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

rapid test kit.pdf

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.

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:

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%

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%

Picture details

Yongyue Medical Technology (Kunshan) Co., Ltd. is a comprehensive high-tech enterprise integrating R&D, manufacturing, sales, and service, focusing on the third category of medical devices and biomedical consumables (IVD in vitro diagnostic systems). The company is located in the High-tech Zone of Kunshan City, Jiangsu Province, covering an area of ​​nearly 20,000 square meters and a building area of ​​12,000 square meters. The company has completely independent product development, mold making, parts production, and finished product assembly full-process capabilities; it has an independent research and development team, an independent microbiology laboratory, and a physical and chemical laboratory of 10,000 square meters; the production workshop has been built with 5000 square meters and 100,000 Level purification workshop is equipped with nearly 40 imported all-electric injection molding machines and multiple fully automated assembly lines. The company has passed the ISO13485:2016 quality system certification, and the products have passed the EU CE certification. Yongyue Medical Technology takes "caring for human health" as its original intention and "improving the quality of life" as its mission. Adhering to the corporate core values ​​of "caring for life, health-oriented; giving back to the society, cultural inheritance", we will wholeheartedly provide high-quality products and first-class services to the majority of users in the medical and health industry. Yongyue Medical is your partner worthy of trust.