ALLTEST Lyme Test Kit (lgC/lgM)
ALLTEST Lyme Test Kit (lgC/lgM)
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The AllTest Lyme IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) (REF: ILY-402) is a rapid lateral flow chromatographic immunoassay designed for the qualitative detection of IgG and IgM antibodies to Borrelia in human whole blood, serum or plasma specimens. Also commonly searched for as a Lyme disease test, Lyme borreliosis test, Borrelia antibody test or Lyme IgG/IgM test, the cassette provides results in approximately 10 minutes. The test is intended for professional in vitro diagnostic use only and can be used with fingerstick or venous whole blood, serum and plasma specimens.
Lyme disease, also known as Lyme borreliosis, is an infectious disease caused by bacteria from the Borrelia genus and is transmitted through the bite of infected ticks. Early symptoms may include an expanding skin rash, fever, headache and fatigue, although not all infected individuals develop the characteristic rash. If left untreated, Lyme disease may be associated with more serious symptoms affecting the joints, nervous system and heart. Antibody testing can support the clinical assessment of suspected Lyme disease and should be interpreted alongside symptoms, patient history and potential exposure to ticks.
The detection of IgM and IgG antibodies may provide useful information during the assessment of immune response to Borrelia infection. However, the test is not intended to be used as the sole criterion for diagnosing Lyme disease, and negative results do not exclude infection, particularly where clinical symptoms persist. Results should therefore be considered alongside other available clinical information and, where appropriate, further laboratory investigations.
Product features
Product features
- Rapid detection of IgG and IgM antibodies to Borrelia
- Supports assessment of Lyme disease and Lyme borreliosis
- Results available in approximately 10 minutes
- Separate IgG and IgM test lines
- Compatible with fingerstick and venous whole blood
- Can also be used with serum or plasma
- Simple lateral flow cassette format
- Internal procedural Control (C) line
- Clear visual interpretation of IgG and IgM results
- Requires minimal laboratory equipment
- Suitable for professional laboratories and clinical settings
- Individually packaged for convenient use and storage
Important: This test detects antibodies to Borrelia and should not be used as the sole criterion for diagnosing Lyme disease. Results should be interpreted alongside clinical findings, patient history and other appropriate diagnostic information.
Accuracy & Qualtity
Accuracy & Qualtity
The AllTest Lyme IgG/IgM Rapid Test has been compared with leading commercial ELISA Lyme IgG and IgM tests.
IgG Performance
Relative Sensitivity: 95.5%
Relative Specificity: 98.9%
Accuracy: 98.2%
Evaluated against a commercial ELISA method
IgM Performance
Relative Sensitivity: 94.4%
Relative Specificity: 98.9%
Accuracy: 98.1%
Evaluated against a commercial ELISA method
Quality Features
Detects IgG and IgM antibodies separately
Internal Control (C) line verifies sufficient specimen volume and correct procedural technique
Intra-assay precision: >99%
Inter-assay precision: >99%
Tested across multiple lots over a three-day period
No cross-reactivity observed with a range of tested positive specimens, including HAV, HCV, HIV, syphilis, H. pylori, HSV and CMV antibodies
No interference observed from a range of tested substances
Specifications
Specifications
- Product Name: Lyme IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)
- Manufacturer: AllTest
- Reference Number: ILY-402
- Test Method: Lateral Flow Chromatographic Immunoassay
- Detection Target: IgG and IgM Antibodies to Borrelia
- Sample Type: Human Whole Blood, Serum or Plasma
- Whole Blood Collection: Fingerstick or Venous Whole Blood
- Result Type: Qualitative
- Result Time: 10 Minutes
- Result Reading Window: Read at 10 minutes; do not interpret after 20 minutes
- Storage Temperature: 2°C to 30°C
- Intended Use: Professional In Vitro Diagnostic Use Only
- Supported Haematocrit Range: 25% to 65%
- Revision Date of IFU: 31 May 2023
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Frequently Asked Questions
If you have a question regarding the ALLTEST Lyme Test Kit (lgC/lgM), send our trade@adtuk.co.uk team an email or give us a call 9-5 weekdays 01263 731168