Lateral Flow Assay Contract Manufacturing

We are well expertised in the accumulation of knowledge and operation of equipments to coat and dry a variety of materials ( e.g. nitrocellulose, glass fiber, etc. ).

We are fully experienced and skilled in conjugating a variety of particles ( e.g. colloidal gold, magnetic beads, etc. ) to specific antibodies or antigens.

Our cutting machines with high precision are applied in the production process, they help greatly in cutting the sheets into strips with consistent and precise dimensions. With those pre-cut strips, a variety of formats ( Midstream / Cassette / Dipstick ) for rapid tests could be easily assembled into finished products.

Our triple quality control processes are in strict accordance to the ISO 9001 management system standards to ensure the accuracy and reliability of finished products. The quality inspection measures key indicators of the test kits ( e.g. sensitivity, specificity, accuracy, repeatability, as well as visual / instrument interpretation and even clinical samples testing ).

Customized packaging and labeling are optional to meet our clients’ special requirements ( e.g. in bulk / single test per box / customized labeling ).

NewScen complies with all relevant regulations and standards ( e.g. ISO 9001 : 2015 / ISO 13485 : 2016 / FDA / NMPA regulations ), to ensure that our products meet the highest quality and safety standards.

We are backup with the robust supply chain management system as well as effective inventory management system, to ensure timely delivery of raw materials, semi-finished and finished products both domestically and globally.

The manufacturing process begins with a thorough analysis of our clients’ requirements and specifications ( e.g. type of test, target analyte, detection limit ).
Then we select and source the high-quality raw materials and use advanced equipment and technologies to coat and dry the materials, conjugate particles to antibodies and antigens, assemble and cut the sheets into various formats for further processing of finished products.

Throughout the manufacturing process, we conduct strict and standard quality control procedures to guarantee the accuracy and reliability of our products. Once the productions are finished, we package and label them according to our clients’ specifications and regulatory requirements for delivery in a recognized timely and efficient manner.