Home / Clinical Laboratory / Test Kits / Test Kit / Test Kit Solana® Molecular Diagnostic SARS-CoV-2 Nasal Swab / Nasopharyngeal Swab Sample 96 TestsM313
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Test Kit Solana® Molecular Diagnostic SARS-CoV-2 Nasal Swab / Nasopharyngeal Swab Sample 96 TestsM313

Test-Kit-Solana®-Molecular-Diagnostic-SARS-CoV-2-Nasal-Swab--Nasopharyngeal-Swab-Sample-96-TestsM313

SKU #

#1182298

MPN #

M313

Brand

Quidel

Stock

In Stock

Quantity

100

Features

REAGENT, SARS COV-2 SOLANA ASSAY (96TEST/KT) D/S

$3,111.29 USD

Product Specifications Product Usage Additional Information
Print
Attribute Name Attribute Value
McKesson # 1182298
Manufacturer # M313
Brand Solana®
Manufacturer Quidel
Application Test Kit
Contents (96) Process Buffer Tubes, (96) Empty Reaction Tubes, 1 Tube Negative Control, 1 Tube Positive Control, (8) Master Mix Tubes
For Use With For use with Solana Instrument
Number of Tests 96 Tests
Product Dating McKesson Acceptable Dating: we will ship >= 90 days
Reading Type Machine Read
Sample Type Nasal Swab / Nasopharyngeal Swab Sample
Storage Requirements Keep Frozen
Test Format Tube Format
Test Method Isothermal Reverse Transcriptase - Helicase-Dependent Amplification (RT-HDA) Assay
Test Name SARS-CoV-2
Test Type Molecular Diagnostic
Time To Results 30 Minute Results
UNSPSC Code 41116144
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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
  • Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high or moderate complexity tests
  • 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