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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 element is used for qualitative examination of 2019 ncov
neutralizing antibody in human serum, plasma and whole blood
samples.
2019 corona beer is new coronavirus. Corona virus. The main
clinical symptoms of viral pneumonia are fever, exhaustion and dry
cough. A few patients will also have nasal congestion, runny nose,
sore throat and diarrhea. In critical cases, dyspnea or hypoxemia
will occur after one week. Critical cases will rapidly develop into
acute dyspnea syndrome, septic shock, refractory metabolic
acidosis, blood coagulation disorder, etc.
Infection with ncov or vaccination in 2019 will induce an immune
response that produces antibodies in the blood. Secrete antibodies
to prevent viral infection. After infection, they stay in the human
circulatory system for months to years. In order to prevent virus
replication, they quickly and firmly combine with pathogens. These
antibodies are called neutralizing antibodies. Neutralizing
antibody tests can tell whether a person has the ability to prevent
viral infection.
Kit used immunochromatography. The inspection card includes quality
management line C, inspection line T and reference line R. Check
the upward diffusion and loading of samples (serum / plasma and
whole blood), connect the RBD manufacturing plate, fix it with NC
membrane protein, detect ACE 2 and send position signal. If there
is a neutralizing antibody in the sample, it will bind to the
labeled s-rbd antigen through the labeled disc. Neutralizing
antibody can prevent the signal value from decreasing when s-rbd
binds to ACE2, and the content of neutralizing antibody is
negatively correlated with ACE2. When the middle and antibody
concentration is high enough, the T-line is colorless. The
reference lines R and QC have colors on the T line. C. use quality
management line
If the c-line is not displayed in color, the test is invalid and
the sample needs to be retested.
This kit consists of a test card and a sample buffer.
Test card: it is composed of aluminum foil bag, desiccant, test
tape and plastic card. The test paper is composed of absorbent,
nitrocellulose film, sample pad, binding pad and rubber pad.
Knitted film t line (inspection line) covers ACE 2 protein, C line
(QC line) covers QC line AB, r line (reference line) covers AB, and
the combination pad includes label 2019 ncov ab.
Sample buffer: phosphate, adenylate sodium, etc.
The storage temperature is 2 ~ 30 ℃, and the validity period is 12
months.
The validity period of aluminum bag is one hour.
Production product number: refer to the label for details.
Validity period: please refer to the label for details.
1. Collect serum, plasma or whole blood samples.
2. The sediment and floating objects in the sample will affect the
experimental results and need to be removed by centrifugation.
3. Prevent coagulation: prevent jellyfish skin from
anticoagulation, prevent EDTA from anticoagulation, and prevent
unclear anticoagulation of sodium citrate.
4. Blood collection needs professional personnel. Serum / serum /
plasma examination is recommended. Whole blood samples can be used
for rapid detection in emergency or special situations.
5.Serum and plasma samples shall not be stored at room temperature
for more than 8 hours.
The storage time is 2-8 ° C to 5 days and - 20 ° C to 6 months.
Avoid repeated thawing and freezing. The whole sample shall be
frozen and stored within 2 ° C to 8 ° C to 48 hours.
Please read the operating instructions carefully before testing.
All test drugs shall be put back to room temperature before the
test, and the test shall be carried out at room temperature.
1. Take out the test card from the package and use it within 1
hour.
2. Put 20L sample (serum, plasma or whole blood) into the charging
hole of the detection card, add two drops of sample buffer (~ 60L)
and start measuring the time.
3. See the results after 10-15 minutes of room temperature
reaction, and there will be no effect after 20 minutes.
Interpretation of test card:
1. Invalid result: the quality management line (line C) is invalid
and needs to be rechecked.
2. Voice results: detection line (t line), color higher than
standard line (r line), quality management line (C line), standard
line (r line).
3. Positive result: the red band of the test line (t line) cannot
be seen, or the red band of the test line (t line) is lower than
that of the standard line (r line). The quality control line (line
C) and reference line (line R) are colors.
1 this element is used for qualitative analysis and only for
in vitro auxiliary diagnosis.
2. Ensure that an appropriate amount of samples are added for
testing. If there are too many or too few samples, the results may
be inaccurate.
3. Hemolysis, hemostasis, jaundice and sample pollution may
affect the test results, which should be avoided as far as
possible.
4. The test results of this reagent are only for clinical
reference and cannot be used as the only basis for clinical
diagnosis and treatment. Based on all clinical and laboratory
results, the final diagnosis of the disease was made.
1. This product is only used for in vitro diagnosis.
2. This product is disposable and cannot be recycled.
3. Read the instructions carefully before operation and carry out
the experimental operation 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 must be carried out after the
experiment.
5. All used samples and reagents should be treated as potential
infectious substances in accordance with local regulations.
6. The reagent must be used within the validity period indicated on
the external package. After the detection card is taken out of the
silver foil bag, it should be used as soon as possible to avoid
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 |
