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Picture of Reagent Solana® Molecular Diagnostic SARS-CoV-2 Master Mix For use with Solana® SARS-CoV-2 Test on the Solana InstrumentM313.A

Reagent Solana® Molecular Diagnostic SARS-CoV-2 Master Mix For use with Solana® SARS-CoV-2 Test on the Solana InstrumentM313.A

Reagent-Solana®-Molecular-Diagnostic-SARS-CoV-2-Master-Mix-For-use-with-Solana®-SARS-CoV-2-Test-on-the-Solana-InstrumentM313-A

SKU #

#1191720

MPN #

M313.A

Brand

Quidel

Stock

In Stock

Quantity

100

Features

REAGENT, SARS COV-2 SOLANA MASTERMIX (8/KT) D/S

$476.79 USD

Product Specifications Product Usage Additional Information
Print
Attribute Name Attribute Value
McKesson # 1191720
Manufacturer # M313.A
Brand Solana®
Manufacturer Quidel
Application Reagent
Container Type Vial
For Use With For use with Solana® SARS-CoV-2 Test on the Solana Instrument
Sample Type Nasal Swab / Nasopharyngeal Swab Sample
Storage Requirements Keep Frozen
Test Name SARS-CoV-2 Master Mix
Test Type Molecular Diagnostic
Time To Results 30 Minute Results
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  • 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
  • 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
  • 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
  • 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
  • Positive results do not rule out bacterial infection or co-infection with other viruses
  • Laboratories within the United States and its territories are required to report all results to the appropriate public health authorities
  • 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
  • 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
  • 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