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cobas® SARS-CoV-2 Qualitative for use on the cobas®5800/6800/8800 Systems is a real-time RT-PCR test intended for the qualitative detection of nucleic acids from SARS-CoV-2 in nasopharyngeal swab specimens collected from individuals with signs and symptoms of COVID-19 and in anterior nasal swab specimens collected from any individuals with or without signs and symptoms of COVID-19.

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 pathogens.

Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions. Results are meant to be used in conjunction with clinical observations, patient history, recent exposures, epidemiological information, and laboratory data, in accordance with the guided by the relevant public health authorities.

cobas® SARS-CoV-2 Qualitative is based on fully automated sample preparation (nucleic acid extraction and purification) followed by PCR amplification and detection. The cobas® 5800 System is designed as one integrated instrument. The cobas® 6800/8800 Systems consist of the sample supply module, the transfer module, the processing module, and the analytic module. Automated data management is performed by the cobas® 5800 or cobas® 6800/8800 Systems software(s), which assigns test results for all tests. Results can be reviewed directly on the system screen, and printed as a report.

Nucleic acid from patient samples and added internal control RNA (RNA IC) molecules are simultaneously extracted. Nucleic acid is released by addition of proteinase and lysis reagent to the sample. The released nucleic acid binds to the silica surface of the added magnetic glass particles. Unbound substances and impurities, such as denatured protein, cellular debris and potential PCR inhibitors, are removed with subsequent wash steps and purified nucleic acid is eluted from the magnetic glass particles with elution buffer at elevated temperature. External controls (positive and negative) are processed in the same way.

Selective amplification of target nucleic acid from the sample is achieved by the use of targetspecific forward and reverse primers for ORF1 a/b non-structural region that is unique to SARS-CoV-2. Additionally, a conserved region in the structural protein envelope E-gene were chosen for pan-Sarbecovirus detection. The pan-Sarbecovirus detection sets will also detect SARS-CoV-2 virus.

Selective amplification of RNA Internal Control is achieved by the use of non-competitive sequence specific forward and reverse primers which have no homology with the coronavirus genome. A thermostable DNA polymerase enzyme is used for amplification.

The cobas® SARS-CoV-2 Qualitative master mix contains detection probes which are specific for the coronavirus type SARS-CoV-2, members of the Sarbecovirus subgenus, and the RNA Internal Control nucleic acid. The coronavirus and RNA Internal Control detection probes are each labeled with unique fluorescent dyes that act as a reporter. Each probe also has a second dye which acts as a quencher. When not bound to the target sequence, the fluorescent signals of the intact probes are suppressed by the quencher dye. During the PCR amplification step, hybridization of the probes to the specific single-stranded DNA template results in cleavage of the probe by the 5' to 3' exonuclease activity of the DNA polymerase resulting in separation of the reporter and quencher dyes and the generation of a fluorescent signal. With each PCR cycle, increasing amounts of cleaved probes are generated and the cumulative signal of the reporter dye increases concomitantly. Each reporter dye is measured at defined wavelengths, which enables simultaneous detection and discrimination of the amplified coronavirus target and the RNA Internal Control. The master mix includes deoxyuridine triphosphate (dUTP), instead of deoxythimidine triphosphate (dTTP), which is incorporated into the newly synthesized DNA (amplicon). Any contaminating amplicons from previous PCR runs are destroyed by the AmpErase enzyme [uracil-N-glycosylase], which is included in the PCR mix, when heated in the first thermal cycling step. However, newly formed amplicons are not destroyed since the AmpErase enzyme is inactivated once exposed to temperatures above 55°C.

cobas® SARS-CoV-2 Qualitative is a qualitative nucleic acid test for use on the cobas® 5800/6800/8800 System for the detection of the 2019 novel coronavirus (SARS-CoV-2) RNA in individual nasal and nasopharyngeal swab samples collected in Copan Universal Transport Medium System (UTM-RT), BD™ Universal Viral Transport System (UVT), cobas® PCR Media, or 0.9% physiological saline. The RNA Internal Control, used to monitor the entire sample preparation and PCR amplification process, is introduced into each specimen.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

The acceptance criteria are implicitly defined by the reported performance metrics of the device, which are Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA) against a comparator algorithm. The device needs to demonstrate high agreement for both positive and negative results in asymptomatic individuals.

Table of Acceptance Criteria and Reported Device Performance:

Note: The document does not explicitly state numerical acceptance criteria in a dedicated section. The "acceptance criteria" are inferred from the robust performance demonstrated and the claim of "equivalent performance" to the predicate device.

Study Details for Demonstrating Acceptance Criteria:

The device's performance was evaluated through two clinical studies focusing on asymptomatic populations: the 2020 National Football League (NFL) COVID-19 Surveillance Program and the 2021 Test Us at Home (TUAH) study.

1. NFL COVID-19 Surveillance Program (Real-world evidence)

• Sample Size Used for the Test Set: A total of 1776 samples were selected for analysis.
• Data Provenance: The data was collected from the United States (NFL COVID-19 Surveillance Program participants). It was retrospective as it used data collected between August 2020-January 2021. Samples were prospectively collected for the surveillance program itself.
• Number of Experts Used to Establish Ground Truth & Qualifications: The document does not specify the number or qualifications of experts used for clinical adjudication within the NFL testing program. It mentions a "comparator algorithm that was based on molecular comparator test results and/or clinical adjudication."
• Adjudication Method: Not explicitly stated beyond "clinical adjudication" as part of the comparator algorithm.
• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No, this type of study was not done. This device is a diagnostic test, not an AI-assisted human reading system.
• Standalone Performance: Yes, this study evaluates the standalone performance of the cobas® SARS-CoV-2 Qualitative device against a composite comparator algorithm.
• Type of Ground Truth Used: "molecular comparator test results and/or clinical adjudication performed within the NFL testing program." This indicates a composite ground truth method.
• Sample Size for the Training Set: Not applicable for a clinical performance evaluation study; this is a validation study. The training set for the development of the device itself is not provided in this document.
• How the Ground Truth for the Training Set was Established: Not applicable.

