The Rubella IgM ELISA test , high accuracy, Elisa Sandwich method, for quantitative measurement

Product Name: The Rubella IgM ELISA test

Intended Use:

The Rubella IgM ELISA Test System is designed for the qualitative and/or quantitative detection of IgM antibodies to rubella virus in human serum. The test system is intended to be used to evaluate single sera for immune status or paired sera to demonstrate seroconversion, and is for in vitro diagnostic use.

Summary:

Rubella is an exanthematous viral disease of children and young adults. It is a self-limited and benign disease characterized by fever, mild upper respiratory symptoms, erythematous rash and suboccipital lymphodenopathy. Rubella can be a very serious disease early in pregnancy leading miscarriages or birth defects up to 85% of cases. Reinfection occurs more frecuently in vaccinated that in naturally immune individuals. The majority of these reinfections occur without symptoms. Rubella reinfections during pregnancy rarely results in transmission of the virus to the unborn child. Antibodies appear at the begining of the disease and initially both IgG and IgM can be detected. IgG antibodies usually persist throughout life. IgM antibodies IgM do not persist beyong 8 weeks.

Regents Provided

TEST PRINCIPLE

The ELISA method is based upon the capture of IgM in the sample with anti-IgM antibodies adsorbed on the polystyrene surface. Unbound immunoglobulins are washed off. Then the antigen labeled with peroxidase react with the IgM captured, and the unbound is eliminated by washing; bound antigen is developed with the aid of a substrate solution (TMB) to render a blue coloured soluble product which turns into yellow after adding the acid stopping solution.

Results

Calculations

1. Check Calibrator Factor (CF) value on the calibrator bottle. This value might vary from lot to lot. Make sure the value is checked on every kit.
2. Calculatethe cut-off value: Calibrator OD × Calibrator Factor (CF).
3. Calculate the Ab (Antibody) Index of each determination by dividing the O.D. value of each sample by cut-off value.

Example of typical results: Calibrator mean OD = 0.8 Calibrator Factor (CF) = 0.5 Cut-off Value = 0.8 x 0.5 = 0.400 Positive control O.D. = 1.2 Ab Index = 1.2/0.4 = 3 Patient sample O.D. = 1.6 Ab Index = 1.6/0.4 = 4.0

Samples with equivocal results must be retested and/or a new sample obtained for confirmation.

Established in 2009, Orient New Life Medical Co., Ltd., is specialized in high-tech biological diagnostic test development, research and production, as well as high-tech medical device development, research and production. New Life has built up two production base, which produce biological diagnostic test and endoscopic medical device respectively. Our products ranged in the following specialties: drug of abuse tests, fertility tests, infectious diseases tests, sexual transmitted diseases tests, tumor markers tests, cardiac markers tests, veterinary tests, and surgical stapler series.

NEW LIFE have 3 wholly-owned and joint stock subsidiary companies, including Orient New Life Medical  Co., Ltd., Orient Gene Biotech Co., Ltd., Qianjing Medical Equipment Co., Ltd.

Company's core technical team with more than 35 employees，3 doctors and 25 masters. They have many years of famous universities in the United States and pharmaceutical companies engaged in the project research and development, production and marketing, business management experience.Company owns hundreds of grade purification workshop and all level of quality checkout room, equipped with various production and testing equipment.