Method Comparison & Bias Estimation Template – CLSI EP09

Product Description

Method Comparison & Bias Estimation Template – CLSI EP09 (Excel)

Designed for small laboratories and physician office laboratories (POLs), this Excel-based template supports method comparison and bias estimation in accordance with CLSI EP09, a core component of accuracy verification for FDA-cleared, non-waived quantitative tests.

Method comparison is required to demonstrate that a new method produces results comparable to an existing or reference method, yet many smaller labs perform these studies infrequently and do not need the cost or complexity of enterprise statistical software. This template provides a practical, inspection-ready alternative, allowing laboratories to document accuracy verification and bias assessment without annual software subscriptions.

The template is structured to support paired patient-sample comparisons, calculation of difference and percent bias, optional exclusion of outliers, and documentation of clinical agreement, consistent with CLSI EP09 guidance. It emphasizes clear documentation and defensible interpretation rather than unnecessary statistical complexity.

Key Features

• Structured worksheet supporting CLSI EP09 method comparison and bias estimation

• Designed for paired patient sample comparison between methods

• Automated calculations for:

  • Difference

  • Percent bias

  • Mean % bias

• Fields to document:

  • Acceptability within AMR

  • Excluded samples (with justification)

  • Clinical category concordance

• Optional entry of externally calculated regression results (slope, correlation)

• Summary section to support inspection-ready interpretation and conclusions

• Clean, professional format suitable for CLIA, CAP, COLA, and TJC inspections

• Designed by a CLSI-experienced Clinical Laboratory Scientist and Laboratory Director

• Reusable for multiple analytes, instruments, and comparator methods

Why This Template Makes Sense for Small Labs and POLs

Many small laboratories and POLs do not need to maintain enterprise statistical software to perform occasional method comparison studies. This template is designed for laboratories that need CLSI-aligned documentation and clear conclusions without unnecessary cost or complexity.

For labs that:

• Perform method comparison during new test implementation or instrument changes

• Operate with limited testing volume

• Prefer clear, inspection-ready documentation over advanced statistical modeling

this template provides the right level of rigor while keeping compliance efforts efficient and affordable.

Intended Use

This spreadsheet is intended to assist clinical laboratories with internal documentation and evaluation of method comparison and bias estimation studies for moderate- and high-complexity testing, when verification is appropriate for FDA-cleared test systems and within the laboratory’s scope of practice.

This template supports accuracy verification through method comparison (CLSI EP09) and does not replace full validation studies or manufacturer performance claims.

Compatibility

• Microsoft Excel (desktop version recommended)

• Not designed for Google Sheets or Excel Online

License

• Single-laboratory use

• Redistribution, resale, or sharing outside the licensed laboratory is prohibited

Disclaimer

This template is provided as an educational and documentation support tool and does not replace professional judgment or regulatory requirements. Laboratories are responsible for ensuring compliance with CLIA, CLSI, CAP, COLA, TJC, and applicable state regulations, and for determining the appropriateness of study design, sample selection, and acceptance criteria for their specific test systems.