FDA Emergency Use Authorization
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.
Molecular identification of SARS-CoV-2 occurs by the use of targeting highly conserved regions of the SARS-CoV-2 virus non-structural Polyprotein (pp1ab).
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 RT-HDA in the presence of target-specific fluorescence probes which is performed in the Solana instrument.
Results are displayed on the touchscreen, can be saved to the instrument, printed, and are capable of being sent to the LIS and exported through one of Solana’s five USB ports. Solana SARS-CoV-2 assay is also supported by the power of Virena®.
Please see chart below for ordering information.
Where can I go for updates and more information?
CDC:
General Information - Coronavirus (COVID-19)
Information for Healthcare Professionals
Information for Laboratories
Laboratory Biosafety
Isolation Precautions in Healthcare Settings
Specimen Collection
Infection Control
FDA:
General Information - Coronavirus (COVID-19)
Emergency Use Authorizations
Additional Information - QuidelOrtho's EUA COVID-19 Products (Scroll down to the list of EUA products and enter “Quidel" or "Ortho” in the search box)
The Solana SARS-CoV-2 assay has not been FDA cleared or approved, but has been authorized by the FDA under an Emergency Use Authorization (EUA) for use by authorized laboratories for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. This assay is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless authorization is terminated or revoked sooner.
FDA Emergency Use Authorization
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.
Molecular identification of SARS-CoV-2 occurs by the use of targeting highly conserved regions of the SARS-CoV-2 virus non-structural Polyprotein (pp1ab).
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 RT-HDA in the presence of target-specific fluorescence probes which is performed in the Solana instrument.
Results are displayed on the touchscreen, can be saved to the instrument, printed, and are capable of being sent to the LIS and exported through one of Solana’s five USB ports. Solana SARS-CoV-2 assay is also supported by the power of Virena®.
Please see chart below for ordering information.
Where can I go for updates and more information?
CDC:
General Information - Coronavirus (COVID-19)
Information for Healthcare Professionals
Information for Laboratories
Laboratory Biosafety
Isolation Precautions in Healthcare Settings
Specimen Collection
Infection Control
FDA:
General Information - Coronavirus (COVID-19)
Emergency Use Authorizations
Additional Information - QuidelOrtho's EUA COVID-19 Products (Scroll down to the list of EUA products and enter “Quidel" or "Ortho” in the search box)
The Solana SARS-CoV-2 assay has not been FDA cleared or approved, but has been authorized by the FDA under an Emergency Use Authorization (EUA) for use by authorized laboratories for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. This assay is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless authorization is terminated or revoked sooner.
| Ordering information | ||
| Catalog number | Description | Kit size / Case size |
| M312 | Solana SARS-CoV-2 assay Kit, LYO MMx | 48 tests, controls |
| M960 | Solana SARS-CoV-2 assay Kit, LYO MMx with nasopharyngeal swabs and universal transport media | 48 tests, controls, 50 NP swabs, 50 universal transport media |
| M961 | Solana SARS-CoV-2 assay Kit, LYO MMx with nasal swabs and universal transport media | 48 tests, controls, 50 NS swabs, 50 universal transport media |
| M5301 | Solana SARS-CoV-2 positive control | Included with kit, additional may be ordered separately |
| M5203 | Solana SARS-CoV-2 negative control | Included with kit, additional may be ordered separately |
Features & benefits
Rapid method of isothermal nucleic acid amplification that does not require thermocycling with RT-HDA technology
Easy-to-use format, just add processed sample to rehydrate with lyophilized master mix reagent.
Small, easy-to-use instrument eliminates the need for dedicated molecular space and costly capital equipment, allowing for testing in smaller labs.
To access safety data sheets, package inserts, quick reference guides and all other technical and promotional materials, visit our technical documents library.
- Specifications
| Product specifications | |
| Sample type | Nasal swabs and nasopharyngeal swabs in transport media obtained from patients suspected of COVID-19 |
| Time to results | Approximately 30 minutes |
| Reagent storage conditions | Process Buffer and Reaction Tubes, 2˚C to 8˚C |
| Controls storage conditions | 2°C to 8°C |
| Sample preparation storage conditions | Specimens should be collected, transported, stored, and processed according to CLSI M41-A. Specimens should be stored at 2°C to 8°C until tested. |
| Specimens collected in BD/Copan UTM, Remel M4RT, or QTM are stable at room temperature (RT), 2°C to 8°C or –70°C or below for up to 4 days. | |
| Specimens collected in the CDC Viral Transport Medium should be stored at 2°C to 8°C for up to 72 hours after collection or at –70°C or below if a delay in testing or shipping is expected. | |
| PPA | Nasal: 98.8% |
| NPA | Nasal: 100% |
