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:
Please refer to the IFU for acceptable sample type and collection device combinations.
Coronaviruses (CoV) are a large family of viruses that cause illness ranging from the common cold to more severe diseases such as Middle East Respiratory Syndrome (MERS-CoV) and Severe Acute Respiratory Syndrome (SARS-CoV). SARS-CoV-2 is a novel coronavirus recently identified in humans.
Signs of infection include respiratory symptoms such as cough, shortness of breath, difficulty breathing and fever. In more severe cases, pneumonia, severe acute respiratory syndrome, kidney failure and death can occur.
FDA-Emergency Use Authorization, CE-IVD
In the United States:
- This test has not been FDA cleared or approved;
- This test has been authorised by FDA under an EUA for use by authorised laboratories;
- This test has been authorised only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens; and,
- This test is only authorised for the duration of the declaration that circumstances exist justifying the authorisation of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorisation is terminated or revoked sooner.
| TARGET | POSITIVE AGREEMENT | NEGATIVE AGREEMENT | LoD (95% Probit) |
| SARS-CoV-2 | 100% | 100% | 0.007 TCID50/mL |
| pan-Sarbecovirus | 100% | 100% | 0.004 TCID50/mL |
| PARAMETER | PERFORMANCE |
| Kit Configurations | 192 and 480 test cassettes |
| Sample Type | Nasal, nasopharyngeal and oropharyngeal swab |
| Transport media for nasal swabs |
cobas® PCR Media Dual Swab Kit, cobas® PCR Media Uni Swab Kit, cobas® PCR Media Kit for nasal swabs, 0.9% Physiological Saline, Copan Universal Transport Medium (UTM-RT) or BD Universal Viral Transport (UVT) |
| Transport media for nasopharyngeal andoropharyngeal swab | Copan Universal Transport Medium (UTM-RT) or BD Universal Viral Transport (UVT) |
| Min. amount of sample required | 0.6 mL |
| Sample processing volume | 0.4 mL |
| Test duration | Results are available within less than 3.5 hours after loading the sample on the system |
| System software | Runs with SW versions 1.2, 1.3, and 1.4 |
| Kit stability | 90 days with 40 re-uses for 192 test cassette and 20 re-uses for 480 test cassette |
