NEW YORK (GenomeWeb News) – Citing the rapid recent growth in the number of multiplex assays making their way to market, a nonprofit medical testing group with industry ties has drawn up a set of recommendations for lab practices and controls.
The Clinical and Laboratory Standards Institute’s recommendation, “Verification and Validation of Multiplex Nucleic Acid Assays; Approved Guideline," offers guidelines for analytic verification and validation of multiplex assays and a review of biologic and synthetic reference materials.
The recommendations cover sample preparation; reference quality control materials; analytic verification and validation; data analysis; and reporting results. It also offers a discussion of multiplex methods and technologies.
The goal of the guide, which costs $120 for non-CLSI members and $60 for members, is to help labs and manufacturers in the development, verification, validation, and implementation of multiplex nucleic acid tests for diagnostic purposes.
“Almost all of the new clinical tests are based on multiplexing of analytes, and there is currently no other reference available for this purpose,” Jean Amos Wilson, a CLSI committee co-chair and senior director of Sequenom’s Genetic Services Lab, said in a statement.
The paper also contains an overview of current technologies, as well as a review of the designs and uses of control materials such as blood samples, residual patient samples, products of whole genome amplification, synthetic oligonucleotide simplex and multiplex controls, and plasmids. The authors also illustrate proper verification and validation protocols using current assay formats and appropriate data analysis and results reporting.
The report is available here.