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 New Coronavirus
neutralizing antibodies in human serum, plasma and whole blood
samples.
2019- New Coronavirus is a kind of New Coronavirus. β Coronavirus.
It can cause viral pneumonia. The main clinical manifestations are
fever, fatigue and dry cough. A few patients will also have nasal
congestion, runny nose, sore throat, diarrhea and other symptoms.
Critical cases usually develop dyspnea and / or hypoxemia after one
week. Critical cases rapidly develop into acute respiratory
distress syndrome, septic shock, uncorrectable metabolic acidosis
and coagulation disorder.
New Coronavirus has a variety of structural proteins, such as
envelope protein (S), envelope protein (E) and membrane protein.
Among them, spike protein contains a receptor binding domain (RBD),
which is responsible for recognizing angiotensin converting enzyme
2 (ACE2) on cell surface receptors. It was found that the 2019-n
coronavirus spike protein RBD interacted strongly with human ACE2
receptor, resulting in host cell endocytosis and virus replication
in the lung.
New Coronavirus infection or vaccination can trigger immune
responses and produce antibodies in the blood. Secreted antibodies
can prevent viral infection. After infection, they will stay in the
human circulatory system for months to years, and quickly and
firmly combine with pathogens to prevent virus replication. These
antibodies are called neutralizing antibodies. Neutralizing
antibody tests can determine whether a person can prevent viral
infection.
The kit uses immunochromatography. The test card includes quality
control line C, test line T and reference line R. the capillary
action load and binding of test samples (serum / plasma and whole
blood) are combined with s-rbd manufacturer's pad. ACE2 is fixed in
NC membrane protein to detect the position line and send a signal.
If there is a neutralizing antibody in the sample, it will bind to
the labeled s-rbd antigen when it flows through the labeling pad.
Neutralizing antibody can prevent s-rbd from binding to ACE2,
resulting in the decrease of signal value. The signal value of
T-line was negatively correlated with the content of neutralizing
antibody. When the antibody concentration is high enough, T-ray is
colorless. The reference line R and the quality control line C are
colored regardless of whether the T line is colored or not. Adopt
product pipeline C
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 a 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 film, sample pad, bonding pad and rubber
plate. Nitrocellulose membrane t line (detection line) covers ACE2
protein, C line (quality control line) covers quality control line,
r line (reference line) covers reference AB, and the binding pad
contains label 2019 ncovab.
Sample buffer: phosphate, sodium azide, etc.
The storage temperature is 2 ℃ ~ 30 ℃, and the validity period is
12 months.
The validity period of aluminum foil package is 1 hour.
Production batch.: See label for details.
Deadline: see the label for details.
1. Collect serum, plasma or whole blood samples.
2. The sediment and suspended solids in the sample may affect the
experimental results and should be removed by centrifugation.
3. Anticoagulation: heparin anticoagulation, EDTA anticoagulation
and sodium citrate anticoagulation have no obvious effect.
4. Blood collection shall be carried out by medical personnel. It
is recommended to give priority to serum / plasma testing. In
emergency or special cases, the patient's whole blood sample can
also be used for rapid detection.
5. Serum and plasma samples were stored at room temperature for
more than 8 hours. He / she / they
It can be stored at 2-8 ℃ for 5 days and below 20 ℃ for 6 months,
but repeated freezing and thawing should be avoided. Whole blood
samples should not be frozen and should be stored at 2 ℃ to 8 ℃ for
no more than 48 hours.
Test card Description:
1. Invalid result: the non response line (line C) on the quality
control line is invalid and should be retested.
2. Negative result: the test line (t line) is displayed as a red
bar, the color is higher than or equal to the reference line (r
line), and the quality control line (C line) and reference line (r
line) are colored.
3. Positive results: there is no red band on the test line (t
line), the color of the red band on the test line (t line) is less
than the reference line (r line), and the quality control line (C
line) and reference line (r line) are color.
1. This kit is used for qualitative detection and only for in vitro
auxiliary diagnosis.
2. Ensure that an appropriate number of samples are added for
testing. Too much or too little sample size will lead to inaccurate
results.
3. Hemolysis, lipid, jaundice and contaminated samples may affect
the test results and should be avoided.
4. The test results of this reagent are only for clinical reference
and should not be used as the only basis for clinical diagnosis and
treatment. The final diagnosis shall be made after a thorough
evaluation of all clinical and laboratory results.
1. Specificity analysis
1.1.1 Cross-reaction: The following types of antibody interfering
reagents were evaluated and no cross-reaction was found.
| 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 sample at specific concentrations to assess their potential interference in the 2019 nCoV and Ab test items. The results showed that all kinds of interfering substances did not interfere 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: 120 positive specimens and 300 negative specimens were selected for detection with the listed 2019 NCOVIGAB detection reagent (colloidal gold method) as the control reagent. 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 disposable and cannot be recycled.
3. Read the operating instructions carefully before operation and
carry out the experimental operation in strict accordance with the
reagent instructions.
4. Avoid testing under harsh environmental conditions (including 84
disinfectants, sodium hypochlorite, acid, alkali, acetaldehyde and
other high concentration corrosive gases, dust, etc.) After the
experiment, the laboratory should be disinfected.
5. All samples and reagents used should be considered as
potentially infectious substances and treated in accordance with
local regulations.
6. The reagent shall be used within the validity period indicated
on the outer package. The test card shall be used as soon as
possible after being taken out of 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
SUNGO Europe B.V.
Olympisch Stadion 24, 1076DE Amsterdam, Netherlands
