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For use with Solana® SARS-CoV-2 Test on the Solana Instrument
Product Dating
SLI Medical Acceptable Dating: we will ship >= 90 days
Sample Type
Nasal Swab / Nasopharyngeal Swab Sample
Specialty
Keep Frozen
Storage Requirements
SARS-CoV-2 Master Mix
Test Category
Molecular Diagnostic
Test Name
30 Minute Results
Test Type
41116144
Time to Results
UNSPSC Code
Features
Solana SARS-CoV-2 Assay is for use under an FDA Emergency Use Authorization: https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations
Solana SARS-CoV-2 Assay is for use under an FDA Emergency Use Authorization: https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations
The Solana SARS-CoV-2 Assay is an isothermal Reverse Transcriptase - Helicase-Dependent Amplification (RT-HDA) assay intended for the qualitative detection of nucleic acid from SARS-CoV-2 in nasopharyngeal (NP) and nasal (NS) swab specimens from individuals suspected of COVID-19 by their healthcare provider
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
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 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 which is performed in the Solana instrument
