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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)


Features & Benefits

FeatureBenefit

RT-HDA technology

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

Frozen Master Mix

Easy-to-use format, just thaw Master Mix before use (see Package Insert)

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

Process Buffer 2˚C to 8˚C storage, Master Mix -70˚C or below

Long shelf life

6 months from date of manufacture

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 Reaction Tubes 2˚C to 8˚C and Master Mix -70˚C or below

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 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.

PPA
Nasal: 97.2%
Nasopharyngeal: 100%
NPA
Nasal: 100%
Nasopharyngeal: 96.9%

*BD/Copan UTM, CDC Viral Transport Media

Ordering Information

Catalog NumberDescriptionKit Size / Case Size
M313

Solana SARS-CoV-2 Assay Kit

96 tests, controls
M956

Solana SARS-CoV-2 Assay Kit with Nasopharyngeal Swabs and Universal Transport Media

96 tests, controls, 100 NP swabs, 100 universal transport media
M958

Solana SARS-CoV-2 Assay Kit with Nasal Swabs and Universal Transport Media

96 tests, controls, 100 NS swabs, 100 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
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