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
Hangzhou Aichek Medical Technology CO., Ltd. Jinxing Cun, Yuhang Community, YuhangDistrict (Future Sci-Tech City), Hangzhou,Zhejiang, P.R. China
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/