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The NEW VIDAS Lyme assays allow for independent measurements of IgG and IgM antibodies to Borrelia burgdorferi. When used together, these assays provide better correlation to disease stage and more specific information for the clinician for better patient management.1
Sensitivity and specificity of these assays is achieved with the addition of innovative recombinant chimeric proteins (VIsE, DbpA, OspC) allowing detection of all main pathogenic Borrelia strains (sensu stricto, afzelii, garinii). The design of the chimeric protein constructs includes C6 (the VIsE invariant region IR6), which allows the VIDAS Lyme IgG II assay to provide high sensitivity and specificity and limit cross reactivity. The VIDAS Lyme IgG II assay has a low level of cross-reactivity to syphilis and other infectious disease, and also reduces the number of unnecessary confirmatory tests needed, resulting in cost reduction.2
Testing with the automated VIDAS platforms can be done in batch or random access modes. Total time to results is 27 minutes facilitating quick diagnostic decisions.
VIDAS Lyme IgG II and VIDAS Lyme IgM II, are first tier assays for the presumptive detection of human antibodies to Borrelia burgdorferi. As such, positive and equivocal specimens should be further tested with a Western Blot assay. Notice that the VIDAS Lyme IgG II assay does not have an equivocal zone and only positive results must be confirmed.
References:
1. VIDAS Lyme IgG and VIDAS Lyme IgM package inserts available at www.mybiomerieux.com.
2. Wormser GP, Levin A, Soman S, Adenikinju O, Longo MV, Branda JA. Comparative cost-effectiveness of the two-tiered testing strategies for serodiagnostics of Lyme disease with non-cutaneous manifestations. J Clin Microbiol. 2013;51(12):4045-4049. doi:10.1128/JCM.01853-13
The CDC recommends a two-tier process for testing for Lyme disease. First, ELISA based assays are used mainly for screening followed by confirmation of positive or equivocal results by Western Blot (WB).
IgM antibody | IgG antibody | Western Blot | Likely Interpretation |
Positive | Positive | Positive | Likely Lyme Disease |
Positive | Negative | Negative | Early infection or false positive |
Negative | Positive | Positive | Late or previous infection |
Negative | Negative | (usually not performed if IgM and IgG are negative) | No infection present, symptoms may be due to another cause or antibody levels too low to detect. |
References:
1. Molins CR, Delorey MJ, Replogle A, Sexton C, Schriefer ME. Evaluation of bioMérieux's dissociated VIDAS Lyme IgM II™ (LYM) and IgG II™ (LYG) as a first-tier 6 diagnostic assay for Lyme disease. J Clin Microbiol. 2017;55(6):1698-1706. dio: 10.1128/JCM.02407-16
2. Wormser GP, Levin A, Soman S, Adenikinju O, Longo MV, Branda JA. Comparative Cost-Effectiveness of the Two-Tiered Testing Strategies for Serodiagnosis of Lyme Disease with Noncutaneous Manifestations. J Clin Microbiol. 2013;51(12):4045-4049. doi: 10.1128/JCM.01853-13
VIDAS Lyme IgG II | VIDAS Lyme IgM II | |
Code | LYG | LYM |
Reference | 417401 | 416436 |
Tests/kit | 60 tests | 60 tests |
Sample type | Plasma, serum | Plasma, serum |
Sample volume | 100 µl | 100 µl |
Calibration | 1 level every 28 days | 1 level every 28 days |
Time to result | 27 minutes | 27 minutes |
Results | Qualitative; no equivocal range | Qualitative |
This webinar, given by Dr. Ursula Lena Prisco, describes the potential diagnostic benefits of using the dissociated VIDAS Lyme IgM II and VIDAS Lyme IgG assays in a 2-tier EIA approach vs. the use of the standard EIA.western blot algorithm.