Cleartest light Influenza A+B

The CLEARTEST® light Influenza A+B is a rapid chromatographic immunoassay for the qualitative detection of influenza A and B antigens in nasopharyngeal swab, throat swab or nasal aspirate specimens. It is intended to aid in the rapid differential diagnosis of influenza A and B virus infections. The test is intended for professional in vitro use only.

Influenza (commonly referred to 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. Influenza outbreaks occur every year in the autumn and winter months. Type A viruses are usually more common than type B viruses and are associated with most severe influenza epidemics, while infections with type B viruses are usually milder. The gold standard for laboratory diagnosis is 14-day cell culture with one of several cell lines that can support influenza virus growth.2 Cell culture has limited clinical utility because results are obtained too late in the clinical course for effective patient intervention. Reverse transcriptase polymerase chain reaction (RT-PCR) is a newer method that is generally more sensitive than culture and has a higher detection rate than culture of 2-23%.3 However, RT-PCR is expensive, complex and must be performed in specialised laboratories.

Performance characteristics

Sensitivity, specificity and accuracy

Nasopharyngeal swab specimen

type A

• Sensitivity: 99.0 %
• Specificity: 98.9 %
• Accuracy: 98.9 %

Type B

• Sensitivity: 97.7 %
• Specificity: 99.0 %
• Accuracy: 98.6 %

Throat swab sample

type A

• Sensitivity: 95.1 %
• Specificity: 99.3 %
• Accuracy: 98.1 %

Type B

• Sensitivity: 94.2 %
• Specificity: 99.4 %
• Accuracy: 97.8 %

Nasal aspirate sample

type A

• Sensitivity: 100 %
• Specificity: 99.2 %
• Accuracy: 99.3 %

Type B

• Sensitivity: 97.9 %
• Specificity: 99.4 %
• Accuracy: 98.8 %

3 step procedure (sample collection, preparation, testing)

Test evaluation after 15 minutes

Can be performed with nasopharyngeal swab, throat swab or nasal aspirate samples

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