PCR qualitative detection of SARS-CoV-2 on cobas® 6800/8800 Systems
The cobas® SARS-CoV-2 Qualitative Test provides reliable and high-quality results for the improved management of COVID-19, in individuals suspected of COVID-19 by their healthcare provider. 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 cobas®SARS-CoV-2 Qualitative 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 may include:
Please refer to the IFU for acceptable sample type and collection device combinations
Since the start of COVID-19 pandemic, Roche is focused on bringing effective diagnostic solutions to healthcare communities worldwide in the fight against the disease.
As communities across the globe still need effective solutions for COVID-19, Roche continues to invest in diagnostics to ensure there are testing options available to healthcare communities and patients worldwide.
Test performance in individual samples*,a,b
View Full TableTest performance in individual samples*,a,b
| TARGET | LoD (95% Probit) |
| SARS-CoV-2 | 200 IU/mLa 0.004 TCID50/mLb |
| pan-Sarbecovirus | 102 IU/mLa 0.007 TCID50/mLb |
* cobas® SARS-CoV-2 Qualitative assay for use on the cobas 6800/8800 Systems (192T & 480T) - Instructions for use
a LoD determined with WHO International Standard for SARS-CoV-2 RNA (NIBSC code: 20/146)
b one TCID50/mL is equal to 7,393 genome equivalents by ddPCR (per vendor’s Certificate of Analysis, USA-WA1/2020, infectious culture, Cat No NR-52281, Lot 70033175)
| SPECIMEN TYPE | TARGET | POSITIVE AGREEMENT | NEGATIVE AGREEMENT |
| Nasopharyngeal | SARS-CoV-2 | 97.2% | 99.9% |
Key Parameters
View Full TableKey Parameters
| PARAMETER | PERFORMANCE |
| Kit Configuration | 192 and 480 test cassettes |
| Sample Type | Nasal, nasopharyngeal |
| 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 and oropharyngeal swab | Copan Universal Transport Medium (UTM-RT) or BD Universal Viral Transport (UVT) |
| Min. amount of sample required | Swab speciment types: 0.6 mL Liquified saliva: 1.2 mL |
| Sample processing volume | Swab specimen types: 0.4 mL |
| System software | Runs with SW version 1.4 on cobas® 6800/8800 Systems |
| Kit stability | 90 days with 40 re-uses for 192 test cassette on cobas® 6800/8800 Systems and 20 re-uses for 480 cassette on cobas® 6800/8800 Systems |
FDA 510(k) clearance
