Table 2.
Initial LoD Testing on Ebola Virus (EBOV) Strain Makona and Sudan Virus (SUDV) Strain Gulu Spiked in EDTA Whole Blood Samples, Using Reference RT-PCR Assays
| Strain, Dilution in PFU/mL | Theoretical Genomic Concentration, Copies/mL | Experimental Genomic Concentration, Copies/mL |
Detection Rate, Proportion of Samples |
Detection Rate, Idylla™ Prototype Ebola Virus Test, Proportion of Samples |
|---|---|---|---|---|
| EZ1 RT-PCR | ||||
| EBOV strain Makona | ||||
| Undiluted stock | 81 500 000 | 81 500 000 | 3/3 | 3/3 |
| 10 000 | 27 167 | 69 547 | 3/3 | 3/3 |
| 1000 | 2717 | 3837 | 3/3 | 3/3 |
| 100 | 272 | 135 | 3/3 | 3/3a |
| 10 | 27 | ND | 0/3 | 1/3a |
| 1 | 3 | ND | 0/3 | 0/3 |
| Trombley RT-PCR | ||||
| SUDV strain Gulu | ||||
| Undiluted stock | 182 000 000 | 182 000 000 | 3/3 | 3/3 |
| 10 000 | 206 116 | 134 818 | 3/3 | 3/3 |
| 1000 | 20 612 | 26 902 | 3/3 | 3/3 |
| 100 | 2061 | 2838 | 3/3 | 3/3a |
| 10 | 206 | 812 | 2/3 | 1/3 |
| 1 | 20 | 122 | 1/3 | 0/3 |
Abbreviations: EBOV, Ebola virus; GP, glycoprotein; ITM, Institute of Tropical Medicine; LoD, limit of detection; ND, not detected; PFU, plaque-forming units; RT-PCR, reverse-transcription polymerase chain reaction; SUDV, Sudan virus.
a Results were not positive in all 4 PCR chambers.