Active Member
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[China]
Address: Office Address: Building 4, No. 51 Jingbei 3rd Road, Jingkai Zone, Zhengzhou City. Henan Province,China.
Contact name:chen
Henan Lantian Medical Supplies Co.,Ltd. |
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The kit is used for the qualitative detection of neutralization in
2019-nCoV
Antibodies in human serum, plasma, and whole blood samples.
The 2019-nCOV, as a new type, is a type of nCOV. Can cause viral
pneumonia, the main clinical manifestations are fever, fatigue, dry
cough. A few patients are accompanied by nasal congestion, runny
nose, sore throat, diarrhea and other symptoms. critically ill
cases usually develop respiratory difficulties and / or hypoxemia a
week later, and severe cases rapidly develop into acute respiratory
distress syndrome, septic shock, difficult to correct metabolic
acidosis, and coagulation dysfunction.
There are several structural proteins in 2019-nCoV, including
spikes, envelope proteins, and membrane proteins
(M) and the Nuclear Cosid (N). Among them, the spiking protein
contains a receptor-binding domain (RBD) responsible for
identifying the angiotensin-converting enzyme 2 (ACE2) on the cell
surface receptors. It was found that RBD of spikes in 2019-nCoV
interacts strongly with the human ACE2 receptor, in turn leads to
endocytosis and viral replication of host cells in the lung.
2019-An nCoV infection or vaccination will trigger an immune
response that produces antibodies in the bloodstream. Antibodies
secreted can prevent virus infection. They exist in human
circulation for months to years after infection and quickly and
firmly bind them to the pathogen to prevent virus replication.
These antibodies are called neutralizing antibodies. Neutralizing
antibody tests can determine whether a person has the ability to
prevent viral infection.
The kit consists of test cards and a sample buffer.
Test card: composed of aluminum foil package, desiccant, test strip
and plastic card. Among them, the test paper consists of water
absorption paper, cellulose nitrate film, sample pad, binding pad
and rubber plate. The cellulose nitrate membrane T line (test line)
is coated with ACE2 protein, C line (QC line) with Ab,R line
(reference line) with reference Ab, binding pad containing
mark-mark 2019-nCoV Ab.
Sample buffer: phosphate, sodium nitride, etc.
Hold at 2 ℃ ~ 30 ℃ and valid is set to 12 months.
The unpacking period of the aluminum foil package is valid for one hour.
Batch number: See the label for details.
Deadline: See the label for details
1. collected serum, plasma, or whole blood samples.
The sediment and suspended objects in the 2. samples may affect the
experimental results and should be removed by centrifugation.
3. anticoagulation: heparin and EDTA, sodium citrate are not
significant.
4. blood collection shall be conducted by professional medical
personnel. Sera / plasma testing is recommended. Whole blood
samples of patients can also be used for rapid detection in
emergency or special situations.
The 5. serum and plasma samples should not be stored at room
temperature for more than 8 hours. They are out there
It can be stored from 2 to 8 ℃ for 5 days and 6 months below-20 ℃,
but repeated freeze-thaw cycles should be avoided. Whole blood
samples shall not be frozen and shall be kept at 2 ℃ ~8 ℃ for no
more than 48 hours.
Read the instructions carefully before testing. Return all reagents
to room temperature at room temperature.
1.The removes the test card from the packaged kit for use
within one hour.
2. adds 20 μL samples (serum, plasma or whole blood) to the loading
hole of the test card, then adds 2 drops (approximately 60 μL)
sample buffer and begins timing.
3. The results were read after 10-15 minutes of reaction at room
temperature. Invalid results after 20 minutes.
Figure for judging test card results:
1.Invalid result: quality control line (C) is not reactive and
should be retest.
2. negative result: a red strip appears in the test line (T line),
color color above or equal to baseline line (R line), quality
control line (C line) and baseline line (R line) coloring.
3. positive results: no red band on the test line (T), or less red
band on the test line (T) than reference line (R), mass control
line (C) and reference line (R).
1. The kit is used for qualitative detection and only for in vitro
assisted diagnosis.
2. ensures that an appropriate amount of samples is added for
testing. Too much or too small the sample size can cause inaccurate
results.
3. hemolytic, lipid blood, jaundice and contaminated samples may
affect the test results and these samples should be avoided.
4. The test results of this reagent are for clinical reference only
and should not be used as the sole basis for clinical diagnosis and
treatment. The final diagnosis of the disease should be made after
a comprehensive evaluation of all clinical and laboratory results.
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 Interference substances: In 2019-nCoV and in the Ab test program, add the following concentration to the sample to assess its potential interference. The results show that the various interfering substances do not disturb 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 study: When the marketed 2019-nCoV IgG Ab test reagent (colloidal gold method) was used as the control reagent, 120 positive samples and 300 negative samples were selected for testing. 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%) | |||
1. This product is used for in vitro diagnosis only.
2. This product is disposable and cannot be recycled.
3. carefully before operation and conduct experimental operation
strictly according to the reagent instructions.
4. avoids experiments in harsh environmental conditions
(environments containing 84 disinfectant, sodium hypochlorite, high
concentrations of corrosive gases such as acid, alkali, or
acetaldehyde, and dust). Laboratory disinfection shall be performed
after the experiment.
All 5. samples and used reagents shall be considered potentially
infectious substances and treated in accordance with local
regulations.
6. reagents shall be used within the period of validity indicated
on the outer package. The test card shall be used as soon as
possible after removal from the aluminum foil bag to prevent
moisture.
| 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 |
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
