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the major requirements of the directive is that products be traceable to “standards of the highest order,” such as internationally recognized certified reference materials (CRMs). Currently, however, there are no CRMs or reference methods for several hundred analytes that are measured in clinical laboratories. As a result, European laboratories commonly use clinical reference laboratories “to establish traceability to higher-order methods.” Such reference laboratories, however, typically do not exist in the United States, making it difficult for U.S. manufacturers to establish traceability. Traditionally, NIST has developed and maintained standard reference
methods and materials for >25 health status markers, including calcium, chloride, cholesterol, creatinine, glucose, lithium, magnesium, potassium, sodium, trigylcerides, urea, and uric acid. Now, with the added impetus of a potential trade barrier for U.S. IVD manufacturers, NIST plans to significantly expand that list. “Our long-term target is to maintain responsibility for about 40% of the well-defined analytes [that are measured in medical laboratories],” says May. Many of the new markers under consideration are proteins, peptides, and other large biomolecules, which are typically present at low concentrations in biological matrixes. For ex-
ample, NIST has begun developing reference systems for measuring the heart-specific protein troponin-I, which is used to determine whether a person has had a heart attack and the severity of the attack, and glycated hemoglobin, which is used in the diagnosis and monitoring of diabetes. Markers for anemia (iron deficiency), hemochromatosis (too much iron), nutritional health status, prostate and breast cancer, thyroid function, and neural tube defects are also high on the list of those needing reference systems. NIST will hold a workshop in November to address measurement traceability in IVD testing. Britt Erickson
NELAC accreditation delayed
in the first round have certifications that will expire be-
In an emergency meeting in May, the board of directors of
tween now and January 2001. It is undecided whether
the National Environmental
these laboratories will need to
Laboratory Accreditation
renew their certifications or
Conference (NELAC) voted to
whether their existing certifica-
delay the announcement of
tions will be extended until
the first class of NELAC ac-
January, when they can be re-
credited laboratories, which was scheduled for this month,
placed by NELAC certification. The NELAC board of direc-
until January 2001.
tors is currently working with the states to resolve this
The decision was made because of concerns regarding insufficient time for laboratories to comply with the NELAC
issue so that laboratories don’t end up paying double accreditation fees.
proficiency testing requirements. “Although we are disap-
NELAC is a nationwide effort to reduce the number of
pointed in the postponement, we believe that it is more im-
accreditations required for U.S. environmental laboratories
portant to assure the integrity of the program than to meet
to conduct business in more than one state (Anal. Chem.
the July 2000 goal,” wrote NELAC Chair Jim Pearson in a
1999, 71, 329 A–331 A). Despite yet another setback, NELAC
memo notifying accrediting authorities of the decision.
officials are optimistic that implementation of the program
Some laboratories that expect to be NELAC-accredited
will continue to move forward. Britt Erickson
J U LY 1 , 2 0 0 0 / A N A LY T I C A L C H E M I S T R Y
453 A
