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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 Reverse Transcriptase — Helicase-Dependent Amplification (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®.

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 - Quidel's EUA COVID-19 Products (Scroll down to the list of EUA products and enter “Quidel” in the search box)


Click Here for Solana SARS-CoV-2 Assay Kit, FRZ MMx Cat. #M313


Features & Benefits

FeatureBenefit

RT-HDA technology

Rapid method of isothermal nucleic acid amplification that does not require thermal cycler

Lyophilized Master Mix reagent

Easy-to-use format, just add processed sample to rehydrate

Small, easy-to-use instrument

Eliminates the need for dedicated molecular space and costly capital equipment, allowing for testing in smaller labs

CLIA moderately complex

Requires minimal training

Storage

No freezer needed, 2˚C to 8˚C

Room temperature set up

No ice or cooling block required

Product Specifications

Product Spec NameProduct Spec Data
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%

Ordering Information

Catalog NumberDescriptionKit 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