TABLE 2.
CDC premarketing panel: first-tier sensitivity comparisonsa
| Test kit | No. of samples or PPA |
Combined |
||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Acute phase |
Convalescent phase |
Late phase |
||||||||||||
| Pos | Equ | Neg | PPA | Pos | Equ | Neg | PPA | Pos | Equ | Neg | PPA | PPA | P | |
| BioPlex 2200 Lyme Total | 33 | 0 | 6 | 84.6 | 29 | 0 | 2 | 93.5 | 20 | 0 | 0 | 100 | 91.1 | Ref |
| Immunetics Lyme C6 | 29 | 0 | 10 | 74.4 | 28 | 1 | 2 | 93.5 | 20 | 0 | 0 | 100 | 86.7 | 0.125 |
| Zeus Borrelia VlsE1/pepC10 | 31 | 1 | 7 | 82.1 | 28 | 0 | 3 | 90.3 | 20 | 0 | 0 | 100 | 88.9 | 0.500 |
| bioMérieux VIDAS Lyme polyvalent | 28 | 5 | 6 | 84.6 | 27 | 2 | 2 | 93.5 | 20 | 0 | 0 | 100 | 91.1 | 1.000 |
| bioMérieux VIDAS Lyme II (lgM+IgG) | 30 | 1 | 8 | 79.5 | 26 | 0 | 5 | 83.9 | 20 | 0 | 0 | 100 | 85.6 | 0.063 |
| bioMérieux VIDAS Lyme II lgM | 23 | 5 | 11 | 71.8 | 23 | 3 | 5 | 83.9 | 6 | 8 | 6 | 70.0 | 75.6 | <0.001 |
| bioMérieux VIDAS Lyme II lgG | 26 | NA | 13 | 66.7 | 26 | NA | 5 | 83.9 | 20 | NA | 0 | 100 | 80.0 | 0.002 |
| MarDx B. burgdorferi Marblot (lgM+IgG) | 24 | NA | 15 | 61.5 | 25 | NA | 6 | 80.6 | 20 | NA | 0 | 100 | 76.7 | <0.001 |
| MarDx B. burgdorferi Marblot lgM | 21 | NA | 18 | 53.8 | 19 | NA | 12 | 61.3 | 8 | NA | 12 | 40.0 | 53.3 | <0.001 |
| MarDx B. burgdorferi Marblot lgG | 11 | NA | 28 | 28.2 | 14 | NA | 17 | 45.2 | 20 | NA | 0 | 100 | 50.0 | <0.001 |
a
A CDC panel of clinically diagnosed Lyme disease-positive patient samples was assessed for reactivity to the listed commercial Lyme test kits. Disease-stage information was provided by the CDC as follows: 39 acute-phase samples (30 early EM, 3 cardiac Lyme, and 6 neurologic Lyme); 31 convalescent-phase samples (30 early EM and 1 neurologic Lyme follow-ups); and 20 late-phase samples (all Lyme arthritis/neurologic) for a combined 90 Lyme-positive samples. PPA, positive percent agreement with CDC results [PPA = (Pos + Equ)/n]. Results for the MarDx Marblot, Immunetics Lyme C6, and bioMérieux VIDAS Lyme polyvalent tests were provided by the CDC.