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Rapid Antigeni Test
Anti Sars-CoV2 Selftest

FEATURES

STANDARDS APPLIED
 
COMPOSITION OF THE KIT
Self-diagnosis
  • GENSURE 2019-NCOV ANTIGEN RAPID TEST (LATERAL FLOW) IS AN IMMUNOCHROMATOGRAPHIC ASSAY FOR THE RAPID IDENTIFICATION OF THE NEW CORONAVIRUS (2019-NCOV) ARISING FROM ANTIGENS EXTRACTED FROM SAMPLES TAKEN VIA NASAL AND NOSOPHARYNGAL SWABS.

  • DETECTION TIME 10/15 MINUTES.

  • THE TEST IS EASY TO PERFORM AND REQUIRES A FEW STEPS TO PERFORM.

  • NO CONTAINMENT OR PREVENTION MEASURES SUCH AS BIOHAZARD HOODS ARE NECESSARY.

  • IT IS POSSIBLE TO ANALYZE SAMPLES STORED IN VIRAL TRANSPORT MEDIA WITH OR WITHOUT ACTIVATOR.

  • FOR PROFESSIONAL USE ONLY

  • NASAL OR NOSOPHARYNGAL SWABS ARE PACKAGED INDIVIDUALLY

  • LATEX FREE, PHTHALATE FREE, APYROGEN.

  • FREE FROM PCR INHIBITORS FOR THE RESEARCH OF SARS COV2

  • BELONG TO THE WANTED PATHOGENS

  • SENSITIVITY: 96.6% (93.29% ~ 98.84%)

  • SPECIFICITY: 100% (9􏰁, 97% 􏰂100%)

  • TOTAL AGREED: 9􏰁, 91% (97.63% ~ 99.60%) LOD: 96.86%

  • EN ISO 13485: 2016
  • ISO 18113-2: 2013
  • ISO 15223-1: 2016
  • ISO 23640: 2015
  • ISO 13641: 2002
  • ISO 14971: 2012
  • ISO 175511: 2003
  • CE N.1434-IVDD-221/2022
  • 1 TEST BOX
  • 1 STERILE SWAB
  • 1 TUBE WITH PRE-FILLED BUFFER SOLUTION
  • 1 CAP FOR TUBE WITH DOSER
  • 1 BAG FOR BIOLOGICAL WASTE
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