Intended Use
ADV/RSV/MP 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), Mycoplasma pneumoniae (MP) antigen in swabs from individuals suspected of ADV, RSV and MP. It can be used for detecting ADV, RSV and MP infection rapidly, which is often used as an auxiliary method in the clinical diagnosis, but not as the only basis.
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.
Mycoplasma pneumoniae is a kind of cell structure without cell wall, between bacteria and viruses, the smallestprokaryotic cell type of microorganism. Mycoplasma pneumoniae is the main type of pathogen causing respiratory tract infections, which usually lead to bronchitis and atypia Pneumonia and a variety of extrapulmonary complications seriously endanger the health of children and adolescents.
Test Kit contents
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 anterior nasal secretion, nasopharyngeal secretion and throat secretion.
For the accuracy of the test, it is recommended to select a nasopharyngeal secretion or a throat secretion.
Sample should be treated with lysis buffffer provided in this kit as soon as possible after collection. If the sample cannot be processed immediately, it should be stored immediately in a dry, sterilized and strictly sealed plastic tube. It can be stored at 2ºC-8ºC for 8 hours. Could be stored at -70ºC for long term storage.
Testing Procedure
Do not open pouch until ready to use. Prep necessary materials: Timer | Tube rack for sampling tubes and specimens | Any necessary personal protective equipment.
1 Sampling: Open the seal of the sampling tube containing lysis buffffer. Insert the swab (after collection) into the buffffer. Rotate the swab against the inner tube wall 10 times and squeeze the swab from the outer tube wall 5 times to completely dissolve the sample in the buffffer, then move the swab up until it is resting on the sample solution, squeeze the swab from the outer tube wall in order to leave the sample in the tube as much as possible. Remove and discard the swab, cover the tube with the dropper.
2 Test procedures: Open the aluminum foil pouch, take out the test cassette and lay it on a clean flflat surface, then mark the cassette with the patient ID or sample number and add 4 drops (approximately 100 μL) processed sample extract into the sample well.
The result should be observed within 20-25 minutes. Results observed after 25 minutes are invalid.
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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