Variability in SHBG assays and the effect thereof on calculated estimates of free testosterone
BackgroundSerum free testosterone is commonly used as a parameter to evaluate testosterone exposure and is mostly calculated using mathematical approximations. As the principal testosterone-binding protein, SHBG concentration is always included in such calculations. However, variability in SHBG meas...
Uloženo v:
| Vydáno v: | Annals of clinical biochemistry Ročník 62; číslo 6; s. 493 |
|---|---|
| Hlavní autoři: | , , , , , , , , , |
| Médium: | Journal Article |
| Jazyk: | angličtina |
| Vydáno: |
England
01.11.2025
|
| Témata: | |
| ISSN: | 1758-1001, 1758-1001 |
| On-line přístup: | Zjistit podrobnosti o přístupu |
| Tagy: |
Přidat tag
Žádné tagy, Buďte první, kdo vytvoří štítek k tomuto záznamu!
|
| Abstract | BackgroundSerum free testosterone is commonly used as a parameter to evaluate testosterone exposure and is mostly calculated using mathematical approximations. As the principal testosterone-binding protein, SHBG concentration is always included in such calculations. However, variability in SHBG measurements may affect reported SHBG levels and consequently free testosterone calculations. In this study, we re-evaluate the effects of SHBG assay choice and interlaboratory variability on calculated free testosterone (cFT).MethodsSerum samples from 113 men and 106 women were collected. SHBG levels were measured using three different SHBG immunoassays (Roche, Abbott and Siemens). Testosterone levels were measured using LC-MS/MS. Afterwards, cFT was calculated using the Vermeulen formula and measured directly. SHBG concentrations, and derived cFT concentrations, from different assays were compared. To simulate interlaboratory SHBG variability, measured levels were modified by 15% after which cFT was recalculated using the Vermeulen, Ly, Sartorius and Södergard formulae. The proportions of diagnoses of hypogonadism or hyperandrogenism were compared.ResultsAssessed SHBG assays showed very good conformity. The largest difference was 7%, between the Abbott and Siemens assay. The difference in cFT levels was at most 3% between the Abbott and Siemens assay. Interlaboratory variability affected the proportion of diagnoses depending on the used formula.ConclusionsOur results do not show large differences between SHBG assays and only minor effects on cFT levels. Therefore, SHBG assay choice is not expected to greatly influence clinical decision making. In contrast, interlaboratory variation in SHBG measurements and choice of formula might considerably affect cFT results and their interpretation. |
|---|---|
| AbstractList | BackgroundSerum free testosterone is commonly used as a parameter to evaluate testosterone exposure and is mostly calculated using mathematical approximations. As the principal testosterone-binding protein, SHBG concentration is always included in such calculations. However, variability in SHBG measurements may affect reported SHBG levels and consequently free testosterone calculations. In this study, we re-evaluate the effects of SHBG assay choice and interlaboratory variability on calculated free testosterone (cFT).MethodsSerum samples from 113 men and 106 women were collected. SHBG levels were measured using three different SHBG immunoassays (Roche, Abbott and Siemens). Testosterone levels were measured using LC-MS/MS. Afterwards, cFT was calculated using the Vermeulen formula and measured directly. SHBG concentrations, and derived cFT concentrations, from different assays were compared. To simulate interlaboratory SHBG variability, measured levels were modified by 15% after which cFT was recalculated using the Vermeulen, Ly, Sartorius and Södergard formulae. The proportions of diagnoses of hypogonadism or hyperandrogenism were compared.ResultsAssessed SHBG assays showed very good conformity. The largest difference was 7%, between the Abbott and Siemens assay. The difference in cFT levels was at most 3% between the Abbott and Siemens assay. Interlaboratory variability affected the proportion of diagnoses depending on the used formula.ConclusionsOur results do not show large differences between SHBG assays and only minor effects on cFT levels. Therefore, SHBG assay choice is not expected to greatly influence clinical decision making. In contrast, interlaboratory variation in SHBG measurements and choice of formula might considerably affect cFT results and their interpretation. BackgroundSerum free testosterone is commonly used as a parameter to evaluate testosterone exposure and is mostly calculated using mathematical approximations. As the principal testosterone-binding protein, SHBG concentration is always included in such calculations. However, variability in SHBG measurements may affect reported SHBG levels and consequently free testosterone calculations. In this study, we re-evaluate the effects of SHBG assay choice and interlaboratory variability on calculated free testosterone (cFT).MethodsSerum samples from 113 men and 106 women were collected. SHBG levels were measured using three different SHBG immunoassays (Roche, Abbott and Siemens). Testosterone levels were measured using LC-MS/MS. Afterwards, cFT was calculated using the Vermeulen formula and measured directly. SHBG concentrations, and derived cFT concentrations, from different assays were compared. To