Assay Performance Verification for Immunoassay Development

9 hours ago
3 min read

Image of Lateral Flow Test, Tablet with a standard curve and Performance Verification Report

Assay performance verification is a critical step in moving a developed assay towards regulatory submission, product launch or transfer into routine use. It provides the planned studies, predefined acceptance criteria and documented evidence needed to show that an assay performs as expected against its intended claims.

For developers of immunoassay based diagnostic products, including lateral flow tests, ELISA and plate based assays, Gyrolab™ assays and automated immunoassay platforms, this stage helps convert assay development work into a structured evidence package for claim substantiation and regulatory review.

Fleet Bioprocessing supports assay performance verification and claim support with studies designed around the assay platform, sample matrix, readout method, workflow, performance claim and intended use.

Our work is designed to support developers preparing for CE marking, FDA 510(k) or PMA submissions and equivalent regulatory routes in other territories.

What Assay Performance Verification Includes

The scope of a performance verification programme depends on the assay, the sample type and the performance claims being made. Typical studies may include:

Analytical sensitivity, including Limit of Detection (LoD) and Limit of Quantification (LoQ)
Precision and Reproducibility
Accuracy and Trueness
Linearity and Measuring Range
Specificity and Cross Reactivity
Interference and Matrix studies
Assay Comparison
Stability
Custom studies designed around specific performance claims

The aim is not simply to generate data, but to generate evidence that is controlled, traceable and suitable for technical or regulatory review.

A Structured Claim Support Process

A robust assay performance verification programme begins with a performance verification plan. This plan identifies the studies required to demonstrate acceptable assay performance and provides the rationale for the chosen approach.

Individual protocols are then prepared for each study. These define the study design, materials, sample requirements, acceptance criteria and reporting expectations.

The studies are executed under controlled conditions, with results assessed against the predefined criteria. Each study is documented in a performance verification report, including the results obtained, any deviations or discrepancies and the overall study outcome.

Finally, a summary performance verification report brings the individual reports together and provides an overall conclusion on the verification status of the assay.

This structure helps ensure that performance verification is not treated as a set of disconnected experiments. Instead, it becomes a coherent evidence package that can support technical documentation, product claims and regulatory submissions.

Where CRO Support Adds Value

A well planned performance verification programme helps assay developers generate the right evidence efficiently, with protocols, acceptance criteria, study execution and reporting aligned from the outset.

This is particularly valuable when verification studies need to follow structured approaches described in recognised guidance, such as CLSI documents. For example, precision studies commonly require repeated testing across multiple days, runs, operators, reagent lots or instruments, which can be difficult to accommodate within a busy development laboratory.

Sensitivity studies require carefully prepared low level panels and sufficient replicate testing around the claimed limit of detection. Interference and cross reactivity studies require justified panels of potentially relevant substances, and in some cases access to biological samples, Category II laboratory facilities, controlled sample handling processes, specialist materials or substances that require a controlled drugs licence.

These requirements can place significant demands on scheduling, sample logistics, laboratory capacity and documentation. A CRO can help by translating the required performance characteristics into a practical verification plan, coordinating the study design and execution, providing access to appropriate facilities and producing clear reports that support the analytical performance claims.

This gives assay developers additional capacity and technical support at the point where development data needs to be translated into a formal, claim supporting evidence package.

Why Work With Fleet

Fleet Bioprocessing has more than 25 years’ experience in immunoassay development and performance verification and is ISO 9001 & ISO 13485 certified.

Our team supports clients from early assay proof of concept through assay optimisation, performance verification, claim support and transfer related activities. This integrated experience helps ensure that verification studies are designed with a practical understanding of assay behaviour, development history and downstream requirements.

Whether you need support with Assay Performance Verification, Lateral Flow Assay Development, ELISA Assay Development, Gyrolab Assay Development or wider Contract Immunoassay Development, Fleet can help design and execute a programme suited to your assay and submission needs.