COVID-19 ANTIBODY TEST KIT (SARS-COV-2)
NEW CORONAVIRUS TEST KIT (2019-NCOV) IGG / IGM (COLLOIDAL GOLD)
Preliminary screening test for patients with suspected COVID-19 infection
Genrui Biotech Inc. is one of the leading Chinese companies specialized in the development, manufacture and marketing of IVD equipment and reagents.
- CE (EU2020006)
- TUV ISO 134815-2016 (SX601312200001)
- COFEPRIS (52026069)
SEROLOGICAL TESTS APPROVED BY COFEPRIS AS OF JUNE 11, 2020 TO DETERMINE IGG AND IGM FOR COVID-19
INTERPRETATION OF POSITIVE TEST FOR ANTIBODIES AGAINST SARS -COV2
The presence of IgG-like antibodies suggests that the subject has been exposed to the virus and has developed an immune response, typically this occurs at least two weeks after exposure and clinical expression of the disease. It does not categorically determine that there is no longer a risk of contracting the disease, but suggests that it is of lower risk than those without antibodies.
The presence of IgM antibodies indicates that the subject has been exposed to the virus and suggests that contact has occurred in the two weeks prior to the sample. The presence of IgG and IgM antibodies simultaneously indicates that the disease is passing its acute form.
MAIN COMPONENT AND ADDITIONAL EQUIPMENT NEEDED
- Positive result, G only: If both the quality control line (C) and the detection line G appear, the IgG antibody has been detected again and the result is positive for the IgG antibody.
- Positive result, M only: If both the quality control line (C) and the detection line M appear, the IgM antibody has been detected again and the result is positive for the IgM antibody.
- Positive result, G and M: if the quality control line (C) and both detection lines G and M appear, the new coronavirus IgG and IgM antibodies were detected and the result is positive for both IgG and IgM.
- Negative result: If only the quality control line (C) appears and the detection lines G and M are not visible, no new coronavirus antibodies have been detected and the result is negative.
- Invalid Result: The QC line (C) does not appear, indicating that the test is invalid and you must retest the sample.
RECOMMENDATIONS AND WARNINGS
- For professional in vitro diagnostic use only. Do not use after the expiration date.
- Do not use if tube / bag is damaged or broken.
- The test is for single use only. Do not reuse under any circumstances.
- Handle all samples as if they contained infectious agents.
- Observe established precautions against microbiological risks during testing and follow standard procedures for the proper disposal of samples.
- Wear protective clothing such as lab coats, disposable gloves, and eye protection when testing samples.
- Humidity and temperature can negatively affect the results.
- Do not perform the test in a room with strong air flow, i.e. electric fan or strong air conditioning.
- The kit can be stored at room temperature or refrigerated (2-30 ° C).
- The test device expires to date printed on the sealed pouch.
- The test device should remain in the sealed pouch until use.
- DO NOT FREEZE. Do not use beyond the expiration date.