Visby Medical NATtrol
The Visby COVID-19 Test is a single-use (disposable), fully integrated, rapid, automated RT-PCR in vitro diagnostic test intended for the qualitative detection of SARS-CoV-2 RNA in nasopharyngeal, nasal, or mid-turbinate swabs collected by a health care provider (HCP), or nasal or mid- turbinate swabs self-collected (in a healthcare setting) from individuals who are suspected of COVID-19 by their healthcare provider.
Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, meets requirements to perform high or moderate complexity tests. Results are for the identification of SARS-CoV-2 RNA. The SARS-CoV-2 RNA is generally detectable in respiratory specimens during the acute phase of infection. Positive results are indicative of the presence of SARS-CoV-2 RNA; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status.
Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of the disease. Laboratories within the United States and its territories are required to report all results to the appropriate public health authorities. Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions.
Negative results must be combined with clinical observations, patient history, and epidemiological information. The Visby Medical COVID-19 Test is intended for use by laboratory personnel who have received specific training on the use of the Visby Medical COVID-19 Test. The Visby Medical COVID-19 Test is only for use under the Food and Drug Administration’s Emergency Use Authorization.
Summary and Explanation of the Procedure
The Visby COVID-19 Test is a rapid, instrument-free, single-use (disposable) molecular in vitro diagnostic test for the qualitative detection of ribonucleic acid from the SARS-CoV-2 virus. The Visby COVID-19 Test contains all components required to carry out an assay for SARS-CoV-2 in nasopharyngeal, nasal, or midturbinate swabs.
Principles of the Procedure
The Visby COVID-19 Test is a single-use (disposable), fully integrated, rapid, compact device containing a reverse transcription-polymerase chain reaction (RT-PCR) based assay for the qualitative detection of viral RNA from the SARS-CoV-2. The SARS-CoV-2 primer and probe sets are designed to detect the nucleocapsid (N) region of SARS-CoV-2 in nasopharyngeal, nasal, or mid-turbinate swabs collected by a health care provider (HCP), or nasal or mid- turbinate swabs self-collected (in a healthcare setting) from individuals who are suspected of COVID-19 by their healthcare provider.
The test automatically performs all steps required to complete sample preparation, complementary DNA production, amplification, and detection. The sample mixes with lyophilized RT-PCR reagents and is then thermocycler such that the cDNA molecules present are amplified enough to be detectable by a colorimetric system. Amplified target (if present) is hybridized to specific locations along a flow channel.
This flow channel is configured to facilitate an enzymatic reaction that utilizes horseradish peroxidase (HRP) and a color-producing substrate. This will result in an observable color change for a positive reaction. The control strategy relies on a positive spot on the flow cell. If all elements in the Visby COVID-19 Test device are functioning properly, then the Results Valid spot will produce color.
The Visby test uses commercially available Universal Transport Media manufactured by Copan Diagnostics or Universal Viral Transport System supplied by BD. See Material Required but Not Supplied for part number information. After collection with Copan’s collection kit, specimens are transferred with a palette into the COVID-19 dilution tube. The cassette is then discarded and the diluted sample is ready for processing with the Visby COVID-19 Test.