Easy Rapid Now™

Covid-19 (Nasal Swab) SurveillanceTest Kit

1 box (5 tests)

Contact us to discuss your CV19 Surveillance Plan – rich@dermacarepkg.com or kelly@dermacarepkg.com

Category: SKU: easyrapidnow

Description

FDA generally does not regulate surveillance testing.

During this pandemic, improved surveillance testing procedures is fundamental.

Surveillance testing is used for population or large group testing to track outbreaks and to help health authorities develop plans to stop the spread of CV19.

For Surveillance Use Only. NOT for use in diagnostic procedures or at home use (USA Only).

 

 

Product Information

PERFORMANCE*

  • SENSITIVITY: 98.72% (100% for samples
    with Ct values ≤33
  • SPECIFICITY: 97.32%
  • CLINICAL STUDY POPULATION: 190
    individuals, including 78 PCR-positives a
    112 PCR-negatives
  • CLINICAL STUDY DATE & LOCATION:
    November 2020 Apollosa (Benevento) Italy

SPECIFICATION:

  • TEST TIME: 5-15 Minutes
  • STORAGE CONDITION: 4°C-30ºC
  • CE MARK
  • SAMPLE TYPE: Nasal (NS) Swab
  • SHELF LIFE: 18 Months

CONTENTS:

  • 5x Test Devices
  • 5x Buffer Bottles with Solution
  • 5x Extraction Tubes
  • 5x Sterile Nasal (NS) Swabs
  • 1x Tube Rack (box)
  • 1x Biohazard Bag
  • 1x Instruction / Information Insert

* Sensitivity and Specificity vs. PCR using Nasopharyngeal swabs.

Instructions

INSTRUCTION_SHEET_US

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