Applications:
The Lyme IgG/IgM Rapid Test Cassette 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.
Description:
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.
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.
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.
How to 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.
INTERPRETATION OF RESULTS
(Please refer to the illustration above)
IgG POSITIVE:* Two colored lines appear. One colored line should
always appear in the control line region (C) and another line
should be in the IgG line region.
IgM POSITIVE:* Two colored lines appear. One colored line should
always appear in the control line region (C) and another line
should be in the IgM line region.
IgG and IgM POSITIVE:* Three colored lines appear. One colored line
should always appear in the control line region (C) and two test
lines should be in the IgG line region and IgM line region.
*NOTE: The intensity of the color in the test line regions may vary
depending on the concentration of anti-Lyme antibodies present in
the specimen. Therefore, any shade of color in the test line region
should be considered positive.
NEGATIVE: One colored line appears in the control line region (C).
No line appears in the IgG region or the IgM region.
INVALID: Control line fails to appear. Insufficient specimen volume
or incorrect procedural techniques are the most likely reasons for
control line failure. Review the procedure and repeat the test with
a new test. If the problem persists, discontinue using the test kit
immediately and contact your local distributor.
Order Information
| Cat. No. | Product Description | Specimen | Format | Kit Size | Cut-Off | Status |
| ILY-402 | Lyme IgG/IgM Rapid Test Cassette | WB/S/P | Cassette | 10 T | See Insert | CE
|
