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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 to qualitatively detect novel coronal virus
neutralizing antibodies in human serum, plasma, and whole blood
samples.
Corona beer is a new long corona virus. Corona virus. May cause
viral pneumonia, the main clinical symptoms are fever, tiredness,
dry cough. A small number of patients also show symptoms such as
stuffy nose, runny nose, sore throat and diarrhea. Severe illness
usually follows a week with dyspnea and/or hypoxemia, acute dyspnea
syndrome, septic shock, refractory metabolic adoxis, and
coagulation dysfunction.
New coronavirus infections or vaccinations in 2019 can cause an
immune response and antibody production in the blood. Secreted
antibodies protect against viral infection. After infection, they
stay in the body's circulatory system for months to years, rapidly
binding to pathogens to prevent viral replication. These antibodies
are called neutralizing antibodies. Neutralizing antibody tests can
determine whether a person is protected against viral infection.
The kit uses immune colorimetry. The inspection card contains
quality control line C, test line T and reference line R. The
detection of NC membrane protein and signal position line signal
transmission were carried out by detecting s-RBD manufacturing
plate combined with capillary sample (serum/plasma and whole blood)
by diffusion loading, binding and immobilization ACE2. When
neutralizing antibodies are present in the sample, they bind to the
labeled S-RBD antigen when passing through the labeled S-RBD
antigen. Neutralizing antibodies prevent S-RBD from binding to
ACE2, resulting in a decrease in signal values inversely related to
neutralizing antibody content. At very high concentrations of
neutralizing antibodies, the T-line becomes colorless. Whether
reference lines R and QCC are stained by T lines. Use quality
control line C
If the C line is not colored, the test is invalid and the sample
needs to be tested again.
The kit consists of test cards and sample buffers.
Test card: aluminum foil bag, desiccant, test strip, plastic card
composition. The test strip consists of absorbing paper,
nitrocellulose film, test pad, bonding pad and adhesive tape. T
line (test line) of nitrifying membrane covers ACE2 protein, C line
(QC line) covers Ab of QC line, R line (reference line) covers
reference Ab, pad contains label 2019.
Sample buffer: phosphate, sodium bambooide, etc.
The storage temperature is 2℃ ~ 30℃, and the validity period is 12
months.
Aluminum foil bags are valid for 1 hour.
Production Lot Number: Refer to the label for details.
Expiry date: Please see the label for details.
1. Serum, plasma or whole blood samples were collected.
2. Sediment and plankton in the sample will affect the experimental
results, so it needs to be removed by centrifugation.
3. Anti-coagulant: luffa anti-coagulant, EDA anti-coagulant, sodium
citrate anti-coagulant effect is not obvious.
4. Blood collection by experts is needed. Serum/serum/plasma tests
are recommended. A patient's whole blood sample can also be used
for rapid testing in emergency or exceptional circumstances.
5. Serum and plasma samples should not be stored for more than 8
hours at room temperature.
2 ~ 8°C within 5 days, less than -20°C can be stored for 6 months,
but please avoid repeated freezing melting. Whole blood samples do
not freeze and need to be stored within 48 hours at 2°C to 8°C.
Please read the instructions carefully before testing. All reagents
must be returned to room temperature prior to testing, which must
be conducted at room temperature.
1. Take the test card out of the box and use it within 1 hour.
2. Add 20L sample (serum, plasma or whole blood) to Vail filled
with test card, add 2 drops (~ 60L) of sample buffer storage and
start timing.
3. After 10 to 15 minutes of reaction at room temperature, read the
results. Invalid after 20 minutes.
Test card description:
1. Invalid result: Quality management line (C line) is invalid and
needs to be tested again.
2. Negative result: The appearance color of test line (T line) is
above the reference line (R line), quality management line (C line)
and reference line (R line).
3. Positive results: The test line (T line) or the red watch band
cannot be seen on the red watch band. The test line (T line) is
below the reference line (R line), quality control (C) line and
reference line. Lines (R lines) are colored.
1. This kit is for qualitative analysis only for invitro diagnostic
purposes.
2. Please add appropriate test samples. If the sample size is too
large or too small, the result may be incorrect.
3. Hemolysis, lipids in the blood, jaundice, sample contamination,
etc., may affect the test results, so it must be avoided as far as
possible.
4. The test results of the reagent are for clinical reference only,
and cannot be used as the sole basis for clinical diagnosis and
treatment. The final diagnosis of the disease is made by combining
all clinical and examination results.
1. This product is only used for Invitro diagnosis.
2. This product is disposable and can't be reused.
3. Please read carefully before operation and strictly follow the
instructions of reagent for experimental operation.
4. Please avoid conducting experiments under harsh environmental
conditions (84 disinfectants, sodium hypochlorite, acid, alkali,
acetaldehyde, other corrosive gases with high concentration, dust,
etc.). Disinfection of the laboratory must be carried out after the
experiment.
5. All samples and reagents used shall be considered as potentially
infectious substances and shall be discarded in accordance with
district regulations.
6. The reagent must be used within the expiry date stated on the
package. To prevent moisture, the test card needs to be removed
from the aluminum foil bag as soon as possible after removal.
| 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 |
