KunShan JiAn Biotech Co., Ltd.
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Description
FLU A&B Antigen Test kit(Colloidal Gold Method) is an in vitro rapid qualitative test that detects influenza type A and type B nucleoprotein antigens directly from nasal swabs, and nasopharyngeal swab specimens obtained from patients with signs and symptoms of respiratory infection. It is intended to aid in the rapid differential diagnosis of influenza A and B viral infections.
2. Specification
| suitable for the crowd | Everyone including the elderly and children |
| Test time | 15 mins |
| Features | Portable, easy carry, accuracy, sensitivity, specificity |
| Brands | Test kits and packages both can be customized |
| Usage | FLU A&B Antigen Test kit(Colloidal Gold Method) is an in vitro rapid qualitative test that detects influenza type A and type B nucleoprotein antigens directly from nasal swab and nasopharyngeal swab specimens were obtained from patients with signs and symptoms of respiratory infection. It is intended to aid in the rapid differential diagnosis of influenza A and B viral infections |
| Methodology | Colloidal Gold Immune Chromatographic Assay |
CE Approved
All our rapid test kits have CE certifications that can be downloaded.
15 types of fast test ce certifications.pdf
Main components
The test kit consists of a test cassette, Extraction Reagent, Sterile Swabs, and Sample Extraction Tubes.
| No. | Components | Main ingredients |
| 1 | FLU A&B test cassette (Colloidal Gold Method) | The test card consists of a desiccant and a test strip. The test strip consists of a sample pad and a gold label pad (fixed with a colloidal gold-marked FLU A antibodyⅠand FLU B antibodyⅠ), a nitrocellulose membrane (coated with FLU A antibodyⅡand FLU B antibodyⅡ, goat anti-mouse IgG polyclonal antibody as the quality control line (C line)), absorbent paper and PVC rubber plate composition. 1 piece for 1 test/kit |
| 2 | Extraction Reagent | 1 tube for 1 test/kit |
| 3 | Sterile Swabs | 1 piece for 1 test/kit |
| 4 | Extraction Tubes | 1 piece for 1 test/kit |
Performance characteristics Clinical performance
This clinical trial only conducts clinical verification for influenza A H1N1 and seasonal H3N2 subtypes and simultaneously detects 1200 clinical specimens with the PCR method. The test results show that the assessment reagents have high consistency with the marketed reagents. The results are as follows:
| Cases | PCR results | Total | ||
| Flu A Positive | Flu A Negative | |||
| FLU A&B Antigen Test kit | Flu A Positive | 161 | 16 | 177 |
| Flu A Negative | 13 | 1010 | 1023 | |
| Total | 174 | 1026 | 1200 | |
Sensitivity: 92.5%(161/174) 95% CI: 87.64-95.58%
Specificity: 98.4%(1010/1026) 95% CI: 97.48-99.04%
Overall Accuracy:97.6%(1171/1200) 95% CI: 96.55-98.31%
| Cases | PCR results | Total | ||
| Flu B Positive | Flu B Negative | |||
| FLU A&B Antigen Test kit | Flu B Positive | 148 | 20 | 168 |
| Flu B Negative | 10 | 1022 | 1032 | |
| Total | 158 | 1042 | 1200 | |
Sensitivity: 93.7%(148/158) 95% CI: 88.74-96.53%
Specificity: 98.1%(1022/1042) 95% CI: 97.05-98.75%
Overall Accuracy:97.5%(1170/1200) 95% CI: 96.45-98.24%
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