Short description:

  • Lollipop test for the detection of SARS-CoV-2.
  • Saliva sample test
  • BfArM approval layman self-test No. 5640-S-032/21
  • Sensitivity: 90.45%; Specificity: 99.45%.
  • Due to the way the sample is taken, the test is especially suitable for children and seniors
  • In packs of 5
Verwendungszweck:

The method of sample collection makes the test particularly child- and senior-friendly. This test is intended for the qualitative in vitro detection of SARS-CoV-2 nucleocapsid (N) protein antigen in human saliva samples. The results are for the identification of SARS-CoV-2 nucleocapsid protein antigen. The antigen is usually detectable in saliva during the acute phase of infection. The Watmind SARS-CoV-2 Antigen Rapid Test provides a rapid and reliable response for both symptomatic and asymptomatic patients or home users with regard to SARS-CoV-2 infection. The SARS-CoV-2 Self-Test Antigen Test Kit contains all required materials and is approved for lay use with self-collected observed direct saliva samples from individuals over the age of 18.

Intended use:

  • Test card with desiccant in sealed foil pouch
  • Tube with extraction buffer for the samples
  • Sterile disposable swab
  • Instructions for use
  • Brief instructions
Features:

  • Sensitivity = 90.45%
  • Specificity = 99.45%
  • Easy to use – Fast and reliable test results in only 15 minutes
  • BfArM approval layman self-test No. 5640-S-032/21
  • Manufacturer: Shenzhen Watmind Medical Co., Ltd.
Other notes:

  • Storage condition: 2 – 30 °C
  • Shelf life: 18 months (manufacturing date and expiry date are indicated on the label).
  • The kit should be stored at 4 – 30°C maximum.
  • After opening the foil pouch, the test should be used within 30 minutes at room temperature (temperature 10 – 30 °C, humidity ≤ 70%).
  • See label for date of manufacture and expiry date.
  • Sensitivity of the test decreases after the first 5 days after the onset of symptoms
  • Test can only tell if antigen is present, not in what concentration
  • Test result depends on quality of specimen collection, processing, transport and storage. Any errors may cause inaccurate test results.
  • People under 18 years of age should be assisted by an adult
  • Intended for in vitro diagnostic use only
  • Use only the swab and sample extraction buffer included in the kit. Do not substitute components
  • For in vitro diagnostic use only.
  • This product has been approved for the detection of SARS-CoV-2 nucleocapsid protein only, not for other viruses or pathogens.
  • Proper specimen collection and handling is essential for accurate results.
  • Do not touch the swab tip when performing the swab test.
  • Leave the test card sealed in the foil pouch until just before use. Do not use if the pouch is damaged or open.
  • Do not use the kit after the expiration date.
  • Do not mix the Test Card and Sample Extraction Solution from different kit lots.
  • All kit components are disposable. Do not use with multiple specimens. Do not reuse the used test card.
  • Do not eat or drink, including chewing gum or tobacco products, for 30 minutes prior to specimen collection.
  • Please be sure to follow the manufacturer’s information within the instructions for use and on the product packaging.