CAP TODAY Pathology/Laboratory Medicine/Laboratory Management
Steven W. Cotten, PhD, assistant professor of pathology and director of chemistry, toxicology, and immunology, Ohio State University Wexner Medical Center, in his presentation on umbilical cord tissue analysis via liquid chromatography/MS, discussed the use of an alternative specimen for assessing in utero drug exposure. Dr. Cotten explained how the use of this emerging matrix has the powerful ability to reshape clinical workflows outside the laboratory. By “unpacking” the extraction, Dr. Cotten described his thought process to tackling challenging matrices. This included considering extraction not just for clean-up but also for tissue disruption, drug isolation, and interference removal. Data from the study included a method comparison for the detection of drugs in both meconium and umbilical cord tissue, which showed good agreement for the drug classes evaluated. Dr. Cotten also shared quantitative outcome data that demonstrated the impact of the new specimen at the hospital. Using quality metrics such as birth-to-order and birth-to-result from the electronic medical record, he showed how umbilical cord tissue had transformed time to intervention from days to hours. In addition, positive opiate results from umbilical cord tissue were correlated with ICD-10 diagnosis codes for neonatal abstinence syndrome, which showed a higher sensitivity and negative predictive value compared with meconium. These results suggest that at his institution, the umbilical cord tissue assay is a better rule-out (screening) test for neonatal abstinence syndrome than it is a rule-in (confirmation) test.
My own lecture was on renal metabolomics and pain management pharmacometabolomics. I provided an introduction to MS-based metabolomics for translational and clinical laboratories, including experimental design, workflow, data analysis, and quality control. I described the development of a multiplexed LC-MS/MS assay of urine to monitor seven renal metabolites: kidney function marker (creatinine), Krebs cycle intermediates (citrate, succinate, and oxoglutarate), oxidative stress (trimethylamine oxide, TMAO), reabsorption (sorbitol), and active kidney secretion and aminoacylase activity (hippurate). The metabolite levels of de-identified patient urines were comparable with those of the published references from the Human Metabolome Database. Future metabolomic applications might be extended to transplantation and addiction.
In a panel discussion, Charles B. Root, PhD, of CodeMap, LLC, suggested that the new reimbursement environment looks promising for new MS-based assays. If a laboratory discovers or implements a new biomarker for patient care, an avenue now exists to secure new proprietary laboratory analyses (PLA) codes from the AMA so that the code can be placed on the clinical laboratory fee schedule and reimbursed by Medicare until commercial payment data can be used to establish a uniform national Medicare payment based on the mean of commercial payments. Clinical biomarkers performed using existing methods generally have existing codes and payment amounts associated with them. These payment levels will also be subject to change based on commercial payer rates starting in 2018 and may make conversion to mass spectrometric versions of these assays more difficult.
Dr. Wong, who was president of the AACC in 2014, is a professor of pathology at Wake Forest University School of Medicine, Winston-Salem, NC. He is director of clinical chemistry and toxicology and co-director of the Clinical and Translational Mass Spectrometry Center.
For a full report of the 2016 conference and the preliminary program for the 2017 conference, to be held Oct. 5–6 in Philadelphia, visit the website of the AACC Mass Spectrometry and Separation Sciences Division at bit.ly/aacc-msss-ev.