IMDNA provides scientific, technical, and non-regulatory support for laboratories implementing new assays, transferring existing methods, introducing assays onto new instruments, or integrating established methods into routine laboratory workflows. Support can include implementation planning, assay-transfer documentation, verification or validation study support, QC and reference materials, comparison studies, workflow integration, technical training support, troubleshooting, optimization, and go-live assistance.
Method implementation is more than following an assay protocol. Performance can be influenced by the laboratory's instrument, operator, sample preparation, reagent configuration, environmental conditions, workflow, controls, software, sample matrix, and local operating procedures. IMDNA helps laboratories identify these practical variables and build a structured implementation plan around the assay's intended use.
An assay that performs well during development may require additional work when transferred to a new laboratory, instrument, operator group, reagent configuration, sample-processing workflow, or testing environment. NIH/NCATS assay guidance recognizes cross-validation or assay-transfer validation as an important step when procedures, instrumentation, personnel, or laboratory location change. For applicable clinical laboratory testing, CLIA also places responsibility on the laboratory to verify or establish required performance specifications before patient results are reported.
Review the assay principle, analyte, specimen, reagents, instrumentation, controls, operating range, known limitations, and intended workflow.
Identify differences between the originating method and the receiving laboratory, including instruments, operators, extraction, software, workflow, or reagent configuration.
Support laboratory studies designed to demonstrate that the method performs appropriately in the receiving environment.
Connect sample preparation, assay setup, controls, analysis, documentation, consumables, and instrument use into a practical operating process.
Provide technical assistance as the method transitions from implementation studies into the laboratory's routine workflow.
Support can be tailored to an IMDNA-developed assay, a laboratory-developed method, a modified assay, a transferred method, or another research or laboratory method where IMDNA has the appropriate scientific and technical capability.
Review the intended method, sample type, workflow, instrument, controls, reagents, staffing, throughput, and technical requirements before implementation begins.
Identify technical differences between the original method and the receiving laboratory, including sample preparation, instruments, software, cycling/incubation conditions, reagents, controls, and analysis rules.
Provide draft implementation, verification, validation, comparison-study, or method-transfer protocols, worksheets, technical templates, and supporting assay documentation where appropriate.
Where appropriate and available, help identify or provide positive and negative controls, QC materials, calibrators, standards, reference materials, or other technical materials needed for study execution.
Support planning for agreement or comparison studies between an existing and new method, instrument, workflow, or laboratory and assist with organization of study samples and data.
Provide technical assistance while the laboratory evaluates applicable performance characteristics for an unmodified test system or transferred method according to its own requirements and intended use.
Support study planning for modified, laboratory-developed, or other methods requiring establishment of method-specific performance characteristics.
Help connect the assay with sample preparation, reagent setup, instrument use, controls, analysis, storage, repeat testing, and day-to-day laboratory operations.
Provide assay-specific technical orientation, workflow guidance, reagent-handling information, troubleshooting considerations, and coordination of relevant training resources.
Help investigate issues involving controls, amplification, background, sample preparation, instrument settings, assay balance, matrix effects, repeatability, or other technical observations.
Support reagent readiness, control setup, instrument/workflow questions, early-run troubleshooting, and practical technical issues during transition into routine laboratory operation.
Continue to assist with assay questions, performance observations, reagent changes, control behavior, workflow refinement, troubleshooting, and technical optimization after implementation.
IMDNA's implementation-support model connects the method's technical design to study execution, workflow transfer, performance review, and practical laboratory operation.
A method should be understood in the context of the receiving laboratory before study work begins. Early review helps identify technical differences that can affect performance.
Study execution should use the method configuration that the laboratory intends to operate so the resulting data are relevant to the receiving workflow.
The terminology and required study scope depend on the assay and setting. For applicable U.S. nonwaived clinical laboratory testing, 42 CFR § 493.1253 distinguishes verification of manufacturer-established performance specifications for unmodified FDA-cleared or approved systems from establishment of performance specifications for modified, laboratory-developed, or other applicable systems. IMDNA can provide technical support, but the laboratory remains responsible for its required studies, documentation, acceptance criteria, and authorization of patient testing.
| Implementation Situation | IMDNA Technical Support May Include | Laboratory Responsibility |
|---|---|---|
| Unmodified established method | Draft protocol support, QC/reference materials, comparison-study assistance, data templates, technical troubleshooting, workflow integration. | Determine applicable verification requirements, execute and document studies, establish acceptance criteria, review results, and approve use. |
| Modified method | Study-design support for relevant performance characteristics, reagent/instrument optimization, interference and range considerations, comparison studies, documentation support. | Determine and establish required performance specifications and approve the final method. |
| Laboratory-developed method | Analytical study-planning support, controls/reference materials, sensitivity/specificity studies, precision/range studies, troubleshooting, technical data review. | Establish and document applicable performance characteristics, intended use, acceptance criteria, and final laboratory authorization. |
| Method transferred between laboratories | Gap assessment, cross-validation or comparison planning, harmonized protocols, shared materials, data review, instrument/workflow troubleshooting. | Define transfer acceptance criteria and determine whether additional verification or validation is required in the receiving laboratory. |
| Method transferred to new instrument/workflow | Instrument-method compatibility review, comparison study, workflow change assessment, control strategy, technical troubleshooting, go-live support. | Determine the impact of the change and the level of evaluation needed before routine use. |
The implementation plan should follow the technology and biological measurement. IMDNA can support different assay types using platform-appropriate technical considerations.
