Visby Medical Controls

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, that meet 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 midtur binate swabs.

Principles of the Procedure

The Visby COVID-19 Test is a single-use (disposable), fully-integrated, rapid,a  compact device containing a reverse transcription polymerase chain reaction (RT-PCR) based assay for 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.