LIMITATIONS OF THE TEST
1. This reagent is a qualitative test and cannot be used for
quantitative determination of antibody content.
2. This reagent is used for the detection of human whole blood,
serum or plasma samples. It cannot be used for the detection of saliva, urine or other body
fluids.
3. The test results of this product are for clinical reference only
and should not be used as the sole basis for clinical diagnosis and treatment. The clinical
management of patients should be considered in combination with their symptoms / signs, medical
history, other laboratory tests, treatment response, and epidemiology.
4. In the early stage of infection, if the virus-specific IgM
antibody is not produced or the titer is very low, it will lead to negative results. If a virus
infection is suspected, the patient should be reminded to check again within 10-20 days and take a
second sample, which should be the same as the first sample. Simultaneously test under
conditions to determine if there is a seroconversion or a virus-specific IgG or IgM antibody
titer that is significantly
higher in the first infection.
5. The interpretation of positive results should be further
determined in conjunction with clinical symptoms and other etiological methods (nucleic acid and
sequencing).
6. Negative results indicate that no new coronavirus IgM / IgG
antibodies have been detected, but if the new coronavirus IgM / IgG antibody content in the sample
is below the minimum detection limit of the kit, negative results may also be obtained.
PRODUCT PERFORMANCE
Appearance: The appearance of the reagent should be neat and tidy,
and the text symbol should be clearly marked. There is no leakage. The test
strip is intact.The positive rate, precision, and minimum detection limit of this
product meet therequirements of quality standards, and the product quality is
stable during the validity period. Hepatitis B virus surface antigen antibody, Hepatitis C
virus antibody, Hepatitis E virus IgM antibody, Hepatitis A virus IgM antibody, Syphilis
antibody, HIV antibody, Rheumatoid factor, Antinuclear antibody, Coxsackie virus A16 IgM
antibodies, adenovirus IgM antibodies, respiratory syncytial virus IgM
antibodies, influenza A virus antibodies, EV71 virus IgM antibodies, Mycoplasma pneumoniae
IgM antibodies, anti-mitochondrial antibody (AMA) positive samples, and
high-concentration
non-specific IgG (serum total IgG) will not cause interference with
this product.
NOTES
This product is for in vitro diagnostic use only.
The operation steps cannot be omitted or simplified.
The positive samples detected by this kit need to be confirmed by
other methods.
Disinfect or treat all samples and reagents as potential sources of
contamination in accordance with local regulations.
INDEX OF SYMBOLS
