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GenPad Test Kits

Test Kit for SARS-CoV-2 Detection

SARS-CoV-2 (COVID-19) RNA Detection Rapid Cartridge/Tests kit
ref ID LPC-C-100IC
Introduction

The etiological agent of COVID-19 was designated as severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2, previously referred to as the 2019 novel coronavirus (2019-nCoV) as well). Test Kit for SARS-CoV-2 RNA Detection is intended to perform the SARS-CoV-2 viral RNA extraction in nasopharyngeal, oropharyngeal, or combined oro- and nasopharyngeal swab collected from individuals who are suspected of COVID-19 infection, master mix preparation and further SARS-CoV-2 viral RNA detection in the specimen using PCR method. The Kit is intended for use with the GenPad Analyzer.


Product Description
  • Name
    Test Kit for SARS-CoV-2 RNA Detection
  • Ref ID
    ID LPC-C-100IC
  • Technology
    NAAT (RT-SmartAMP)
  • Time to results
    20-40 minutes
  • Equipment
    Portable device GenePad
Key Benefits
High accuracy
Sensitivity >98%, specificity 100%
Ease of use
Suitable for maternities, clinics, hospitals, and mobile setups
Rapid Diagnosis
Possibility to provide treatment in time
Instruction for Use
The test involves a single-step pre-treatment process to lyse the viral capsid of coronavirus in the specimens. Following pre-treatment, the test employs fully automated processes, including RNA extraction and isothermal nucleic acid amplification. The method is based on the detection of specific viral RNA fragments (Nsp15, N) by obtaining a DNA copy (cDNA) from the RNA matrix using a reverse transcription reaction and detection of its accumulation (amplification) using SmartAmp Real-Time PCR method. Amplification is detected by the analyzer through fluorogenic oligonucleotides in the reaction mixture.

Documents
Instructions for Use (pdf)
Learn more about SmartAmp
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