The cobas® SARS-CoV-2 Test provides reliable and high-quality results for clinical decision-making for the improved management of COVID-19 patients and to reduce the risk of SARS-CoV-2 infection. Healthcare professionals can use this test to assess if patients are at risk of developing disease by this pathogen, which can contribute to severe upper 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 is also available as a CE-IVD test for countries accepting the CE-mark. Pooling workflow is not available 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.
Expansion of the claimed specimen types to include nasal samples collected according to standard collection technique using flocked or polyester-tipped swabs and immediately placed in 3 mL of Copan Universal Transport Medium (UTM-RT) or BD Universal Viral Transport (UVT)
Addition of the following as acceptable collection and transport media for nasal swabs:
cobas® PCR Media Dual Swab Kit
cobas® PCR Media Uni Swab Kit
cobas® PCR Media Kit for nasal swabs
and 0.9% Physiological Saline
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). The novel coronavirus (SARS-CoV-2) is a new strain which has not previously been 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 authorized by FDA under an EUA for use by authorized laboratories;
- This test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens; and,
- This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization 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 authorization is terminated or revoked sooner.
Test performance in individual samplesView Full Table
Test performance in individual samples
|TARGET||POSITIVE AGREEMENT||NEGATIVE AGREEMENT||LoD (95% Probit)|
Key ParametersView Full Table
|Kit Configuration||192 test cassette|
|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 µL|
|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|