Diagnostic test kit cobas® SARS-CoV-2 Duo

COVID-19SARS-COV-2nasal

Overview
cobas® SARS‑CoV‑2 Duo for use on the cobas® 5800/6800/8800 systems is an automated real‑time RT‑PCR assay for in vitro qualitative and quantitative detection of SARS‑CoV‑2 RNA in healthcare provider‑instructed self‑collected nasal (anterior nares and mid‑turbinate) swab specimens (collected on site), and healthcare provider‑collected nasal (anterior nares and mid‑turbinate) and nasopharyngeal swab specimens. Quantitation of viral RNA is provided; only the qualitative result is intended for diagnostic aid.

Intended use and regulatory status
For in vitro diagnostic use. cobas® SARS‑CoV‑2 Duo is authorized for use under Emergency Use Authorization (EUA) where applicable. In the United States, use is limited to CLIA‑certified laboratories authorized to perform high or moderate complexity testing. Results require clinical correlation for interpretation.

Key clinical notes
Positive results indicate presence of SARS‑CoV‑2 RNA but do not exclude bacterial infection or co‑infection with other respiratory viruses. Negative results do not rule out SARS‑CoV‑2 infection and should not be the sole basis for patient management; combine with clinical findings, exposure history and epidemiological information. Quantitative viral load values are provided for informational purposes and are not established for specific clinical diagnoses, prognoses or management decisions.

Sample types and applications

• Healthcare provider‑instructed self‑collected nasal swabs (anterior nares and mid‑turbinates) collected on site
• Healthcare provider‑collected nasal swabs (anterior nares and mid‑turbinates)
• Healthcare provider‑collected nasopharyngeal swabs
• Application: qualitative detection (intended use) and quantitative reporting (informational only)

Assay principle and workflow
Fully automated nucleic acid extraction and purification followed by real‑time RT‑PCR amplification and detection on cobas® 5800/6800/8800 systems. Extraction employs proteinase and lysis reagents and magnetic glass particles for binding, wash and elution steps. Instrument software performs automated data management; results can be reviewed on the system display and printed.

Analytical design

• Dual‑target virus‑specific approach targeting conserved regions in ORF1a and ORF1a/b (two viral probes)
• Internal RNA Quality/Standard (RNA‑QS) monitored by a non‑competitive sequence‑specific primer/probe set (one probe)
• Simultaneous amplification of viral targets and RNA‑QS using a universal PCR profile
• Master mix contains dUTP and uracil‑N‑glycosylase (AmpErase) for carryover contamination control
• Detection via cleavage of fluorescently labeled oligonucleotide probes with real‑time fluorescence monitoring

Controls

• External controls processed with each run: high positive, low positive and negative control
• Internal RNA‑QS for run and process monitoring

Ordering information
Material number | Material description | Pack/notes
09500111190 | KIT C58/68/88 SARS‑COV2 DUO 192T | 1 Kit = 192 tests

Regulatory disclaimer
For in vitro diagnostic use. cobas® SARS‑CoV‑2 Duo is intended for use by qualified clinical laboratory personnel trained in real‑time PCR techniques and in operation of cobas® 5800/6800/8800 systems. Use and reporting must follow applicable regional regulatory authorizations and laboratory certifications.

Technical specifications

• Commercial name: cobas® SARS‑CoV‑2 Duo
• Assay type: automated real‑time RT‑PCR (qualitative intended for diagnosis; quantitative reporting for information)
• Compatible systems: cobas® 5800, cobas® 6800, cobas® 8800
• Target regions: ORF1a and ORF1a/b (dual viral targets)
• Internal control: RNA‑QS (non‑competitive)
• External controls: high positive, low positive, negative
• Contamination control: dUTP + AmpErase (uracil‑N‑glycosylase)
• Sample types: nasal (anterior nares, mid‑turbinates) and nasopharyngeal swabs
• Kit configuration / ordering: KIT C58/68/88 SARS‑COV2 DUO 192T (1 kit = 192 tests); material number 09500111190
• Regulatory / lab requirements: EUA where applicable; intended for CLIA‑certified labs (high or moderate complexity) in the U.S.
• Intended users: qualified clinical laboratory personnel trained in real‑time PCR and instrument operation