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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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This kit is for qualitative testing of 2019 ncov neutralization
Antibodies in human serum, plasma and whole blood samples
The 2019 type ncov is a new type β Cov. It can cause viral
pneumonia, and the main clinical symptoms are fever, lethargy, and
dry cough. Some patients have symptoms such as stuffy nose, runny
nose, sore throat, and diarrhea. Severe patients usually develop
respiratory distress and / or hypoxemia after 1 week, and severe
patients rapidly develop acute respiratory distress syndrome,
infectious shock, refractory metabolic acidosis, coagulopathy, etc.
Proceed.
2019 ncov has several structural proteins such as spinodon,
envelope, envelope, etc.
(m) Nuclear capsid protein (n). Among them, the spike protein
contains one receptor binding domain (RBD) and is involved in the
recognition of angiotensin converting enzyme 2 (ACE2) on the cell
surface receptor. The 2019 ncov peplomer RBD was found to interact
strongly with the human ACE2 receptor, causing intracellular
receptor and viral replication in the lung host.
In 2019, NV infection and vaccination will cause an immune
response, and antibodies will be produced in the blood. Antibody
secretion prevents viral infections. Once infected, it remains in
the circulatory system for months to years and binds to pathogens
quickly and safely to prevent viral replication. These antibodies
are called neutralizing antibodies. Neutralizing antibody tests
determine whether a person can prevent a viral infection.
The kit consists of a test card and sample buffer.
Test card: Aluminum foil bag, desiccant, test sheet, plastic card.
It consists of an absorbent, a nitrocellulose membrane, a sample
pad, a lining, and a rubber plate. The T line (detection line) of
the nitrocellulose membrane is coated with the ACE2 protein, the C
line (quality control line) is coated with the quality control
antibody, and the R line is coated with a large antibody. The group
sheet is coated with the 2019 ncov antigen.
Sample buffer: Phosphoric acid, sodium azide
1. Collect serum, plasma or whole blood samples.
2. Precipitates and suspended matter in the sample affect the
experimental results and must be removed by centrifugation.
3. Use of anticoagulants: jellyfish skin, EDTA, sodium citrate
Anticoagulants have little effect.
4. Blood collection should be done by a medical professional.
Priority is given to serum / plasma tests. In emergencies and
special cases, a patient's whole blood sample can be used for rapid
testing.
5. The storage time of serum and plasma samples at room temperature
should not exceed 8 hours. 2 ° C-8 ° Can be stored at ° C for 6
months and 5 days, but do not overwhelm the freeze-thaw cycle. All
blood samples should be frozen at 48 ° C to 8 ° C.
Please read the instructions carefully before the test. Bring all reagents to room temperature before testing. The inspection is performed at room temperature.
1. Remove the test card from the packaged reagent bag and use it
within 1 hour.
2. Test well loading Well μ add L (serum, plasma or whole blood)
sample, μ add sample buffer and start timing.
3. The result will be invalidated after 20 minutes.
Interpretation of test card
1. Invalid result: The quality control line (C line) is invalid.
There is no reaction line and it will need to be retested.
2. Negative result: A red band appears on the test line (t line),
and the color development performance is the standard line (r
line), quality control line (C line), and reference line (r line).
3. Positive result: No red band appears on the test line (t line).
The red band on the test line (t line) is color coded based on the
reference line (r line) and quality control line (C line), and is
color coded based on the reference line (r line).
This device is used only for in vitro diagnostics.
2. If there are too many or too small samples, the result will be
false.
3. Hemolysis, blood fats, jaundice, and contaminated samples should
be affected as they can affect test results.
4. Reagent test results are for clinical reference only and cannot
be the sole basis for clinical diagnosis and treatment. The final
diagnosis of this disease should be based on a comprehensive
assessment of all clinical and laboratory results.
1. Specificity analysis
1.1 cross reaction: the following types of antibody evaluation were
conducted for interference with reagents, and no cross reaction
occurred.
| 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: The new coronavirus (2019 ncov) neutralizing antibody test item evaluates the potential interference of the following substances by adding the following substances to a sample of a specific concentration. As a result, it was clarified 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 and 300% negative samples selected from Novell Coronavirus (2019 nCoV) IgG detection reagent (colloidal gold method) as controls. 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%) | |||
1.This product is used only for in vitro diagnosis.
2.It cannot be used after processing.
3. Before you start, read the operating guidelines carefully and
follow the reagent guidelines.
4. Disinfectant, corrosive gas such as sodium hypochlorite, alkali
acid, acetaldehyde, poor environment. After the experiment is over,
the laboratory needs to be disinfected.
5. All samples and reagents used are potentially contagious and
must be disposed of in accordance with local regulations.
6. Reagents must be used within the shelf life indicated on the
package. Use the guide card as soon as possible and remove it from
the aluminum foil bag to prevent moisture.
