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Introduction Doctoral-level clinical chemists work in various settings including academia, healthcare systems, reference laboratories, and industry. Information regarding compensation and benefits for PhD board-certified clinical chemists is limited. The American Association for Clinical Chemistry’s (AACC) Society for Young Clinical Laboratorians (SYCL) Core Committee completed a compensation survey in February 2021 and compared that to previous survey results. Methods The 2021 salary survey was made available to all doctoral-level AACC members working in the United States and Canada. Respondents provided information on type of degree and board certification, years of experience, employment sector, geographic location, and gender. The survey collected confidential self-reported data from 208 respondents, with 187 (90%) respondents residing in the United States. Results The 25th percentile, median and 75th percentile total compensation range for 113 PhDrespondents who are certified by the American Board of Clinical Chemistry (ABCC) and residing in the United States was $150 000 to $159 000, $180 000 to $189 000, and $230 000 to $239 000, respectively. Most of the respondents worked in either an academic, hospital, or healthcare system setting, with 47% of respondents working at academic medical centers. Conclusions In this 2021 compensation survey, we continue to see an upward trend in compensation ranges for board certified PhD clinical chemists. This report is important in allowing individuals to actively advocate with prospective and current employers for equal and fair compensation as well as other benefits that impact career development and growth.

Background Doctoral level board-certified clinical chemists play an invaluable role in many facets of laboratory medicine and healthcare. However, information concerning their total compensation is sparse. Content A confidential self-reported compensation survey was conducted by the American Association for Clinical Chemistry’s Society for Young Clinical Laboratorians (AACC SYCL) Core Committee from April 1 to April 17, 2018. Respondents provided information on geographic location, employment sector, gender, and years of experience to account for the influence of these variables on compensation. There were 199 respondents in total from the United States and Canada, however, only respondents employed in the United States with an earned doctoral degree and certification by the American Board of Clinical Chemistry (n = 133), were included in the full analysis. In comparison to compensation reported in AACC SYCL salary surveys conducted in 2010 and 2013, early career median salaries are trending upwards after correction for inflation. Summary This survey is the first to collect the gender of respondents, and identify a pay gap for some geographic groups. However, this gap could be due in part to a difference in the years of experience, since males were highly represented in the group with >20 years of experience (25 out of 35, 71%). Future studies on compensation trends within clinical chemistry that do not rely on self-report are needed to ensure accuracy and completeness of the dataset.

BACKGROUND: Chromogranin A (CgA) is a nonspecific marker for the presence of neuroendocrine tumors and neuroendocrine differentiation. The objective of this study was to evaluate the performance of the CisBio CgA ELISA. METHODS: Precision, linearity, limit of blank, and recovery of the CisBio CgA ELISA were evaluated. Seventy waste serum samples obtained from the clinical laboratory at Memorial Sloan Kettering Cancer Center were analyzed by the CisBio CgA ELISA. Results were compared to those obtained from a reference laboratory that used a proprietary ELISA for serum CgA measurement. Paired waste plasma samples were also collected from 24 of these patients to assess possible differences between CgA in serum and plasma. Finally, a preliminary reference range study was performed with samples from healthy volunteers in serum (n = 60) and plasma (n = 60). RESULTS: Within-run and between-run precision ranged from 3.0% to 5.1% and 4.8% to 12.9%, respectively. The limit of blank was 2.4 ng/mL. Recovery ranged from 88% to 102%. A statistically significant bias was observed when the CisBio CgA assay results were compared to those of a reference laboratory. Comparison of the 2 assays yielded a slope of 9.05, intercept of −18.0, and a correlation coefficient of 0.955. CgA values in serum correlated well to values measured in plasma. CONCLUSIONS: The analytical performance of the CisBio CgA ELISA was acceptable. However, CgA results are method-specific owing to lack of standardization and use of different antibodies. This lack of standardization results in several challenges for the clinical laboratory when evaluating a CgA assay.

