cobas^® SARS-CoV-2

The cobas SARS-CoV-2 Nucleic acid test for use on the cobas® liat System - IFU - EUA-IVD, v3.0, 06-04-2023; cobas SARS-CoV-2 Nucleic acid test for use on the cobas® liat System - CE - IVD - English v2.0, 11-01-2023.  Pleasanton, CA; Roche Molecular Systems is an automated real-time RT-PCR assay intended for the rapid in vitro qualitative detection of SARS-CoV-2 in self-collected nasal swabs (collected in a healthcare setting with instruction by a healthcare provider) and healthcare provider-collected nasopharyngeal and nasal swabs from either individual suspected of respiratory viral infection consistent with COVID-19 by their healthcare provider or from individuals without symptoms or other reasons to suspect COVID-19.

cobas^® SARS-CoV-2 is intended for use in the detection of SARS-CoV-2 in clinical specimens. SARS-CoV-2 viral RNA is generally detectable in upper respiratory specimens during the acute phase of infection. Positive results are indicative of active infection but do not rule out co‑infection with other pathogens not detected by the test. Clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. The agent detected may not be the definite cause of disease.

Negative results do not preclude infection from SARS-CoV-2 and should not be used as the sole basis for diagnosis, treatment or other patient management decisions. Negative results must be combined with clinical observations, patient history, and/or epidemiological information.

cobas^® SARS-CoV-2 is intended for use by health professionals or trained operators who are proficient in using the cobas® liat system at the point of care (POC) or in a clinical laboratory setting.

The cobas^® SARS-CoV-2 Nucleic acid test for use on the cobas® Liat® System (cobas^® SARS-CoV-2) is an automated real-time RT-PCR assay intended for the rapid in vitro qualitative detection of nucleic acid from SARS-CoV-2 in self-collected anterior nasal (nasal) swabs (collected in a healthcare setting with instruction by a healthcare provider) and healthcare provider-collected nasopharyngeal, mid-turbinate and anterior nasal (nasal) swabs from either individuals suspected of COVID-19 by their healthcare provider or from any individual, including individuals without symptoms or other reasons to suspect COVID-19.

Results are for the identification of SARS-CoV-2 nucleic acids. SARS-CoV-2 RNA is generally detectable in respiratory specimens during the acute phase of infection. Positive results are indicative of the presence of SARS-CoV-2 RNA. Positive results do not rule out bacterial infection or co-infection with other viruses. Clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. The agent detected may not be the definite cause of disease.

Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for diagnosis, treatment or other patient management decisions. Negative results must be combined with clinical observations, patient history, and/or epidemiological information.

cobas^® SARS-CoV-2 is intended for use by health professionals or trained operators who are proficient in using the cobas® liat system.

In the United States (US), testing with cobas^® SARS-CoV-2 is authorized for laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform moderate or high complexity tests. cobas^® SARS-CoV-2 is also authorized for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.

Laboratories within the U.S. and its territories are required to report all SARS-CoV-2 results to the appropriate public health authorities.

In the U.S., cobas^® SARS-CoV-2 is only for use under the Food and Drug Administration’s Emergency Use Authorization."