Salofa Oy – Sienna™ COVID-19 Antigen Rapid Test Kit (Pallet) FDA EUA Approved

Category:

Description

The Sienna COVID-19 Antigen Rapid Test Cassettes is a rapid chromatographic immunoassay for the qualitative detection of COVID-19 antigen in Nasopharyngeal swab. The identification is based on the monoclonal antibodies specific for the Nucleocapsid spiked protein of SARS-CoV-2. This test offers results easy to interpret in less than 10-15 minutes.

FDA-Emergency Use Authorized (EUA)

Nasopharyngeal Swab

RAPID RESULTS: 15-20 MINUTES

  • For PRESCRIPTION use only
  • For in-vitro diagnostic use only

The COVID-19 Rapid Antigen Test Cassette (Nasopharyngeal Swab) is a qualitative, lateral flow immunoassay for the detection of the N protein of SARS-CoV-2 in Nasopharyngeal swab. In this test, an antibody specific to the N protein of SARS-CoV-2 is separately coated on the test line regions of the test cassette. During testing, the extracted specimen reacts with the antibody to N protein of SARS-CoV-2 that is coated onto particles. The mixture migrates up the membrane to react with the antibody to N protein of SARS-CoV-2 on the membrane and generate one colored line in the test regions. The presence of this colored line of the test regions indicates a positive result. To serve as a procedural control, a colored line will always appear in the control region if the test has performed properly.

DEPENDABLE ACCURATE RESULTS

  • Sensitivity 93.8%
  • Specificity 99.2%*
  • Accuracy 98.7%

UNMATCHED CONVENIENCE

  • Individual Buffer Vials
    (Helping multiple operators at the same time)
  • Visual Results Easy to Interpret
  • 15 Minute Test Time

EACH PALLET CONTAINS 12 CARTONS (588 BOXES of 25 TEST KITS PER BOX):

  • 14,700 test kits including:
    • 14,700 Individually Pouched Test Cassettes
    • 14,700 Extraction Buffer Tubes
    • 14,700 Sterile Swabs,
    • 588 Instruction Sheet Inserts (1 per box).