Medical Device Link.

Originally Published IVD Technology May 2004

INDUSTRY NEWS

After much deliberation, the Joint Committee for Traceability in Laboratory Medicine (JCTLM) has approved the first of potentially many lists of higher-order materials and methods. The materials and methods on the list can be used to establish traceability of IVD products sold in the European Union (EU). 

This initial list was used primarily to establish a review methodology and to practice diplomacy among various interests in the IVD industry and experts from international locales. The materials and methods on the list are already used throughout the IVD industry. 

“I don’t think that anything on that list today is new or different” says Neil Greenberg, a member of two JCTLM review teams and a regulatory specialist at Ortho-Clinical Diagnostics (Rochester, NY). It is really an exercise in declaring that something that is already well known is what it is. 

The information provided by the list is fairly minimalistic. “It was not intended to go into all of the possible scenarios for how the materials and methods could be used,” says Richard Miller, chair of a JCTLM review team and a staff scientist at Dade Behring (Newark, DE). 

The list includes materials, methods, and some brief comments. Most importantly, it provides contact information that can be used to obtain further details and determine whether a particular material or method is appropriate for a specific IVD product. According to Miller, “There are materials and methods on this list that are perfectly good for certain applications but that may not be applicable for every version of a test for a particular analyte. The manufacturer still has a technical obligation to assess that.”

Together, the National Committee for Clinical Laboratory Standards (Wayne, PA) and the International Federation of Clinical Chemistry and Laboratory Medicine (Milan, Italy) are working to provide a guidance document for industry that will clarify how best to use the tools on the list. Until then, manufacturers will need to rely on the ISO standards 15193 and 15194, as well as the applicable CITAC documents for direction.

Not only does the list provide bare-bones information, but it is also fairly limited in its scope and applicability to the entire range of IVDs on the market today. “This is really a long-term effort. There’s a lot of additional work that remains to be done,” says Greenberg.

When deciding which categories of IVD testing to tackle first, the JCTLM working groups considered the importance of testing areas to the interests of both the IVD market and healthcare. “There are two issues here, there is a medical relevance issue, and there is also a potential market impact since the IVD Directive potentially halts the sales of devices for which manufacturers cannot establish traceability,” says Willie May, PhD, cochair of the JCTLM Reference Materials and Reference Procedures Working Group and chief of NIST’s Analytical Chemistry Division. 

This first list includes materials and methods for IVDs that test for enzymes, electrolytes, metabolites and substrates, proteins, nucleic acids, drugs, hormones, and coagulation factors. 

“Within each of these areas, we worked very hard to make sure that we had very good geographic representation. We also gathered representation from all of the constituency groups, the national standards laboratories, the professional organizations, the IVD industry, and the accreditation community,” says May. 

Next, the JCTLM will tackle materials and methods used to establish traceability for tests for blood grouping and typing, blood gas, microbial serology, nonelectrolyte metals, and vitamins.

The JCTLM is also developing a list of materials and methods that are frequently used by manufacturers but are not traceable to the international system of units (SI). These “conventional” materials and methods therefore cannot be formally considered to be of a higher order.

That list will include materials and methods for which either the structure of the analyte of interest is not known or for which the analyte is difficult to measure. 

“Most of the proteinaceous hormones fall in that area. When testing for HCT, LH, and FSH levels, [due to the presence of various substances] we don’t know exactly what’s being measured. Troponin would be on that secondary list today because even though everyone understands the structure, they haven’t developed a solid reference method for it. All of the nucleic acids ended up on that list,” says Miller.

The issue of how to demonstrate traceability for tests for which there are no approved higher-order materials still remains. In addition, “There is no official legal status of that list, per se. It’s really a consensus activity,” says Greenberg. 

Nonetheless, the JCTLM found the list important enough to invest time and effort into developing. “The list is broadly recognized by a consensus of professional, industry, and government participants on an international level, whereas previous efforts in the industry were done by a more limited constituency,” says Greenberg. 

Manufacturers should link their products to an applicable material or method on the list, if one is present. “The general recommendation is that demonstrating traceability to the materials on the list should be addressed within two years of the material or method appearing on the published list,” says Miller.

The list has been posted on-line and will be updated annually. The Database of Higher-Order Reference Materials and Reference Measurement Procedures can be accessed at www1.bipm.org/en/committees/jc/jctlm/jctlm-db/.    

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