Hangzhou Aichek Medical Technology Co.,Ltd

Hangzhou Aichek Medical Technology Co.,Ltd

Manufacturer from China
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Swab 97.7% Influenza AB Test Infectious Disease Rapid Test Kits

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Hangzhou Aichek Medical Technology Co.,Ltd
City:hangzhou
Province/State:zhejiang
Country/Region:china
Contact Person:MrEdward YU
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Swab 97.7% Influenza AB Test Infectious Disease Rapid Test Kits

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Brand Name :Aichek
Model Number :FLU-A01
Certification :CE
Place of Origin :China
MOQ :5000 Test
Price :negotiable
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 :COVID-19 and Influenza A+B Antigen Rapid Test
For the crowd :Preliminary screening of infected people
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Double check COVID-19 and Influenza A+B Antigen Rapid Test with CE

Product Name Double check COVID-19 and Influenza A+B Antigen Rapid Test with CE
Formats Strip(3mm)Device(4mm)
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.

The COVID-19 Antigen Rapid Test device is a lateral flow chromatographic immunoassay for the qualitative detection of the nucleocapsid(N) protein antigen from SARS-CoV-2 in nasopharyngeal swab, oropharyngeal swab. It provides an aid in the diagnosis of infection with 2019-nCOV.

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.

Accuracy
A side-by-side comparison was conducted by the results of the test reagent and RT-PCR. 420 clinical swab specimens (including
Ct≤33 and Ct>33)were evaluated, 111 were positive and 309 were negative. Base on the results from the clinical studies, the
statistical analysis was made as follows:
Clinical sensitivity:98.10% (95% CI: 93.32%~99.48%)
Clinical specificity:99.68% (95% CI: 98.19%~99.94%)
Total Coincidence rate:99.28% (95% CI: 97.89%~99.75%).
Clinical sensitivity:97.30% (95% CI: 92.35%~99.08%)
Clinical specificity:99.68% (95% CI: 98.19%~99.94%)
Total Coincidence rate:99.05% (95% CI: 97.58%~99.63%).
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