Table 2.
Details of discordant results between Cue COVID-19, Hologic Aptima, and/or laboratory-developed RT-PCR assays.
| Patient # | Cue result | Reference result (method) | RLU or Cp value | Other testing performed (days ± study enrollment) | Reference Consensus result |
|---|---|---|---|---|---|
| 1 | Negative | Positive (Hologic) | RLU 1139 | None | Positive |
| 2 | Negative | Positive (Hologic) | RLU 1097 | Negative LDT RT-PCR (1 day before enrollment) | Negative |
| 3 | Negative | Positive (LDT RT-PCR) | Cp 35.00 | Positive Hologic (8 days before enrollment) | Positive |
| 4 | Positive | Negative (Hologic) | RLU 288 | None | Negative |
| 5 | Positive | Negative (Hologic) | RLU 279 | None | Negative |
| 6 | Positive | Negative (Hologic) | RLU 283 | None | Negative |
| 7 | Positive | Negative (Hologic) | RLU 287 | Negative Hologic (4 days after enrollment) | Negative |
RLU = relative light unit, Hologic Aptima test results are based upon total RLU and the kinetic curve type; Cp = crossing point, a positive LDT RT-PCR has a Cp ≤ 40 and a valid amplification curve; LDT = laboratory-developed test; RT-PCR = reverse transcription polymerase chain reaction