Government and Society: Standards glow with the flow - Analytical

Nov 1, 2004 - Government and Society: Standards glow with the flow. Laura Ruth. Anal. Chem. , 2004, 76 (21), pp 387 A–387 A. DOI: 10.1021/ac041668p...
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GOVERNMENT AND SOCIETY

At a workshop this month, the National Institute of Standards and Technology (NIST) and the U.S. Food and Drug Administration (FDA) hope to set the stage for establishing a consortium with flow cytometry companies so that “fluorescence standardization will be the norm, not a novelty,” says Robert Vogt of the U.S. Centers for Disease Control and Prevention (CDC). The NIST workshop comes on the heels of the release of a key document published by the NCCLS, formerly known as the National Committee for Clinical Laboratory Standards, in August. The NCCLS document Fluorescence Calibration and Quantitative Measurement of Fluorescence Intensity targets standards toward flow and image-based cytometry, as well as the microsphere and microarray communities. It is the result of 6 –7 years of discussion, says Howard Shapiro of the Center for Microbial Cytometry in Newton, Mass., who was a member of the NCCLS. Vogt, who cochaired the committee, further explains that the document presents a consensus of recommendations based on the needs of medical laboratories as well as of the suppliers that provide reagents and instruments to them. One of the recommendations is for the use of the NIST fluorescent standard, developed in 2001 as a reference material. According to NCCLS guidelines, “the real benefit will be the direct translation of relative fluorescence measurements into standardized

molar quantities, opening the way for accurate measurements of cellular expression in health and disease.” Quantitative fluorescent standards will allow fluorescence intensity measurements to be compared for data from different laboratories and instruments, says Vogt. Abe Schwartz of the Center for Quantitative Cytometry (Puerto Rico) gives one example, “The evaluation of new vaccines and drugs in multicentered clinical trials will especially benefit from having standardized fluorescence data.” Vogt elaborates that one future application of the standard is pooling cellular measurement data from many sources into a central cytomics database. Gunter Valet of the Max–Planck Institute for Biochemistry (Germany) explains that cytomics, a word introduced into the field of flow cytometry in 2001, is defined as phenotypic and functional studies of the cell to understand complex cellular interactions. Other areas that could benefit from the standard include newborn screening, drug development (especially monoclonal antibodies), and disease diagnostics. In August, Trillium Diagnostics released a research bead kit for sepsis based on the NIST fluorescein reference material. Sepsis is a bacterial infection of the blood or a body tissue. According to Sepsis.com, there are more than 700,000 severe cases of sepsis per year in the United States and several million worldwide. In 2001, healthcare costs for sepsis were es-

COURTESY OF NIST

Standards glow with the flow

Glowing fluorescent microspheres keep flow cytometers calibrated.

timated to be $16–17 billion per year. Bruce Davis from Trillium Diagnostics and the Maine Medical Center Research Institute hopes the kit will obtain FDA approval for clinical use by the end of this year. In addition to developing other bioassays, such as a tissue crossmatch that tests compatibility between organ donors and recipients, Vogt expects the standards to be applied to newer generations of fluorescent diagnostics, such as those based on nanocrystals. Kathy Turner of Bangs Laboratories, which began supplying the NIST reference material in August, says, “Availability of this NIST reference material has generated considerable excitement for quantitative fluorescence analyses in flow cytometry and fluorescence microscopy, and we look forward to seeing what impact it has on these applications.” a —Laura Ruth

PEOPLE Gordon F. Kirkbright Bursary 2005 In 1985, a fund was established as a memorial to Gordon F. Kirkbright in recognition of his contributions to analytical spectroscopy and to science in general. The fund is administered by the committee of the Association of British Spectroscopists (ABS) and by the ABS Trust.

Applications are invited for the 2005 Gordon F. Kirkbright Bursary. This prestigious award enables promising nontenured young scientists of any nation to attend a recognized scientific meeting or visit a place of learning. The award is not restricted to spectroscopists.

For further information, contact John Chalmers, Department of Physical Chemistry, University of Nottingham, University Park, Nottingham NG7 2RD, U.K.; fax +44 (0)1642 714306; vibspecconsult@ aol.com. The closing date for entries is March 18, 2005.

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