Originally Published IVD Technology July/August 2001
Industry News
NCCLS to take on industry standards projects
Three of the proposed projects are of particular interest to IVD manufacturers.
- OTC Pregnancy Test Kits.
- Quality Assessment Programs for Molecular Methods.
- Specifications for Immunochemical Reagents and Products Manufactured for In Vitro Diagnostic Assays Detecting Antigens.
The other two projects are of interest to both manufacturers and their laboratorian customers.
- Determining Clinical Utility of Genetic Tests.
- Performance of Cellular Immune Functional Assays.
"IVD manufacturers have been pushing NCCLS to do more for them," says Donald Powers, president of Powers Consulting Services (Rochester, NY) and a former member of the NCCLS board of directors. "And FDA has been asking NCCLS to develop standards that manufacturers could use in the abbreviated 510(k) process."
In fact, according to Louise Ciccarelli at NCCLS, FDA suggested the over-the-counter (OTC) pregnancy test kit and the immunochemical reagents and products projects. The quality assessment project was proposed by a member of the industry.
The OTC pregnancy kit project will address false-positive and false-negative test results, as well as issues that affect lay-user testing and interpretation. The consensus standard developed by this group will explain how manufacturers should document consumer complaints and it will also dictate what information should be included in package inserts to help minimize user error.
The quality assessment project will provide manufacturers of analyte-specific reagents with guidelines for production and offer recommendations for design control. It will also provide guidance for professionals who conduct these tests and recommendations for fair assessment of organizations that conduct quality programs.
The proposed project on specifications for immunochemical reagents will provide guidance for establishing reagent and product specifications, and for applying appropriate methods to maintain process control during the manufacture of direct antigen test products. According to NCCLS, the document will provide a framework and details useful for developing applicable quality systems for manufacturing these products using specifications and objective evidence consistent with user needs and intended use.
The purpose of the project on determining the clinical utility of genetic tests is to clearly define "clinical utility" in reference to genetic testing. The need for such a definition is in response to recent statements by several government agencies that genetic testing should not be performed unless a clinical utility has been clearly demonstrated.
"A definition will also determine whether a manufacturer decides to commercialize a test, whether FDA will approve it, and whether the Centers for Medicare and Medicaid Services will cover and reimburse for it," says Powers.
NCCLS says that a consensus guideline developed by this group will provide a means by which users can evaluate potential clinical utility in all phases of genetic testing.
Subcommittee members of the cellular immune functional assay group will craft a consensus guideline for performing assays for cellular immune function. Applications for these tests include HIV, cancer, transplantation autoimmune disease, and allergy. Assays that will be addressed are those to evaluate antigen-presenting cells, CD4T-cells, and CD8T-cell immune function.
Members of the
subcommittees will have primary responsibility for drafting individual standards
and guidelines, and for evaluating comments received during each phase of the
consensus process prior to final approval by the NCCLS board of directors.
Copyright ©2001
IVD Technology
—Susan
Wallace
