New York, USA – November 29, 2021 – STEMart, a provider of integrated medical device CRO services dedicated to medical device and diagnostic clinical development, now launches sensitization testing services for the medical device industry. This new service is used to assess the potential of chemicals and medical devices to cause a delayed hypersensitivity reaction following a single or repeated exposure to the body.
Sensitization is one of the three most common biocompatibility tests required to ensure the safety of medical devices. General procedures of the sensitization test includes exposing the animals to the test materials or extracts across multiple induction phases and a single challenge phase, as well as observing the challenge sites for about 24 and 48 hours after the removal of the test materials or extracts and evaluating skin sensitization reactions. Sensitization reactions are noted by observing erythema and/or edema as it interacts with the body’s immune system.
STEMart offers several methods as in vivo and in vitro assays for sensitization biocompatibility testing following the biocompatibility guidelines modified for medical devices. The sensitization testing is designed and performed based on the route of exposure to the body and acceptance of the notified body. And there are two types of tests that have been developed: an adjuvant test in which sensitization is potentiated by the injection of Freund’s Complete Adjuvant (FCA), and non-adjuvant tests.
STEMart’s sensitization testing service such as the Local Lymph Node Assay (LLNA), Guinea Pig Maximization Test (GPMT), Buehler Assay (BA), and In Vitro Sensitization can meet customers’ needs in assessing the potential of chemicals and medical devices to cause a delayed hypersensitivity reaction following a single or repeated exposure to the body. For instance, LLNA studies the induction period of skin sensitization and delivers quantitative data for dose-response assessment. LLNA is an in vivo method that will not eliminate the use of animals but has the potential to reduce the number of animals required for this purpose and causes less pain and distress. LLNA does not require that challenge-induced dermal hypersensitivity reactions to be elicited or the use of an adjuvant.
Another example is the Buehler Assay. The Buehler Assay is a non-adjuvant in vivo test to screen for substances that cause human skin sensitization (i.e. allergens). In the test, Guinea pigs are exposed to a high dose of the substance, followed by a challenge dose, which is the highest dose that does not cause irritation.
If you have additional questions about medical device sensitization testing services or would like to find out more about the medical device development service, please visit https://www.ste-mart.com.
STEMart is an industry-leading eCommerce platform with an expanded global footprint and has a broad portfolio of more than 10,000 products. It aims to provide best-in-class lab materials, medical instruments and consumables, excellent technologies, and high-quality services to global customers in the fields of science, technology, and engineering, from the discovery stage towards the manufacturing process. STEMart is dedicated to making research and biotech production simpler and safer, and through that to accelerate access to better health for people everywhere.