Published Technical Documents
Standards, guidance and application literature from the bodies and manufacturers that publish it. Every entry links to the document page itself and quotes the sentence that says what it covers.
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Emergency Use Listing Procedure
Technical guidanceWHO Regulation and Prequalification
The risk-based listing procedure for diagnostics not yet under stringent regulatory assessment.
Source: extranet.who.int · Retrieved 2026-10-30
Performance Evaluation
Technical guidanceWHO Regulation and Prequalification
How WHO independently verifies assay performance and operational fitness for resource-limited settings.
Source: extranet.who.int · Retrieved 2026-10-30
EP15 | User Verification of Precision and Estimation of Bias
Technical guidanceCLSI
A short user-verification protocol for precision and bias that a lab can complete in five days.
Source: clsi.org · Retrieved 2026-10-30
EP17 | Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures
Technical guidanceCLSI
The reference procedure for evaluating limit of blank, limit of detection and limit of quantitation.
Source: clsi.org · Retrieved 2026-10-30
EP23 | Laboratory Quality Control Based on Risk Management
Technical guidanceCLSI
Risk-based quality-control planning, built around the measuring system and the setting it runs in.
Source: clsi.org · Retrieved 2026-10-30
CLSI
The molecular-reference standard for solid-tumor testing, addressed to lab directors, developers and regulators.
Source: clsi.org · Retrieved 2026-10-30
CLSI’s framework for building evidence of clinical validity, written for manufacturers and for labs developing their own tests.
Source: clsi.org · Retrieved 2026-10-30
Key takeaways
Every item here is a technical document its publisher made public: a standards-body scope page, a regulator guidance document, or a manufacturer application note or journal article. The entry links to that page and quotes the sentence describing what the document covers. It is not a record of work IVDmap has done.
Target audienceImplementation teams, labs, procurement managers
Review and references
Compiled from public manufacturer materials and regulatory sources. Not independently verified and not reviewed by a named clinician.
2026-10-01
2026-10-09
professional use
Every document below is published by the body named on it, and this page links to that page. Nothing here is a record of work IVDmap has done.