CDIA Rubella IgG/IgM Rapid Test Kit

Sample

Whole Blood/Serum/Plasma

Intended Use

The Rubella IgG/IgM Rapid Test Cassette is a rapid chromatographic immunoassay for the qualitative detection of antibodies (IgG and IgM) to Rubella (Virus) in Whole Blood/Serum/Plasma. It provides an aid in the diagnosis of infection with RV.

Storage

Store as packaged in the sealed pouch at temperature (4-30°C or 40-86°F). The kit is stable within the expiration date printed on the labeling.
Once open the pouch, the test should be used within one hour. Prolonged exposure to hot and humid environment will cause product
deterioration.
The LOT and the expiration date were printed on the labeling.

Performance Characteristics

Accuracy
A statistical comparison for IgM was made between the results yielding a clinical relative sensitivity: 96.8%, relative specificity: 98.0%, overall agreement: 97.6%. A statistical comparison for IgG was made between the results yielding a clinical relative sensitivity: 97.4%, relative specificity: 98.5%, overall agreement: 98.1%.

Precision

Reproducibility studies were performed for the Rubella IgG/IgM Rapid Test at three physician office laboratories (POL). Sixty (60) clinical serum specimens, 20 negative, 20 borderline positive and 20 positive, were used in this study. Each specimen was run in triplicate for three days at each POL. The intra-assay agreements were ＞99%. The inter-site agreement was ＞99%.

General Description

Rubella is an acute respiratory infection caused by the rubella virus (RV), including congenital infection and acquired acquired infection. Clinical features include short precursors, low fever, rash, and occipital lymph node enlargement. The general condition is mild, the course of the disease is short and the prognosis is good. But rubella is very easy to cause outbreaks, which can happen throughout the year, with many diseases in winter and spring. The susceptible age is mainly 1~5 years old. So the prevalence is prevalent in preschool children. Although the clinical symptoms are mild, the virus can infect the fetus through the fetal blood barrier. Both overt and non-dominant infection can lead to congenital congenital rubella syndrome (CRS), such as congenital fetal malformation, stillbirth, premature birth, etc. Therefore, the early diagnosis and prevention of Rubella are very important.