We have implemented proprietary antibody screening methods and recombinant protein standards that are designed for the development of Immunoassay. Our employees follow strict guidelines for quality control, with an emphasis on in-depth optimization and validation of all aspects of test development, including antibody specificity, test sensitivity, intra- and inter-test reproducibility, cross-reactivity, standard curve range, test accuracy (linearity and recovery) and kit stability. A change in the terms and conditions of these Terms and Conditions is not binding on the Company unless it is written and signed by an authorized representative of the company. This agreement is considered to be concluded and subject to the internal laws of the Commonwealth of Massachusetts. If a provision of these terms and conditions of sale is considered legally unenforceable, the applicability of the other provisions is in no way considered to be impaired or altered. Any paragraph and provision of these Terms and Conditions are decouple from the entire Agreement and, if a provision of this Agreement is found to be invalid or unenforceable, the rest of the Agreement will nevertheless remain fully in force. Notice to you will be sent to your last known address. Notification to the company under this contract must be made in writing and mailed to first Class-Post or courier service received at the following address or other address (including facsimiles or e-mail) as written, and takes effect upon receipt: Glines- Rhodes, Inc., 189 East St., Attleboro, MA 02703, USA. For validation, the FDA recommends a “clinical agreement study,” as well as loD detection and cross-reactivity studies. We focus here on clinical matching, which generally compares the results of two different methods.
The FDA states that “designed clinical samples” can be used, which means that it is acceptable to take samples with a high quality control material (preferably inactive). The FDA recommendation applies to 30 reactive samples (20 low reagents for 1 to 2 times loD and 10 times higher, covering the test area) and 30 non-reactive samples. The FDA also requires that the first 5 positive and first 5 negative results of the patient be confirmed by a previously approved EEA method. We would be happy to know your specific needs and discuss how our personalized immuno-health development services could contribute to your research. The company provides services in accordance with your analysis form. The entity reserves the right to refuse, at its sole discretion, the analysis requirement forms. No party other than you is authorized to give instructions regarding the services, including the extent of the review or delivery of the results. The entity provides personalized services that exceed the company`s standard level of service, solely on the basis of the reciprocal written agreement of the parties. Our service expertise includes cardiovascular disease, oncology, inflammatory and autoimmune diseases, infectious diseases and psychiatric diseases. What is remarkable is that we offer development services for different types of biomarkers, including proteins, nucleic acids, carbohydrates and fats.
We can also create diagnostic kits for the analysis of enzyme activity, protein-protein interaction, nucleic-protein acid interaction and inhibitor characterization.