Henan Lantian Medical Supplies Co.,Ltd.
| Supply Ability | 10000 Kit/Kit per Day |
| Delivery Time | To be negotiated |
| Packaging Details | Kit |
| Product name | 2019-NCoV Neutralizing Antibody Rapid Test (Immunochromatography) |
| Composition | Detection card, sample buffer |
| Storage conditions | 2℃～30℃ |
| term of validity | twelve months |
| Sample requirements | Serum, plasma or whole blood |
| Brand Name | ZOSBIO |
| Model Number | 2019-NCoV Neutralizing Antibody |
| Certification | CE BfArm |
| Place of Origin | Henan,China |
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Product Specification
| Supply Ability | 10000 Kit/Kit per Day | Delivery Time | To be negotiated |
| Packaging Details | Kit | Product name | 2019-NCoV Neutralizing Antibody Rapid Test (Immunochromatography) |
| Composition | Detection card, sample buffer | Storage conditions | 2℃～30℃ |
| term of validity | twelve months | Sample requirements | Serum, plasma or whole blood |
| Brand Name | ZOSBIO | Model Number | 2019-NCoV Neutralizing Antibody |
| Certification | CE BfArm | Place of Origin | Henan,China |
| High Light | New Coronavirus Neutralizing Antibody Rapid Test ，Serum Coronavirus Neutralizing Antibody Rapid Test ，Plasma neutralizing antibody test for covid-19 | ||
This kit is used to qualify the normal coronavirus (2019 ncov) neutralizing antibody in human serum, plasma and whole blood samples.
New coronavirus (2019 ncov) is a novel coronavirus β Coronavirus belongs to genus. It causes viral pneumonia, and is mainly caused by fever, sorrow, and cough, and there are not many patients with symptoms such as nasal congestion, DDT, sore throat, diarrhea. Severe respiratory distress syndrome, septic shock, metabolic acidosis, and coagulation disorder are progressed.
The novel coronavirus has several structural proteins, including stab (s), envelope (E), membrane (m), and nuclear capsid (n). The receptor binding domain (RBD) has tyrosine receptor 2 (acs2). In the present study, it was clarified that the tyrosine RBD of 2019 ncov strongly interacts with the ACE 2 receptor of the human body, and it causes the endocytosis of the host cell in the lung and replication of the virus.
2019 ncov infection and vaccination can result in an immune response, and antibodies can be made in the blood. The secreted antibody prevents viral infection and exists in the circulating system of the body for several months to several months after infection, and quickly binds with the pathogen to prevent the replication of the virus. These antibodies are called neutralizing antibodies. Detecting neutralizing antibodies can determine whether the ability to prevent viral infections is provided.
The kit consists of a test card and a sample buffer.
Test card: aluminum foil bag, desiccant, tester sheet, plastic card. Of these, the sheet is composed of a water absorbing paper, a cellulose hydroxide film, a sample pad, a bonding pad, and an adhesive plate. There is an ACE 2 protein in the scaffold of the cellulose succinate membrane, the quality control line antibody is connected to the c-line (quality control line), and the contrast line is combined with the control line, and it is combined with the 2019 ncov antigen marked by the marker.
Sample buffer solution: phosphate, sodium azide
Save at 2 to 30 degrees Celsius, and the effective period is 12 months.
The aluminum foil bag is opened and the effective period is 1H.
Product lot number: see the label for details.
Product invalid date: see the label for details.
1 serum, plasma or whole blood samples.
Since precipitates and floatings in the sample may affect the experimental results, centrifugation must be removed.
Anticoagulants using anticoagulant heparin, EDTA and sodium citrate were not effective.
4. It is recommended that a professional medical staff should do so and prioritize serum / plasma examination. In case of an emergency or a special case, the patient's whole blood sample can also be used for quick inspection.
5.Serum and plasma samples can not exceed 8h at room temperature, can be stored at 5 to 8 degrees Celsius for 5 days, and can be kept at - 20 degrees Celsius for 6 months to avoid repeated freezing and thawing. The whole blood sample should not be frozen, and should not be stored above 48 h at 2 to 8 ° C.
Please read the usage instructions before the test. Return all reagents to room temperature before the test. Test should be done at room temperature.
1. Take out the test card from the packed reagent bag and use it within 1 hour.
2.Sample (serum, plasma or whole blood) 20 μ 2 drops of sample buffer solution μ L).
3. Reading after 20 minutes is invalid.
Explanation of the test card
1.An invalid result: the quality control line (C line) reaction line appears, the detection is invalid, and the retest should be done.
2.Negative result: the red band appears in the inspection line (t line), and the color is higher than the control line (r line), and the quality control line (C line) and the control line (r line) color.
3.Positive result: the red band does not appear in the inspection line (t line), and the red band appears in the inspection line (t line), but the color is lower than the control line (r line), and the quality control line (C line) and the control line (r line) color.
1.This kit is a qualitative test and is used only for in vitro diagnosis.
2. If the number of samples is too small or too small, the result may be inaccurate.
3. Hemolysis, lipidemia, jaundice, contamination samples should be avoided because it may affect the test results.
4. The results of this reagent are only provided for clinical reference and should not be the only basis for clinical practice, and the final diagnosis should be performed after overall evaluation of all clinical and laboratory results.
1. Specificity analysis
1.1Cross reaction: no interference was observed when the interference was tested for the following types of antibodies.
| 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 In order to evaluate the possibility of interferers, the following concentrations were added to the specified concentration samples. As a result, it was shown that various interferences did not interfere with the detection result 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 study: a novel test of the normal coronavirus (2019-ncov) IgG antibody test reagent (colloidal gold method) was carried out as a comparative reagent, and 120 positive and 300 samples were tested
| 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%) | |||
1.This product is for in vitro diagnosis.
2. This product is disposable, and cannot be used again.
3.
Avoid disseminated environments such as 84 disinfectants, sodium hypochlorite, acid alkaloids, acetaldehyde, and so on.
5. All samples and Empress's reagents are regarded as potential infectious substances and must be treated according to the local laws when disposing.
6.The reagent should be used within the effective period of the display of packaging. Use the soap card from the aluminum foil bag as soon as possible and prevent moisture.
Company Details
Business Type:
Manufacturer,Exporter,Seller
Year Established:
2016
Employee Number:
500~1000
Ecer Certification：
Active Member
Zhongxiu Science And Technology Co.,Ltd., founded in 2016, is located in Dingluan Industrial Zone, Changyuan City, Henan Province. The company covers an area of about 100 acres and the initial investment is about 200 million yuan. The company has a scientific and complete management system, a purifi... Zhongxiu Science And Technology Co.,Ltd., founded in 2016, is located in Dingluan Industrial Zone, Changyuan City, Henan Province. The company covers an area of about 100 acres and the initial investment is about 200 million yuan. The company has a scientific and complete management system, a purifi...
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