Roche Diagnostics cobas™ Liat SARS-CoV-2, Influenza A/B and RSV RT-PCR Assay Kit

The cobas™ liat SARS-CoV-2, Influenza A/B and RSV nucleic acid test for use on the cobas Liat System is a multiplex real-time polymerase chain reaction (PCR) test that detects and differentiates SARS-CoV-2, Influenza A, Influenza B and RSV in nasopharyngeal or anterior nasal swab specimens.

Supplier:  Roche Diagnostics 09731261190

Catalog No. 21-200-319

Description

The cobas™ liat SARS-CoV-2, Influenza A/B and RSV Nucleic acid test for use on the cobas™ Liat™ System 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, and respiratory syncytial virus nucleic acid in nasopharyngeal swab (NPS) and anterior nasal swab (ANS) specimens from individuals with signs and symptoms of respiratory tract infection. This test has no age restrictions

Specifications

• Content And Storage: 3 sets of positive and negative controls per kit
• CPT Code: 87637 (for assay)
• Clia Complexity: Waived (EUA)
• Detection Method: RT-PCR
• Format: Kit
• Sensitivity: For assay: Influenza A, B, RSV = 100% positive agreement; SARS-CoV-2=96.7% positive agreement
• Disposable: Single-use
• For Use With (Equipment): Used with the cobas™ liat analyzer to validate lots or run control tests
• Quantity: 1
• Analysis Time: 20 min.
• Weight (English): 0.1 lb.

• Control Sets: integrated sample processing control, positive and negative controls
• CE Marker: Yes
• Detectable Analytes: SARS-CoV-2, Influenza A and B, Rubella Virus Antibodies
• DoA Calibrators: No
• Sample Type: For assay: nasaopharyngeal or anterior nasal
• Type: Control
• For Use With (Application): Detection of SARS-CoV-2, Influenza A/B, and RSV
• Product Line: cobas™
• Specificity: For assay: SARS-CoV-2=96.7% negative agreement; Influenza A = 98.1% negative agreement; Influenza B = 97.7% negative agreement; RSV = 97.2% negative agreement
• Dimensions (L x W x H): 6.1 x 10 x 1.4 in.
• Form: Ready-to-Use (RTU)

Safety and Handling

ShelfLife : 12 Months