Background Cutoff activities for diagnosing disaccharidase deficiencies are historical and are difficult to verify from a reference population. The objectives of this study were to validate the utility of historical disaccharidase cutoffs using data from clinical samples and to evaluate the demographics of individuals for whom intestinal disaccharidase testing was performed. Methods Results from 14,827 disaccharidase test samples were extracted from the laboratory information system. Data were analyzed by the Hoffman method to calculate a reference interval for each enzyme, and the lower limits were compared to historical cutoffs. The observed frequencies of disaccharidase deficiencies were determined using historic and calculated cutoffs. Results The median patient age of the entire data set was 13 years (range Conclusions Disaccharidase testing is most commonly performed in patients

Introduction Lipemia in clinical chemistry samples is a problematic form of interference. Clearing these samples for routine testing can be time consuming and increases the turn-around time for these specimens. In our laboratory, samples with a lipemia index >50 (L-index) are manually inspected and visibly lipemic specimens are cleared by ultracentrifugation. Objective The objective of this study was to determine at what L-index ultracentrifugation of lipemic BMP specimens is necessary prior to sample testing to ensure accurate results. Methods Specimens consisted of routinely ordered basic metabolic panels (BMP) that met current criteria for ultracentrifugation, which included an L-index >50 as measured on the Abbott Architect c8000 and visual lipemia. Specimens meeting these criteria were ultracentrifuged and retested. The difference of the pre-ultracentrifuged and post-ultracentrifuged result was evaluated and put into a percent to find the ‘percent difference’ and evaluated against the total allowable error (TEa) for each analyte. If the difference observed following ultracentrifugation was less than or equal to 50% of the TEa, clearance of lipemia by ultracentrifugation was considered unnecessary. Values from all BMP component tests were analyzed in order to find an L-index threshold at which samples need to be ultracentrifuged which could be applied to the entire panel. The report of lipemic indices for BMPs for the month of January 2020 were extracted from the laboratory information system to evaluate the potential impact of altering the L-index threshold for ultracentrifugation. Results Based on the acceptance criteria of ≤50% of TEa, L-index thresholds for Na, K, Cl, calcium, glucose, creatinine, CO2 and BUN were Conclusion These data suggest that an L-index greater than 150 can be used for all analytes within a BMP as the threshold for requiring ultracentrifugation. The BMP is one of the most frequently ordered tests in our laboratory and consistently accounts for a substantial portion of the lipemic samples that require ultracentrifugation. Increasing the L-index at which samples will be ultracentrifuged from 50 to 150 would potentially result in an 88% reduction in one month of BMP samples requiring ultracentrifugation.

Heavy metals testing remains an ongoing challenge for diagnosing acute or chronic exposure to heavy metals. In this study, we determined the positivity rates of single element and panel testing for toxic elements, and evaluated the potential utility of an expanded detection protocol for screening of toxic element exposures. The retrospective analysis included data from urine (n = 19,343) and blood (n = 196,019) specimens tested using inductively coupled plasma-mass spectrometry (ICP-MS) for arsenic, cadmium, lead and mercury (blood), and arsenic, cadmium, copper, lead, mercury and zinc (urine). Lead industrial monitoring in blood and cadmium exposure in blood and urine were included to represent directed single element ordering. The percent of positive results, defined as results greater than the upper limit of the reference interval was determined. For blood, the highest positivity was observed for lead occupational exposure monitoring (26.2%) whereas for urine, the highest positivity was observed for zinc testing (28.1%). Remarkably, reanalysis using an expanded panel, of 120 blood and 174 urine specimens originally negative identified 42% (50 of 120) of the blood specimens with at least one elevated result and 48% (83 of 174) of the urine specimens with at least one elevated result. Our results indicate that a broad elemental screening panel may help ensure easier identification of elemental exposure and may eliminate the need for additional follow-up sample collections.

Objectives: Compliance testing in pain management requires a distinct approach compared with classic clinical toxicology testing. Differences in the patient populations and clinical expectations require modifications to established reporting cutoffs, assay performance expectations, and critical review of how best to apply the available testing methods. Although other approaches to testing are emerging, immunoassay screening followed by mass spectrometry confirmation remains the most common testing workflow for pain management compliance and drug abuse testing. Methods: A case-based approach was used to illustrate the complexities inherent to and uniqueness of pain management compliance testing for both clinicians and laboratories. Results: A basic understanding of the inherent strengths and weaknesses of immunoassays and mass spectrometry provides the clinician a better understanding of how best to approach pain management compliance testing. Conclusions: Pain management compliance testing is a textbook example of an emerging field requiring open communication between physician and performing laboratory to fully optimize patient care.

Thyroid hormones undergo extensive metabolism to regulate hormone activity. A labeled thyroid hormone would be useful to track hormone metabolism through various pathways. While radiolabeled thyroid hormones have been synthesized and used for in vivo studies, a stable isotope labeled form of thyroid hormone is required for studying thyroid hormone metabolism by LC-MS/MS, an analytical technique that has certain advantages without the complications of radioactivity. Here we report the synthesis of 13C9-15N-T2 and 13C9-15N-T4, two labeled thyroid hormone derivatives suitable for in vivo LC-MS/MS studies.

