TABLE 4.
CDC premarketing panel: first-tier specificity comparisonsa
| Test kit | No. of samples or NPA |
Combined |
||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Healthy, nonendemic |
Healthy, endemic |
Look-alike diseases |
||||||||||||
| Pos | Equ | Neg | NPA | Pos | Equ | Neg | NPA | Pos | Equ | Neg | NPA | NPA | P | |
| BioPlex 2200 Lyme Total | 1 | 0 | 49 | 98.0 | 0 | 2 | 48 | 96.0 | 1 | 2 | 87 | 96.7 | 96.8 | Ref |
| Immunetics Lyme C6 | 1 | 0 | 49 | 98.0 | 2 | 0 | 48 | 96.0 | 2 | 1 | 87 | 96.7 | 96.8 | 1.000 |
| Zeus Borrelia VlsE1/pepC10 | 3 | 3 | 44 | 88.0 | 0 | 3 | 47 | 94.0 | 6 | 5 | 79 | 87.8 | 89.5 | 0.004 |
| bioMérieux VIDAS Lyme polyvalent | 0 | 0 | 50 | 100 | 0 | 0 | 50 | 100 | 22 | 1 | 67 | 74.4 | 87.9 | <0.001 |
| bioMérieux VIDAS Lyme II (lgM+IgG) | 2 | 5 | 43 | 86.0 | 1 | 5 | 44 | 88.0 | 6 | 10 | 74 | 82.2 | 84.7 | <0.001 |
| bioMérieux VIDAS Lyme II lgM | 2 | 5 | 43 | 86.0 | 1 | 5 | 44 | 88.0 | 4 | 10 | 76 | 84.4 | 85.8 | <0.001 |
| bioMérieux VIDAS Lyme II lgG | 0 | NA | 50 | 100 | 0 | NA | 50 | 100 | 2 | NA | 88 | 97.8 | 98.9 | 0.289 |
| MarDx B. burgdorferi Marblot (lgM+IgG) | 0 | NA | 50 | 100 | 0 | NA | 50 | 100 | 0 | NA | 90 | 100 | 100 | 0.031 |
| MarDx B. burgdorferi Marblot lgM | 0 | NA | 50 | 100 | 0 | NA | 50 | 100 | 0 | NA | 90 | 100 | 100 | 0.031 |
| MarDx B. burgdorferi Marblot lgG | 0 | NA | 50 | 100 | 0 | NA | 50 | 100 | 0 | NA | 90 | 100 | 100 | 0.031 |
a
A CDC panel of clinically diagnosed Lyme negative controls (n = 190) were assessed for reactivity to the listed commercial Lyme test kits. Sample descriptions were provided by the CDC as follows: 50 healthy nonendemic, 50 healthy endemic, and 90 “look-alike” disease controls for a combined 190 Lyme disease-negative samples. NPA, negative percent agreement with CDC results [NPA = (Neg)/n]. The results for the MarDx Marblot, Immunetics Lyme C6, and bioMérieux VIDAS Lyme polyvalent tests were provided by the CDC.