Custom Assay/Sample Testing (CAST) FAQs

Have questions about our Single Molecule Counting (SMC^®) Custom Assay /Sample Testing (CAST) services? View frequently asked questions (FAQs) below to find the answers.

• Assay Development Services FAQs
• Sample Testing Services FAQs

Assay Development Services FAQs

Can you source and screen antibodies for us?

Yes, we offer antibody sourcing and screening services and will assist you in selecting the optimal antibody. We then request you order the antibodies and have them drop shipped to our facility located in St. Louis, Missouri USA.

If we use commercial antibodies in the assay, will you commercialize the kit?

Unless specified in the material service agreement (MSA), we have the option to commercialize if the reagents are not proprietary.

We tried a MILLIPLEX^® assay that did not detect all of our samples. Can this be transferred to an SMC^® assay?

The CAST team can adapt most ELISA-based assay formats, including those available in the MILLIPLEX^® portfolio to the SMC^® format for enhanced sensitivity. The project scope ranges from proof-of-concept SMCxPlore™ services for academic customers to fully verified and characterized assays.

How much standard analyte do we need to send?

We require 20 100 µL single-use aliquots of > 10 µg/mL concentration.

How much antibody do you need?

We require 0.5 mg of both capture and detection antibody, free of amines, glycerol, BSA, or carrier protein (i.e., no ascites) if testing a single antibody orientation. For testing both orientations, 1 mg is required.

We have our own antibodies and have to ship them from outside the United States (US). Can you help?

We advise you to work with your regional field application scientist to understand the appropriate customs documents required for importing biological materials to the US. Once completed, we can review the paperwork and apply for the necessary permits to avoid delays in customs. It is important to choose a shipping company that will store and transport your shipment at appropriate temperatures.

Why do you recommend derivatizing in both capture and detection orientation when we know which orientation is best in our current immunoassay?

When transferring an assay from typical plate-based immunoassays to the bead-based SMC^® technology, we occasionally see differences in performance between antibody pair orientations. Thus, we recommend reevaluating both orientations during the assay development process.

How are we invoiced?

You are only invoiced for completed milestones following data review. The work plan is written with agreed milestones with go/no-go decisions and invoiced points.

Sample Testing Services FAQs

What are the best days to ship my samples?

We advise scheduling sample shipments for receipt between Monday and Wednesday. Additionally, we require confirmation that shipments do not conflict with US holidays.

Can you advise how samples shipped from outside of the US should be managed?

We advise you to work with your regional field application scientist to understand the appropriate documents required for customs. Once completed, we can review the paperwork and apply for import permits, if needed, to avoid delays in customs. It is important to choose a shipping company that will re-ice your shipment as well, as all sample shipments must comply with US CDC and US DOT shipping regulations.

Your assay is not currently optimized for our sample type. Can we still send you samples to test?

Yes, we can test non-verified matrices in our assays.

Is your system compatible with cell lysates?

Yes. However, we request a small sample of the lysis buffer to evaluate interference with our assays.

Is your system compatible with whole skin samples?

We accept many tissue sample types, but they have to be lysed and clarified.

What is the required sample volume?

For duplicate testing, we request 500 μL per analyte, if possible.

Do you accept diseased and drug-treated samples?

We accept disease state samples and infectious samples on a case-by-case basis subject to our internal EHS (environmental, health, and safety) review.

Can controls be added to our testing?

Client-prepared controls can be added. In addition, we can prepare controls according to your specifications for an additional charge.

What is the turn-around time for sample testing?

Typically, we can provide results for up to 200 samples in a week, contingent on current resources. Expedited service can be provided for an additional rush charge.

If there is a leftover sample, can you dispose of this or ship it back?

We either dispose of samples following our SOP/GLP guidelines or return remnant samples at the clients’ cost.

What is the set-up fee and what does it cover?

The setup fee includes the preparation of the work plan, cost of consumables, and a pretest of the kit to confirm it meets assay specifications before client samples are assayed.

What is a sample reconciliation fee?

A sample reconciliation fee is applied only if the order of samples received does not match the shipping manifest, due to the time required to reconcile sample arrangement to ensure samples are logged accurately.

What is a rearray fee?

If clients request their samples to be tested in a different order than how they are shipped, we can rearray the samples to meet the needs as permitted by the plate layout, such as sorting samples on a plate by donor or treatment dose if the samples were not shipped as such originally.

For sample testing, if I have less than 30 samples, do I have to pay for a whole plate?

For SMC^® kits, we test and charge per 96-well plate. For assays in development, we charge by sample number. In both circumstances, every dilution counts as a sample, therefore 15 samples tested in duplicate at two dilution levels equals 30 samples, or 1 plate of testing.

Is your Custom Assay/Sample Testing (CAST) lab GLP?

We work to GLP standards and within our robust QA systems that support ISO 9001 or ISO 13485 certification held by our manufacturing. We are fully auditable, and we run samples up to Phase II and Phase III clinical trials.

What form of reporting can you do?

We can:

• Add results onto electronic shipping manifests so the metadata is preserved
• Upload results following client’s Data Transfer Specifications (DTS) to a secure server if the manifest variables match the DTS and there is access to the server
• Provide a written report if needed

A fee applies for each.

For Research Use Only. Not For Use In Diagnostic Procedures.