TABLE 2.
Characteristics of samples with various lineages, including variants of concern, and results of testing with 1st- and 2nd-generation SARS-CoV-2 Xpert Xpress assay
| Sample | Pango lineage | NextStrain clade | WHO VOC designation | 1st-generation SARS-CoV-2 Xpressa interpretation | 1st-generation SARS-CoV-2 Xpressa
CT value |
2nd-generation CoV-2 RUOb interpretation | 2nd-generation CoV-2 RUOb
CT value |
2nd-generation CoV-2/Flu/RSV-plus Xpressa interpretation | 2nd-generation CoV-2/Flu/RSV-plus Xpress a CT value for SARS-CoV-2 | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| E | N2 | E | N2 | RdRp | ||||||||
| CD025 | B.1.1.7 | 20I/501Y.V1 | Alpha | SARS-CoV-2 positive | 31.6 | 33.7 | SARS-CoV-2 positive | 26.3 | 28.9 | 28.9 | SARS-CoV-2 positive | 28.6 |
| CD026 | B.1.351 | 20H/501Y.V2 | Beta | SARS-CoV-2 positive | 25.3 | 28.0 | SARS-CoV-2 positive | 25.2 | 28.3 | 26.7 | SARS-CoV-2 positive | 25.0 |
| CD027 | B.1.429 | 20C | Epsilon | SARS-CoV-2 positive | 19.8 | 22.3 | SARS-CoV-2 positive | 21.1 | 23.9 | 22.6 | SARS-CoV-2 positive | 21.7 |
| CD028 | B.1.525 | 20A | Eta | SARS-CoV-2 positive | 20.4 | 22.7 | SARS-CoV-2 positive | 19.8 | 22.6 | 21.4 | SARS-CoV-2 positive | 22.1 |
| CD029 | B.1.526 | 20C | Iota | SARS-CoV-2 positive | 20.2 | 22.8 | SARS-CoV-2 positive | 19.1 | 22.2 | 20.6 | SARS-CoV-2 positive | 20.2 |
| CD030 | B.1.621 | 20A | Mu | SARS-CoV-2 positive | 35.1 | 37.2 | SARS-CoV-2 positive | 33.1 | 36.1 | 35.5 | SARS-CoV-2 positive | 34.5 |
| CD031 | B.1.617.2 | 21A | Delta | SARS-CoV-2 positive | 26.2 | 27.6 | SARS-CoV-2 positive | 22.1 | 25.9 | 24.6 | SARS-CoV-2 positive | 24.7 |
| CD038 | B.1.617.2 | 21A | Delta | SARS-CoV-2 positive | 28.3 | 31.1 | SARS-CoV-2 positive | 27.3 | 30.8 | 29.3 | SARS-CoV-2 positive | 28.6 |
| CD040 | B.1.2 | 20G | NAc | SARS-CoV-2 positive | 26.6 | 28.4 | SARS-CoV-2 positive | 25.6 | 28.3 | 27.8 | SARS-CoV-2 positive | 27 |
| CD041 | B.1.529.1 | 21K | Omicron BA.1 | SARS-CoV-2 positive | 17.2 | 19.4 | SARS-CoV-2 positive | 15.7 | 19.2 | 17.5 | SARS-CoV-2 positive | 17.3 |
| CD042 | B.1.529.1 | 21K | Omicron BA.1 | SARS-CoV-2 positive | 19.8 | 22 | SARS-CoV-2 positive | 18.7 | 22.1 | 20.3 | SARS-CoV-2 positive | 19.5 |
| CD043 | B.1.529.1 | 21K | Omicron BA.1 | SARS-CoV-2 positive | 17.2 | 19.7 | SARS-CoV-2 positive | 15.7 | 19.5 | 17.4 | SARS-CoV-2 positive | 17.3 |
| CD044 | B.1.529.1 | 21K | Omicron BA.1 | SARS-CoV-2 positive | 18.4 | 20.6 | SARS-CoV-2 positive | 17 | 20.7 | 18.9 | SARS-CoV-2 positive | 18.5 |
| CD045 | B.1.529.1 | 21K | Omicron BA.1 | SARS-CoV-2 positive | 22.8 | 25.1 | SARS-CoV-2 positive | 21.9 | 25.3 | 23.8 | SARS-CoV-2 positive | 22.8 |
| CD046 | B.1.529.1 | 21K | Omicron BA.1 | SARS-CoV-2 positive | 22.2 | 24.5 | SARS-CoV-2 positive | 21.2 | 24.9 | 23.2 | SARS-CoV-2 positive | 22 |
| CD047 | B.1.529.1 | 21K | Omicron BA.1 | SARS-CoV-2 positive | 29.6 | 32.5 | SARS-CoV-2 positive | 27.9 | 31.8 | 30.1 | SARS-CoV-2 positive | 29.1 |
| CD048 | B.1.529.1 | 21K | Omicron BA.1 | SARS-CoV-2 positive | 27.2 | 28.9 | SARS-CoV-2 positive | 25.1 | 28.6 | 27.3 | SARS-CoV-2 positive | 27.2 |
| CD049 | B.1.529.1 | 21K | Omicron BA.1 | SARS-CoV-2 positive | 21.2 | 23.4 | SARS-CoV-2 positive | 19.4 | 22.9 | 21.4 | SARS-CoV-2 positive | 20.9 |
| CD050 | B.1.529.1 | 21K | Omicron BA.1 | SARS-CoV-2 positive | 26.5 | 28.9 | SARS-CoV-2 positive | 24.4 | 27.9 | 26.7 | SARS-CoV-2 positive | 26.6 |
The assay has been issued U.S. Food and Drug Administration emergency use authorization.
The research use only (RUO) assay has not been authorized as a diagnostic device by the U.S. Food and Drug Administration. This assay is technically equivalent to the Xpress CoV-2-plus test, which received FDA EUA after this testing was performed.
NA, not applicable.