INTENDED USE

The Lyme IgG/IgM Rapid Test is a lateral flow chromatographic immunoassay for the qualitative detection of IgG and IgM antibodies to Borrelia in human whole blood, serum or plasma specimen.

SUMMARY AND EXPLANATION THE TEST

Lyme disease, also known as Lyme borreliosis, is an infectious disease caused by bacteria of the Borrelia sp. which is spread by ticks. The most common sign of infection is an expanding area of redness on the skin, known as erythema migrans, that begins at the site of a tick bite about a week after it has occurred. The rash is typically neither itchy nor painful. Approximately 25-50% of infected people do not develop a rash.1 Other early symptoms may include fever, headache and feeling tired. If untreated, symptoms may include loss of the ability to move one or both sides of the face, joint pains, severe headaches with neck stiffness, or heart palpitations, among others.1 Months to years later, repeated episodes of joint pain and swelling may occur.1 Occasionally, people develop shooting pains or tingling in their arms and legs. Despite appropriate treatment, about 10 to 20% of people develop joint pains, memory problems, and feel tired for at least six months.
Lyme disease is transmitted to humans by the bite of infected ticks of the genus Ixodes. Usually, the tick must be attached for 36 to 48 hours before the bacteria can spread. In North America, Borrelia burgdorferi and Borrelia mayonii are the causes. In Europe and Asia, the bacteria Borrelia afzelii and Borrelia garinii are also causes of the disease. The disease does not appear to be transmissible between people, by other animals, or through food. Diagnosis is based upon a combination of symptoms, history of tick exposure, and possibly testing for specific antibodies in the blood. Blood tests are often negative in the early stages of the disease.2 Testing of individual ticks is not typically useful.

PRINCIPLE

The Lyme IgG/IgM Rapid Test is a qualitative membrane-based immunoassay for the
detection of IgG and IgM antibodies to Borrelia in whole blood, serum or plasma specimens. This test consists of two components, an IgG component and an IgM component. In the IgG component, antihuman IgG is coated in IgG test line region. During testing, the specimen reacts with Borrelia antigen-coated particles in the test cassette.
The mixture then migrates upward on the membrane chromatographically by capillary action and reacts with the anti-human IgG in IgG test line region, if the specimen contains IgG antibodies to Borrelia. A colored line will appear in IgG test line region as a result of this. Similarly, anti-human IgM is coated in IgM test line region and if specimen contains IgM antibodies to Borrelia, the conjugate-specimen complex reacts with anti-human IgM.
A colored line will appear in IgM test line region as a result. Therefore, if the specimen contains anti-Borrelia IgG antibodies, a colored line will appear in IgG test line region. If the specimen contains anti-Borrelia IgM antibodies, a colored line will appear in IgM test line region. If the specimen does not contain anti- Borrelia nantibodies, no colored line will appear in either of the test line regions, indicating a negative result. To serve as a procedural control, a colored line will always appear in the control line region, indicating that the proper volume of specimen has been added and membrane wickinq has occurred.