How do labs implement molecular tests to meet complex clinical needs?
Laboratory developed tests (LDTs) and In Vitro Diagnostics (IVDs) are both in vitro diagnostic tests using body fluids (such as blood or urine) or cells/tissues (e.g., pap smear, biopsy) to detect or quantify levels of a desired biomarker. As LDTs and IVDs are both used to diagnose health conditions, it is crucial to understand the differences and advantages.
Differences between IVD tests and LDTs
In vitro diagnostic test | Laboratory developed test |
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*Must comply with the Clinical Laboratory Improvement Amendments (CLIA) of the U.S. Centers for Medicare and Medicaid Services.
- Quality system—Tests subject to number of requirements (design controls, manufacturing controls, and handling complaints)
- Clinical validity—Helps ensure test detects or measures specified target analyte, or that it is useful for determining presence/absence of clinical condition or predisposition, prior to marketing
- Technical support from supplier—To troubleshoot and replace faulty products
- Broad distribution—Many laboratories utilizing the test provide data that can increase (or possibly decrease) confidence in the test. Laboratories performing the same IVD test can report proficiency results to confirm the accuracy of the test.
- Simplified inventory control—Only order manufactured tests for anticipated use, which reduces the amount of documentation required. Requires less time and effort to maintain in-house IVD inventories.
- Rapid adaptation—LDTs can be developed and modified relatively quickly to respond to market needs
- Control over content—Laboratories can select specific and relevant targets
- Lower cost per test—Technological advances and the availability of off-the-shelf bulk reagents have made complex analyses faster and more affordable
- Laboratory qualification—The laboratory quality management system (QMS) covers all tests, including LDTs, which is not the case for IVD kit production
- Consolidation into a single test—Testing for multiple analytes provides more data per sample and may enable faster diagnosis
Demystify molecular test development and implementation
As COVID-19 testing needs wane, laboratories need to consider what they can offer next.
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7 spell-binding questions about laboratory developed tests
In this webinar, Professor Mara Aspinall brings a fresh perspective on the reasons to develop an LDT or purchase an IVD. She lays out a clear path for LDT implementation.
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An introduction to diagnostic testing in laboratories
In this paper, we describe different diagnostic assays and explain why they are important for clinical laboratories. Learn about the advantages of IVDs and LDTs, and read about real-world examples.
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See what others are saying about molecular testing.
Challenges of establishing laboratory developed tests
Dr. Vijay Singh dispels common misconceptions about laboratory developed tests and shares his strategy for implementing LDTs in the lab.
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Are you ready to take the next step to implement a molecular test in your lab?
If you’re new to molecular test implementation, then we recommend you start with Introduction to Diagnostic Testing in Clinical Labs.
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LDT and IVD reimbursement in the U.S. explained
Having a basic understanding of coverage and reimbursement concepts will help you make informed and confident decisions when planning your strategy.
Navigating regulatory guidance for clinical laboratories
FDA regulation of IVDs and LDTs has fueled an ongoing, two-decade debate. IVD tests manufactured for use in multiple laboratories, including clinical assays...
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