TABLE 3

Combined results of interlaboratory reproducibility studya

GBS sample panel concentrationAgreement typePerformance requirement (%)NeuMoDx
% agreement95% CI
Moderate-positive samples (4× LOD, 95% CI upper limit)Positive (PPA)>99100 (75/75)95.1–100
Low-positive samples (1.5× LOD, 95% CI upper limit)Positive (PPA)>9597.3 (73/75)90.8–99.3
Low-negative samples (1:100 dilution of 1× LOD, 95% CI upper limit)Negative (NPA)>9598.7 (74/75)92.8–99.8)
Negative samples (no target present)Negative (NPA)∼100100 (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.