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Serum Phosphoric Acid COVID-19 Neutralizing Ag Rapid Test Kit Sample Buffer

Henan Lantian Medical Supplies Co.,Ltd.

Serum Phosphoric Acid COVID-19 Neutralizing Ag Rapid Test Kit Sample Buffer

Brand Name : ZOSBIO

Model Number : 2019-NCoV Neutralizing Antibody

Certification : CE BfArm

Place of Origin : Henan,China

MOQ : To be negotiated

Price : To be negotiated

Supply Ability : 10000 Kit/Kit per Day

Delivery Time : To be negotiated

Packaging Details : Kit

Product name : COVID-19 Neutralizing Ag Rapid Test Kit Sample Buffer

Composition : Detection card, sample buffer

Storage conditions : 2℃~30℃

term of validity : 12 months

Sample requirements : Serum, plasma or whole blood

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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.

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


Serum Phosphoric Acid COVID-19 Neutralizing Ag Rapid Test Kit Sample Buffer

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

Serum Phosphoric Acid COVID-19 Neutralizing Ag Rapid Test Kit Sample Buffer

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


Serum Phosphoric Acid COVID-19 Neutralizing Ag Rapid Test Kit Sample Buffer

Do not re-use

Serum Phosphoric Acid COVID-19 Neutralizing Ag Rapid Test Kit Sample Buffer

Store at 2℃~30℃

Serum Phosphoric Acid COVID-19 Neutralizing Ag Rapid Test Kit Sample Buffer

Consult instructions for use

Serum Phosphoric Acid COVID-19 Neutralizing Ag Rapid Test Kit Sample Buffer

In vitro diagnostic medical

device

Serum Phosphoric Acid COVID-19 Neutralizing Ag Rapid Test Kit Sample Buffer

Batch code

Serum Phosphoric Acid COVID-19 Neutralizing Ag Rapid Test Kit Sample Buffer

Use-by date
Serum Phosphoric Acid COVID-19 Neutralizing Ag Rapid Test Kit Sample Buffer Keep dry

Serum Phosphoric Acid COVID-19 Neutralizing Ag Rapid Test Kit Sample Buffer

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Serum Phosphoric Acid COVID-19 Neutralizing Ag Rapid Test Kit Sample Buffer

Authorized representative in the

European Community

Serum Phosphoric Acid COVID-19 Neutralizing Ag Rapid Test Kit Sample Buffer

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


Serum Phosphoric Acid COVID-19 Neutralizing Ag Rapid Test Kit Sample BufferSerum Phosphoric Acid COVID-19 Neutralizing Ag Rapid Test Kit Sample BufferSerum Phosphoric Acid COVID-19 Neutralizing Ag Rapid Test Kit Sample BufferSerum Phosphoric Acid COVID-19 Neutralizing Ag Rapid Test Kit Sample Buffer
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.


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