Solana SARS-CoV-2 Assay Kit

SKU

QDL-M313

(96 Tests per Kit, Controls Included)

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^®.

Additional positive controls (QDL-M5301) and negative controls (QDL-M5203) can be purchased upon request.

All EUA authorized COVID-19 products are non-returnable with no exceptions unless damaged in transit, product is recalled for manufacturer erformacne issues or deemed defective by the manufacturer. Buyer should beware that EUA authorized products could be revoked by FDA and removed from authorization list. Products that are revoked are non-returnable and non-refundable. Note: Manufacturer recalls are returnable for replacement product only. No Cash refund will be given for manufacturer-initiated recall.

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Details

Features & Benefits

Feature	Benefit
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

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

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