PCR qualitative detection of SARS-CoV-2 on cobas® 5800/6800/8800 Systems with expanded sample types.
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, and those without symptoms or other reasons to suspect COVID-191. 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.
This test is also intended for the qualitative detection of nucleic acids from SARS-CoV-2 in pooled samples containing up to and including six individual samples.2
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.
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*Se hela tabellen
Test performance in individual samples*
|TARGET||LoD (95% Probit)|
* cobas® SARS-CoV-2 Qualitative assay for use on the cobas® 5800/6800/8800 Systems Instructions for use. (09343784001-03EN, Doc. Rev. 3.0), Pleasanton, CA. Roche Molecular Systems, 2021.
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|
Key ParametersSe hela tabellen
|Kit Configuration||192 and 480 test cassettes|
|Sample Type||Nasal, nasopharyngeal and oropharyngeal swab3
|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
Liquified saliva: 0.85 mL
|System software||Runs with SW version 1.4 on cobas® 6800/8800 Systems and SW version 1.0 on cobas® 5800 System|
|Kit stability||90 days with 40 re-uses for 192 test cassette on cobas® 5800/6800/8800 Systems; 40 re-uses for 480 test cassette on cobas® 5800 System and 20 re-uses for 480 cassette on cobas® 6800/8800 Systems|
CE-IVD & FDA 510(k) clearance