INTRODUCTION

Fluorescence based particle immunoassay using recombinant antigens for the detection of IgG or IgM antibodies against Borrelia burgdorferi sensu lato in human serum, plasma or CSF

The bacterium Borrelia burgdorferi sensu lato, a spirochete, is the responsible agent for Lyme borreliosis. This disease is transmitted to humans by ticks. Lyme borreliosis is a multisystemic disease with diverse manifestations which make clinical diagnosis difficult. In routine diagnosis, the serological detection of Borrelia specific antibodies represents the easiest and safest method for the detection of a Borrelia infection.

Enzyme immunoassays like recomWell Borrelia are mainly used for screening. For confirmation of borderline and positive results strip tests like recomLine Borrelia are approved and safe detection systems. The modern multiplex technology integrates the advantages from ELISA and stripe assays: Quantitative detection of antibodies against individual antigens. The recomBead Borrelia is using the approved and highly specific recombinant antibodies.

PRODUCT ADVANTAGES

• Recombinant antigens
  • High sensitivity and specificity
  • Immunodominant antigens of the five pathogenic genospecies: B. burgdorferi sensu strictu, B. garinii, B. afzelii, B. spielmanii and B. bavariensis
  • Minimised cross reactivity
• Ideal screening or confirmation assay for high sample throughput
• Automated interpretation with feasible connection with LIMS
• Integration of advantages from ELISA and confirmation assay: Quantitative detection of antibodies against individual antigens
• Very high measuring accuracy and very good reproducibility of test results, therefore reliable testing of follow-up samples
• Integrated controls - no additional control samples necessarySmall sample volume (10 µl)
• Standardised CSF-serum-analysis available
• CE label: the recomBead Borrelia tests meet the high standard of the EC directive 98/79/EC on in vitro diagnostic medical devices
• Ideal amendment as confirmation test for the recomWell Borrelia tests (ELISA)
• Conform to MiQ Lyme Borreliosis¹ and DIN 58969-44²

1) Wilske B, Zöller L, Brade V, Eiffert H, Göbel UB, Stanek G, and Pfister HW: MIQ 12, Lyme-Borreliose. In Qualitätsstandards in der mikrobiologisch-infektiologischen Diagnostik. H. Mauch and R. Lütticken, eds. Munich, Germany, Urban & Fischer Verlag, 2000, pp. 1-59

2) DIN 58969-44: Medizinische Mikrobiologie - Serologische und molekularbiologische Diagnostik von Infektionskrankheiten - Teil 44: Immunoblot (IB); Spezielle Anforderungen für den Nachweis von Antikörpern gegen Borrelia burgdorferi

TESTPRINCIPLE AND PROCEDURE

1^st Incubation
Microspheres coated with Borrelia specific antigens are incubated with diluted serum or plasma for 60 min.

wash 3 times

2^nd Incubation
Phycoerythrin marked anti-human antibodies (IgG or IgM specific) are added. Incubate for 30 min.

Aspirate and add system fluid

Measurement
Either with Luminex® 100™ or Luminex® 200™ system

RECOMBINANT BORRELIA ANTIGENS

EVALUATION

Seroprevalene

*Within the 35 (17, 5%) IgG/IgM positive samples 30 (15, 0%) showed the typical antibody pattern of an infection with Borrelia burgdorferi. The remaining 5 samples (2, 5%) exhibit weak unspecific reactivities (background).

Sensitivity

STORAGE AND SHELF LIVE

At +2°C - +8°C 12 months from the time of production

COMMERCIAL PRODUCT