Validation Assistance Services
We know the assay validation process takes time and effort that most labs simply cannot commit to regularly. Therefore, we offer IDK® Assay Validation Assistance Services tailored to your lab’s needs to support you.
Validation Assistance Overview
Assay Validation Assistance Services
Laboratories must continuously update their testing menu to improve clinical outcomes and remain competitive. However, validating a new assay takes time and effort that most labs simply cannot commit to regularly due to existing projects and a lack of resources. Therefore, we offer IDK® Assay Validation Assistance Services that can be tailored to your lab’s needs to fully support your validation.
When lab resources are tight, and the testing volume is high, we understand that the assay validation process can become even more challenging. Our first step in providing assay validation assistance is to speak with your lab management team to understand your overall needs, timeline, protocol, and operations. Because all labs are different, we customize your services based on your available resources.
Our highly experienced Technical Applications Team, led by Technical Applications Scientist Jamie Bolduc, will guide you through every phase of the process, from your initial consultation to training and final validation to continuous remote support following completion. We can also provide in-person support to your lab by assisting with a full initial evaluation of any IDK® assay kit to determine whether you would like to move forward with a complete validation.
Validation Assistance Program Benefits
Save Time & Money
Our experienced Technical Support team can help you avoid costly mistakes and delays during the validation process.
Ensure Compliance
We will help ensure that your validation meets all regulatory requirements.
Expert Training
Our team provides guidance throughout the process, from your initial consultation to on-site training and continued remote support.
Resource Downloads
How We Empower Your Lab
Dedicated Assay Training
Once a full evaluation has been completed and approved by your lab, we will come on-site to assist in validating the assay on the instrument used. Our Technical Applications Team will work to ensure all validation materials, including assay kits and samples, are available.
Jamie can train technicians to run the assay and process the data as a group or one-on-one. Additionally, she can qualify anyone on your team to train other technicians in your lab and provide them with a certificate of training. This empowers your staff to continue building upon their expertise while fulfilling your accreditation training requirements.
You will receive a complete packet from EP Evaluator when validation testing is final. Finally, your lab will be officially ready to add the new IDK® assay to your offering.
Ongoing Assay Support After Validation
Our assay validation assistance services do not end when your assay validation is complete. Following assay validation, you will continue to have access to Jamie and our network of experts for ongoing remote support. When your lab needs retraining or guidance to troubleshoot the assay, she will work with you remotely or return for in-person assistance.
We will continuously check lot-to-lot consistency to ensure you do not experience any variability issues. If your lab adopts an esoteric test, we also offer proficiency testing services to confirm lab-to-lab consistency.
We will continuously check lot-to-lot consistency to ensure you do not experience any variability issues. In the instance that your lab adopts an esoteric test, we also offer proficiency testing services to confirm lab-to-lab consistency.
Meet Jamie Bolduc
Technical Applications Scientist
Jamie is the Technical Applications Scientist at Immundiagnostik, Inc., leading our Assay Validation Assistance services. She has a degree in Medical Laboratory Science and received her board certification from the American Society for Clinical Pathology. Before joining our team, she was a Technical Applications Scientist at Zeus Scientific, Inc., and worked as a Serologist at the Mayo Clinic.
Other Services
Laboratory Services
We offer a variety of services to help your organization. From general product and procedure questions to in-person support, our team is here to assist you.
Custom Bulk Packaging
Many labs are establishing initiatives to reduce waste and increase space while saving as much time and money as possible. Custom bulk packaging can help reduce your lab’s environmental impact, maximize storage space, and increase efficiency at a lower cost.
Get Your Validation Project Started
Whether your lab is considering a validation or ready to expand its offering, you can contact us to set up a consultation and discuss your validation project needs.