Clinical Sensitivity, Specificity and Accuracy
The Influenza A+B Antigen Rapid Test has been tested compared with RT-PCR. 539 nasopharyngeal swabs and oropharyngeal swabs were evaluated with the Influenza A+B Rapid Test.
| Substances | Concentration | Substances | Concentration |
| Nasal Spray | 15% v/v | Hemoglobin | 10% v/v |
| Mucin | 0.5 % w/v | Mupirocin | 10 mg/mL |
| Nasal Drops | 15% v/v | Mouthwash | / |
| Chloraseptic | 1.5 mg/mL | Levofloxacin | 40 ug/mL |
| Oseltamivir | 2ug/mL | Ribavirin | 0.2ug/mL |
| Fluticasone propionate | 5% v/v | Ceftriaxone | 800 ug/mL |
| Tobramycin | 4ug/mL | Saline Nasal Spray | 10% v/v |
For Influenza A
| Method | RT-PCR | Total Results | ||
| Influenza A+B Rapid Test | Results | Positive | Negative | |
| Positive | 116 | 1 | 117 | |
| Negative | 5 | 417 | 422 | |
| Total Results | 121 | 418 | 539 | |
Clinical sensitivity：95.87% (95% CI: 90.69%~98.22%) Clinical specificity：99.76% (95% CI: 98.66%~99.96%) Total Coincidence rate：98.89% (95% CI: 97.59%~99.49%).
For Influenza B:
| Method | RT-PCR | Total Results | ||
| Influenza A+B Rapid Test | Results | Positive | Negative | |
| Positive | 97 | 1 | 98 | |
| Negative | 6 | 435 | 441 | |
| Total Results | 103 | 436 | 539 | |
Clinical sensitivity：94.17% (95% CI: 87.87%~97.30%) Clinical specificity：99.77% (95% CI: 98.71%~99.96%) Total Coincidence rate：98.70% (95% CI: 97.34%~99.37%).
Analytical Sensitivity/LOD
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Hangzhou Aichek Medical Technology CO., Ltd. Jinxing Cun, Yuhang Community, YuhangDistrict (Future Sci-Tech City), Hangzhou,Zhejiang, P.R. China |
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SUNGO Europe B.V. Olympisch Stadion 24, 1076DE Amsterdam, Netherlands |
The limit of detection (LOD) was identified by evaluating different concentrations of influenza A virus and influenza B virus in the Influenza A+B Antigen Rapid Test. The concentrations identified as the LOD levels tested are listed below. Influenza A (H3N2): 5×103 TCID50/mL Influenza A (H1N1): 2.5×103 TCID50/mL Influenza A (H1N1 pdm09): 2.5×103 TCID50/mL Influenza B (Yamagata): 3.5×103 TCID50/mL Influenza B (Victoria): 1.0×103 TCID50/mL
Analytical Specificity (Cross Reactivity)
To determine the analytical specificity of the Influenza A+B Antigen Rapid Test, several commensal or pathogenic microorganisms that may be present in the upper respiratory tract were tested. Positive and negative specimens were spiked with these microbes were evaluated at a concentration of 106 TCID50/mL, including SARS-CoV-2, Human coronavirus HKU1, OC43, NL63, 229E, MERS, Rhinovirus, Adenovirus, Enterovirus, Metapneumovirus, Parainfluenza, Respiratory syncytial virus, Mycoplasma pneumonia, Chlamydia pneumonia, Streptococcus pneumonia, Staphylococcus aureus, Mycobacterium tuberculosis, Haemophilus influenzae, Streptococcus pyogenes. No cross-reactivity was seen with the Influenza A+B Antigen Rapid Test.
INTENDED USE
Influenza A+B Antigen Rapid Test is a lateral flow immunoassay intended for the qualitative detection influenza A and influenza B antigens in nasopharyngeal swab and oropharyngeal swab.
Company Advantage
1. Professional Manufacturer, a national-level technologically advanced “giant” enterprise 2. Deliver goods as order request 3. ISO13485, CE, Prepare various shipping documents 4. Reply customers questions within 24 hours
Media Contact
Company Name: Hangzhou Hengsheng Medical Technology Co., Ltd.
Email: Send Email
Phone: +86-571-57127506
Country: China
Website: https://www.hengshengmd.com/