Chromatographic immunoassay for the qualitative detection of SARS-CoV-2 nucleocapsid protein, influenza A, influenza B and respiratory syncytial virus (RSV) antigens.

The CLEARTEST SARS-CoV-2/Influenza A+B/RSV Antigen Combo Rapid Test is a chromatographic immunoassay for the qualitative detection of SARS-CoV-2 nucleocapsid protein, influenza A, influenza B and respiratory syncytial virus (RSV) antigens in nasopharyngeal swabs. The results refer to the detection of the SARS-CoV-2 nucleocapsid protein, as well as influenza A+B and the RSV antigens. One antigen is generally detectable in upper respiratory tract specimens during the acute phase of infection.

Sensitivity, specificity and accuracy:

SARS-CoV-2 test

• Sensitivity: >97.0%
• Specificity: >99.0%
• Accuracy: >98.0%

Influenza A+B test

• Sensitivity: >95.0%
• Specificity: >99.1%
• Accuracy: >98.4%

RSV test

• Sensitivity: >94.3%
• Specificity: >96.2%
• Accuracy: >95.9%

3 step procedure (sample collection, preparation, testing)

Test evaluation after 15 minutes

Can be performed with swab from the posterior nasal region

Store sealed bag at room temperature or refrigerated (2 - 30 °C). Do not freeze.

The new coronaviruses belong to the β-genus. COVID-19 is an acute infectious disease of the respiratory tract. Humans are generally susceptible to it. Currently, patients infected with the novel coronavirus are the main source of infection; asymptomatically infected people may also be a source of infection. According to current epidemiological studies, the incubation period is 1 to 14 days, in most cases, 3 to 7 days. The main symptoms include fever, fatigue and dry cough. Nasal congestion, runny nose, sore throat, myalgia and diarrhoea occur in a few cases.

Influenza (commonly known as "flu") is a highly contagious, acute viral infection of the respiratory tract. It is a communicable disease that is easily transmitted by coughing and sneezing aerosolised droplets of live virus. There is a strong general feeling of illness.

Respiratory syncytial virus (RSV), which causes infection of the lungs and airways, is a major cause of respiratory illness in young children. Up to the age of three, RSV is one of the most common triggers of acute respiratory infections worldwide. Adults may only experience symptoms of a cold, such as, a stuffy or runny nose, sore throat, mild headache, cough, fever, and general malaise.

Scope of delivery:

• Test cassettes
• Extraction tubes with pre-filled buffer solution
• Drip tips
• Sterile swabs

For professional in vitro diagnostic use only. Manual in German and English.