Hangzhou Aichek Medical Technology Co.,Ltd
| Payment Terms | T/T |
| Supply Ability | negotiable |
| Packaging Details | 40box/carton |
| 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 uncut sheet |
| For the crowd | Preliminary screening of infected people |
| Brand Name | Aichek |
| Model Number | CHL-A01 |
| Certification | CE |
| Place of Origin | China |
View Detail Information
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Product Specification
| Payment Terms | T/T | Supply Ability | negotiable |
| Packaging Details | 40box/carton | 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 uncut sheet |
| For the crowd | Preliminary screening of infected people | Brand Name | Aichek |
| Model Number | CHL-A01 | Certification | CE |
| Place of Origin | China | ||
| High Light | Influenza A+B Rapid Test Uncut Sheet ，Uncut Sheet Nasopharyngeal Swab Rtk ，rtk antigen swab test Uncut Sheet | ||
Infection Disease Influenza A+B Antigen Rapid Test with CE certificate uncut sheet
|
Product Name |
Influenza A+B Antigen Rapid Test uncut sheet |
|
Formats |
Strip(3mm)Device(4mm) uncut sheet |
|
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
【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.
【PRINCIPLE】
The Influenza A+B Rapid Test Device (Swab/Nasal Aspirate) is a qualitative, lateral flow immunoassay for the detection of Influenza A and Influenza B nucleoproteins in nasal swab, throat swab or nasal aspirate specimens. In this test, antibody specific to the Influenza A and Influenza B nucleoproteins is separately coated on the test line regions of the test Device. During testing, the extracted specimen reacts with the antibody to Influenza A and/or Influenza B that are coated onto particles. The mixture migrates up the membrane to react with the antibody to Influenza A and/or Influenza B on the membrane and generate one or two colored lines in the test regions. The presence of this colored line in either or both of the test regions indicates a positive result. To serve as a procedural control, a colored line will always appear in the control region if the test has performed properly
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% |
|||||
Company Details
Business Type:
Manufacturer
Year Established:
2012
Total Annual:
500000-1000000
Employee Number:
150~200
Ecer Certification：
Active Member
Hangzhou Aichek Medical Technology Co.,Ltd Hangzhou Aichek Medical Technology Co.,Ltd is a high-tech company specialises in manufacturing rapid diagnostic and healthcare products. With five product lines of fertility, infectious diseases, cardiac marker, tumor marker and drug of... Hangzhou Aichek Medical Technology Co.,Ltd Hangzhou Aichek Medical Technology Co.,Ltd is a high-tech company specialises in manufacturing rapid diagnostic and healthcare products. With five product lines of fertility, infectious diseases, cardiac marker, tumor marker and drug of...
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