3-Iodothyronamine (T1AM) is an endogenous thyroid hormone derivative with unknown biosynthetic origins. Structural similarities have led to the hypothesis that T1AM is an extrathyroidal metabolite of T4. This study uses an isotope-labeled T4 [heavy-T4 (H-T4)] that can be distinguished from endogenous T4 by mass spectrometry, which allows metabolites to be identified based on the presence of this unique isotope signature. Endogenous T1AM levels depend upon thyroid status and decrease upon induction of hypothyroidism. However, in hypothyroid mice replaced with H-T4, the isotope-labeled H-T3 metabolite is detected, but no isotope-labeled T1AM is detected. These data suggest that T1AM is not an extrathyroidal metabolite of T4, yet is produced by a process that requires the same biosynthetic factors necessary for T4 synthesis.

Many studies published in current scientific journals include a P value as part of the data analysis, often as an indication of statistical significance of the results. What does the P value mean? A P value is related to the null hypothesis (i.e., there is no difference between the no-treatment and treatment groups) and represents the probability of obtaining the observed results if the null hypothesis is true (1). For example, a P value of 0.05 represents a 5% probability of obtaining the observed results if the null hypothesis (no difference) is true. In a recent Viewpoint article published in JAMA (2), John P.A. Ioannidis discusses a …

There is great interest lately in the availability of analytical methods for quantification of 3-iodothyronamine from blood and tissues. To date, no validated method for determination of 3-iodothyronamine from biological matrices has been described. Detailed in this report is an LC-MS/MS method that permits accurate and reproducible quantification of pharmacological concentrations of 3-iodothyronamine from rat serum, with a 0.0008 M lower limit of quantification. Endogenous 3-iodothyronamine was observed from rodent and human serum (0.2 mL) at the method limit of detection. In summary, the LC-MS/MS method enables quantification of circulating 3-iodothyronamine to allow examination of a relationship with biological activity.

Opioids, including the naturally occurring opiates morphine and codeine, are commonly prescribed medications for the treatment of chronic pain. Opioids for chronic pain are variably effective, since tolerance may develop with extended use. Because of their highly addictive nature and the sensation of euphoria commonly produced, opioids are often abused recreationally. Potential sources of opioids for recreational abuse include the diversion of prescription medications and illegal street production. The opium poppy plant, Papaver somniferum, is the natural source for the opiates morphine and codeine, both of which produce analgesic effects, as well as thebaine, which is a precursor to synthetic opioids. Although chemical syntheses of morphine have been published since the 1950s, commercial production …

Objectives: The objective was to evaluate the utility of a screen with reflex-to-fractionation testing compared with direct-to-fractionation testing for suspected toxic exposure. Methods: This study was based on a retrospective data analysis of urine arsenic results from previously tested samples (n = 12,960). Total urine arsenic by inductively coupled plasma mass spectrometry was used as a screening method to identify elevated arsenic concentrations. Arsenic fractionation was the speciation assay to differentiate toxic and benign arsenic species. Results: Screening samples based on total arsenic concentration resulted in less than 10% of samples requiring arsenic fractionation, with a final positivity rate of less than 1% for toxic arsenic. Samples with fractionation ordered directly had a positivity rate for toxic arsenic of 3.3%. The overall positivity rate for exposure to toxic arsenic was less than 1%. Conclusions: A total arsenic screen before fractionation reduces the number of samples requiring fractionation by more than 91%, supporting the use of a screen with a reflex-to-fractionation approach for urine arsenic.

3-Iodothyronamine (T 1 AM) is an endogenous derivative of thyroxine. Recently there have been numerous reports of analytical methods to quantify endogenous T 1 AM levels, but substantial discrepancies in concentration depending on the method of analysis (LC–MS/MS or immunoassay) suggest endogenous T 1 AM may be covalently modified in vivo . Using information dependent acquisition methods to perform unbiased scans for T 1 AM metabolites following a single IP injection in mice, we have identified O-sulfonate-T 1 AM, N-acetyl-T 1 AM and T 1 AM-glucuronide as conjugates occurring in vivo , as well as the oxidatively deaminated 3-iodothyroacetic acid and non-iodinated thyroacetic acid. 3-iodothyroacetic acid, O-sulfonate-T 1 AM and T 1 AM-glucuronide are present in serum at greater concentrations that unmodified T 1 AM and all metabolites are extensively distributed to tissues. These results suggest covalent modifications of T 1 AM may play a critical role in regulating distribution and biological activity of T 1 AM, and analytical methods to quantify endogenous T 1 AM should be able to account for these metabolites as well.