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| Product Name | Lyme Disease IgM Home Screening Test |
| Catalog No. | BI-QCY-0048 |
| Product Overview | A rapid qualitative immunoassay for detection of anti-Borrelia IgM antibodies. Designed for self-testing with a fingerstick whole-blood specimen; results should be interpreted with clinical context. |
| Applications | Consumer self-screening for anti-Borrelia IgM antibodies after potential tick exposure; follow-up with a healthcare professional for interpretation and confirmatory testing. |
| Certificate | CE, ISO 13485 |
| Detection Target | Anti-Borrelia IgM antibodies (European strains) |
| Sample Type | Whole blood from a fingertip |
| Result Type | Qualitative (positive/negative) |
| Time to Result | 10 minutes |
| Pack Size | 1T |
| Storage Conditions | 4–30°C, do not freeze |
| Methodology | Lateral flow immunoassay |
| Test Procedure | Prepare the lancet. Very important: twist the grey cap off, never pull it. Keep turning until it comes away. Draw a drop of blood from your fingertip. Very important: use the pipette correctly — touch the drop, do not squeeze the bulb, fill to the line. Put the blood into the sample well. Press the pipette bulb to release the blood into the sample well. Then wait 30 to 40 seconds until it is absorbed. Add exactly 4 drops of diluent. Very important: add the diluent only after the 30 to 40 seconds. Hold the vial upright and add exactly four drops, 2–3 seconds apart. Read the result after 10 minutes. Not after 15. Set a timer. |
| Result Interpretation | Positive: Antibodies found. Both C and T lines are visible. IgM antibodies against Borrelia are present, which points to a recent infection. See your doctor without delay. Negative: None detected. Only the C line is visible. No IgM antibodies were detected. Repeat the test 2 to 6 weeks later. Repeat: Invalid. No C line. The result cannot be read. This happens most often when the diluent is added before the blood has been absorbed. Repeat with a new test and a fresh blood sample, and wait the full 30 to 40 seconds before you add the diluent. |
| Package Contents | 1 × test device in a sealed foil pouch 1 × dropper vial of diluent 1 mL 2 × micro-pipettes one is a spare 2 × safety lancets one is a spare 1 × alcohol pad 1 × instructions for use in seven languages 1 × desiccant bag discard it, do not open it |
| Timing of Lyme Disease Testing | Timing matters for this test. After a tick bite the body needs time to make IgM antibodies against Borrelia. A test done too early can be negative even when an infection is present. 2–6 weeks after the tick bite is the time to test. First 2 weeks: too early. No detectable antibodies yet. From 2 to 6 weeks: test. IgM antibodies are present in 40–60 % of infected people at 2 to 4 weeks, and in 70–90 % 4 to 6 weeks later. |
| Notes | If antibodies were found: See your doctor promptly and show the result. Lyme disease is treated with antibiotics, and early treatment prevents the later complications. A positive result can also come from an infection years ago or after a completed treatment; your doctor will judge that. If none were detected: Do not take one negative as final. Test again 2 to 6 weeks later. If a red patch, with or without fever, persists, see your doctor whatever the test says. |
For in vitro diagnostic use.
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