Access Genetics’ experienced molecular testing consultants guide your technologists through the in-house assay development and validation process with concise, detailed instructions for comprehensive testing and reliable results. Our consultants are readily available by phone, providing your newly trained technologists with professional support.
ASSAY VALIDATION PLAN
Access Genetics recommends a step-by-step plan to facilitate your lab’s assay validation process. Our consultants help you customize the plan to fit your unique needs. Based on your laboratories’ suite of tests, our consultants can suggest the number and type of specimens necessary for CLIA-recommended analytic and clinical validity.
Access Genetics’ Web-Enabled Telemedicine Portal links you with our central system during your assay testing process, allowing immediate professional feedback and technical support on indictors of test quality.
SENSITIVITY STANDARDS
Sensitivity standards, necessary for determining the reliability of your assays, can be provided by Access Genetics. It is your responsibility to check with your state regulatory requirements in the event your state has specific verification requirements. As part of Access Genetics’ ongoing service, we strive to share appropriate information as standards are adopted or revised.
(This service is provided for an additional fee.)
POSITIVE SAMPLES OF SELECT TESTS
If needed, Access Genetics can provide positive sample sets for rare or difficult to find mutations to expedite your assay validation testing. (This service is provided for an additional fee.)
VALIDATION DATA ANALYSIS
From your validation data, Access Genetics offers to provide analysis and documentation of your test results (This service is provided for an additional fee).
For your convenience, we can assist in providing a final assay validation report that is ready for medical director’s review, modification, approval and signature. If you choose to write your own report, our staff is readily available to offer suggestions if questions arise. (This service is provided for an additional fee.)
CLSI FORMATTED PROCEDURES (Formerly NCCLS)
We offer CLSI-compliant Standard Operating Procedures for each process your lab will perform. (This service is provided for an additional fee.)