Intended Use

The Rubella IgG/IgM Rapid Test Cassette is a lateral flow chromatographic immunoassay for the qualitative monitoring of IgG and IgM antibodies to Rubella in whole blood, serum or plasma specimens, for patients who have an existing, diagnosed Rubella infection.

The relationship between rubella virus infection and perinatal adverse outcomes has been widely regarded. Generally speaking, Rubella virus infection in pregnant women is a rash disease that causes a mild degree of fever and can heal itself without treatment. However, once the rubella virus is vertically transmitted from the placenta to the fetus during pregnancy, it can lead to serious adverse pregnancy outcomes and the occurrence of birth defects, and even congenital rubella syndrome (CRS) in newborns. Symptoms of CRS include blindness, deafness, congenital heart disease, and mental retardation. Positive RV-IgM indicated acute RV infection, and significantly elevated RV-IgG titer also indicated acute RV infection. The Rubella IgG/IgM Rapid Test Cassette is a rapid chromatographic immunoassay for the qualitative monitoring of IgG and IgM antibodies to Rubella in whole blood, serum or plasma specimens, for patients who have an existing, diagnosed Rubella infection.

The Rubella IgG/IgM Rapid Test Cassette is a qualitative, lateral flow immunoassay for the detection of Rubella virus IgM and Rubella virus IgG antibodies in whole blood, serum or plasma. Each test consists of two components, an IgG component and an IgM component. In the IgG component, mouse anti-human IgG is coated in IgG test line region. During testing, the specimen reacts with Rubella virus antigen-coated particles in the test cassette. The mixture then migrates upward on the membrane chromatographically by capillary action and reacts with the mouse anti-human IgG in the IgG test line region.If the specimen contains IgG antibodies to Rubella virus, a coloured line will appear in the IgG test line region. In the IgM component, mouse anti-human IgM is coated in IgM test line region. During testing, IgM antibodies to Rubella virus, if present in the specimen, reacts with the Rubella virus antigencoated particles in the test cassette, and this complex is captured by the mouse anti-human IgM, forming a coloured line in IgM test line region. Therefore, if the specimen contains IgG antibodies to Rubella virus, a coloured line will appear in IgG test line region. If the specimen contains IgM antibodies to Rubella virus, a coloured line will appear in the IgM test line region. If the specimen does not contain IgG and IgM antibodies to Rubella virus, no coloured line will appear in either of the test line regions, indicating a negative result. Whether or not the IgG or IgM antibodies to Rubella virus are present in the sample, the Chicken IgG conjugated with colloid gold is bound to Goat anti-Chicken IgG in the membrane quality control zone (C) during chromatography, where a coloured line appears. The coloured line displayed in the quality control area (C) is the standard for determining whether there are enough specimens and whether the chromatographic process is normal. It also serves as the internal control standard for reagents.

Specification

Read time	10-20 min
Shelf life	36 months
Store temperature	2-30℃
Operation temperature	15-30℃
Sensitivity	IgG 95.1%; IgM 94.0%
Specificity	IgG 99.9%; IgM 98.8%
Accuracy	IgG 97.7%; IgM 98.2%

Why To Test

1.What is Rubella ?

Rubella, commonly known as German Measles, is a contagious viral infection caused by the rubella virus. It is different from the virus that causes measles. While many infections are mild or even asymptomatic, rubella poses a significant threat to pregnant women. If contracted during pregnancy, particularly in the first trimester, the virus can be passed to the developing fetus and cause serious birth defects known as Congenital Rubella Syndrome (CRS). Vaccination has made rubella rare in many countries, but it remains a concern in areas with low vaccination coverage.

2.How does Rubella spread?

The rubella virus spreads primarily through respiratory droplets when an infected person coughs or sneezes. It can also be transmitted through direct contact with infected respiratory secretions. A person can spread the virus from one week before to one week after the appearance of the characteristic rash. Importantly, individuals who are infected but show no symptoms can still transmit the virus. If a pregnant woman is infected, the virus can cross the placenta and infect the fetus, leading to CRS.

3.What are the symptoms of Rubella and severe Rubella?

Symptoms of rubella are often mild and may be absent in 25-50% of cases, making it easy to spread unknowingly. When present, symptoms typically appear 2 to 3 weeks after exposure .

Common Symptoms:

A red or pink rash that often starts on the face and spreads to the rest of the body (lasting about 3 days),Low-grade fever,Headache and Runny nose.
Swollen lymph nodes (particularly behind the ears and at the back of the neck) .

Severe Symptoms & Complications:

The most serious complications are associated with Congenital Rubella Syndrome (CRS), which occurs when a fetus is infected during pregnancy. This can lead to:

Miscarriage, stillbirth, or premature delivery.
Serious birth defects, including heart problems, loss of hearing or eyesight, intellectual disability, and damage to the liver or spleen .
In rare cases, mainly in adult women, rubella can cause complications such as arthritis and, very rarely, encephalitis (inflammation of the brain) .

Test Method

2026-01-26091319284

NEGATIVE: One coloured line appears in the control line region (C) of every section. No line appears in IgG and IgM test line region (G and M). It indicates a negative test result for IgG/IgM antibodies to Rubella virus.