CTK Biotech has released the first of its kind rapid test in Rubella diagnostics with a 4-line semi-quantitative OnSite Rubella IgG/IgM Rapid Test. This novel, cost effective kit allows medical professionals to accurately distinguish if and when someone was infected with rubella or if successful vaccination has taken place. With high degree of agreement with the market leading ELISA kit and calibrated against WHO reference standard RUBI-1-94, this easy to use rapid test with fast results will become the go-to tool for rubella diagnosis.
Accurate rubella diagnostics is most critical in pregnant women or women at childbearing age. Acute rubella infection during the first trimester of pregnancy can result in birth defects such as deafness, cataracts, heart defects, mental retardation, and liver and spleen damage. Worldwide, an estimated 110,000 babies are born with birth defects due to acute rubella infection every year (who.org). When rubella infection status of a pregnant women or one of child bearing age is known, precautionary and proper measures can be taken.
- A disease caused by the rubella virus
- Is transmitted by air (coughing and sneezing)
- Vaccination is available to protect from infection, but not administered in all countries
- An infection during the 3-4th month of pregnancy is associated with fetal infections and birth defect (congenital rubella)
- SHOULD be tested for proper action and for a healthy baby
Who Should Get Tested for Rubella?
- Women of childbearing age
- Pregnant woman at first post-conceptual appointment, or in first-trimester
- Any person who’s rubella vaccination status is unknown
How Is Rubella Diagnosed?
- Clinical symptoms are unreliable to diagnosis Rubella.
– Rash symptom is not specific for rubella
– Up to 50% of rubella infection is asymptomatic
- Laboratory test is essential for diagnosis of Rubella.
1) Serological test is the primary diagnostic method: levels of IgG indicate if protective immunity is present; IgM and increase in IgG titer to indicate potential acute infection
2) Virus culture / PCR to confirm an acute infection.
Summary of OnSite Rubella IgG/IgM Rapid Test (Cat. R0243C)
The ONLY test on the market to predict if a patient is:
1. at risk of an infection, or
2. currently infected, or
3. protected from infection
- Differentiates 15 IU/mL and 250 IU/mL of IgG
- Be used with serum, plasma and WHOLE BLOOD specimens
- High degree agreement with the market leading ELISA on the BBI rubella performance panel
- IgG results are calibrated against WHO reference standard RUBI-1-94
- Evaluation with 10,000 random clinical specimens reported positive rates of 0.3-1.7% IgM, 80-94% IgG at 15 IUmL, and 3.4% IgG rate at 150 IU/mL
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