2019 NCOV Phosphate Ag Rapid Test Kit Colloidal Gold 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
2019 NCOV Whole Blood Ag Rapid Test Kit Colloidal Gold Antigen Test
Intended Use
This kit is for qualitative testing of 2019 NCOV neutralization
Antibodies in human serum, plasma and whole blood samples
The 2019 NCOV is the new NCOV. The main clinical symptoms of viral
pneumonia are fever, fatigue and dry cough. Some patients complain
of stuffy nose, runny nose, sore throat, and diarrhea. Dyspnea or
hypoxemia develops after 1 week in severely ill patients, and acute
respiratory distress syndrome, infectious shock, metabolic
acidosis, and coagulation disorders develop rapidly in severely ill
patients.
2019 NCoV contains several structural proteins including
spinosaurus, envelope, envelope
(m) and nuclear cosid (n). Of these, the spy protein contains a
receptor binding domain (RBD) that is involved in the
identification of angiotensin converting enzyme 2 (ACE 2) on the
cell surface receptor. It was revealed that the rbd peak of ncov in
2019 strongly interacts with the human aceh2 receptor, causing
intracellular receptor in the host and viral replication in the
lung.
NCoV infection or vaccination in 2019 provokes an immune response
and produces antibodies in the blood. Virus infection can be
prevented by secreting an antibody. They are present in the human
circulation months to years after infection and rapidly bind to
pathogens to prevent viral replication. These antibodies are called
neutralizing antibodies. Neutralizing antibody tests determine
whether a person is capable of resisting a viral infection.
Principle of Detection
The immunochromatography test card used by KKit has a quality
control line c, a detection line t, and a reference line r. The
sample (serum / plasma / whole blood) is raised by capillarity in
the filling hole. The ACE 2 protein immobilized on the NC membrane
binds to the s-rbd on the pad, and the signal can be detected at
the position of the test line. Neutralizing the antibody in the
sample flows through the labeled pad and binds to the labeled s-rbd
antigen. Neutralizing antibodies interfere with the binding of
s-rbd to ACE 2 and reduce signal values. The T-ray signal value has
a negative correlation with the neutralizing antibody
concentration, and the T-line does not develop color when the
intermediate antibody concentration is sufficiently high. T line
Color the T line. The quality control line is used for quality
control. If there is no color display on line C, the test is
invalid and the sample is re-examined.
Main Components
The kit consists of a test card and sample buffer.
Test card: Consists of aluminum foil packaging, desiccant, test
sheet, plastic card. The test paper consists of a water-absorbent
paper, a cellulose nitrate film, a test piece pad, an adhesive pad,
and a rubber plate. The T line (test line) of the cellulose nitrate
membrane is covered with an adhesive pad containing the ACE 2
protein, C line (QC line), AB line, R line (reference line),
reference AB and NCOV AB marks.
Sample buffer: Phosphate, sodium nitride, etc.
Storage Conditions and Validity
Keep at 2 ° C~30 ° C and set the validity period to 12 months.
The opening period of the aluminum foil pack is 1 hour.
Lot number: Look at the label.
Deadline: See detail label
Sample Requirements
1. Collect serum, plasma or whole blood samples.
2. Sediments and suspended solids in the sample affect the
experimental results and must be removed by centrifugation.
Anticoagulant therapy Heparin, EDTA, sodium citrate are not
important.
3. Blood collection is performed by a professional medical staff.
Serum / plasma tests are recommended. The patient's entire blood
sample can also be used for rapid testing in emergencies and
special cases.
The storage time of serum and plasma samples at room temperature
should not exceed 8 hours. They are there
It can be stored at 2-8 degrees Celsius, 5 days Celsius, and 6
months Celsius, but repeated freeze-thaw cycles should be avoided.
Whole blood samples should not be frozen and should be stored at 2
° C-8 ° C for at least 48 hours.
Test Method
Please read the instructions carefully before testing. Bring all
reagents to room temperature.
1. Remove the test card from the packaging kit within an hour.
2. Add l sample (serum, plasma or whole blood) to the load hole,
add 2 drops (about 60 drops) to the μ test card, start buffering
the μ sample, and start time counting.
3. It reacts at room temperature for 10 to 15 minutes and gives a
result, but after 20 minutes, no result is obtained.
Interpretation of Test Results
Test card result judgment sheet
1. Invalid result: Quality control line (c) is invalid and needs to
be retested.
2. Negative result: Red stripes appear above or above the detection
line (T line), baseline (R line), quality control line (C line) and
baseline (R line).
3. Positive result: The red band on the test line (t), or the
following red band on the test line (t), instead of the reference
line (r), quality control line (c) and reference line (r).
Limitation of Test Method
1. The kit can be used not only for qualitative tests but also for
in-vitro assisted diagnosis.
2. Put an appropriate amount of sample in advance and inspect.
Results may be inaccurate if there are too many or too small
samples.
3. Hemolysis, blood fats, jaundice, and contaminated samples should
be avoided as they can affect test results.
4. It should not be the sole basis for clinical trials and
treatment. The final diagnosis of this disease should be made by
comprehensively assessing the results of all clinical and
experimental studies.
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 |
1.2 Interfering substances: In the 2019 NCoV and AB test plans, the following concentrations will be added to the sample to assess potential interference. As a result, it was found that each interfering substance did not interfere with the detection result 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: 120 positive samples and 300 negative samples are selected using a commercially available 2020 ncov igg antibody detection reagent (colloidal gold method) as a control reagent. The 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 collected.
3. Strictly follow the reagent instructions before surgery to
perform the experiment.
4. Avoid experiments in harsh environmental conditions (84
disinfectants, sodium hypochlorite, environments containing
corrosive gas and high concentrations of dust, such as acids,
alkalis, acetaldehyde). Disinfect after the experiment.
5. Samples and reagents used are considered potential contagious
substances and are treated according to local regulations.
6. Reagents should be used within the validity period of the
outsourced label. The test card must be removed from the aluminum
foil bag and used as soon as possible 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.
2019 NCOV Phosphate Ag Rapid Test Kit Colloidal Gold Antigen Test
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