1. Collect serum, plasma or whole blood samples.
2. Sediments and suspended solids in samples may affect the
experimental results and should be removed by centrifugation.
3. Anticoagulants: heparin, EDTA and sodium citrate had no
4. Blood collection should be carried out by professional medical
personnel. It is recommended to give priority to serum/plasma test.
In case of emergency or special circumstances, the whole blood
sample of patients can also be used for rapid detection.
5. The storage time of serum and plasma samples at room temperature
shall not exceed 8 hours. They ..
It can be stored at 2℃ to 8℃ for 5 days and below -20℃ for 6
months, but repeated freeze-thaw cycles should be avoided. Whole
blood samples should not be frozen and stored at 2℃~8℃ for no more
than 48 hours.
Please read the instructions carefully before testing. Please
reduce all reagents to room temperature before the test, and the
test should be carried out at room temperature.
1. Take out the test card from the packaged reagent bag and use it
within one hour.
2. Add 20μL sample (whole serum and plasma), then add 2 drops
(about 60μL) of sample buffer, and then start timing.
3. Please read the results when reacting for 10-15 minutes at room
temperature. After 20 minutes, the result is invalid.
Interpretation of Test Results
Figure for judging test card results:
1. invalid result: there is no reaction line on the quality control
line (line c), which is invalid, and the test should be carried out
2. Negative result: the red band appears on the test line (T line),
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)
3. Positive results: the test line (T line) has no red band, which
is smaller than the reference line (R line), and the quality
control line (C line) and reference line (R line) are colored.
Limitation of Test Method
1. This kit is used for qualitative detection, only for in vitro
2. Make sure to add an appropriate number of samples for testing.
Too much or too little sample size may lead to inaccurate results.
3. Hemolysis, lipidemia, jaundice and contaminated samples may
affect the test results, so these samples should be avoided.
4. The test results of this reagent are for clinical reference
only, and should not be used as the only basis for clinical
diagnosis and treatment. The final diagnosis should be made after
comprehensive evaluation and laboratory results of all clinical
Product Performance Indicators
1. Analysis of specificity
1.1 1.1 Cross-reaction: The following types of antibody
interference reagents were evaluated, and the results showed that
there was 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: Add the following substances to the
samples at specific concentrations to evaluate their potential
interference in 2019-nCoV and Ab test projects. The results showed
that all kinds of interfering substances did not interfere with the
test results of this reagent.
|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: 120 positive samples and 300 negative samples
were selected for detection with the listed 2019-nCoVIgGAb
detection reagent (colloidal gold method) as the comparative
reagent. The research 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 in vitro diagnosis.
2. This product is disposable and cannot be recycled and reused.
3. Read the instructions carefully before operation, and carry out
experimental operation in strict accordance with the reagent
4. Avoid testing under severe environmental conditions (including
84 kinds of disinfectants, sodium hypochlorite, high concentration
corrosive gases such as acid and alkali or acetaldehyde and dust).
After the experiment, the laboratory should be disinfected.
5. All samples and reagents used should be regarded as potentially
infectious substances and disposed of according to local laws and
6. Reagents should be used within the validity period marked on the
outer packaging. After taking it out of the aluminum foil bag, use
the test card as soon as possible to prevent moisture.
|Do not re-use||Store at 2℃～30℃|
|Consult instructions for use|
In vitro diagnostic medical
|Batch code||Use-by date|
|Keep dry||Keep away from sunlight|
Authorized representative in the
ZHONGXIU SCIENCE AND TECHNOLOGY CO.,LTD
Dingluan industrial zone ,Changyuan City,453400,P.R.CHINA
SUNGO Europe B.V.
Olympisch Stadion 24, 1076DE Amsterdam, Netherlands
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