CLUNGENE Covid-19 Antigen Rapid Test

• For the detection of acute SARS-CoV-2 infection
• Detects Omicron mutations like Eris and BA.2.86, and more
• Very high specificity and sensitivity
• 25 sealed test cassettes and accessories
• Test results within 15 minutes

CLUNGENE Covid-19 Antigen Rapid Test

The CLUNGENE Covid-19 antigen rapid test is a lateral flow immunoassay for the qualitative detection of an acute SARS-CoV-2 infection. The rapid test is delivered with the necessary accessories and can be carried out at the point of care. The results can be read 15 minutes after specimen application. No cross-reactivity with influenza viruses and human coronaviruses (229E, OC43, NL63, HKU1) has been detected.

The test is designed to detect SARS-CoV-2 nucleocapsid antigens in nasal, nasopharyngeal and oropharyngeal swab specimens

Nasopharyngeal specimens are collected by inserting a swab into the nose to collect the specimen from the posterior wall of the nasopharynx. Oropharyngeal specimens are collected by inserting a swab into the posterior pharynx and tonsillar areas and rubbing over both tonsillar pillars and the posterior oropharynx.

The nasal swab is taken from the nasal mucosa - to do this, the swab is inserted approx. 2.5 cm into the nostril and passed along the nasal mucosa several times. The procedure is repeated with the same swab in the other nostril. 

The antigen test is suitable for the detection of the following variants: Alpha (B.1.1.7), Beta (B.1.351), Gamma (P.1), Delta (B.1.617.2), Lambda (C.37) and Omicron (B.1.1.529)

Please note that this rapid test cannot be returned or exchanged.

Product Details

• CLUNGENE Covid-19 antigen rapid test
• Lateral flow immunoassay
• Qualitative antigen test
• On the European Commission common list of COVID-19 rapid antigen tests
• EU-ID: 1363
• CE Certified
  
• Specificity: 99,7%
• Sensitivity: 98,0% (≤33)
• Sample material: nasal, nasopharyngeal and oropharyngeal swabs
• No cross-reactivity with influenza viruses, rhinoviruses or human coronaviruses (229E, OC43, NL63, HKU1)
• Test results can be read after 15 minutes
• Storage between 4 and 30°C
• Test performance at room temperature (15-30°C, test material should be brought to room temperature first)
• Each test is sealed in a foil pouch
• Only for use by medical professionals
• Please note that the CLUNGENE Covid-19 antigen rapid test cannot be exchanged or returned
• 1 Pack contains 25 tests

Delivery Contents:

• 25 Test cassettes
• 25 Sterile swabs
• 25 Pre-filled extraction tubes
• 25 Dropper caps
• Work station
• Instructions for use

*The test result of rapid tests that are on the European Commission's common list of COVID-19 antigen rapid tests is recognised in all member states of the EU.