocellulose membrane T line (test line) is ACE2 protein, C line
(QC line) is Ab, R line (baseline), benchmark Ab, labeling
2019-nCoVAb is included in the binding pad coating.
Sample buffers: phosphoric acid, sodium nitride, etc.
Storage Conditions and Validity
It is kept at 2 ℃ ~ 30 ℃ and the period of validity is set at 12
months.
The opening time of aluminum foil package is 1 hour.
Batch number: see the label for details.
Closing date: see the label for details
Sample Requirements
1.A sample of serum, plasma, or whole blood collected.
2.The precipitates and suspended solids in the samples may affect
the experimental results, so they need to be removed by
centrifugation.
3.Anticoagulant therapy: heparin, EDTA and sodium citrate are not
important.
4.Blood collection should be carried out by professional medical
personnel.
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 stored for more than 8
hours at room temperature.
They're right there.
It can be stored at 2-8 degrees Celsius for 5 days and below-20
degrees Celsius for 6 months, but avoid repeated freeze-thaw
cycles.
Whole blood samples cannot be frozen and must be stored at 2 ℃ to 8
℃ for 48 hours.
Test Method
Please read the instructions carefully before testing.
Restore all reagents to room temperature at room temperature.
1.Remove the test card from the test package for use within 1 hour.
2.Add a sample of 20 μ L (serum, plasma or whole blood) to the
loading hole of the test card, then add 2 drops (about 60 μ L) of
the sample buffer to start the timing.
3.The results were read after the reaction at room temperature for
10 ~ 15 minutes.
The result is invalid after 20 minutes.
Interpretation of Test Results
Figure used to judge the result of test card:
1. Invalid result: the quality management line (c) does not respond
and needs to be retested.
2. Negative result: red band is displayed on the test line (t
line), the color above the baseline (r line), the color of the
quality control line (C line), and the color of the baseline (r
line).
With or without red (R) on the reference line, and the test result
is less than 3 (R) on the reference line.
Limitation of Test Method
1. The kit is only used for qualitative detection and invitro
assisted diagnosis.
2. Confirm that appropriate equivalent samples are added for the
test. Too large or too small sample size may produce inaccurate
results.
3. Hemolytic, lipid blood, jaundice or contaminated samples may
affect the test results, so these samples should be avoided.
4. The test results of this reagent are only for clinical reference
and should not be used as the only basis for clinical diagnosis and
treatment. The final diagnosis of the disease must be made after a
comprehensive evaluation of all clinical and examination results.
Product Performance Indicators
1. Analysis of specificity
1.1 Cross reaction: evaluate the interference of the following type of antibody to the reagent and show 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 |
1.2Interfering substances: in the 2019 ncov and ab test procedures, the following concentrations were added to the samples to assess potential interference. The results show that various interfering substances will not interfere with the detection results 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 trial: when using commercial 2019 ncov IgG AB test reagent (gold colloid method) as control reagent, 120 positive samples and 300 negative samples were selected for the trial. The 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 invitro diagnosis.
2. This product is disposable and cannot be reused.
3. Please pay attention to the experimental operation in strict
accordance with the instructions of the reagent before operation.
4. Avoid experiments under harsh environmental conditions
(including 84 disinfectant, sodium hypochlorite, acid, alkali,
acetaldehyde and other high concentration corrosive gases and
dust). The disinfection of the laboratory should be carried out
after the experiment.
5. All samples and used reagents will be regarded as potentially
infectious substances and treated in accordance with local
regulations.
6. The reagent shall be used within the validity period indicated
on the packing box. The test card should be used as soon as
possible after being removed 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.
Serum Phosphoric Acid COVID-19 Neutralizing Ag Rapid Test Kit Sample Buffer
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