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 |
fg/μL femtograms in 1 microliter, pg/μL picograms in 1 microliter, GE/μL genomic equivalents in 1 microliter, ND not detectable, R2 correlation coefficient