New Coronavirus Neutralizing Antibody Rapid Test For Serum Plasma
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
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Product Details
2019-NCoV Neutralizing Antibody Rapid Test (Immunochromatography) Precautions
Intended Use
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.
Principle of Detection
This kit uses immunochromatography. The inspection card contains a
quality control line C, an inspection line T, and an inspection
line R, and the sample to be examined (serum / plasma / whole
blood) diffuses upward by the capillary action at the edge end.
S-rbd, which contains markers in the binding pad, associates with
the ACE2 protein immobilized in the NC membrane to detect the
signal at the T line position. When neutralizing antibody is
present in the sample, it is combined with the s-rbd antigen
labeled in the marker pad. Neutralizing antibody inhibits s-rbd and
ACE 2 binding, and signal values decrease. There was a negative
correlation between the neutralizing antibody content and the
signal value of the T line. The control line R and the quality
control line C should be colored regardless of the color of the T
line. Quality control line C is used for quality control, but if
the C line has no color, the test is disabled, so the sample must
be retested.
Main Components
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
Storage Conditions and Validity
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.
Sample Requirements
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.
Test Method
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.
Interpretation of Test Results
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.
Limitation of Test Method
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.
Product Performance Indicators
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%) | |||
Precautions
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 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.
New Coronavirus Neutralizing Antibody Rapid Test For Serum Plasma
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