12 months at 2 to 30 degrees Celsius.
Aluminum foil is valid for 1 hour after opening.
Configuration number: see the label for more information.
Deadline: please refer to the label for details.
1.Collect serum, plasma, or whole blood samples.
2.The precipitates and floats in the sample affect the experimental
results, so they must be removed by centrifugation.
3.Use of anticoagulant: jellyfish skin, EDTA, sodium citrate
anticoagulant has little effect.
4.Blood sampling should be done by a medical specialist. Serum /
plasma test is the first choice. In case of emergency or special
circumstances, you can perform rapid inspection using the whole
blood sample of the patient.
5.Storage time of serum and plasma samples should not exceed 8
hours at room temperature. 2 ° C-8 ° Within 6 months, 5 days ° You
can save it in C, but do not repeat the freeze thaw cycle. The
freezing time of all blood samples must be 48 hours to 8 degrees
Read the instructions carefully before testing. Return all reagents
to room temperature before the test. Examinations should be
performed at room temperature.
1. Take the test card from the packaged reagent bag and use it
within 1 hour.
2. Test well loading well μ Add a sample of L (serum, plasma, or
whole blood) and then μ Add a sample buffer and start timing.
3. The result will be disabled after 20 minutes.
Interpretation of Test Results
Interpretation of test cards
1. Invalid results: the quality control line (C line) is invalid
because there is no reaction line, and you need to do the test
2.Negative results: the red band appears in the test line (t line),
the color rendering performance is the standard line (r line), the
quality control line (C line) and the reference line (r line).
3.Positive results: the red band is not displayed on the test line
(t line), and the red band of the test line (t line) is color coded
from the reference line (r line) and the quality control line (C
line), and the reference line (r line) is color coded.
Limitation of Test Method
This element is only used for in vitro diagnosis.
2. If the sample is too many or too small, the result is false.
3. Hemolysis, blood lipids, jaundice, and contaminated samples
should be affected because they may affect the test results.
4.The results of a reagent test are for clinical reference and
cannot be used as the sole basis for clinical diagnosis and
treatment. The final diagnosis of the disease should be based on a
comprehensive assessment of all clinical and laboratory results.
Product Performance Indicators
1. Specificity analysis
1.1 cross reaction: the following types of antibody evaluation were
conducted for interference with reagents, and 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|
1.2 interfering substances: in New Coronavirus (2019 ncov)
neutralizing antibody test items, the potential interference of the
following substances is assessed by adding the following substances
in a specific concentration sample. The results show that all kinds
of interfering substances will not interfere with the detection
results of reagents.
|Interfering substances||Concentration||Interfering substances||Concentration|
|Rheumatoid factor||≤500IU/mL||Human total IgG||≤14mg/mL|
|Histamine hydrochloride||10mg/mL||Triamcinolone acetonide||5mg /mL|
2.Clinical study: 120% positive and 300 negative samples were
selected from Novell coronavirus (2019 nCoV) IgG test reagents
(colloidal gold method) as controls. The results are summarized
2019-nCoV IgG Ab detection reagent (colloidal goldmethod)
|Sensitivity||95.83%, (95%CI: 90.62%～98.21%)|
|Specificity||98.33%, (95%CI: 96.16%～99.29%)|
This product is only used for in vitro diagnosis.
Cannot be used after disposal.
3. Before you begin, read the operation guide carefully and follow
the reagent guide.
4. Disinfectant, sodium hypochlorite, acid-base, acetaldehyde,
other corrosive gas, and environment in a harsh environment. After
experimentation, it is necessary to disinfect in the laboratory.
5. All samples and reagents used are potentially potentially
contagious and must be destroyed according to local regulations.
6. The reagent must be used within the validity period listed in
the outer package. Use the guidance card as soon as possible to
remove the card from the aluminum foil bag and prevent moisture.
Zhongxiu Science And Technology Co.,Ltd., is a high-tech enterprise
engaged in the research and development, production and operation
of in vitro diagnostic products. The in vitro diagnostic products
developed by the company cover POCT series, microbial series,
biochemical series and immune series reagents and supporting
The company has always adhered to the core concept of "fast and
accurate, living up to life", committed to providing society with
excellent products and services, and contributing to the cause of