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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 new coronavirus
(2019-nCoV) neutralizing antibodies in human serum, plasma, and
whole blood samples.
The new type of coronavirus (2019-nCoV) is a new type of
coronavirus, belonging to the beta genus of coronaviruses. It can
cause viral pneumonia. The clinical manifestations are mainly
fever, fatigue, and dry cough. A few patients are accompanied by
nasal congestion, runny nose, sore throat and diarrhea. Severe
cases often develop dyspnea and/or hypoxemia within a week, and
severe cases rapidly progress to acute respiratory distress
syndrome, septic shock, difficult-to-correct metabolic acidosis,
and coagulation dysfunction.
The new coronavirus has several structural proteins, including
spikes (S), envelope (E), membrane (M) and nucleocapsid (N). Among
them, the spike protein contains a receptor binding domain (RBD),
which is responsible for recognizing the cell surface receptor
angiotensin converting enzyme 2 (ACE2). Studies have found that the
RBD of the 2019-nCoV spike protein strongly interacts with the
human ACE2 receptor, which in turn leads to the endocytosis and
virus replication of host cells in the lung.
2019-nCoV infection or vaccination will trigger an immune response
and produce antibodies in the blood. The secreted antibodies can
prevent virus infection. They will exist in the human circulatory
system for months to years after infection, and will quickly and
firmly bind to pathogens to prevent virus replication. These
antibodies are called neutralizing antibodies. Neutralizing
antibody testing can determine whether people have this ability to
prevent viral infections.
The kit consists of a test card and sample buffer.
Test card: It is composed of aluminum foil bag, desiccant, test
strip and plastic card. The test strip is composed of absorbent
paper, nitrocellulose membrane, sample pad, bonding pad, and rubber
sheet. Nitrocellulose membrane T line (detection line) is coated
with ACE2 protein, C line (quality control line) is coated with
quality control line antibody, R line (control line) is coated with
control antibody, and the binding pad contains markers 2019-nCOV
antigen.
Sample buffer: phosphate, sodium azide, etc.
It can be stored at 2 ℃ to 30 ℃ for 12 months.
After the aluminum foil bag is unsealed, it is valid for 1 hour.
Product batch number: see label for details.
Expiration date: see label for details.
1. Collect serum, plasma or whole blood samples.
2. The sediment and suspended matter in the sample may affect the
results of the experiment and should be removed by centrifugation.
3. Anticoagulant: The use of heparin, EDTA and sodium citrate
anticoagulant has no significant effect.
4. Blood collection should be performed by professional medical
personnel. It is recommended to give priority to serum/plasma
testing. In emergency or special circumstances, the patient's whole
blood sample can also be used for rapid testing.
5. Serum and plasma samples should not be stored at room
temperature for more than 8 hours. They can be stored at 2°C to 8°C
for 5 days, and at -20°C they can be stored for 6 months but avoid
repeated freezing and thawing. Whole blood samples should not be
frozen and stored at 2℃～8℃ for no more than 48h.
Read the instruction manual carefully before testing. Please return
all reagents to room temperature before the test, and the test
should be performed at room temperature.
1. Take out the test card from the packaged reagent bag and use it
within 1 hour.
2. Add 20μL of sample (serum, plasma or whole blood) to the sample
hole of the test card, and then add 2 drops (about 60μL) of sample
buffer to start timing.
3. Read the result when reacting at room temperature for 10-15
minutes. The read result is invalid after 20 minutes.
Test card result judgment icon:
1. Invalid result: the quality control line (line C) has no
response line, and the test is invalid. The experiment should be
repeated.
2. Negative result: A red band appears on the test line (T line),
and the color is higher than or equal to the control line (R line),
and the quality control line (C line) and control line (R line) are
colored.
3. Positive result: there is no red band on the test line (T line)
or red band on the test line (T line), but the color is lower than
the control line (R line), the quality control line (C line) and
the control line (R Line) color development.
1. This kit is a qualitative test 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 may cause inaccurate results.
3. Hemolysis, lipemia, 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: The following types of antibodies were
evaluated for interference with reagents, and the results showed 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: The following substances were added to the specified concentration samples to evaluate their potential interference in the new coronavirus (2019-nCoV) neutralization antibody test project. The results show that various interfering substances will 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: Using the marketed new coronavirus (2019-nCoV) IgG antibody detection reagent (colloidal gold method) as a comparison 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 only used for in vitro diagnosis.
2. This product is a one-time use product, after use, it cannot be
recycled and reused.
3. Read the instruction manual carefully before operation, and
carry out the experimental operation in strict accordance with the
reagent manual.
4. Avoid conducting experiments in harsh environments (such as
environments containing 84 disinfectant, sodium hypochlorite,
acid-base or acetaldehyde and other high-concentration corrosive
gases and dust) conditions. Laboratory disinfection should be
performed after the experiment.
5. All samples and reagents after use should be regarded as
potentially infectious substances, and should be disposed of in
accordance with local regulations when they are discarded.
6. Please use the reagents within the validity period indicated on
the outer packaging, and use the test card as soon as possible
after taking it out of 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
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Olympisch Stadion 24, 1076DE Amsterdam, Netherlands
