COVID-19 Rapid Antigen Test CE Marking

Product Number: RAPG-CVA-019

Pack size

20 tests

covid-19 rapid cassette

Product Description

The Biopanda COVID-19 Rapid Antigen (Ag) Test Kit is a qualitative lateral flow immunochromatographic assay for the detection of SARS-CoV-2 viral antigens in human nasopharyngeal or throat swab specimens. It is intended for use as a tool to assist in the diagnosis of SARS-CoV-2 infections. This test should not be used to rule out the possibility of infection on the basis of its results alone.
This test kit is CE-marked for healthcare professional use only.

Test Attributes

  • Nasopharyngeal or throat swabs may be used for testing
  • Results available in only 10-15 minutes
  • All reagents and consumables included
  • Easy to use
  • Results can be read visually
  • No need for an analyser
  • Cost effective method for assisting in diagnosing COVID-19 infection.

Sensitivity and Specificity

The COVID-19 Rapid Antigen Test has been evaluated using 571 nasopharyngeal and nasal swab samples and directly compared to RT-PCR.

Positive percent agreement (sensitivity): 94.1% (95%CI: 90.6% - 96.6%)
Negative percent agreement (specificity): 99.7% (95%CI*: 98.2% - 99.9%)

Storage Conditions

+ 2 - 30 °C, DO NOT FREEZE. Unopened test cassettes and buffer are stable for up to 24 months from date of manufacture.

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