Hangzhou Aichek Medical Technology Co.,Ltd
Hangzhou Aichek Medical Technology Co.,Ltd
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| Product Name | Influenza A+B Antigen Rapid Test |
| Formats | Strip(3mm)Device(4mm) |
| Place of Origen | China |
| Specimen | swab |
| Read Time | 15 minutes |
| Shelf life | 2 years |
| Package | 25 device/box or 50 strip/Box |
| Storage | 2℃-30℃ |
For professional in vitro diagnostic use only
The Influenza A+B Rapid Test Device is a rapid chromatographic immunoassay for the qualitative detection of influenza A and B antigens in nasal swab or throat swab or nasal aspirate specimens. It is intended to aid in the rapid differential diagnosis of influenza A and B viral infections.
The Influenza A+B Rapid Test Device (Swab/Nasal Aspirate) has been evaluated with specimens obtained from the patients. RT-PCR is used as the reference method for the Influenza A+B Rapid Test Device (Swab/Nasal Aspirate). Specimens were considered positive if RT-PCR indicated a positive result. Specimens were considered negative if RT-PCR indicated a negative result Nasal Swab Specimen.
Nasal Swab Specimen
| Type A | Type B | ||||||
| RT-PCR | Total | RT-PCR | Total | ||||
| Positive | Negative | Positive | Negative | ||||
Flu A+B Rapid Test Strip | Positive | 100 | 2 | 102 | 85 | 2 | 87 |
| Negative | 1 | 180 | 181 | 2 | 200 | 202 | |
| Total | 101 | 182 | 283 | 87 | 202 | 289 | |
| Relative Sensitivity | 99.0% | 97.7% | |||||
| Relative Specificity | 98.9% | 99.0% | |||||
| Accuracy | 98.9% | 98.6% | |||||
Throat Swab Specimen
| Type A | Type B | ||||||
| RT-PCR | Total | RT-PCR | Total | ||||
| Positive | Negative | Positive | Negative | ||||
Flu A+B Rapid Test Device | Positive | 58 | 1 | 59 | 65 | 1 | 66 |
| Negative | 3 | 150 | 153 | 4 | 162 | 166 | |
| Total | 61 | 151 | 212 | 69 | 163 | 232 | |
| Relative Sensitivity | 95.1% | 94.2% | |||||
| Relative Specificity | 99.3% | 99.4% | |||||
| Accuracy | 98.1% | 97.8% | |||||
Nasal Aspirate Specimen
| Type A | Type B | ||||||
| RT-PCR | Total | RT-PCR | Total | ||||
| Positive | Negative | Positive | Negative | ||||
Flu A+B Rapid Test Device | Positive | 46 | 2 | 48 | 94 | 1 | 95 |
| Negative | 0 | 241 | 241 | 2 | 158 | 160 | |
| Total tal tal | 46 | 243 | 289 | 96 | 159 | 255 | |
| Relative Sensitivity | 100% | 97.9% | |||||
| Relative Specificity | 99.2% | 99.4% | |||||
| Accuracy | 99.3% | 98.8% | |||||
Influenza (commonly known as ‘flu’) is a highly contagious, acute viral infection of the respiratory tract .It is a communicable disease easily transmitted through the coughing and sneezing of aerosolized droplets containing live virus. 1 Influenza outbreaks occur each year during the fall and winter months. Type A viruses are typically more prevalent than type B viruses and are associated with most serious influenza epidemics, while type B infections are usually milder. The gold standard of laboratory diagnosis is 14-day cell culture with one of a variety of cell lines that can support the growth of influenza virus. 2 Cell culture has limited clinical utility, as 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 with improved detection rates over culture of 2-23%.3 However, RT-PCR is expensive, complex and must be performed in specialized laboratories. The Influenza A+B Rapid Test Device (Swab/Nasal Aspirate) qualitatively detects the presence of Influenza A and/or Influenza B antigen in nasal swab or throat swab or nasal aspirate specimens ,providing results within 15 minutes. The test uses antibodies specific for Influenza A and Influenza B to selectively detect Influenza A and Influenza B antigen in nasal swab, throat swab or nasal aspirate specimens.