cobas SARS-CoV-2 Test

The cobas^® SARS-CoV-2 Test provides reliable and high-quality results for the improved management of COVID-19, in individuals suspected of COVID-19 by their healthcare provider, and those without symptoms or other reasons to suspect COVID-19. Healthcare professionals can use this test to assess if patients are at risk of developing the disease by this pathogen, which can contribute to severe respiratory distress, complications, and potential death.

The test is for use on the fully-automated cobas® 6800/8800 Systems under FDA Emergency Use Authorization (EUA) for individual samples and for pooled samples containing up to and including six individuals. This test, including the pooling workflow, is also available as a CE-IVD test for countries accepting the CE-mark.

Features and benefits of the cobas^® SARS-CoV-2 Test

The cobas® SARS-CoV-2 Test is a single-well dual target assay, which includes both specific detection of SARS-CoV-2 and pan-Sarbecovirus detection for the Sarbecovirus subgenus family that includes SARS-CoV-2. The assay has a full-process negative control, positive control and internal control. Two kit sizes accommodating either 192 or 480 test reactions are available.

Claims include:

• Use of nasal, nasopharyngeal and oropharyngeal swab sample types
• Use of collection and transport media
• cobas PCR Media Dual Swab Kit
• Uni Swab
• PCR Media Kit
• Copan Universal Transport Media (UTM-RT)
• BD™ Universal Viral Transport (UVT)
• 0.9% Physiological Saline
• Please refer to the IFU for acceptable sample type and collection device combinations