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.
