2℃~ 30℃, the validity period is 12 months.
The validity period of the unpackaged aluminum foil bag is 1 hour.
Details: Please refer to the label.
Expiry date: Please refer to "Label" for details.
1. Collect serum, plasma or whole blood samples.
2. The sediments and suspensions in the reagents have an impact on
the experimental results and are removed by centrifugal separation.
3. Anticoagulant: heparin, EDTA, sodium citrate anticoagulant have
4. Blood collection should be done by professional medical
personnel. It is recommended to give priority to serum and blood
sample examinations. In emergency or special circumstances, the
patient's whole blood sample can also be used for rapid testing.
5. Serum and plasma reagents should not be stored at room
temperature for more than 8 hours. These 2 days can be stored for 5
days, the temperature reaches ℃ 8 ℃, and then the temperature
reaches ℃ in the next 6 months, but repeated freezing and thawing
cycles must be avoided. The whole blood sample cannot be frozen,
and the temperature is 2℃~8℃ for more than 48 hours.
Please read the instructions carefully before taking the exam.
Please test all the reagents at room temperature to room
temperature, and test at room temperature.
1. Take out the test card from the packaged reagent bag and use it
within 1 hour.
2. Add L of the sample (serum, plasma or whole blood) in the
loading well of the μ test card, followed by the start timing of
adding 2 drops (approximately 60 drops of μL) of sample buffer.
3. Observe the result of the reaction for 10 to 15 minutes at room
temperature. The result is invalid after 20 minutes.
Interpretation of Test Results
Explanation of the test card
1. Invalid result: The quality management line (line C) is invalid
because there is no response line, and you need to retest.
2. Negative results: the red band is displayed on the test line (T
line), and the color rendering is represented by the standard line
(R line), the quality management line (C line) and the reference
line (R line).
3. Affirmative result: display the red band on the test line (T
line), color-code the red band of the test line (T line) from the
reference line (R line) and the quality management line (C line),
and put the reference line ( R line) coloring.
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: Due to the interference of reagents, the
following types of antibodies were evaluated, and no
cross-reactions occurred as a result.
|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 the new coronavirus (2019ncov)
neutralizing antibody test project, the potential interference of
the following substances is evaluated by adding the following
substances to a sample of a specific concentration. All kinds of
interfering substances will not interfere with the test results of
|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 research: Use the 2019 ncov igg ab test reagents
(colloidal gold method) that have been on the market as comparison
reagents, and select 120 positive reagents and 300 negative
reagents as tests. The results are summarized as follows.
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%)|
1. This product is only used for biological in vitro diagnosis.
2. It cannot be used after being voided.
3. Before starting, please read the operating instructions
carefully and follow the reagent instructions.
4. Disinfectant, sodium hypochlorite, acid and alkali solution,
acetaldehyde, other corrosive gases and environment in harsh
environment. After the experiment, it needs to be disinfected in
5. All samples and reagents used are potentially infectious and
must be destroyed in accordance with local regulations.
6. Reagents must be used within the validity period indicated on
the outer packaging. Remove the card from the aluminum foil bag to
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