2. Test Us at Home (TUAH) Study (Clinical Study)

• Sample Size Used for the Test Set: 38,192 samples from the TUAH study were included.
• Data Provenance: The data was collected from the United States (TUAH study participants). It was prospective as samples were collected between October 2021 and April 2022 specifically for the longitudinal study.
• Number of Experts Used to Establish Ground Truth & Qualifications: The document does not specify the number or qualifications of experts. The comparator algorithm for this study relies on "two consecutive test results (molecular comparator)."
• Adjudication Method: The comparator algorithm used "two consecutive test results (molecular comparator) over 48 hours" to determine the ground truth. This is a form of algorithmic adjudication based on molecular tests, not human expert adjudication in the traditional sense.
• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No, this type of study was not done.
• Standalone Performance: Yes, this study evaluates the standalone performance of the cobas® SARS-CoV-2 Qualitative device against a composite comparator algorithm based on molecular results.
• Type of Ground Truth Used: Comparator algorithm based on "two consecutive test results (molecular comparator)." This indicates a molecular test-based composite ground truth.
• Sample Size for the Training Set: Not applicable for a clinical performance evaluation study.
• How the Ground Truth for the Training Set was Established: Not applicable.

Summary of In Silico Analysis (Non-Clinical Performance):

• An in-silico analysis was conducted in January 2025 using SARS-CoV-2 sequences from the GISAID database (as of January 15, 2025).
• Sample Size for Test Set: 16,156,883 sequences from the GISAID database.
• Data Provenance: Global (various countries submitting to GISAID). Retrospective, as it used existing sequence data.
• Ground Truth: Bioinformatic analysis of shared viral sequences.
• Results: >99.9% of sequences for SARS-CoV-2 had no changes in primer/probe binding sites at both target regions simultaneously. All sequences were predicted to be detected by at least one of the two targets. This addresses potential variations in the virus that might affect detection.

This document clearly outlines the analytical and clinical performance of the device, particularly focusing on its effectiveness in detecting SARS-CoV-2 in asymptomatic individuals against established comparator methods.

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The cobas® SARS-CoV-2 & Influenza A/B Nucleic acid test for use on the cobas® Liat® System (cobas® SARS-CoV-2 & Influenza A/B) is an automated rapid multiplex real-time, reverse transcriptase polymerase chain reaction (RT-PCR) test intended for the simultaneous qualitative detection and differentiation of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), influenza A, and influenza B virus nucleic acid in nasopharyngeal swab (NPS) and anterior nasal swab (ANS) specimens from individuals with signs and symptoms of respiratory tract infection. Clinical signs and symptoms of respiratory tract infection due to SARS-CoV-2 and influenza can be similar.

cobas® SARS-CoV-2 & Influenza A/B is intended for use as an aid in the differential diagnosis of SARS-CoV-2, influenza A, and/or influenza B infection if used in conjunction with other clinical and epidemiological information, and laboratory findings. SARS-CoV-2, influenza A and influenza B viral nucleic acid are generally detectable in NPS and ANS specimens during the acute phase of infection.

Positive results do not rule out co-infection with other organisms. The agent(s) detected by the cobas SARS-CoV-2 & Influenza A/B may not be the definite cause of disease.

Negative results do not preclude SARS-COV-2, influenza A, and/or influenza B infection. The results of this test should not be used as the sole basis for diagnosis, treatment, or other patient management decisions.

cobas® SARS-CoV-2 & Influenza A/B assay uses real-time reverse transcriptase polymerase chain reaction (RT-PCR) technology to rapidly (approximately 20 minutes) detect and differentiate between SARS-CoV-2, influenza A, and influenza B viruses from nasopharyngeal and nasal swabs. The automation, small footprint, and easy-to-use interface of the cobas® Liat® System enable performance of this test to occur at the POC or in a clinical laboratory setting.

The provided text describes the acceptance criteria and the study that proves the device meets those criteria for the "cobas SARS-CoV-2 & Influenza A/B Nucleic acid test for use on the cobas Liat System". This is a diagnostic test, not an AI/ML device, so many of the requested elements (like "number of experts used to establish ground truth" or "multi reader multi case comparative effectiveness study") are not applicable or described in the same way they would be for an AI/ML product. However, I will extract and present the information as per the prompt's structure, noting where the information is N/A or conceptually different due to the nature of the device.

Device Name: cobas® SARS-CoV-2 & Influenza A/B Nucleic acid test for use on the cobas® Liat® System

Device Type: Automated rapid multiplex real-time, reverse transcriptase polymerase chain reaction (RT-PCR) test for qualitative detection and differentiation of SARS-CoV-2, influenza A, and influenza B virus nucleic acid.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" as a separate, pre-defined table. Instead, the performance metrics, such as Limit of Detection (LoD), inclusivity, cross-reactivity, and clinical performance (PPA, NPA), serve as the de facto acceptance criteria. The reported device performance is presented against these metrics.

Implicit Acceptance Criteria and Reported Performance for Key Metrics:

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