Reagent Solana Molecular Diagnostic SARS-CoV-2 Master Mix For use with Solana SARS-CoV-2 Test on the Solana Instrument
- 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 \n
- 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 \n
- 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 \n
- 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 \n
- Positive results do not rule out bacterial infection or co-infection with other viruses \n
- Laboratories within the United States and its territories are required to report all results to the appropriate public health authorities \n
- 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 \n
- 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 \n
- 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
- Storage requirements:
- keep frozen
- Time to results:
- 30 minute results
- UNSPSC:
- 41116144
- Sample type:
- nasal swab / nasopharyngeal swab
- Mckesson #:
- 1191720
- For use with:
- for use with solana sars-cov-2 test on the solana instrument
- Brand:
- Solana
- Test type:
- molecular diagnostic
- Test name:
- sars-cov-2 master mix
- Container type:
- vial
- Application:
- reagent
- Manufacturer:
- Quidel
- Product dating:
- mckesson acceptable dating: we will ship >= 90 days
- Manufacturer #:
- m313.a
