TABLE 3.
Combined results of interlaboratory reproducibility studya
| GBS sample panel concentration | Agreement type | Performance requirement (%) | NeuMoDx |
|
|---|---|---|---|---|
| % agreement | 95% CI | |||
| Moderate-positive samples (4× LOD, 95% CI upper limit) | Positive (PPA) | >99 | 100 (75/75) | 95.1–100 |
| Low-positive samples (1.5× LOD, 95% CI upper limit) | Positive (PPA) | >95 | 97.3 (73/75) | 90.8–99.3 |
| Low-negative samples (1:100 dilution of 1× LOD, 95% CI upper limit) | Negative (NPA) | >95 | 98.7 (74/75) | 92.8–99.8) |
| Negative samples (no target present) | Negative (NPA) | ∼100 | 100 (75/75) | 95.1–100 |
a
The lower and upper limits of the 95% CI were calculated using 95% CI method according to CLSI-approved guideline EP12-A2. LLOD, lower limit of detection; PPA, positive percent agreement; NPA, negative percent agreement.