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Related Experiment Video

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Field Postmortem Rabies Rapid Immunochromatographic Diagnostic Test for Resource-Limited Settings with Further Molecular Applications

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Reference materials for molecular diagnostics: Current achievements and future strategies.

Rongrong Jing¹, Huimin Wang¹, Shaoqing Ju¹

¹Department of Laboratory Medicine, Affiliated Hospital of Nantong University, Nantong, China.

Clinical Biochemistry

|April 22, 2018

Summary

Reference materials (RMs) are crucial for standardizing molecular diagnostic tests. This review highlights the progress and strategies for developing higher order RMs to improve nucleic acid testing comparability.

Keywords:

Harmonizaiton Nucleic acid testing Reference material Standardization

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Area of Science:

Laboratory Medicine
Molecular Diagnostics
Metrology

Background:

Molecular diagnostic testing is increasingly utilized in laboratory medicine for nucleic acid detection.
Variability in test results arises from diverse assay methods and targets.
Reference materials (RMs) are essential for ensuring result comparability across clinical laboratories.

Purpose of the Study:

To review the definition, production, and characteristics of higher order reference materials.
To discuss the future strategies of various organizations involved in RM development.
To address the need for harmonization and standardization in molecular diagnostics.

Main Methods:

Literature review focusing on the definition and production of higher order RMs.
Analysis of progress and strategies from international organizations.
Examination of the characteristics of higher order RMs.

Main Results:

Recent advancements in the definition of RMs by the Joint Committee for Guides in Metrology are presented.
The production and characteristics of higher order RMs from international bodies are described.
Progress in developing RMs for molecular diagnostics is detailed.

Conclusions:

There is a critical need for reference materials, particularly higher order RMs, in nucleic acid testing.
Cooperation among organizations is proposed to advance harmonization and standardization.
Diverse approaches for developing higher order RMs are necessary to meet the growing demand.