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Letters June 2003 Tissue banking We share the excitement evidenced in your article about gene-based research using tissue banks (March 2003, page 1). That’s why, in 1999, Impath Inc. launched the Impath predictive oncology (IPO) division and its GeneBank tissue, serology, and information archive. GeneBank consists of more than 12,000 well-characterized, fully consented tissue samples with rights to followup data over a multi-year period. This tissue and information archive procures only oncology specimens, with each sample undergoing a standardized pathology review after it is collected in accordance with well-defined, institutional-review-board-approved protocols. In the relatively short time we have been developing this resource, we have established relationships with many academic medical institutions and hospital centers. We have participated in projects with numerous biopharma companies leading oncology drug discovery and development. Impath’s exclusive focus on cancer positions our IPO division to play a growing role in bringing the next generation of novel gene-based therapies to market for cancer patients. Carter
H. Eckert Specimen stability In the March issue of CAP TODAY (page 112) there was a question and answer about the stability of specimens for vitamin B12 and folate, with specific reference to Quest Diagnostics. The conclusions of the responders, Frederick Kiechle, MD, PhD, and J. Douglas Ferry, PhD, may be misleading, especially to physicians and hospitals that depend on the accuracy and reliability of testing performed within our network of laboratories. Quest Diagnostics, like laboratories across the country, is dedicated to providing physicians with laboratory results that accurately reflect the analytes measured. We base our guidelines for specimen preparation on both published and internal studies. First, the responders cite a study published in Clinical Chemistry that indicates specimens are stable when exposed to light for up to eight hours (Mastropaolo W, Wilson MA. Clin Chem. 1993;39:913). This is consistent with the specimen requirements listed in our manuals because few specimens are exposed to light for more than this length of time. Specimens are stored in refrigerators and collection boxes before pickup. Couriers transport specimens in coolers and containers that are protected from light. Analysis is frequent, with nearly all test results available the next morning. Thus, the published study applies to the typical specimen tested by Quest Diagnostics. Second, Quest Diagnostics has performed internal studies that support exposure to light for up to 24 hours. These studies form the basis of our recommendations in our manuals and on our Web site. We found no significant clinical change in the concentration of vitamin B12 in specimens exposed to light for up to five days, and our findings for folate, when specimens are exposed to light for up to 24 hours, were similar. Third, we review the distribution of test results to ensure it is what we expect. For these two analytes, less than three percent of results fall below the reference range. If degradation were affecting the analysis, the percentage would be significantly higher. Thus, we are assured that we are observing the reporting of an expected distribution of results without degradation due to excessive exposure to light. Quest Diagnostics stands by its published specimen requirements for vitamin B12 and folate. We urge other laboratories to perform studies that define the specimen requirements based on their processes and equipment. Harvey
W. Kaufman, MD |
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