Visby SARS-CoV-2, Influenza A, and Influenza B Rapid PCR Test

General Details

• CLIA Complexity: Waived

• Detectable Analytes: Influenza A, Influenza B, SARS-CoV-2 RNA

• Format: Integrated, instrument-free RT-PCR test

• Sample Type: Nasopharyngeal and anterior nasal swab specimens

• Sensitivity: LoD (Limit of Detection) is approximately 100 copies/swab for SARS-CoV-2, 106 copies/swab for Influenza A (H1N1), and 728 copies/swab for Influenza B.

• For Use With (Application): RT-PCR for the detection of influenza A, influenza B, and COVID-19 RNA

• Test Time: ∽30 minutes

• Power Source: Requires Visby Power Adapter (9 V, 3.5 A DC)

• Quantity: Comes in packs of 10 tests

• Shelf Life: Store between 36°F-86°F (2°C-30°C). Shelf life details are available in the product's instructions for use.

• Manufacturer: Visby Medical, Inc.

Box Components

• Visby Medical Respiratory Health Test Device – Quantity: 10

• Visby Fixed Volume Pipette (650 µl) – Quantity: 12

• Visby Respiratory Health Buffer Tube (5.85 mL) – Quantity: 12

• Disposal Bags – Quantity: 12

Accessories Available Separately

• Visby Power Adapter (PS-000855 or PS-000288) – Required for powering the test device.

• External Controls – Respiratory Health Positive and Negative Control Swabs (PS-400381) for quality control checks.

• Swabs – Only sterile nylon, foam, or polyester flocked flexible shaft swabs are compatible with this test. Cotton and rayon swabs are not recommended.

Intended use

The Visby Medical Respiratory Health Test is a single-use, instrument-free molecular in vitro diagnostic test utilizing reverse transcription polymerase chain reaction (RT-PCR) technology for the qualitative detection and differentiation of nucleic acid from influenza A, influenza B, and SARS-CoV-2. It is designed for use with clinician-collected nasopharyngeal and anterior nasal swab specimens, or clinician-instructed self-collected nasal swabs (collected on-site) from individuals showing symptoms of respiratory tract infection consistent with COVID-19. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform high, moderate, or waived complexity tests. The Visby Medical Respiratory Health Test is authorized for use at the Point of Care (POC), in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.

The Visby Medical Respiratory Health Test provides simultaneous detection and differentiation of SARS-CoV-2, influenza A, and influenza B RNA, which are generally detectable in nasopharyngeal and anterior nasal swab specimens during the acute phase of infection. Positive results indicate the presence of viral RNA and require clinical correlation with patient history and other diagnostic information to determine infection status. Positive results do not rule out bacterial infection or co-infection with other pathogens. Laboratories within the United States are required to report all SARS-CoV-2 results to the appropriate public health authorities.

Negative results do not rule out SARS-CoV-2, influenza A, or influenza B infections and should not be used as the sole basis for patient management decisions. They must be combined with clinical observations, patient history, and epidemiological information.

The Visby Medical Respiratory Health Test is intended for use by operators trained in its procedures. It is authorized for use under the Food and Drug Administration’s Emergency Use Authorization (EUA).