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COVID-19 Antigen Test - 5301COVID-19 Antigen Test - 5301
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5301

COVID-19 Antigen Test

Nasal swab
Self-test
Self-test
Self-test

A in-vitro diagnostic rapid self-test using nasal swab for the qualitative detection of SARS-CoV-2 antigens (Ag)

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Product information

REF 
5301

A in-vitro diagnostic rapid self-test using nasal swab for the qualitative detection of SARS-CoV-2 antigens (Ag). Suitable for people with COVID-19 symptoms to assist the early diagnosis of SARS-CoV-2 infection. Can also be used by people without COVID-19 symptoms to regularly monitor their COVID-status.

  • Self-test using nasal swab
  • Quick test method for ongoing infection
  • Results in 15 minutes
  • Minimal discomfort during test procedure
  • Test with or without symtoms

Contact a healthcare provider in case of a positive result. Additional testing may be required to confirm viral infection or to initiate infection tracing. Always follow local and governmental recommendations.

Specifications

  • Manufacturer: New Gene
  • Test method: Nasal swab self-test
  • Regulatory: CE1434, IVDD 98/79/EC
  • Sensitivity: 97,1 %
  • Specificity: 99,2 %
  • Total accuracy: 98,4 %
  • Storage temp: 2-30°C
  • Shelf-life: 24 months
  • Packaging: 1, 5 or 25 pcs
  • 1 pcs: 122x83x15 mm
  • 5 pcs: 122x68x49 mm
  • 25 pcs: 230x120x75 m

Instructions

INSTRUCTIONS

BEFORE PERFORMING THE TEST
: Read and follow the instructions. Perform the test at room temperature. Blow nose to clear nasal cavities. Wash your hands before and after.

TAKING THE SAMPLE: 1 Open the package containing the sampling swab. Do not touch the swab tip. Gently insert the tip of the swab into one nostril, 2-3 cm. Press it against the nasal wall and rotate for 20 seconds to collect nasal secretion. Repeat in the other nostril. 2 Remove the sample extraction tube seal and insert the swab. Press it against the sides and rotate for 10 seconds. 3 Squeeze the sides of the tube to expel sample solution from the swab. Place the tube cap firmly onto the tube. Avoid touching the top of the tube cap. Shake the tube, or gently press the tube, to mix the sample solution. Let it rest for one minute to release viral antigens.

TEST PROCEDURE: 4 Peel to open the foil pouch and remove the test cartridge from its package. Place it on a flat surface. Avoid touching the well and window of the test cartridge. 5 Turn and tap the test tube to mix the liquid again. Avoid touching the top of the tube cap. Hold the tube upside down and squeeze to expel 3 drops of sample solution into the loading well. Testresult is displayed after 15-30 minutes.

RESULTS: POSITIVE: Red line at C and T, regardless of how faint. White line at T is considered negative. NEGATIVE: Red line at C only, see Limitations. INVALID: Without line at C, retest with another test cartridge.

AFTER TESTING: Contact a healthcare provider in case of a positive result. Additional testing, such as PCR test, may be required to confirm viral infection or to initiate infection tracing. Always follow local and governmental recommendations. Disinfect used products and samples, or place in a sealed waste bag, before discarding in household waste.

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Contact

Ideon Science Park
SE-223 70 Lund
info@gibsonmedical.se

Sweden
tel +46 10 330 50 50
© Gibson Medical AB