Self Test Diagnostic Kit For Igm Antibody To 2019-Ncov Rapid Test

Self Test Diagnostic Kit For IgM Antibody To 2019-NCoV Rapid Test

INTENDED USE

The kit is used for the qualitative detection of novel coronavirus (2019-nCoV) IgM antibodies in human serum and plasma samples in vitro. It is only used as a supplementary detection index for suspected negative cases of new coronavirus nucleic acid detection, or in collaboration with nucleic acid detection in the diagnosis of suspected cases, and can not be used as a basis for the diagnosis and elimination of pneumonia caused by new coronavirus infection. It is not suitable for screening in general population.
Only for medical institutions.

The test results are positive and need further confirmation. Negative results can not exclude the possibility of infection.

This product is restricted to clinical use and emergency stockpile during the period of new coronavirus pneumonia infection since December 2019. It can not be used as a routine in vitro diagnostic reagent. The results of this kit are for clinical reference only. It is suggested that the disease be comprehensively analyzed combined with clinical manifestations and other laboratory tests.

Laboratory testing of the COVID-19 should comply with “the requirements of the laboratory guidelines for detection of coronavirus pneumonia”, and do a good job in biosafety.

Interpretation of test results

To develop color on C line only

To develop color on both C line and T line;

To develop color on T line only

If no C line is developed, the assay is invalid regardless of any color in the T line.

Samples should be processed according to infectious contaminants and samples should be collected again.

Sample requirements

• Serum and plasma samples were collected from the venous blood by conventional method. The treatment of plasma sample: heparin solution, sodium citrate solution and EDTA solution can be used to anticoagulate blood.
• Serum or plasma samples can be stored at 2 ~ 8 ℃ if tests will be done within 5 days, otherwise stored at -20 ℃. No more than 3 times of freeze-thaw.
• The result of haemolysis sample test is invalid.
• Samples containing suspended fibrin or polymer are recommended for centrifugation and supernatant for testing. Hemolytic samples can not be detected.
• There should be no other microbial contamination in the samples to be tested.
• The specimen transfer box should have special identification. After removing the specimen from the sealed bag, it must be sterilized by ultraviolet or 75% ethanol spray.
• Before use, the sample should be kept at room temperature for more than 30 minutes, and the sample should be mixed before freezing.

Biovantion Inc is independent from international department of Bioneovan Co., Ltd., which established in 2 0 0 5, is an in vitro diagnostic reagents manufacturer engaged in the research, development, production, and focus on clinical testing for infectious diseases, such as Hepatitis virus, Noro virus, Parvo virus test kits, our products include rapid test cassette and Elisa kits.

All our products have been registered in National Medical Products Administration of China, in year 2020 we get Certificate of ISO 13485:2016 – QUALITY MANAGEMENT SYSTEMS FOR MEDICAL DEVICES from SGS. More importantly, we have awarded the registration certificate from National Medical Products Administration for Diagnostic Kit for IgM Antibody to COVID-19 and IgG antibody to COVID-19 during the outbreak in China, and also we developed COVID-19 Antigen test ; Neutralizing Antibody Test, these products selling well all overthe world