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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 the qualitative detection of novel coronavirus
neutralizing antibodies in human serum, plasma, and whole blood
samples.
2019-nCOV is a novel coronavirus that belongs to the β coronavirus.
It can cause viral pneumonia, with the main clinical manifestations
being fever, fatigue, and dry cough. A small number of patients
also have symptoms such as nasal congestion, runny nose, sore
throat, and diarrhea. Critical cases often develop dyspnea and/or
hypoxemia after one week, and critical cases rapidly progress to
acute respiratory distress syndrome, septic shock,
difficult-to-correct metabolic acidosis, and coagulation
dysfunction.
The novel coronavirus has a variety of structural proteins such as
panicle protein (S), envelope protein (E), and membrane protein
Among them, the spike protein contains a receptor binding domain
(RBD), which is responsible for recognizing angiotensin-converting
enzyme 2 (ACE2) on the cell surface receptor. The study found that
the 2019-nCoV spike protein RBD interacts strongly with human ACE2
receptors, which in turn causes host cells to endocytosis in the
lungs and viral replication.
2019-nCoV infection or vaccination triggers an immune response that
produces antibodies in the blood. Secreted antibodies protect
against viral infections. They remain in the body's circulatory
system for months to 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 is capable of
preventing a viral infection.
The kit uses immunochromatography. The test card contains quality control line C, test line T and reference line r. Samples are tested (serum/plasma and whole blood) for upward diffusion of capillary action loading, binding and S-RBD manufacturer pad binding immobilized ACE2 in the NC membrane protein, which can detect and signal the position line. If there is a neutralizing antibody in the sample, it binds to the labeled S-RBD antigen when it flows through the labeled pad. Neutralizing antibodies can prevent S-RBD from binding to ACE2, resulting in a decrease in signal values, and the t-line signal values are inversely correlated with neutralizing antibody content, and when the neutralizing antibody concentration is high enough, the t-rays are colorless. Regardless of whether the T-line is colored or not, reference line R and quality control line C are colored. Quality control line C is used
Quality control. If there is no color display on the C line, the test is invalid and the sample must be retested.
The kit consists of a test card and sample buffer.
Test card: it is composed of aluminum foil bag, desiccant, test
strip, plastic card. Among them, the test strip is composed of
absorbent paper, nitrified cotton film, specimen mat, lashing pad
and rubber sheet. The nitrified cotton film T-line (detection line)
coats the ACE2 protein, the C line (quality control line) coats Ab
on the quality control line, the R line (reference line) coats the
reference Ab, and the binding pad contains label 2019-nCoV Ab.
Sample buffers: phosphate, sodium azide, etc.
The storage temperature is 2 °C ~ 30 °C, and the validity period is 12 months.
The validity period of the aluminum foil bag is one hour.
Production lot number. : See labels for details.
Expiration date: See label for details.
1. Collection of serum, plasma or whole blood samples.
2. Deposits and suspended solids in the sample may affect the
experimental results and should be removed by centrifugation.
3. Anticoagulants: Heparin anticoagulants, EDTA anticoagulants and
sodium citrate anticoagulants have no obvious effect.
4. Blood collection should be carried out by a medical
professional. Priority is recommended for serum/plasma testing. In
urgent or exceptional circumstances, a patient's whole blood sample
may also be used for rapid testing.
5. Serum and plasma samples should not be stored at room
temperature for more than 8 hours. They
2 - 8 °C can be stored for 5 days, -20 °C below can be stored for 6
months, but repeated freeze-thaw should be avoided. Whole blood
specimens should not be frozen and should be stored at 2 °C ~ 8 °C
for no more than 48 h.
Read the instruction manual carefully before testing. Put all
reagents back to room temperature before testing, and testing
should be performed at room temperature.
1. Remove the test card from the packaged reagent bag and use it
within one hour.
2. Add 20 μL of sample (serum, plasma, or whole blood) to the test
card filling hole, add 2 drops (~60 μL) of sample buffer, and then
start timing.
3. React at room temperature for 10-15 min and read the results.
Invalid after 20 minutes.
Test Card Interpretation:
1. Invalid result: No reaction line on the quality control line (C
line) is invalid and should be re-tested.
2. Negative results: The test line (T line) appears with a red
band, and the color rendering is higher than or equal to the
reference line (R line), the quality control line (C line) and the
reference line (R line) colored.
3. Positive results: the red band is not seen on the detection line
(T line), or the red strip on the detection line (T line) is less
colored than the reference line (R line), and the quality control
line (C line) and the reference line (R line) are colored.
1. This kit is for qualitative testing and is only used for in
vitro auxiliary diagnosis.
2. Make sure to add an appropriate amount of sample for testing.
Too much or too little sample size can lead to inaccurate results.
3. Hemolysis, lipids, jaundice and contaminated samples may affect
the test results and 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. A final diagnosis of the disease should be made after a
comprehensive evaluation of all clinical and laboratory
results.
1. Analysis of specificity
1.1 1.1 Cross-reaction: The following types of antibody
interference reagents were evaluated, and the results showed that
there was 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: Add the following substances to the samples at specific concentrations to evaluate their potential interference in 2019-nCoV and Ab test projects. The results showed that all kinds of interfering substances did not interfere with the test results of this 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 research: 120 positive samples and 300 negative samples were selected for detection with the listed 2019-nCoVIgGAb detection reagent (colloidal gold method) as the comparative reagent. The research 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 only used for in vitro diagnostics.
2. This product is a disposable product and cannot be recycled.
3. Carefully read the instructions before operation, and carry out
experimental operations in strict accordance with the reagent
instructions.
4. Avoid experiments under harsh environmental conditions
(including 84 disinfectant, sodium hypochlorite, acid, alkali,
acetaldehyde and other high concentration corrosive gases, dust,
etc.). Laboratory disinfection should be performed after the end of
the experiment.
5. All samples and reagents used should be considered potentially
infectious substances and disposed of in accordance with local
regulations.
6. Reagents should be used within the validity period indicated on
the outer packaging. The test card should be used as soon as
possible after being removed from the 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
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