High Accuracy Rubella Igm ELISA TEST KIT

INTENDED USE

Rubella IgM Elisa test is intended for the qualitative detection of IgM antibody to rubella in human serum for the presumptive diagnosis of acute, recent, or reactive rubella infection

RESULTS

• For the assay to be valid, the mean OD value of negative controls must be less than or equal to 0.1 and the mean OD value of positive controls must be greater than or equal to 0.8.
• Cut off value = NCx2.1

NC= the mean absorbance value for two negative controls

When NC is less than 0.05, please calculate as 0.05.

• OD value of the sample ³ cut off value, it is positive for anti-Rubella IgM.

OD value of the sample < cut off value, it is negative for anti-Rubella IgM.

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