PRUEBA COVID PCR

Prueba de PCR en tiempo real COVID-19 CE

Esta prueba está diseñada para la detección específica y cuantitativa del nuevo coronavirus SARS-CoV-2, responsable de COVID-19, en hisopos orofaríngeos, hisopos nasofaríngeos o muestras de esputo como ayuda en el diagnóstico de infecciones por COVID-19.

Se basa en la amplificación en tiempo real de porciones específicas del ARN del SARS-CoV- 2: 

REGIONES OBJETIVO ORF1AB Y GEN N

• Uso de sondas fluorescentes multiplex de PCR, combinadas con tecnología rápida de RT-PCR de un solo paso

  • CTK’s Aridia COVID-19 Real-Time PCR Test has 100% (95% CI: 89.1-100%) Sensitivity; 100% (95% CI: 98.2 -100%) Specificity by utilizing multiplex PCR-fluorescent probe technology combined with fast, one-step RT-PCR technology.
  • CTK’s Aridia COVID-19 Real-Time PCR Test is able to detect B1.1.1.7 SARS-CoV-2 variant with the same limit of detection as the original SARS-CoV-2 strain.
  • With the designed dual-target gene detection primer-probe, the test is designed to work with open PCR systems, making CTK’s COVID-19 Real-Time PCR Test a practical solution for all varieties of laboratories.
  • Furthermore, CTK is working to submit its PCR test to the Foundation for Innovative New Diagnostics (FIND) in response to FIND’s expression of interest (EOI) for evaluating assays using its standardized, independent protocol. CTK is also participating in the WHO program “In-Vitro diagnostics for SARS-CoV-2 for emergency use listing”.
  • For use with nasal swab specimens, sputum specimens, etc.
  • Detects ORF1ab, nucleocapsid protein gene
  • Test packaging: 96 tests/kit
  • LOD: ≥10 RNA copies per reaction
  1. Analytical Specificity

The analytical specificity for Aridia COVID-19 Real-Time PCR Test was confirmed by testing a panel consisting of different microorganisms representing the most common respiratory pathogens. No cross-reactivity was detected between any of the microorganisms tested.

Reagents and Materials provided:

  1. COVID-19 PCR Mix (24 tests per vial) 4 vials, 1 per pouch
  2. COVID-19 Positive Control 1 vial in pouch
  3. COVID-19 Negative Control 1 vial in pouch
  4. PCR-Grade Water
  5. Instructions for Use

Materials Required but not provided:

  1. Real-Time PCR thermocycler compatible with FAM, ROX and HEX channels (check “COMPATIBILITY of REAL-TIME PCR THERMOCYCLERS” section)
  2. RNA purification kit
  3. 5 mL centrifuge tubes
  4. Centrifuge for 1.5 mL tubes and PCR-well strips or 96-well plate (if available)
  5. Vortex
  6. Micropipettes (0.5-20 µL, 20-200 µL)
  7. Filter micropipette tips

JR IMPORTADORES 2021. DERECHOS RESERVADOS. DISEÑO WEB POR LIBERI MKS

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