Roche Diagnostics cobas Liat SARS-CoV-2 Assay

Description

Nucleic acid test for use on cobas Liat system is the first real-time RT-PCR test authorized for use in screening and testing asymptomatic/symptomatic individuals for SARS-CoV-2 at the point of care

• Screen asymptomatic individuals to help prevent the silent spread of SARS-CoV-2
• Provide answers patients need in 20 min. enabling quick actions to manage patient care
• Offers broad strain coverage of SARS-CoV-2 variants

Specifications

• Certifications/Compliance: EUA
• Content And Storage: 2°C to 8°C
• Control Sets: SARS-CoV-2 Control Kit used to verify each new lot of SARS-CoV-2 assay
• CPT Code: 87635
• CE Marker: Yes
• Clia Complexity: Waived (EUA)
• Detectable Analytes: ORF 1a/b and N gene SARS-CoV-2
• DoA Calibrators: Yes
• Format: Assay Tube
• Sample Type: Nasopharyngeal swab, Mid turbinate swab, Nasal swab
• Sensitivity: SARS-CoV-2: Symptomatic individuals: 96.1% Positive Agreement, 96.8% Negative Agreement; Asymptomatic individuals 100% Positive Agreement, 98.9% Negative Agreement* *compared to an FDA-cleared EUA, Cobas™ SARS-CoV-2 Test on Cobas™ 6800/8800 systems
• Type: Assay Kit
• Disposable: Single-use
• For Use With (Application): RT-PCR
• For Use With (Equipment): Cobas™ Liat system analyzer
• Material: Plastic
• PCR Method: RT-PCR
• Quantity: 20 Tests/Kit
• Shipping Condition: Cold chain
• Sterility: Non-sterile
• Target Organism Class: Dual-target ORF 1a/b & N gene SARS-CoV-2
• Test Time: 20 min.