Lyme IgG/IgM Rapid Test
¡¾SUMMARY¡¿
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. 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. 1 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. 6 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. 2 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.
¡¾DIRECTIONS FOR USE ¡¿
Allow the test, specimen, buffer and/or controls to reach room temperature (15-30°C) prior to testing.
1. Bring the pouch to room temperature before opening it. Remove the test cassette from the sealed pouch and use it as soon as possible.
2. Place the cassette on a clean and level surface.
For Serum/Plasma specimen:
· Use a pipette: To transfer 5m mL of Serum/ Plasma to the specimen well(S), then add 3drops
of buffer (approximately 120m mL) to the buffer well (B).
· Use a dropper: Hold the dropper vertically, draw the specimen up to the upper end of the
nozzle as shown in illustration below (approximately 5m mL). Transfer the specimen to the specimen well(S), then add 3 drops of buffer (approximately 120m mL) to the buffer well (B), and start the timer.
For Whole Blood specimen:
· Use a pipette: To transfer 10m mL of whole blood to the specimen well(S), then add 3drops
of buffer (approximately 120m mL) to the buffer well (B).
· Use a dropper: Hold the dropper vertically, draw the specimen about 1 cm above the upper
end of the nozzle and transfer 1 full drop (approx. 10μL) of specimen to the sample well(S). Then add 3 drops of buffer (approximately 120m mL) to the buffer well (B), and start the timer.
3. Wait for the colored line(s) to appear. Read results at 10 minutes. Do not interpret the result after 20 minutes.
Note: It is suggested not to use the buffer, beyond 3 months after opening the vial.
¡¾DIRECTIONS FOR USE ¡¿
Allow the test, specimen, buffer and/or controls to reach room temperature (15-30°C) prior to testing.
1. Bring the pouch to room temperature before opening it. Remove the test cassette from the sealed pouch and use it as soon as possible.
2. Place the cassette on a clean and level surface.
For Serum/Plasma specimen:
· Use a pipette: To transfer 5m mL of Serum/ Plasma to the specimen well(S), then add 3drops
of buffer (approximately 120m mL) to the buffer well (B).
· Use a dropper: Hold the dropper vertically, draw the specimen up to the upper end of the
nozzle as shown in illustration below (approximately 5m mL). Transfer the specimen to the specimen well(S), then add 3 drops of buffer (approximately 120m mL) to the buffer well (B), and start the timer.
For Whole Blood specimen:
· Use a pipette: To transfer 10m mL of whole blood to the specimen well(S), then add 3drops
of buffer (approximately 120m mL) to the buffer well (B).
· Use a dropper: Hold the dropper vertically, draw the specimen about 1 cm above the upper
end of the nozzle and transfer 1 full drop (approx. 10μL) of specimen to the sample well(S). Then add 3 drops of buffer (approximately 120m mL) to the buffer well (B), and start the timer.
3. Wait for the colored line(s) to appear. Read results at 10 minutes. Do not interpret the result after 20 minutes.
Note: It is suggested not to use the buffer, beyond 3 months after opening the vial.
![](https://cdn1.npcdn.net/userfiles/21392/image/Lyme_IgG(1).jpg)
Cat. No. |
Product Description |
Specimen |
Format |
Kit Size |
Cut-Off |
Status |
ILY-402 |
Lyme IgG/IgM Rapid Test |
WB/S / P |
Cassette |
10 T |
See Insert |
CE |