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Lyme Disease ViraStripe
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The Borrelia B31 ViraStripe® are new Lineblot test kits (IgG and IgM) using proprietary  purification technology to produce native B31 Borrelia burgdorferi antigen Lineblots. Each of the CDC recommended antigens have been highly purified and printed on the blot format to produce easy to read, superior confirmatory Lyme disease assays. All antigens are located at defined position which are consistent from kit to kit, lot to lot.

Now FDA cleared, test kits for B. burgdorferi IgG and IgM serology are available for immediate release.  Cleared as substantially equivalent to the Western blot confirmatory test, the ViraStripe® is consistent and reliable for laboratory analysis of clinical serum specimens. This assay is in compliance with the CDC recommendations from the 1995 Dearborn Conference.

 Each test strip contains a serum control and conjugate control stripe for the added security of proper test function. Established protocols can use fixed substrate timing for dependable blot results and interpretation, simplifying the test procedure. The defined antigen locations of the Virastripe® makes assisted digital image analysis and online technical support possible. Each kit contains 50 determinations for economical Lyme blot testing.

Viramed Biotech AG – Borrelia B31  Virastripe®

A Lineblot serologic assay for the detection of specific antibodies against Borrelia burgdorferi in human serum

The Borrelia B31  ViraStripeÒ uses the strain Borrelia burgdorferi sensu stricto (American strain Borrelia burgdorferi B31, low passage, tick isolate). This antigen composition guarantees an optimal sensitivity and specificity of the assay. Each membrane strip has an integrated control system with controls for function and conjugate specificity.

Each kit contains one developed positive control strip (band locator).

Intended Use:

The Viramed Biotech Borrelia B31 IgG ViraStripe® is intended for use in the testing of human serum for the presence of human IgG antibodies to Borrelia burgdorferi as an aid in the diagnosis of Lyme borreliosis. For InVitro Diagnostic Use. High complexity test.

 

IgG Kit                          50 tests: Product-No.: V-BBSGUS

IgM Kit                          50 tests: Product-N0.: V-BBSMUS

 

Specimen:                       20µl serum

Time for testing:            90 minutes

Storage/Stability:          12 months at 2-8 °C


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Last modified: 05/27/10