Product Manual

Solana SARS-CoV-2 Assay Page 2 of 13
Results are for the identification of SARS-CoV-2 RNA. The SARS-CoV-2 is generally detectable upper 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
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 Solana SARS-CoV-2 Assay is intended for use by laboratory personnel who have received specific training on the use
of the Solana SARS-CoV-2 Assay and/or the Solana Instrument. The Solana SARS-CoV-2 Assay is only for use under the
Food and Drug Administration’s Emergency Use Authorization.
SUMMARY AND EXPLANATION
SARS-CoV-2, also known as the COVID-19 virus, was first identified in Wuhan, Hubei Province, China December 2019. This
virus, as with the novel coronavirus SARS-1 and MERS, is thought to have originated in bats, however the SARS-CoV-2
may have had an intermediary host such as pangolins, pigs or civets.
1
On March 11, the WHO had declared the SARS-
CoV-2 as a global pandemic. As of 13 December 2020, the number of new COVID-19 cases and deaths continued to rise
with 70 million cumulative cases and 1.6 million deaths globally since the start of the pandemic. The Regions of the
Americas and Europe continue to shoulder the burden of the pandemic, accounting for 85% of new cases and 86% of new
deaths globally
1
.
The median incubation time is estimated to be 5.1 days with symptoms expected to be present within 12 days of
infection.
2
The symptoms of COVID-19 are similar to other viral respiratory diseases and include fever, cough and
shortness of breath.
3
The Solana SARS-CoV-2 Assay has been designed to specifically detect SARS-CoV-2 RNA.
PRINCIPLE OF THE TEST
The Solana SARS-CoV-2 Assay amplifies and detects viral RNA present in nasopharyngeal or nasal swab specimens
collected and placed into viral transport media.
The assay consists of two major steps: (1) specimen preparation, and (2) amplification and detection of target sequences
specific to SARS-CoV-2 using isothermal Reverse Transcriptase – Helicase-Dependent Amplification (RT-HDA) in the
presence of target-specific fluorescence probes.
A patient nasal or nasopharyngeal swab specimen in viral transport media is transferred to a Process Buffer Tube, mixed,
and subjected to heat treatment at 95°C for 5 minutes. The frozen Master Mix vial contains RT-HDA reagents, dNTPs,
primers and probes. The thawed Master Mix is transferred to empty reaction tubes. The processed sample is then
transferred to a Reaction Tube containing Master Mix. Once the Master Mix and the processed sample are mixed, the
Reaction Tube is placed in Solana for amplification and detection of SARS-CoV-2 specific target sequences. In Solana, the
target sequences are amplified by SARS-CoV-2 specific primers and detected by SARS-CoV-2 specific fluorescence probes,
respectively. A competitive process control (PRC) is included in the Master Mix to monitor sample processing, inhibitory
substances in clinical samples, reagent failure or device failure.
The target and PRC probes are labeled with a quencher on one end and a fluorophore on the other end. In addition, the
target probe and PRC probe have one or more bases that are comprised of ribonucleic acid. Upon annealing to SARS-CoV-
2 or PRC amplicons, the fluorescence probes are cleaved by RNaseH2 and the fluorescence signal increases due to
physical separation of fluorophore from quencher.
Solana measures and interprets the fluorescent signal, using on-board method-specific algorithms. Solana then reports
the test results to the user on its display screen, and it can print out the results via an integrated printer.