Table 4.
In Vitro Reactivity Testing With the Idylla™ Prototype Ebola Virus Test at Approximately 2× the Limit of Detection (LoD) Concentration and Threshold Cycle (Ct) Values Detected Using the ITM GP Reverse-Transcription Polymerase Chain Reaction as a Reference Test
| Virus/strain | Specimen Type | Concentration | Ct Value, ITM GP RT-PCR | Detection Rate, Idylla™ Prototype Ebola Virus Test Proportion of Samples |
|---|---|---|---|---|
| EBOV | GP RNA transcript | 10−6 | 19.70 | 1/1 |
| EBOV | GP dsDNA (gBlock), spiked in whole blood | 10−4 | 30.80 | 1/1 |
| EBOV/Guinea C07 | Encapsulated RNA, spiked in whole blood | NA | 19.12 | 2/2 |
| EBOV/Zaire 76 | Encapsulated RNA, spiked in whole blood | NA | 20.24 | 2/2 |
| EBOV/Zaire 95 | Encapsulated RNA, spiked in whole blood | NA | 19.95 | 2/2 |
| EBOV/Gabon 2003 | Inactivated virus, spiked in whole blood | 2× the LoD | 20.27 | 6/6 |
| EBOV/Gueckedou-C05 | Inactivated virus, spiked in whole blood | 2× the LoD | 16.75 | 6/6 |
| EBOV/Gueckedou-C07 | Inactivated virus, spiked in whole blood | 2× the LoD | 16.40 | 6/6 |
| EBOV/Kissidougou-C15 | Inactivated virus, spiked in whole blood | 2× the LoD | 17.70 | 6/6 |
| EBOV/Mayinga | Inactivated virus, spiked in whole blood | 2× the LoD | 18.66 | 6/6 |
| SUDV | GP RNA transcript | 10−6 | 20.00 | 1/1 |
| SUDV | GP dsDNA (gBlock), spiked in whole blood | 10−4 | 31.90 | 1/1 |
| SUDV/Boniface | Encapsulated RNA, spiked in whole blood | NA | 19.45 | 2/2 |
| SUDV/Boniface | RNA, spiked in whole blood | 0.25 <LoD | ND | 6/7 |
| SUDV/Gulu | Encapsulated RNA, spiked in whole blood | NA | 22.09 | 2/2 |
| SUDV/Gulu | Inactivated virus, spiked in whole blood | 2× the LoD | 19.96 | 6/6 |
Abbreviations: dsDNA, double-stranded DNA; NA, not applicable; ND, not detected.