Borreliosis (Lyme Disease)

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Borreliosis (Lyme Disease)

Overview

Borreliosis (Lyme Disease) Testing

Anti-Borrelia (Lyme) EIA IgG, IgM and IgA

Sample Results

The Bio-Rad Anti-Borrelia (Lyme) Microplate EIA tested using 250 sera from asymptomatic blood donors collected from areas other than the upper Midwestern and Northeastern United States (hyperendemic regions), was 100% specific. Six samples (2.4%) tested borderline.

The specificity was also determined using sera from Lyme disease negative, symptomatic subjects (see Specificity table below). Because of the high frequency of false positive reactions with samples from syphilis patients, subjects suspected to have syphilis or related disorders must also be tested with a non-treponemal test (e.g. RPR) to rule out this cause.


Specificity — Lyme Disease Negative Patients

Sample Type Nonreactive Borderline Reactive Specificity
ANA + 37 1 0 100%
CMV IgM + 24 0 1 96%
Heterophile + 20 4 1 96%
RF + 23 1 1 96%
Syphilis + 0 1 11 8%
HIV + 15 0 0 100%

Sera from 77 patients diagnosed with Lyme borreliosis were used to assess assay sensitivity. Diagnoses were based on epidemiological, clinical, and serological criteria. These studies were conducted by two outside laboratories. The results are summarized in the Sensitivity table below.


Sensitivity — Diagnosed Lyme Disease Patients

Sample Type Nonreactive Borderline Reactive Specificity
Stage 1 (Early) 0 1 7 88%
Stage 2 (Neurological) 0 0 1 N/A
Stage 3 (Arthritis) 0 0 21 100%
Unknown Stage 0 0 47 100%
Platelia™ Lyme IgM and IgG Testing

Platelia™ Lyme IgM and IgG

Performance

Platelia™ Lyme assays demonstrate a high negative, positive, and overall agreement with the CDC panel (internal data).

 

Commercially Available

Agreement with Clinical Diagnosis1,4 Bio-Rad Platelia™ Lyme Assays2 Lyme IgG and IgM Assays (Kit A, B) Lyme Total Ig Assay (Kit C)3 Lyme Total Ig Assay (Kit D)2
IgM 74.4% (32/43) 63.6% (28/44) Not applicable Not applicable
IgG 69.8% (30/43) 63.6% (28/44) Not applicable Not applicable
Total Antibody
(Overall Agreement)5
90.7% (39/43) 86.4% (38/44) 81.4% (35/43) 83.7% (36/43)
Total Antibody
(Negative Agreement)5
80.0% (4/5) 80.0% (4/5) 100.0% (5/5) 60.0% (3/5)
Total Antibody
(Positive Agreement)5
92.1% (35/38) 87.2% (34/39) 78.9% (30/38) 86.8% (33/38)


1. Equivocal samples were considered as positive.
2. One sample was not tested due to insufficient sample volume.
3. One sample was not tested.
4. Combined result is considered positive when sample is positive for IgM and/or IgG. Combined result is considered equivocal when both IgM and IgG are equivocal, or IgM is equivocal with IgG negative, or IgM is negative with IgG equivocal. Combined result is considered negative when sample is negative for both IgM and IgG.
5. Overall agreement, negative agreement, and positive agreement for Total Antibody was calculated by combining results of IgM and IgG.


Results

Results obtained on positive retrospective samples demonstrate excellent sensitivity of Platelia™ Lyme assays for both localized and disseminated stages of Lyme disease.

% Sensitivity Platelia™ Lyme IgM Platelia™ Lyme IgG Platelia™ Lyme IgM and/or IgG2,3
Early Stage 85.0% (102/120) 59.2% (71/120) 90.8% (109/120)
Disseminated Stage 87.9% (29/33) 60.6% (20/33) 93.9% (31/33)
Late Stage 46.2% (6/13) 100.0% (13/13) 100.0% (13/13)
All Stages 82.5% (137/166) 62.7% (104/166) 92.2% (153/166)


1. Equivocal results were considered as positive for calculation of sensitivity.
2. Combined result is considered positive when sample is positive for IgM and/or IgG. Combined result is considered equivocal when both IgM and IgG are equivocal, or IgM is equivocal with IgG negative, or IgM is negative with IgG equivocal. Combined result is considered negative when sample is negative for both IgM and IgG.
3. Dual positives have been included in the calculations only once.

The Bio-Rad Anti Borrelia (Lyme) EIA is used for the qualitative and/or semi-quantitative detection of of IgG, IgM, and IgA antibodies to Borrelia burgdoferi in human serum. This assay is highly sensitive and specific for Lyme borreliosis and is used as an aid in diagnosing Lyme disease. Its improved sensitivity combines purified Bb lysate and recombinant p39 proteins as antigens. For higher specificity, serum is absorbed in a blocking solution containing E. coli proteins.

Bio-Rad also offers two separate assays (Platelia™ Lyme IgG EIA and Platelia™ Lyme IgA EIA) offering highly sensitive and specific detection of IgG and IgM antibodies for accurate and precise screening of Lyme borreliosis.

Bio-Rad Anti-Borrelia (Lyme) EIA Kit

32507
96 microplate enzyme immunoassays to detect Borrelia burgdorferi as an aid in diagnosis of Lyme disease

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Platelia™ Lyme IgM EIA

25296
96 microplate enzyme immunoassays to detect IgM antibodies to Borrelia burgdorferi sensu stricto as an aid in diagnosis of Lyme disease

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Platelia™ Lyme IgG EIA

25297
96 microplate enzyme immunoassays to detect IgG antibodies to Borrelia burgdorferi sensu stricto as an aid in diagnosis of Lyme disease

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