- Differentiated serological profile
- Facilitates classification of Lyme borreliosis, based on IgM and/or IgG positivity.
- Helps ensure patients receive rapid results, avoid unnecessary anxiety and additional testing.
- Better patient management
- IDS Borrelia assays are based on recombinant proteins to reduce the cross-reactivity problems, providing higher specificity.
- IDS Borrelia IgM uses two recombinant antigens: OspC, an outer surface protein highly specific for IgM detection (early phase infection), and the VlsE protein. This combination assures a higher diagnostic sensitivity, making this assay a suitable diagnostic tool for the early stages of Lyme disease.
- IDS Borrelia IgG employs the antigen VlsE, an outer surface lipoprotein that plays a key role in the immune response to Lyme disease, leading to increased sensitivity in neuroborreliosis (NB).
- Streamlined workﬂow, rapid results and cost effective
- Ready to use reagents with up to 60 days on-board storage.
- Calibrate once every 28 days with common controls for both IgM and IgG assays.
- Suitable for use with serum or plasma (sodium heparin, sodium citrate, K3-EDTA) samples.
- Decreased number of samples requiring confirmation test when using IgM and IgG assays in combination.
The IDS Borrelia IgG and IDS Borrelia IgM assays use chemiluminescence immunoassay (CLIA) technology for the quantitative determination of specific IgG or IgM antibodies to Borrelia burgdorferi sensu lato in human serum or plasma samples on the IDS system. The results are intended to aid in the assessment of immunity status in patients with signs and symptoms consistent with Lyme disease.
Lyme disease (LD) is a tick-borne disease caused by the bacterium, Borrelia burgdorferi sensu stricto in the United States. In Europe and certain other regions of the world, the disease is caused by Borrelia burgdorferi sensu lato consisting of Borrelia burgdorferi sensu stricto (herein referred to as B burgdorferi), Borrelia afzelii, Borrelia garinii. 1
Transmission of Lyme Disease-associated Borrelia requires at least 36 hours of tick attachment. The disease occurs in three stages, evolving from early to late disease when left untreated:2
- Stage I – Early localized disease (days to weeks): Approximately 80% of infected individuals will develop an erythema migrans, commonly called bull’s eye rash.
- Stage II: Early disseminated disease (ED): In the absence of treatment, patients may progress ED, which is characterised by neurologic manifestations often associated with B garinii infection, occurs within a few weeks to months.
- Stage III: Late persistent disease (LD): Patients with late LD often present with intermittent or persistent arthralgia (associated with B burgdorferi infection), or with acrodermatitis chronica atrophicans (infection with B afzelii ) which occurs months or years later.
Serological testing for antibodies directed to B. burgdorferi is the most common method for the biological detection of an infection. The immune response to B. burgdorferi has been well characterized and involves the production of both IgM and IgG antibodies.4 The IDS Borrelia IgG and IgM kits are used for assessing the presence of IgM and IgG antibodies and offer information on the disease progression. Simultaneous use of IDS Borrelia IgM only or IDS Borrelia IgG antibodies may provide additional information to allow the clinicians better to manage the disease in patients.
- Burgdorfer, W. Discovery of the Lyme disease spirochete and its relation to tick vectors. Yale Jrnl. Biol. Med. 1984, 57 : 515-520.
- Dattwyler RJ: Lyme borreliosis: an overview of clinical manifestations. Lab Med. 1990;21:290-292
- Aguero-Rosenfeld, M. E., Wang, G., Schwartz, I., Wormser, G. P. Diagnosis of Lyme borreliosis. Microbiol. Rev.. 2005; 18:484–509.
- Reed, K. D. Laboratory testing for Lyme disease: possibilities and practicalities. J. Clin. Microbiol.. 2002; 40:319–324.
- M.G. Leeflang et al. The diagnostic accuracy of serological tests for Lyme borreliosis in Europe : a systematic review and meta-analysis, BMC Infectious Diseases 2016 16 :140