The Lyme Borrelia IgG/IgM Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of IgG and IgM antibodies to Borrelia spp. in human whole blood, serum or plasma specimen.
Lyme disease, also known as Lyme borreliosis, is an infectious disease caused by bacteria of the Borrelia spp. 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.1 The rash is typically neither itchy nor painful. Approximately 25-50% of infected people do not develop a rash. 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. Months to years later, repeated episodes of joint pain and swelling may occur. 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. Testing of individual ticks is not typically useful.
The Lyme Borrelia IgG/IgM Rapid Test is a rapid test that utilizes a combination of Borrelia antigen coated colored particles for the detection of IgG and IgM to Borrelia spp. antibodies in human whole blood, serum, or plasma.
Materials Provided
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Materials Required but Not provided
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INTERPRETATION OF RESULTS
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IgG Positive:* The colored line in the control line region (C) appears, and a colored line appears in test line region G The result is positive for Borrelia specific-IgG and is probably indicative of secondary Borrelia infection. |
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IgM Positive:* The colored line in the control line region (C) appears, and a colored line appears in test line region M. The result is positive for Borrelia specific-IgM antibodies and is indicative of primary Borrelia infection. |
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IgG and IgM Positive:* The colored line in the control line region (C) appears, and two colored lines should appear in test line regions G and M. The color intensities of the lines do not have to match. The result is positive for IgG & IgM antibodies and is indicative of secondary Borrelia infection. |
*NOTE: The intensity of the color in the test line region(s) (G and/or M) will vary depending on the concentration of Borrelia antibodies in the specimen. Therefore, any shade of color in the test line region(s) (G and/or M) should be considered positive. |
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Negative:Only one colored band appears, in the control region (C). No line appears in test line regions G or M. |
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INVALID: No Control line (C) appears. Insufficient buffer volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the procedure with a new test device. If the problem persists, discontinue using the test kit immediately and contact your local distributor. |
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The Lyme Borrelia IgG/IgM Rapid Test is for in vitro diagnostic use only. The test should be used for the detection of Lyme Borrelia antibodies in whole blood, serum or plasma specimens only. Neither the quantitative value nor the rate of increase in Borrelia antibody concentration can be determined by this qualitative test.
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The Lyme Borrelia IgG/IgM Rapid Test will only indicate the presence of Borrelia antibodies in the specimen and should not be used as the sole criteria for the diagnosis of Borrelia.
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The continued presence or absence of antibodies cannot be used to determine the success or failure of therapy.
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Results from immunosuppressed patients should be interpreted with caution.
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As with all diagnostic tests, all results must be interpreted together with other clinical information available to the physician.
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If the test result is negative and clinical symptoms persist, additional testing using other clinical methods is recommended. A negative result does not at any time preclude the possibility of Borrelia infection.
For the primary and secondary infection, the overall sensitivity is IgM 79.17%, IgG 59.72%, the overall specificity is IgM 99.29%, IgG 99.64% and the overall accuracy is 86.39% .