Lyme disease is an infectious disease caused by bacteria of the genus Borrelia, which are transmitted by ticks. The most common sign of infection is a spreading area of redness on the skin, known as erythema migrans, which begins at the site of the tick bite about a week after it occurs. The rash is usually not itchy or painful.
The Lomina Lyme IgG/IgM Test is a qualitative membrane immunoassay for the detection of IgG and IgM antibodies to Borrelia in whole blood.
Lyme disease is an infectious disease caused by bacteria of the genus Borrelia, which are transmitted by ticks. The most common sign of infection is a spreading area of redness on the skin, known as erythema migrans, which begins at the site of the tick bite about a week after it occurs. The rash is usually not itchy or painful. Approximately 25-50% of infected persons do not develop the rash. Other early symptoms may include fever, headache and feeling tired. If left untreated, symptoms may include, but are not limited to, loss of the ability to move one or both sides of the face, joint pain, severe headaches with neck stiffness or heart palpitations. Months to years later, repeated episodes of pain and swelling in the joints may occur. Occasionally, people experience shooting pains or tingling in the hands and feet. Despite appropriate treatment, about 10 to 20 % of people develop joint pain, memory problems and fatigue for at least six months. Lyme disease is transmitted to humans by the bite of an infected tick of the genus Ixodes. Usually, the tick must be attached for 36 to 48 hours for the bacteria to spread. The disease does not appear to be transmitted between humans, other animals or through food. Diagnosis is based on a combination of symptoms, a history of contact with the tick, and possibly testing for specific antibodies in the blood. Blood tests are often negative in the early stages of the disease.
The test is developed and tested for the use of blood samples taken from a finger.
Test duration: 10 min
IVD category: IVD other
Sensitivity: 95.5% (95%CI: 72.7%-99.9%)
Specificity: 98.9% (95%CI: 94.0%-100%)
Accuracy: 98.2% (95%CI*: 93.7%-99.8%)
A single coloured line appears in the control area (C). No coloured line appears in the test area (IgG or IgM).
Two/Three coloured lines appear. One colour line should be in the control area (C) and the other colour line should be in the test area IgG or IgM or both. The intensity of the colour in the test area (IgG or IgM) will vary depending on the concentration of Lyme antibodies present in the sample. Therefore, any shade of colour in the test area (IgG or IgM) should be considered positive.
The control line is not displayed. The most likely cause of control line failure is insufficient sample volume or incorrect procedures. Check the procedure and repeat the test with a new cartridge. If the problem persists, stop using the test kit immediately and contact your local distributor.