1. Collect serum, plasma or whole blood samples.
2. The sediment and suspended matter in the sample may affect the
experimental results and should be removed by centrifugation.
3. Anticoagulants: heparin, EDTA and sodium citrate had no
significant effect on anticoagulants.
4. Blood collection should be carried out by professional medical
personnel. It is recommended that serum / plasma should be tested
first. In emergency or special cases, whole blood samples of
patients can also be used for rapid detection.
5. Serum and plasma samples should not be stored for more than 8
hours at room temperature, 5 days at 2 ℃～ 8 ℃ and 6 months at - 20
℃ without repeated freezing and thawing. The whole blood samples
should not be frozen and stored at 2 ℃ - 8 ℃ for more than 48
Read the instructions carefully before the test. Please return all
reagents to room temperature before the test, and the test should
be conducted at room temperature.
1. Take out the test card from the packaged reagent bag and use it
within 1 hour.
2. Add 20 drops to the sample adding hole of the test card μ L
sample (serum, plasma or whole blood), then add 2 drops (about 60
ml) μ 50) Sample buffer, start timing.
3. Read the results when reacting at room temperature for 10-15
minutes. The read result is invalid after 20 minutes.
Interpretation of Test Results
The results of the test card are as follows:
1. Invalid result: there is no reaction line in the quality control
line (line C), and the test is invalid, so the experiment should be
2. Negative results: the detection line (t line) appeared red band,
and the color was higher than or equal to the control line (r
line), quality control line (C line) and control line (r line).
3. Positive results: there was no red band in the test line (t
line) or red band in the test line (t line), but the color
development was lower than that of the control line (r line), and
the color development of the quality control line (C line) and the
control line (r line).
Limitation of Test Method
1. The kit is qualitative and only used for in vitro auxiliary
2. Please make sure to add the right amount of samples for testing.
Too many or too few samples may lead to inaccurate results.
3. Hemolysis, lipidemia, jaundice and contaminated samples may
affect the test results and should be avoided.
4. The test results of this reagent are only for clinical reference
and should not be used as the only basis for clinical diagnosis and
treatment. The final diagnosis of the disease should be made after
comprehensive evaluation of all clinical and laboratory results.
nsive evaluation of all clinical and laboratory results.
Product Performance Indicators
1. Analysis of specificity
1.1 cross reaction: the interference evaluation of the following
types of antibodies with reagents showed that there was no cross
|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 interference substance: the following concentration substances
were added into the specified concentration samples, and the
potential interference in the New Coronavirus (2019-nCoV)
neutralization antibody test items was evaluated. The results
showed that various interfering substances would not interfere with
the detection results of the 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: using the New Coronavirus (2019-nCoV) IgG
antibody test reagent (colloidal gold method) as the contrast
reagent, 120 positive samples and 300 negative samples were
detected respectively. The results were 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 a one-time use product, which cannot be recycled
3. Read the operation manual carefully before operation, and carry
out the experimental operation in strict accordance with the
4. Avoid to carry out the experiment in the bad environment (such
as the environment containing 84 disinfectant, sodium hypochlorite,
acid-base or acetaldehyde and other high concentration corrosive
gas and dust). The laboratory disinfection should be carried out
after the end of the experiment.
5. All samples and used reagents should be regarded as potentially
infectious substances, and should be disposed of in accordance with
6. The reagent should be used within the validity period marked on
the outer package. The test card should be used as soon as possible
after it is taken out of the aluminum foil bag 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