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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 used for qualitative detection of 2019 ncov
neutralization
Antibodies in human serum, plasma and whole blood samples.
As a new type, 2019 ncov is a kind of β- Cov. It may cause viral
pneumonia, and the main clinical symptoms are fever, fatigue and
dry cough. Several patients are accompanied by nasal congestion,
runny nose, throat pain, diarrhea and other symptoms. Severe cases
often develop respiratory distress and / or hypoxemia after a week,
and serious cases rapidly progress to acute respiratory distress
syndrome, septic shock, difficult metabolic acidosis, and
coagulation dysfunction.
2019 ncov has several structural proteins such as spike (s),
envelope (E), and membrane
(m) and Nucleocapsid (n). Among them, the spike protein contains a
receptor binding domain (RBD) involved in the recognition of
angiotensin converting enzyme 2 (ACE2) on the cell surface
receptor. Research shows that the RBD of the 2019 ncov spike
protein strongly interacts with the human ACE2 receptor and causes
endocytosis and virus replication in the host cells of the lung.
2019 NV infection or vaccination causes an immune response that
produces antibodies in the blood. Secreted antibodies can prevent
viral infections. They exist in the human circulatory system for
several months to several years after infection, and quickly and
securely bind to the pathogen to prevent viral replication. These
antibodies are called neutralizing antibodies. Neutralizing
antibody tests can determine if a person has the ability to prevent
viral infections.
The kit consists of a test card and a sample buffer.
Test cards: aluminum foil bag, desiccant, test strip and plastic
cards. The strip is made up of absorbent, nitrocellulose membrane,
sample pad, inner liner and rubber plate. The T line (detection
line) of the nitrocellulose membrane was coated with the ACE2
protein, the C line (quality control line) was coated with the
antibody of the quality control line, and the R-line was coated
with a large antibody. Group. Combination pad is coated with 2019
ncov antigen.
Sample buffer: phosphoric acid, sodium azide
1.Collect serum, plasma, or whole blood samples.
2.The precipitates and floats in the sample affect the experimental
results, so they must be removed by centrifugation.
3.Use of anticoagulant: jellyfish skin, EDTA, sodium citrate
anticoagulant has little effect.
4.Blood sampling should be done by a medical specialist. Serum /
plasma test is the first choice. In case of emergency or special
circumstances, you can perform rapid inspection using the whole
blood sample of the patient.
5.Storage time of serum and plasma samples should not exceed 8
hours at room temperature. 2 ° C-8 ° Within 6 months, 5 days ° You
can save it in C, but do not repeat the freeze thaw cycle. The
freezing time of all blood samples must be 48 hours to 8 degrees
Celsius.
Read the instructions carefully before testing. Return all reagents
to room temperature before the test. Examinations should be
performed at room temperature.
1. Take the test card from the packaged reagent bag and use it
within 1 hour.
2. Test well loading well μ Add a sample of L (serum, plasma, or
whole blood) and then μ Add a sample buffer and start timing.
3. The result will be disabled after 20 minutes.
Interpretation of test cards
1. Invalid results: the quality control line (C line) is invalid
because there is no reaction line, and you need to do the test
again.
2.Negative results: the red band appears in the test line (t line),
the color rendering performance is the standard line (r line), the
quality control line (C line) and the reference line (r line).
3.Positive results: the red band is not displayed on the test line
(t line), and the red band of the test line (t line) is color coded
from the reference line (r line) and the quality control line (C
line), and the reference line (r line) is color coded.
This element is only used for in vitro diagnosis.
2. If the sample is too many or too small, the result is false.
3. Hemolysis, blood lipids, jaundice, and contaminated samples
should be affected because they may affect the test results.
4.The results of a reagent test are for clinical reference and
cannot be used as the sole basis for clinical diagnosis and
treatment. The final diagnosis of the 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: in New Coronavirus (2019 ncov) neutralizing antibody test items, the potential interference of the following substances is assessed by adding the following substances in a specific concentration sample. The results show that all kinds of interfering substances will not interfere with the detection results of reagents.
| 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 were selected from Novell coronavirus (2019 nCoV) IgG test reagents (colloidal gold method) as controls. The results are summarized below.
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%) | |||
This product is only used for in vitro diagnosis.
Cannot be used after disposal.
3. Before you begin, read the operation guide carefully and follow
the reagent guide.
4. Disinfectant, sodium hypochlorite, acid-base, acetaldehyde,
other corrosive gas, and environment in a harsh environment. After
experimentation, it is necessary to disinfect in the laboratory.
5. All samples and reagents used are potentially potentially
contagious and must be destroyed according to local regulations.
6. The reagent must be used within the validity period listed in
the outer package. Use the guidance card as soon as possible to
remove the card from the aluminum foil bag and prevent moisture.
