Table 3.
Limit of detection for CDC and PHL bacterial respiratory LDTs in 96 well format. LoD is expressed as the highest dilution (lowest concentration) of extracted reference standard that met acceptance criteria for the experiment.
| Column | A | B | C | D | E | F |
|---|---|---|---|---|---|---|
| State PHL | IA | NY | WA | WI | HI | |
| Assay type | CDC | LDT | LDT | CDC | CDC | CDC |
| Instrument 7500 = ABI 7500 Fast |
7500 | 7500 | 7500 | 7500 | 7500 | 7500 |
| B. pertussis | −7 | −7 | −7 | NA | −7 | NA |
| C. pneumoniae | −3 | −3 | −5 | −3 | NA | NA |
| H. influenzae | NA | NA | −6 | −5 | NA | -5 |
| Legionella spp. | A | −5 | −6 | −5 | NA | NA |
| M. pneumoniae | −5 | −5 | −6 | −5 | NA | NA |
| S. pneumoniae | NA | NA | −6 | −5 | −4 | NA |
| S. pyogenes | NA | NA | −5 | −5 | −5 | NA |
A – 15/20 positive (75%) detection at −6.
NA – assay not assigned to site.