Table 2 Summary of results for each parameter evaluated in the analytical validation
Validation parameters | sip-qPCR |
|---|---|
Inclusivity (detectable for qPCR) (fg/μL) | |
GBS serotype Ia (n = 3) | 24 |
GBS serotype Ib (n = 2) | 24 |
GBS serotype II (n = 4) | 24 |
GBS serotype III (n = 2) | 24 |
GBS serotype IV (n = 3) | 24 |
GBS serotype V (n = 2) | 24 |
GBS serotype VI (n = 2) | 24 |
GBS serotype VII (n = 3) | 24 |
GBS serotype VIII (n = 1) | 24 |
Exclusivity (non-detectable qPCR) (0.1 to 1000 pg/μL) | |
S. pyogenes ATCC 12384 | ND |
S. aureus ATCC 25923 | ND |
E. faecalis ATCC 29212 | ND |
S. pneumoniae ATCC 49619 | ND |
E. coli ATCC 25922 | ND |
K. pneumoniae ATCC 700603 | ND |
K. aerogenes ATCC 13048 | ND |
S. saprophyticus | ND |
Proteus spp | ND |
S. marcescens | ND |
Reportable range (GE/μL) | |
GBS ATCC 12403 serotype III | 20.000-2 |
Limit of detection (GE/μL) | |
GBS ATCC 12403 serotype III | 0.7 |
Robustness | |
GBS ATCC 12403 serotype III (% correct positives) | 100 |
Samples non-GBS (% correct negatives) | 100 |
PCR efficiency (ε) (%) | 105.4 |
Linearity (R2) | 0.9937 |