Product details & mandatory information
The CLEARTEST® Borreliosis (Lyme- IgG/IgM) is an innovative rapid test for the qualitative determination of IgG and IgM antibodies against Borrelia in whole blood, serum or plasma. Developed for professional use in diagnostic laboratories, this test offers a rapid and reliable diagnosis of Lyme disease.
Intended use
The CLEARTEST® Borreliosis (Lyme IgG/IgM) is a lateral flow chromatographic immunoassay. It is used for the qualitative detection of antibodies against Borrelia in human blood samples. This is particularly important for the early diagnosis of Lyme borreliosis, a tick-borne bacterial infection.
Product advantages
- Fast results: Test results are available within just 10 minutes.
- High sensitivity and specificity: The test shows high agreement with leading ELISA tests (over 98%).
- Easy to use: Can be performed with minimal equipment.
- Versatile: Suitable for whole blood, serum and plasma.
Why CLEARTEST® Lyme disease (Lyme IgG/IgM)?
Lyme disease is a serious illness caused by bacteria of the genus Borrelia and is transmitted by ticks. Early symptoms include reddening of the skin, fever, headache and fatigue. If left untreated, the disease can lead to serious health problems such as joint pain and neurological disorders. The CLEARTEST® Lyme Disease (Lyme IgG/IgM) provides a rapid and reliable diagnosis, which is crucial for timely treatment.
Test principle
The test consists of two components: IgG and IgM test strips coated with human antibodies. On contact with a blood sample containing Borrelia antibodies, these react with the specific antibodies on the test strip and produce a coloured line indicating a positive result.
Application steps
- Sample preparation: Use blood, serum or plasma.
- Performing the test: Add the sample and buffer to the test cassette.
- Interpretation of results: Read the results after 10 minutes. A coloured line indicates a positive result for IgG or IgM.
Safety and storage
- Storage: Store at room temperature or refrigerated (2-30 °C). Do not freeze.
- Safety instructions: For in vitro diagnostic use by specialised personnel only. Wear suitable protective clothing and dispose of the test according to local regulations.
Manufacturer: Servoprax GmbH
Ideally suited for
- Doctors and medical practices
- Pharmacies
- Emergency services
- Outpatient clinics
- Hospitals
Advantages
- Results are available within just 10 minutes.
- The test offers high sensitivity and specificity with over 98% agreement with leading ELISA tests.
- Versatile with whole blood, serum and plasma, requires minimal equipment.
Important notes
Use is recommended for healthcare professionals only
Notes on returns
For consumers, the right of cancellation does not apply to contracts for the delivery of sealed goods that are not suitable for return for reasons of health protection or hygiene if their seal has been removed after delivery.
Instructions for use (1796-1)
