1. Collect serum, plasma or whole blood samples.
2. Sediments and suspended solids in the samples may affect the
experimental results and should be removed by centrifugation.
3. Anticoagulants: The use of heparin, EDTA and sodium citrate
anticoagulants has no significant effect.
4. Blood collection should be carried out by professional medical
personnel. It is recommended to give priority to serum/plasma
detection. In emergency or special circumstances, whole blood
samples of patients can also be used for rapid detection.
5. Serum and plasma samples should not be stored at room
temperature for more than 8 hours, and can be stored for 5 days at
2℃ ~ 8℃, and for 6 months below -20℃, but avoid repeated freezing
and thawing. Whole blood samples shall not be frozen and stored at
2℃ ~ 8℃ for no more than 48 hours.
Read the instruction manual carefully before testing. Please
restore all reagents to room temperature before testing, and the
testing should be carried out at room temperature.
1. Take out the test card from the packaged reagent bag and use it
within 1 hour.
2. Drop 20μL sample (serum, plasma or whole blood) into the sample
adding hole of the test card, then drop 2 drops (about 60μL) of
sample buffer, and start timing.
3. Read the results when reacting for 10 ~ 15 minutes at room
temperature. The reading result is invalid after 20 minutes.
Interpretation of Test Results
Figure for judging test card results:
1. Invalid result: there is no reaction line in the quality control
line (C line), and the test is invalid, so the experiment should be
2. Negative result: the detection line (T line) appears red band,
and the color development is higher than or equal to that of the
control line (R line), and the quality control line (C line) and
the control line (R line) develop color.
3. Positive results: there is no red band in the detection line (T
line) or red band in the detection line (T line), but the color
development is lower than that of the control line (R line), and
the quality control line (C line) and the control line (R line).
Limitation of Test Method
1.This kit is a qualitative test, and is only used for auxiliary
diagnosis in vitro.
2. Please make sure that an appropriate amount of samples are added
for testing. Too much or too little sample may lead to inaccurate
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 of the disease should
be made after comprehensive evaluation of all clinical and
Product Performance Indicators
1. Analysis of specificity
1.1 Cross-reaction: The interference of the following types of
antibodies was evaluated with reagents, 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: The following substances were added to
the samples with specified concentrations, and their potential
interference in the neutralization antibody test project of novel
coronavirus (2019-nCoV) was evaluated. The results show that
various interfering substances will not interfere with the
detection 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: Using the novel coronavirus (2019-nCoV)IgG
antibody detection reagent (colloidal gold method) as the contrast
reagent, 120 positive samples and 300 negative samples were
selected for detection respectively, and 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%)|
1. This product is only used for in vitro diagnosis.
2. This product is disposable and cannot be recycled after use.
3. Read the instruction manual carefully before operation, and
carry out experimental operation in strict accordance with the
reagent instruction manual.
4. Avoid the harsh environment (such as the environment containing
high-concentration corrosive gases and dust such as 84
disinfectant, sodium hypochlorite, acid, alkali or acetaldehyde).
Laboratory disinfection should be carried out after the experiment.
5. All samples and used reagents should be regarded as potentially
infectious substances, and should be disposed of in accordance with
local regulations when discarded.
6. Please use the reagent within the validity period marked on the
outer packaging, and use the test card as soon as possible after
taking it 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