Respiratory infection test kit cobas® SARS-COV-2

COVID-19diagnosticSARS-COV-2

Product summary
cobas® SARS‑COV‑2 is a qualitative real‑time RT‑PCR assay developed for fully automated processing on cobas® 6800 and cobas® 8800 Systems. The assay integrates automated extraction, purification, amplification and detection with built‑in data management to support high‑throughput clinical laboratories.

Intended use
The assay is intended for qualitative detection of SARS‑CoV‑2 RNA in healthcare provider‑instructed self‑collected anterior nasal swabs (collected on site) and healthcare provider‑collected nasal, nasopharyngeal and oropharyngeal swab specimens from symptomatic and asymptomatic individuals. Pooled testing of up to six specimens per pool is supported where permitted; negative pooled results are presumptive and inconsistent results should prompt individual testing.

Key features and workflow

• Assay type: qualitative real‑time reverse transcription PCR (RT‑PCR).
• Platform: optimized for cobas® 6800/8800 Systems with automated sample supply, transfer, processing and analysis.
• Automated sample prep: simultaneous nucleic acid extraction and RNA internal control processing using magnetic glass particle technology.
• Targets: ORF1 a/b (SARS‑CoV‑2 specific) and E‑gene (pan‑Sarbecovirus) to ensure target coverage.
• Multiplex detection: distinct fluorescent reporters for target discrimination and internal control monitoring.
• Contamination control: dUTP/AmpErase chemistry to reduce carryover contamination.
• Users: intended for qualified clinical laboratory personnel trained in molecular diagnostics; in the US use is limited to CLIA‑certified labs under FDA EUA when applicable.

Kit variants & ordering information

• KIT COBAS 6800/8800 SARS‑COV‑2 480T (pack size: 480 tests)
• KIT COBAS 6800/8800 SARS‑COV‑2 192T (pack size: 192 tests)
• Japan variants: KIT COBAS 6800/8800 SARS‑COV‑2 192T JP and KIT COBAS 6800/8800 SARS‑COV‑2 480T JP (regional pack/configuration variants)

Regulatory & performance notes
Selected kit configurations are CE‑IVD marked. In the United States, cobas® SARS‑COV‑2 is authorized under FDA Emergency Use Authorization (EUA) for use in CLIA‑certified laboratories meeting applicable complexity requirements. Positive results indicate detection of SARS‑CoV‑2 RNA and require clinical correlation; negative results do not rule out infection and should be interpreted with clinical and epidemiological information.

Intended specimens

• Healthcare provider‑instructed self‑collected anterior nasal swab (on site)
• Healthcare provider‑collected nasal swab
• Nasopharyngeal swab
• Oropharyngeal swab
• Pooled samples (up to 6 specimens) where indicated — negative pooled results are presumptive

Analytical & technical notes

• Simultaneous extraction of sample nucleic acid and RNA internal control for run‑level process verification.
• Sequence‑specific primers and probes produce target‑dependent fluorescent signals measured at defined wavelengths.
• Thermostable polymerase and multiplex chemistry support concurrent detection of viral targets and internal control.

Technical specifications

• Assay format: Qualitative real‑time RT‑PCR.
• Platform compatibility: cobas® 6800 and cobas® 8800 Systems.
• Sample types: anterior nasal (self‑collected on site), nasal, nasopharyngeal, oropharyngeal swabs.
• Pooled testing: supported up to 6 samples per pool (subject to reduced sensitivity and local regulations).
• Targets: ORF1 a/b (SARS‑CoV‑2 specific) and E‑gene (pan‑Sarbecovirus).
• Controls: RNA internal control included; external positive/negative controls recommended per run.
• Automation: extraction, purification, amplification, detection and data management automated on cobas® 6800/8800.
• Regulatory status: CE‑IVD for indicated kits; EUA status in US where applicable.
• Intended users: trained clinical laboratory personnel with molecular diagnostics expertise.