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Test Kit Solana® Molecular Diagnostic SARS-CoV-2 Nasal Swab / Nasopharyngeal Swab Sample 96 TestsM956

Test-Kit-Solana®-Molecular-Diagnostic-SARS-CoV-2-Nasal-Swab--Nasopharyngeal-Swab-Sample-96-TestsM956

SKU #

#1182299

MPN #

M956

Brand

Quidel

Stock

In Stock

Quantity

100

Features

TEST KIT, NASAL SWAB SARS COV-2 SOLANA (96TEST/KT) D/S

$3,333.53 USD

Product Specifications Product Usage Additional Information
Print
Attribute Name Attribute Value
McKesson # 1182299
Manufacturer # M956
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, (100) NP Swabs, (100) Universal Transport Media
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