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WHAT ARE THE iDart™ Lyme ImmunoBlot Kits
The iDart™ Lyme IgG ImmunoBlot Kit and iDart™ Lyme IgM ImmunoBlot Kit are intended for the in vitro qualitative detection of IgG antibodies to Borrelia burgdorferi in human serum. Positive results are supportive evidence for the presence of antibodies and exposure to B. burgdorferi. Negative results do not preclude infection with B. burgdorferi. The kits are intended to aid in the diagnosis of Lyme disease and the test kit should only be used on samples from patients with clinical history, signs and symptoms consistent with Lyme disease. Test results are to be used in conjunction with information obtained from the patient’s clinical evaluation and other diagnostic procedures.
HOW WERE THE KITS DEVELOPED
A specialty testing lab located in Northern California, IGeneX, Inc., has had a licensing agreement with ID-FISH Technology since 2017 to use the Lyme IgG and IgM ImmunoBlot strips in its laboratory-developed (LDT) Lyme ImmunoBlot assays.
The ImmunoBlots have become the most prescribed test at IGeneX, and due to this popularity and demand from other labs to use similar technology, both the Lyme IgG and IgM ImmunoBlot tests have been converted to FDA cleared test kits.
The IGeneX lab tests that correspond to the FDA cleared kits are as follows:
325 Lyme ImmunoBlot IgM
335 Lyme ImmunoBlot IgG
The IGeneX tests can be ordered today by any licensed practitioner.
KIT CONTENTS
Each iDart Lyme IgM ImmunoBlot Kit contains the following items:
- 50 Lyme IgM ImmunoBlot strips
- IB Sample diluent – 55ml
- IB Wash Buffer – 60ml
- Milk powder – 0.75g package
- Lyme IgM IB Conjugate – 60ml
- IB Phosphatase Substrate – 60ml
- LYME IgM IB Kit Positive Control – 60μl
- LYME IgM IB Kit Negative Control – 60μl
- LYME IgM IB Package Insert – 1 each
- LYME IgM IB Reading Guide – 1 each
Price – $3750 ($75 for each strip)
For more information on the contents within each kit, please see the package insert.
Each iDart Lyme IgG ImmunoBlot Kit contains the following items:
- 50 Lyme IgG ImmunoBlot strips
- IB Sample diluent – 55ml
- IB Wash Buffer – 60ml
- Milk powder – 0.75g package
- Lyme IgG IB Conjugate – 60ml
- IB Phosphatase Substrate – 60ml
- LYME IgG IB Kit Positive Control – 60μl
- LYME IgG IB Kit Negative Control – 60μl
- LYME IgG IB Package Insert – 1 each
- LYME IgG IB Reading Guide – 1 each
Price – $3750 ($75 for each strip)
For more information on the contents within each kit, please see the package insert.
WHO CAN PURCHASE KITS?
The kits are available to CLIA certified labs across the United States, as well as International labs with comparable certification.
We are not able to sell kits directly to doctors or patients.
Purchase Kits
Please complete the form below and we will contact you.