The Threat of Commercial Hormone Kits to Endocrinology

Main Article Content

Jens Frederik Rehfeld

Abstract

Over the last decades, the market for commercial hormone kits has grown considerably. The kits are today used extensively in endocrine research and diagnostics. Unfortunately, a significant fraction of the kits are unreliable in both analytical and diagnostic terms. Consequently, the aim of the present article is to draw critical attention among endocrinologists to the reliability of commercial hormone kits. For that purpose, we have briefly reviewed the kit situation for four different hormones: The brain-gut hormone cholecystokinin (CCK); the antral hormone gastrin; the pancreatic hormone glucagon; and the cardiac natriuretic hormones. We conclude that the situation for the described peptide hormones probably shows only the tip of an iceberg. Therefore, we strongly recommend kit producers examine their products carefully with respect to the new endocrine biology and diagnostic reliability before the kits are marketed. Moreover, we also recommend quality regulation of the kit market in line with the regulations applied to the pharmaceutical drug market.

Article Details

How to Cite
REHFELD, Jens Frederik. The Threat of Commercial Hormone Kits to Endocrinology. Medical Research Archives, [S.l.], v. 11, n. 11, nov. 2023. ISSN 2375-1924. Available at: <https://esmed.org/MRA/mra/article/view/4592>. Date accessed: 16 may 2024. doi: https://doi.org/10.18103/mra.v11i11.4592.
Section
Editorial

References

1. Yalow RS, Berson SA. Immunoassay of endogenous plasma insulin in man. J Clin Invest. 1960;39:1157-1174.
2. Engvall E, Perlmann P. Enzyme-linked immunosorbent assay (ELISA) Quantitative assay of immunoglobulin G Immunochemistry. 1971;8:871-874.
3. Rehfeld JF, Goetze JP. Gastrointestinal hormones: history, biology and measurement. Adv Clin Chem. 2023 (in press).
4. Rehfeld JF. The art of measuring gastrin in plasma: A dwindling diagnostic discipline? Scand J Clin Lab Invest. 2008;68:353-361.
5. Rehfeld JF, Gingras MH, Bardram L. Hilsted L, Goetze JP, Poitras P. The Zollinger-Ellison syndrome and mismeasurement of gastrin. Gastroenterology. 2011;140:1444-1453.
6. Rehfeld JF. Bad kits in the diagnosis of endocrine tumors. Int J Endocrine Oncol. 2020;7:IJE30.
7. Rehfeld JF. Measurement of cholecystokinin in plasma with reference to obesity studies. Nutr Res. 2020;76:1-8.
8. Rehfeld JF, Stadil F, Rubin B. Promotion and evaluation of antibodies for the radioimmunoassay of gastrin. Scand J Clin Lab Invest. 1972;30:221-232.
9. Schubert ML, Rehfeld JF. Gastric peptides – gastrin and somatostatin. Compr Physiol. 2020;10:197-228.
10. Rehfeld JF, de Magistris L, Andersen BN. Sulfation of gastrin: Effect on immunoreactivity. Regul Pept. 1981;2:333-342.
11. Albrechtsen NJW, Holst JJ, Cherrington AD, Finan B, Gluud LL, Dean ED, Campbell JE, Bloom SR, Tan TM-M, Knop FK, Müller. 100 years of glucagon and 100 more. Diabetologia. 2023;66:1378-1394.
12. Albrechtsen NJW, Kjeldsen SAS, Jensen, Rungby, Veedfald S, Bojsen-Møller KN, Dirksen C, Jensen CZ, Martinussen C, Madsbad S, Holst JJ. On measurements of glucagon secretion in healthy, obese, and Roux-en-Y gastric bypass operated individuals using sandwich ELISA. Scand J Clin Lab Invest. 2022;82:75-83.
13. Wu T, Rayner CK, Jones KL, Horowitz M, Feinle-Bisset C, Standfield SD, Xie C, Deacon CF, Holst JJ, Albrechtsen NJW. Measurement of plasma glucagon in humans: A shift in the performance of a current commercially available radioimmunoassay kit. Diabetes Obes Metab. 2022;24:1182-1184.
14. Kramer CK, Zinman B, Choi H, Connelly PW, Retnakaran R. The impact of chronic liraglutide therapy on glucagon secretion in type 2 diabetes: Insight from the LIBRA trial. J Clin Endocrinol Metab. 2015;100:3702-3709.
15. Kramer CK, Zinman B, Choi H, Connelly PW, Retnakaran R. Impact of the glucagon assay when assessing the effect of chronic liraglutide therapy on glucagon secretion. J Clin Endocrinol Metab. 2017;102:2729-2733.
16. Albrechtsen NJW, Veedfald S, Plamboeck A, Deacon CF, Hartmann B, Knop FK, Vilsboll T, Holst JJ. Inability of some commercial assays to measure suppression of glucagon secretion. J Diabetes Res. 2016:8352957.
17. Goetze JP, Bruneau BG, Ramos HR, Ogawa T, de Bold MK, de Bold AJ. Cardiac natriuretic peptides. Nat Rev Cardiol. 2020;17:698-717.
18. Yandle T, Fisher S, Espiner E, Richards M, Nicholls G. Validating aminoterminal BNP assays: a word of caution. Lancet. 1999;353:1068-1069.
19. Goetze JP. B-type natriuretic peptide: from posttranslational processing to clinical measurement. Clin Chem. 2012;58:83-91.
20. Goetze JP, Kastrup J, Pedersen F, Rehfeld JF. Quantification of pro-B-type natriuretic peptide and its products in human plasma by use of an analysis independent of precursor processing. Clin Chem. 2002;48:1035-1042.
21. Costello-Boerrigter LC, Lapp H, Boerrigter G, Lerman A, Bufe A, Macheret F, Heublein DM, Larue C, Burnett JC Jr. Secretion of prohormone of B-type natriuretic peptide, proBNP1-108, is increased in heart failure. JACC Heart Fail. 2013;1:207-212.
22. Hansen LH, Madsen TD, Goth CK, Clausen H, Chen Y, Dzhoyashvili N, Iyer SR, Sangaralingham SJ, Burnett JC Jr, Rehfeld JF, Vakhrushev SY, Schjoldager KT, Goetze JP. Discovery of O-glycans on atrial natriuretic peptide (ANP) that affect both its proteolytic degradation and potency at its cognate receptor. J Biol Chem. 2019;294:12567-12578.
23. Madsen TD, Hansen LH, Hintze J, Ye Z, Jebari S, Andersen DB, Joshi HJ, Ju T, Goetze JP, Martin C, Rosenkilde MM, Holst JJ, Kuhre RE, Goth CK, Vakhrushev SY, Schjoldager KT. An atlas of O-linked glycosylation on peptide hormones reveals diverse biological roles. Nat Commun. 2020;11:4033.
24. Nersting J, Terzic D, Hansen LH, Goetze JP. Next-Level Natriuretic Peptide Measurement. Clin Chem. 2023;69:313-315.