IDK® Validation Assistance Services

IDK® Assay Validation Assistance Services

Laboratories must continuously update their testing menu to help improve clinical outcomes and remain competitive. However, the process of validating a new assay takes time and effort that most labs simply are not able to 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 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 the resources you have available. 

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 for you to determine if you would like to move forward with a complete validation.

Here are just a few of the benefits of our Validation Assistance Program:

• Save Time and 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.

Watch our overview video to discover more.

Empowering Your Lab Team Through 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 being used. Our Technical Applications Team will work to ensure all validation materials are available including assay kits and samples. Jamie can train technicians on how 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; therefore, empowering your staff to continue to build upon their expertise, while also fulfilling your accreditation training requirements. 

When validation testing is finalized, you will be provided with a complete validation packet from EP Evaluator and your lab will be ready to officially 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 return for in-person assistance. 

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. 

Get Your Validation Project Started

We understand how validating a new assay in your lab can become a much bigger undertaking than it should be due to the growing challenges facing laboratories. In order to help your organization remain competitive and provide more testing, we offer customized IDK® Validation Assistance Services. With the support of our highly experienced Technical Applications Scientist, Jamie Bolduc, and our network of experts, your lab will be able to fully validate a new assay without the need to reallocate resources.

IDK® Validation Assistance Resources

Download our Validation Assistance Guide or Infographic to discover how our Technical Applications Team can help your lab expand its product offering and validate a new Immundiagnostik assay.

Meet Jamie

This is Jamie Bolduc. She is the Technical Applications Scientist here at Immundiagnostik, Inc., and leads 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 Mayo Clinic.

With her extensive background and wealth of knowledge, Jamie now helps us provide top-notch technical support services to the lab professionals we serve. Learn more about Jamie here.