INTENDED USE

The JEV IgG IgM Rapid Test Kit (Colloidal Gold) is intended for use by healthcare professionals, including laboratory technicians and clinicians. The test is designed to be used as an initial screening tool for the detection of JEV infection. Positive results should be confirmed by additional testing, such as a plaque reduction neutralization test (PRNT). Negative results do not rule out JEV infection and should be interpreted in conjunction with clinical symptoms and epidemiological risk factors. The JEV IgG IgM Rapid Test Kit (Colloidal Gold) is a valuable tool for the early diagnosis and management of JEV infection, which can help to reduce the morbidity and mortality associated with this disease.

SUMMARY AND EXPLANATION THE TEST

Japanese encephalitis (JE) is an infection of the brain caused by the Japanese encephalitis virus (JEV). While most infections result in little or no symptoms, occasional inflammation of the brain occurs. In these cases, symptoms may include headache, vomiting, fever, confusion and seizures. This occurs about 5 to 15 days after infection.
JEV is generally spread by mosquitoes, specifically those of the Culex type. Pigs and wild birds serve as a reservoir for the virus. The disease occurs mostly outside of cities. Diagnosis is based on blood or cerebrospinal fluid testing.
Prevention is generally with the Japanese encephalitis vaccine, which is both safe and effective. Other measures include avoiding mosquito bites. Once infected, there is no specific treatment, with care being supportive. This is generally carried out in a hospital. Permanent problems occur in up to half of people who recover from JE.
The disease primarily occurs in East and Southeast Asia as well as the Western Pacific. About 3 billion people live in areas where the disease occurs. About 68,000 symptomatic cases occur a year, with about 17,000 deaths. Often, cases occur in outbreaks. The disease was first described in Japan in 1871.

PRINCIPLE

The JEV IgG/IgM Rapid Test is a lateral flow chromatographic immunoassay. The test cassette consists of: 1) a burgundy colored conjugate pad containing JEV recombinant envelope antigens conjugated with colloid gold (JEV conjugates) and rabbit IgG-gold conjugates,2) a nitrocellulose membrane strip containing two test bands (G and M bands) and a control band (C band). The G band is pre-coated with the antibody for the detection of IgG anti-JE virus, M band is coated with antibody for the detection of IgM anti-JE virus, and the C band is pre-coated with goat anti rabbit IgG.