FDA Accepts Data for Variant Detection
Studies have been conducted using live SARS-CoV-2 virus at independent laboratories which showed detection of the below variants of concern.
| Variant | Detected |
|---|---|
| Alpha B.1.1.7 |
|
| Beta B.1.351 |
|
| Gamma P.1 |
|
| Delta B.1.617.2 |
|
| Omicron B.1.1.529, BA.1, BA.2, BA.2.12.1, BA.3 & BA.5 |
|
InteliSwab® detects the Omicron BA.2, BA.2.12.1, BA.3 and BA.5 subvariants with similar levels of detection to the original SARS-CoV-2 strain and other previous variants of concern, including Delta, Alpha, Beta, Gamma and Omicron BA.1. The Omicron sublineage studies were conducted using live SARS-CoV-2 virus at an independent, third-party laboratory and showed InteliSwab® detected the Omicron variants at similar viral load levels, or limit of detection, as previous variants that were tested.