It is a rapid test for the detection of IgG and IgM antibodies against Borrelia in human blood, serum or plasma. It is used for in vitro diagnostic purposes and is performed under the supervision of a health professional.
Accuracy >98 %
Sensitivity 95 %
Specificity 98,9 %
Results in 10 minutes
The sample is finger blood.
The problem
The main signs of Lyme disease infection are fever, fatigue, muscle and joint pain and a rash of erythema migrans.
- Test cartridges
- Droppers
- Package leaflet
- Lancets
- Buffer
- Spirit napkin
Allow the test cartridge, buffer and/or control materials to cool to room temperature (15-30 °C) before testing.
- Keep the bag at room temperature before opening it. Remove the test cartridge from the sealed bag and use as soon as possible.
- Place the cartridge on a clean and flat surface.
Serum/plasma sample:- Use a pipette: drop 5 µL of serum/plasma into the sample well (S), then add 3 drops of buffer (approx. 120 µL) into the buffer well (B).
- Use the dropper: holding the dropper vertically, draw the sample to the upper end of the nozzle as shown in the figure below (approximately 5 µL). Transfer the sample to the sample well (S), then add 3 drops of buffer (approximately 120 µL) to the buffer well (B) and start the timer.
Whole blood sample:
- Use a pipette: pipette 10 µL of whole blood into the sample well (S), then add 3 drops of buffer (approx. 120 µL) into the buffer well (B).
- Use the dropper: holding the dropper vertically, draw the sample up to about 1 cm above the upper end of the nozzle and drop 1 full drop of sample (about 10 µL) into the sample well (S). Then add 3 drops of buffer (approximately 120 µL) to the buffer well (B) and start the timer.
- Wait for the coloured line(s) to appear. Check the results after 10 minutes. After 20 minutes, do not check the results again.
IgG CONFIRMED:* two coloured lines appear. One coloured line should always appear in the area of the control line (C) and the other line should appear in the area of the IgG line.
IgM CONFIRMABLE:* two coloured lines appear. One coloured line should always appear in the area of the control line (C) and the other line should appear in the area of the IgM line.
IgG and IgM TESTABLE:* three coloured lines appear. One coloured line should always appear in the area of the control line (C) and two test lines should appear in the area of the IgG line and the IgM line.
* NOTE: The intensity of the colour in areas of the test line may vary depending on the concentration of IgM IgG disease antibodies in the sample. Therefore, any shade in the line area of the test line should be considered a positive result.
DENIED: A single coloured line appears in the control area (C). No line appears in the IgG area or in the IgM area.
NOT: the control line does not appear. The most likely reasons for the non-appearance of the reference line are insufficient sample quantity or an incorrect procedure. Revise the procedure and repeat the test with a new test. If the problem persists, stop using the test kit and contact your local distributor.
Ingredients
- Test cartridges
- Droppers
- Package leaflet
- Lancets
- Buffer
- Spirit napkin
Instructions
Allow the test cartridge, buffer and/or control materials to cool to room temperature (15-30 °C) before testing.
- Keep the bag at room temperature before opening it. Remove the test cartridge from the sealed bag and use as soon as possible.
- Place the cartridge on a clean and flat surface.
Serum/plasma sample:- Use a pipette: drop 5 µL of serum/plasma into the sample well (S), then add 3 drops of buffer (approx. 120 µL) into the buffer well (B).
- Use the dropper: holding the dropper vertically, draw the sample to the upper end of the nozzle as shown in the figure below (approximately 5 µL). Transfer the sample to the sample well (S), then add 3 drops of buffer (approximately 120 µL) to the buffer well (B) and start the timer.
Whole blood sample:
- Use a pipette: pipette 10 µL of whole blood into the sample well (S), then add 3 drops of buffer (approx. 120 µL) into the buffer well (B).
- Use the dropper: holding the dropper vertically, draw the sample up to about 1 cm above the upper end of the nozzle and drop 1 full drop of sample (about 10 µL) into the sample well (S). Then add 3 drops of buffer (approximately 120 µL) to the buffer well (B) and start the timer.
- Wait for the coloured line(s) to appear. Check the results after 10 minutes. After 20 minutes, do not check the results again.
Results
IgG CONFIRMED:* two coloured lines appear. One coloured line should always appear in the area of the control line (C) and the other line should appear in the area of the IgG line.
IgM CONFIRMABLE:* two coloured lines appear. One coloured line should always appear in the area of the control line (C) and the other line should appear in the area of the IgM line.
IgG and IgM TESTABLE:* three coloured lines appear. One coloured line should always appear in the area of the control line (C) and two test lines should appear in the area of the IgG line and the IgM line.
* NOTE: The intensity of the colour in areas of the test line may vary depending on the concentration of IgM IgG disease antibodies in the sample. Therefore, any shade in the line area of the test line should be considered a positive result.
DENIED: A single coloured line appears in the control area (C). No line appears in the IgG area or in the IgM area.
NOT: the control line does not appear. The most likely reasons for the non-appearance of the reference line are insufficient sample quantity or an incorrect procedure. Revise the procedure and repeat the test with a new test. If the problem persists, stop using the test kit and contact your local distributor.
Informative video
Instruction leaflet
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