Borrelia burgdorferi Antibody Rapid Test
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 Borrelia Burgdorferi Antibody Rapid Testis a rapid test that utilizes a combination of Borrelia antigen coated colored particles for the detection of Borrelia spp. antibodies in human whole blood, serum, or plasma.
· Individually packed test devices
· Disposable pipettes
· Package insert
Materials Required but Not provided
· Specimen collection container
INTERPRETATION OF RESULTS
POSITIVE: Two colored bands appear on the membrane. One band appears in the control region (C) and another band appears in the test region (T).
NEGATIVE: Only one colored band appears in the control region (C). No apparent colored band appears in the test region (T).
INVALID: Control band fails to appear. Results from any test which has not produced a control band at the specified read time must be discarded. Please review the procedure and repeat with a new test. If the problem persists, discontinue using the kit immediately and contact your local distributor.
For the infection, the sensitivity is 90.9%, the specificity is >99.0% and the accuracy is 95.4%.