This sponsor is an anti-doping laboratory tasked with testing athlete samples for prohibited substances by the World Anti-Doping Agency and other agencies.
This study is intended to measure:
Urinary/serum hCG (human chorionic gonadotropin) and urinary biotin concentrations in both treatment groups before, during, and after hCG intervention using standard immunoassay methods
To monitor hCG in both treatment groups before and after diafiltration of urine samples prior to analysis
To compare urinary and serum detectability (detection window, sensitivity) of hCG abuse in the hCG-only group compared to the hCG + biotin group

开始日期2022-10-27

申办/合作机构

Sports Medicine Research & Testing Laboratory

NCT04073849 / Completed早期临床1期

Evaluation of CD71 Expression in a Dried Blood Spot Following rEPO Administration

Understand the effect of recombinant EPO (rEPO) boosting and microdosing on the hematological module of the Athlete Biological Passport (ABP)
Measure the change in CD71 longitudinally in subjects from both cohorts
Assess whether rEPO administration can be detected in a dried blood spot (DBS) using recent advances in analytical methodologies
Compare windows of rEPO detection using both Athlete Biological Passport models and direct detection using analytical methods in urine, blood, and DBS

开始日期2019-07-15

申办/合作机构

Sports Medicine Research & Testing Laboratory

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2024-09-15·Drug testing and analysis

Evaluation of Minimum Reporting Limits to Determine In-Competition Use of Stimulants.

Article

作者: Goodrum, Jenna M ; Hanelli, Fatjon A ; Nair, Vinod S ; Eichner, Daniel ; Miller, Geoffrey D ; Moore, Chad ; Crouch, Andre

The applicability of urinary minimum reporting limits (MRLs) to determine in-competition use of prohibited substances is an evolving topic. Most stimulants are subject to a universal MRL, despite the wide range of commercially available dosages for commonly used stimulants. Further, it is unknown whether the urinary MRL is reflective of a pharmacological dose ingested after the start of the in-competition period. To evaluate whether urinary MRLs can distinguish between in-competition and out-of-competition use, a controlled administration study was performed with three commonly used stimulants-amphetamine, methylphenidate, and modafinil at relatively low but therapeutically relevant dosages. Four to six volunteers were administered a particular drug once per day for five consecutive days. Urine, serum, dried blood spots (DBS), and oral fluid (OF) were collected during the active administration period and for 48 h after cessation of use. For all participants, urinary concentrations for all target analytes exceeded the MRL even 48 h after cessation of use. In serum and DBS, most volunteers showed detectable amounts at 48 h post use. Peak concentrations were variable between target compounds even with similar administered dosages. Further, there was a reproducible difference between serum and DBS concentrations. Interpretation of results from OF measurements was challenging due to the inability to normalize for hydration status and OF viscosity. Analyte concentrations decreased steadily over the washout period but did not correlate across matrices for all target analytes. The study reiterates the challenges associated with determining in-competition use by relying on urinary concentrations.

2023-11-01·Drug Testing and Analysis

Influence of multiple human chorionic gonadotropin administrations on serum and urinary steroid Athlete Biological Passport profiles in males

Article

作者: Crouch, Andre K ; Miller, Geoffrey D ; Eichner, Daniel ; Goodrum, Jenna M ; Moore, Chad

AbstractThe Athlete Biological Passport (ABP) is a longitudinal tool used in anti‐doping to monitor biological parameters known to change with performance‐enhancing drug use. The ABP consists of multiple modules, including two aimed at detecting the use of endogenous anabolic androgenic steroids: the urinary and serum steroid modules. Human chorionic gonadotropin (hCG) is a protein hormone potentially abused by male athletes to increase the production of endogenous testosterone. To date, no studies have investigated the impact of extended hCG administration on the urinary and serum steroid modules of the ABP. The goal of this study was to identify the impact of multiple hCG administrations on the parameters tracked as part of the urinary and serum steroid modules of the ABP. Ten recreationally active, healthy male individuals self‐administered seven 250 μg hCG injections over 3 weeks. Serum and urine samples were collected before, during, and 2 weeks following the final injection. All ABP parameters were quantified in the respective matrix, and steroid profiles were created with Anti‐Doping Administration and Management System adaptive model upper and lower limits for both matrices. In both serum and urine profiles, testosterone increased; however, the testosterone/epitestosterone ratio in urine and the testosterone/androstenedione ratio in serum showed minimal changes. Additionally, serum luteinizing hormone (LH) was quantified using an immunoassay, and a serum testosterone/LH ratio was generated. Serum LH values decreased during administration causing large increases in the serum T/LH ratio, indicating this ratio may be a more sensitive parameter for detecting hCG abuse than urinary testosterone/epitestosterone or serum testosterone/androstenedione.

2023-11-01·Drug Testing and Analysis

δ¹³C values of urinary 19‐norandrosterone in antidoping samples and potential for adverse findings from boar offal consumption

Article

作者: Fedoruk, Matthew ; Nair, Vinod S ; Ahrens, Brian ; Campbell, Thane ; Eichner, Daniel ; Howa, John D ; Beggs, Lacey ; Morrison, Matthew S

Abstract19‐Norandrosterone (19NA) is the preferred urinary target compound to identify doping with nandrolone or related 19‐norsteroids. At concentrations between 2.5 and 15 ng/mL, isotope ratio mass spectrometry (IRMS) is required to establish exogenous origin of urinary 19NA. An absolute difference of 3‰ between urinary 19NA and an endogenous reference compound (ERC) constitutes a finding for exogenous origin of 19NA. Over the last 3 years, 77 samples containing urinary 19NA between 2.5 and 15 ng/mL were analyzed at our laboratory. The measured δ13C values for 19NA ranged from −29.5‰ to −16.8‰. In comparison, the δ13C values for the corresponding urinary ERCs ranged from −22.4‰ to −16.2‰. Due to the considerable overlap in values between the target compound and the natural range of urinary ERCs, it can be challenging to distinguish between endogenous and exogenous origins of urinary 19NA. In addition, it is well known that consumption of offal from non‐castrated pigs can produce 19NA in urine. To determine whether this could cause a positive IRMS finding under the current IRMS positivity criteria, meat from non‐castrated boars fed a mixture of corn and soy was consumed by 13 volunteers. Two volunteers produced 19NA findings above 2.5 ng/mL, and the measured isotope values, while inconsistent with documented 19‐norsteroid preparations, did meet IRMS positivity criteria. However, these increases in 19NA urinary concentrations were short‐lived due to rapid elimination. Timely follow‐up collections may help support a claim for dietary exposure when low urinary concentrations of 19NA with pseudo‐endogenous isotope values are observed.

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