Primer/probe configuration, extraction, controls, amplification efficiency, dynamic range, sensitivity, specificity, multiplex balance, instrument settings, analysis, and workflow transfer.
Sample dilution, calibration curve, controls, matrix behavior, antibody/reagent handling, incubation, washing, reader settings, precision, and workflow consistency.
Analyte ranges, common dilution, cross-talk, matrix effects, controls, calibrators, bead/reagent handling, instrument setup, and analyte-specific performance review.
Sample preparation, antibody panels, controls, compensation/unmixing, instrument settings, gating workflow, reproducibility, operator consistency, and data-analysis transfer.
Cell model, density, culture conditions, stimulation/treatment, controls, response window, plate effects, readout settings, reproducibility, and workflow integration.
NIH/NCATS assay guidance describes cross-validation as useful when an assay moves between investigators, laboratories, instruments, personnel, or procedural configurations. The objective is to demonstrate an acceptable level of agreement before and after transfer or change using well-documented methods and predefined comparison criteria.
Compare originating and receiving environments to identify differences in instrumentation, reagents, consumables, operators, sample preparation, software, and workflow.
Help align the critical steps of the method so the receiving laboratory can reproduce the intended assay configuration.
Where practical, use common QC or reference materials to reduce uncertainty when comparing performance between sites or configurations.
Assist laboratories in organizing measurable technical criteria for agreement or transfer studies based on the assay and intended purpose.
Help investigate inconsistent results by reviewing sample handling, assay conditions, controls, instruments, reagents, analysis settings, and operator workflow.
Support method-transfer summaries, study worksheets, technical reports, issue logs, and implementation documentation.
Implementation is easier to interpret when the method has a clear control architecture and traceable technical documentation.
Help laboratories identify appropriate positive, negative, process, internal, extraction, no-RT, endogenous, exogenous, calibrator, or other controls according to method needs.
Support selection or provision of suitable materials, where available, to challenge relevant aspects of method performance.
Provide practical tools for sample tracking, run organization, replicate planning, control documentation, and study data capture.
Assist with organization of study design, observations, data summaries, deviations, troubleshooting, and technical conclusions for laboratory review.
Support assay flow diagrams, instrument setup notes, reagent preparation tools, sample-routing diagrams, and practical operating checklists.
Help document technical changes made during implementation so the laboratory can understand how the final method differs from the original configuration.
Go-live is a transition point, not the end of implementation. Early routine use can reveal practical issues that were not obvious during controlled study runs.
Review initial reagent, QC, reference-material, consumable, storage, and backup-supply needs before routine workload begins.
Help ensure the assay workflow is practically integrated with the intended instrument, sample-preparation steps, analysis software, and laboratory process.
Assist with questions arising during early runs, including control behavior, curves, signals, repeatability, workflow, and technical troubleshooting.
Help organize technical issues that require assay redesign, optimization, vendor support, instrument service, or laboratory review.
Support practical improvements in reagent preparation, batching, sample movement, instrument use, repeat testing, and day-to-day assay execution.
Continue to assist with assay performance observations, reagent changes, control issues, method updates, troubleshooting, and optimization after implementation.
IMDNA provides general assay-development, scientific and technical, method-transfer, validation-support, implementation, workflow-integration, and non-regulatory laboratory support based on the needs of each laboratory organization. Support may include assistance with implementation planning, method-transfer review, validation or verification study-planning support, protocols and supporting documentation, QC and reference-material support, comparison-study assistance, troubleshooting, assay optimization, workflow integration, training resources, and technical assistance through go-live.
Where appropriate, IMDNA may also provide general educational information and practical guidance through its scientific, technical, and laboratory-experienced team to help customers understand assay and method implementation considerations and identify resources relevant to their project.
IMDNA is not a regulatory, licensing, accreditation, certification, legal, or governmental authority. Regulatory approvals, laboratory certification, accreditation, licensing, official inspection, authorization of patient testing, and other official determinations are made only by the applicable authorized organizations and the laboratory's responsible personnel.
Each laboratory is responsible for determining the verification, validation, quality-control, personnel, documentation, authorization, and other requirements applicable to its own methods, instruments, testing activities, location, and operations and for approving its own protocols, acceptance criteria, study conclusions, and final implementation decisions.
Any information, protocol, documentation, technical review, or guidance provided by IMDNA is intended to support laboratory study planning and implementation and should not be interpreted as regulatory approval, certification, accreditation, legal determination, reimbursement determination, or a guarantee of regulatory acceptance.
References to governmental, regulatory, accreditation, scientific, or professional organizations are provided for general informational purposes only and do not imply endorsement, approval, affiliation, certification, or sponsorship of IMDNA or its services.
The following official and scientific resources support the general concepts of method verification, establishment of performance specifications, assay transfer, robustness, controls, and implementation. These references are provided for independent educational use and do not imply endorsement of IMDNA or establish one universal implementation pathway for every assay.
Tell IMDNA about the assay, specimen type, instrument, current method, receiving laboratory, required controls, comparison needs, workflow, technical challenges, and intended implementation timeline. Our scientific and technical team can help organize a practical implementation plan covering transfer, study support, materials, performance evaluation, troubleshooting, workflow integration, and go-live technical assistance.