HomeSingle Molecule Counting (SMC®) TechnologyCustom Assay/Sample Testing (CAST) FAQs

Custom Assay Development & Innovation (CADI) Services Frequently Asked Questions

Have questions about our Custom Assay Development & Innovation (CADI) services?
View frequently asked questions (FAQs) below to find the answers. Note, sample testing services are only for our Single Molecule Counting (SMC®) platform.

Assay Development Services FAQs

Can you source reagents and screen antibodies for us?

Yes, we can source standards and antibodies for your project. When screening is complete we will present the data and our recommendations together as we select the optimal reagents.

Yes, you can provide your own reagents. The CADI scientist on your project will let you know how much of each reagent is necessary and in what format. For example, we typically require antibodies to be purified (no ascites) and free of amines, glycerol, BSA, or other carrier proteins.

We typically determine if customer samples are required at the beginning of every project but we sometimes find they are needed at the later stages of assay development. If samples are required, we will work with you to coordinate shipping or procurement.

Please work with us and your institutional logistic/shipping team to ensure you have the appropriate customs documents required for importing biological materials to the U.S. It is important to choose a shipping company that will store and transport your shipment at appropriate temperatures.

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

Most ELISA-based assay formats, including the MILLIPLEX® multiplex panels, can be adapted to the SMC® format for enhanced sensitivity.

Our special product release (SPR) panel is a combination of analytes from ≤3 existing panels. A MILLIPLEX® custom assay is a combination of analytes from 4 or more existing panels or any project requiring new analyte development.

The work plan outlines project milestones with go/no-go decisions and invoice points.

All custom products produced by the CADI team are for research use only (RUO) and are not to be used for any other purpose, which includes but is not limited to, unauthorized commercial uses, in vitro diagnostic uses, ex vivo or in vivo therapeutic uses or any type of consumption or application to humans or animals.

While a number of standard operating procedures (SOPs) are used during assay development, the customizations required for customer-directed assay development are incompatible with ISO 9001. The CADI team does operate at an ISO 9001 certified site and utilizes the infrastructure (quality assurance (QA); environmental, health, and safety (EHS); information technology (IT); and security) covered under that certification.

Sample Testing Services FAQs

What are the best days to ship my samples?

We recommend scheduling sample shipments so they are delivered between Monday and Wednesday. Please coordinate shipments with us to confirm they do not conflict with U.S. holidays and to ensure we can monitor them.

Please work with us and your institutional logistic/shipping team to ensure you have the appropriate customs documents required for importing biological materials to the U.S. It is important to choose a shipping company that will store and transport your shipment at appropriate temperatures.

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

Yes, but please also send a small sample of your lysis buffer so we can evaluate interference with the assay.

As long as the samples are lysed and clarified, we accept a variety of tissue types.

We typically request 500 μL per analyte for duplicate testing but the necessary volume will be confirmed at the project kickoff meeting.

We accept disease state samples and infectious samples on a case-by-case basis after a review by our internal EHS team. In general, we cannot accept Biosafety Level 3 (BSL-3) samples, unknown disease state samples unless they are “apparent healthy/normal”, or viral positive cell culture samples.

Yes, client-prepared controls can be added. We can also prepare controls for an additional charge.

It varies by project size and complexity. Estimated lead times are provided on the work plan and confirmed at the kickoff meeting. Typically, we can assay up to 200 samples per week without any capacity constraints. Expedited service is available for an additional rush charge.

No. Samples will be run as batches once they arrive. After the data review, samples will be discarded or returned.

We either dispose of samples per our SOP or return remnant samples at the clients’ cost.

The set-up fee includes project initiation costs and a confirmatory pretest to ensure the assay meets specifications before client samples are assayed.

If the order of samples received does not match the shipping manifest, a sample reconciliation fee is applied to cover the time required to reconcile sample arrangement and ensure samples are logged accurately.

If clients want their samples to be tested in a different order than how they were shipped, we can rearrange the samples to meet that need if permitted by the plate layout. For example, we can sort samples by donor or treatment dose if the samples were not shipped in that order originally.

You will pay per sample. Please note every dilution counts as a sample so 15 samples tested in duplicate at two dilution levels equals 30 samples (1 plate).

We can support your RUO, non-GLP/non-CLIA fit-for-purpose sample testing projects. All internally produced custom and commercial assays used by the CADI team are for research use only (RUO). While SOPs are followed during sample testing, the CADI team does not fall under the site ISO 9001 certificate. We do, however, utilize the infrastructure (QA, EHS, IT, and security) covered under that certification.

Our standard report format is an Excel table; PowerPoint slides may be provided as well depending on the scope of the project. If required, you can also purchase the following options:

  • Provide a written report if needed
  • Add results onto electronic shipping manifests to preserve the metadata
  • Upload results per the client’s Data Transfer Specifications (DTS) to a secure server (assuming the manifest variables match the DTS and we can access the server)

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

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