One Step Influenza A&B Test is intended for use by healthcare professionals and as qualitative screening in vitro diagnostic test for detection of influenza type A (including the subtype H1N1) and B nucleoprotein antigens extracted from the nasal swab specimen. These devices are used to aid in the differential diagnosis of influenza type A and B infection.
Cat. No: CHL-A01
Benefits
Fast：Instant results within 15 minutesConvenient: Room temperature storage (2-30℃) , valid for 24 months
Easy to Use: No equipment is required to process the specimens or read the results
Non-Invasive Sampling: Swab/Nasal Aspirate
99.6% Influenza AB Rapid Test Infectious Disease Rapid Test Kits
Description| Storage: | 2℃-30℃ | Sample Type: | Swab |
|---|---|---|---|
| User: | Professional | Accuracy: | 99.6% (97.7%-99.9%) |
| Certificate: | CE ISO 13485 | OEM: | OEM Customized Packing Avaliable |
| Formats: | 25T/box 1T/box | After-sales Service: | Available |
| Key Words: | Influenza A+B Antigen Rapid Test | For The Crowd: | Preliminary Screening Of Infected People |
| High Light: | 99.6% Influenza AB Rapid Test99.6% Infectious Disease Rapid Test Kitsinfluenza ab test kit | ||
Infection Disease Influenza A+B Antigen Rapid Test with CE certificate Test Device
| Product Name | Influenza A+B Antigen Rapid Test |
| Formats | Strip(3mm)Device(4mm) |
| Place of Origen | China |
| Specimen | Swab/ nasal aspirate |
| 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.
Intended Use
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.
Sensitivity, Specificity and Accuracy
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% | |||||
1.Store at 4~30℃ in the sealed pouch up to the expiration date printed on the package. Do not freeze.
2.The test cassette/strip should be used within 1 hour after taking out from the sealed pouch.
3.Keep away from sunlight, moisture and heat.
4.The manufacturing date is printed on the outer box.