Custom Assay Service

To assist clients who lack the means to develop a chromatographic assay the ACL offers a "Custom Assay" design service. This page is designed to explain the limits that the ACL places on this service.

Does The ACL Design Custom Assays That Are "Compliance Ready?"

  • The ACL is a non-regulated academic laboratory. That means that we will not validate an assay unless specifically requested by the client.

  • If that request is made, the ACL will treat it like a research project and invoice the client accordinginly.

  • The reason is that "method validation" is a multi-month, multi-injection process where the batch-to-batch accuracy and precision are determined for any and all relevant matrix/analyte combinations. In addition the stability of the analyte must be assessed under the conditions seen in both the sample preparation and analysis protocol conditions.

Why Is The Fee Not All Inclusive?

The Custom Assay fee was set after a review of the assays the ACL was commissioned to design during the 2014-2016 period. Clients with assay requirements atypical to those developed this period will be levied additional fees to cover specialist materials not factored into the current Custom Assay fee. Please remember that KUMC plays host to 23 different research centers and institutes investigating everything from Alzheimer's Disease to Uterine cancer. It is impossible for ACL staff to budget for or design fee schedules accurately anticipate the needs of every researcher and project type at an institution with a research portfolio this diverse.  

ACL POLICY ON THE PROVISION OF SPECIALIST MATERIALS FOR ITS CUSTOM ASSAY DESIGNED SERVICE

The purchase and provision of samples and unique consumables used to build custom assays are the responsibility of the client. These items include (but are not restricted to): 

       a.   Matrix compounds (i.e. pooled blank plasma, liver tissue, brain tissue)
       b.   Additional assays (i.e. protein determination on sample supernatant) and the glass and plasticware required to prepare them. 
       c.   Purified compounds for use as internal standards (i.e. isotope labeled versions of the analyte).
       d.   Purified analytes used to develop the assay and to build external calibration curves.
       e.  Specialized solvents and reagents -- particularly those uncommonly used for reversed phase U/HPLC work or those with a limited shelf-life -- examples include:

      • Reducing agents (e.g. DTT).

      • Oxidizing agents (e.g. sodium hypochlorite)

      • Perishable acids or bases (e.g. perchloric acid)

      • Labeling and derivatizing agents (e.g. dansyl chloride).

      • Adducting agents (lithium chloride)

      • Ion-pairing compounds (e.g. triethylamine, triethylammonium acetate)

      • Mobile phase modifiers, particularly those non-volatile compounds used to modulate pH or ionic strength (e.g. hexafluoroisopropanol, TRIS).

      • APPI dopants (e.g. acetone, toluene)

      • Atypical mobile phase components (e.g. ethanol)

      • Atypical sample diluents (e.g. DMF, DMSO)

      • Mobile phase components that are corrosive to the instruments in their typical configuration (e.g. nitric acid, citric acid, THF, sodium salts of phosphate).

                f.  Specialized U/HPLC columns.

ACL POLICY ON SPECIALIZED U/HPLC COLUMNS.

  • The purpose of offering a custom assay development service is assist researchers in determining the optimal sample preparation procedure and chromatographic conditions for their assay. Armed with these details the client is EXPECTED to purchase their own column.

  • The ACL has a limited library of U/HPLC columns (100 mm in length) covering the most common column chemistries used in reversed-phased and HILIC chromatography applications. Use of these for method-development and -- by prior negotiation with the ACL Director -- limited collection of data for grant proposals is included in the custom assay fee.

  • The ACL's custom assay design fee supports only the styles and scales of chromatography popular with our clients. The ACL is capable of developing custom assays using a wider variety of chromatographic separations (e.g. SEC and ion exchange) than the basic custom assay development fee supports. However, the minority of clients requiring such assays will necessarily be charged extra. This merely reflects the reality that it is impossible to remain solvent and maintain a library with every known flavor of U/HPLC column.

Last modified: Jan 08, 2018
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