Basic Info.
Model NO.
Antigen Test
HS Code
3002150090
Production Capacity
5, 000, 000 Pieces/Month
Product Description
Intended Use
ADV/RSV/STREP A Antigen Combo Rapid Test Kit (LFIA) is an immunochromatography based one step in vitro test. It is designed for the rapid qualitative detect Adenovirus(ADV), Respiratory syncytial virus(RSV), Group A streptococci (STREP A) antigen in swabs from individuals suspected of ADV, RSV and STREP A.
Introduction
Human adenovirus(ADV) belongs to the adenoviridae family, mammalian adenovirus genus, which is a double-stranded DNA virus without an envelope, mainly infects human respiratory tract, digestive tract and urogenital tract. The main ADV related to respiratory diseases is ADV-B Group (ADV-3, 7, 11, 14, 16, 21, 50, 55), ADV-C Group (ADV-1,2,5,6) and ADV-E group (ADV-4). Acute respiratory adenovirus (ADV) infection which is one of the most common acute respiratory infections in infants and young children. It mainly causes fever, cough, dyspnea and other symptoms.
Respiratory syncytial virus (RSV) belongs to Pneumovirus of Paramyxoviridae with only one serotype, which is a single stranded negative-strand RNA virus with an envelope. RSV infection mainly causes bronchiolitis and pneumonia in infants under 6 months of age and upper respiratory tract infections such as rhinitis and colds in older children and adults.
Group A streptococci, STREP A, is called streptococcus pyogenes, which belongs to β hemolytic streptococcus. Common mode of transmission is spread through the respiratory tract. STREP A can invade any part of the human body, but upper respiratory tract infection is the most common, followed by skin and soft tissue infection. STREP A can cause both suppurative diseases and non- suppurative complications. STREP A is also an indirect cause of the allergic diseases rheumatic fever and acute glomerulonephritis.
Test Principle
Medomics ADV/RSV/STREP A Antigen Combo Rapid Test Kit(LFIA) uses double antibody sandwich method to detect the Adenovirus(ADV), Respiratory syncytial virus (RSV) and Group A streptococci (STREP A) by colloidal gold immunochromatog raphy technology.
When the appropriate amount of test samples treated with lysis buffffer is added to the sample well of the test cassette, the sample will move forward along the test strip by capillary action. If the sample contains ADV, RSV and STREP A antigen, and the concentration is higher than the limit of detection, the antigen will form immune complexes with corresponding antibody labeled with colloidal gold respectively, which are captured by lines A line, R line, and SA line. If test sample contains ADV, RSV and STREP A, forming a red A, R and SA line, indicating a positive result for ADV, RSV and STREP A.
Additionally, the test strip also contains a control line (C line). The C line should be formed to indicate that the sample has been transported properly through the membrane regardless of whether sample contains antigens or not. If the C line does not appear, it indicates that the test result is invalid and the sample need to retest.
Storage Instructions
The test kit should be stored away from direct sunlight at 2ºC to 30ºC with a shelf-life of 24 months. Do not freeze.
Sample Requirements
One test cassette can only be used to test one sample type. Sample types include nasopharyngeal secretion and throat secretion.
About Medomics
Jiangsu Medomics Medical Technology Co., Ltd., is located at Biotech and Pharmaceutical Valley of the National Jiangbei New Area, Nanjing, Jiangsu Province. It is an international high-tech enterprise driven by innovation in the area of medical devices R&D, production and sales. Medomics focuses on diagnosis of microorganisms, tumors and some rare diseases, mainly engaged in the research and development, production and sales of in vitro diagnostic reagents and automatic instruments.
Medomics owns two R&D centers in China and the US, independent intellectual property rights of fluorescent staining technology, protein labeling technology, time-resolved immunofluorescence detection technology, image processing and analysis technology and other innovative technology platforms, as well as a total of more than 10,000 square meters of GMP purification production workshop that meets the product standards of FDA, CE and CFDA. Until now, Medomics has more than 100 employees across the world and R&D personnel accounts for over 50%. Medomics also has a multidisciplinary expert team with abundant experience in the industry, including senior experts in immunology, microbiology, applied physics, polymer materials, medical imaging, optical systems, etc. The members of the technical team are led by doctors from many famous institutions, such as Osaka University, North Carolina University, University of Nebraska Lincoln, Zhejiang University, Sichuan University and other institutions.
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