simulate interlaboratory SHBG variability, measured levels were modified by 15% after which cFT was recalculated using the Vermeulen, Ly, Sartorius and Södergard formulae. The proportions of diagnoses of hypogonadism or hyperandrogenism were compared.ResultsAssessed SHBG assays showed very good conformity. The largest difference was 7%, between the Abbott and Siemens assay. The difference in cFT levels was at most 3% between the Abbott and Siemens assay. Interlaboratory variability affected the proportion of diagnoses depending on the used formula.ConclusionsOur results do not show large differences between SHBG assays and only minor effects on cFT levels. Therefore, SHBG assay choice is not expected to greatly influence clinical decision making. In contrast, interlaboratory variation in SHBG measurements and choice of formula might considerably affect cFT results and their interpretation.BackgroundSerum free testosterone is commonly used as a parameter to evaluate testosterone exposure and is mostly calculated using mathematical approximations. As the principal testosterone-binding protein, SHBG concentration is always included in such calculations. However, variability in SHBG measurements may affect reported SHBG levels and consequently free testosterone calculations. In this study, we re-evaluate the effects of SHBG assay choice and interlaboratory variability on calculated free testosterone (cFT).MethodsSerum samples from 113 men and 106 women were collected. SHBG levels were measured using three different SHBG immunoassays (Roche, Abbott and Siemens). Testosterone levels were measured using LC-MS/MS. Afterwards, cFT was calculated using the Vermeulen formula and measured directly. SHBG concentrations, and derived cFT concentrations, from different assays were compared. To simulate interlaboratory SHBG variability, measured levels were modified by 15% after which cFT was recalculated using the Vermeulen, Ly, Sartorius and Södergard formulae. The proportions of diagnoses of hypogonadism or hyperandrogenism were compared.ResultsAssessed SHBG assays showed very good conformity. The largest difference was 7%, between the Abbott and Siemens assay. The difference in cFT levels was at most 3% between the Abbott and Siemens assay. Interlaboratory variability affected the proportion of diagnoses depending on the used formula.ConclusionsOur results do not show large differences between SHBG assays and only minor effects on cFT levels. Therefore, SHBG assay choice is not expected to greatly influence clinical decision making. In contrast, interlaboratory variation in SHBG measurements and choice of formula might considerably affect cFT results and their interpretation. |
| Author | Reyns, Tim Narinx, Nick Kaufman, Jean-Marc Lapauw, Bruno Antonio, Leen Keevil, Brian Fiers, Tom Walravens, Joeri Adaway, Joanne Nyamaah, Jennifer Afrakoma |
| Author_xml | – sequence: 1 givenname: Joeri orcidid: 0000-0001-5159-3238 surname: Walravens fullname: Walravens, Joeri organization: Department of Internal Medicine and Pediatrics, Ghent University & Department of Endocrinology, University Hospital Ghent, Ghent, Belgium – sequence: 2 givenname: Joanne orcidid: 0000-0003-4352-3410 surname: Adaway fullname: Adaway, Joanne organization: Department of Clinical Biochemistry, Manchester University Hospital NHS Foundation Trust, Wythenshawe Hospital, Manchester, UK – sequence: 3 givenname: Tim surname: Reyns fullname: Reyns, Tim organization: Department of Clinical Chemistry, University Hospital Ghent, Ghent, Belgium – sequence: 4 givenname: Nick orcidid: 0000-0002-7342-8724 surname: Narinx fullname: Narinx, Nick organization: Laboratory of Clinical and Experimental Endocrinology, KU Leuven Leuven, Belgium – sequence: 5 givenname: Jennifer Afrakoma surname: Nyamaah fullname: Nyamaah, Jennifer Afrakoma organization: Laboratory of Clinical and Experimental Endocrinology, KU Leuven Leuven, Belgium – sequence: 6 givenname: Leen surname: Antonio fullname: Antonio, Leen organization: Laboratory of Clinical and Experimental Endocrinology, KU Leuven Leuven, Belgium – sequence: 7 givenname: Jean-Marc surname: Kaufman fullname: Kaufman, Jean-Marc organization: Department of Internal Medicine and Pediatrics, Ghent University & Department of Endocrinology, University Hospital Ghent, Ghent, Belgium – sequence: 8 givenname: Brian orcidid: 0000-0002-0684-9318 surname: Keevil fullname: Keevil, Brian organization: Department of Clinical Biochemistry, Manchester University Hospital NHS Foundation Trust, Wythenshawe Hospital, Manchester, UK – sequence: 9 givenname: Tom surname: Fiers fullname: Fiers, Tom organization: Department of Clinical Chemistry, University Hospital Ghent, Ghent, Belgium – sequence: 10 givenname: Bruno orcidid: 0000-0002-1584-4965 surname: Lapauw fullname: Lapauw, Bruno organization: Department of Internal Medicine and Pediatrics, Ghent University & Department of Endocrinology, University Hospital Ghent, Ghent, Belgium |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/40500910$$D View this record in MEDLINE/PubMed |
| BookMark | eNpNkEtLxDAQgIOsuA_9AV4kRy_VSZpHe9Rl3RUWPPg4WpJ2gpVuuybpYf-9EVfwNB_Mx_AxczLphx4JuWRww5jWtwAgpMo5lyyXoLQ6ITOmZZExADb5x1MyD-Ez6VwDnJGpAAlQMpiR9zfjW2Pbro0H2vb0eXO_piYEcwjU9A2NH0jROazjD3ocHB16WpuuHjsTsaEYYrtLFGhaOY9IE8chRPQp9pycOtMFvDjOBXl9WL0sN9n2af24vNtmNS9FzCQrlbJWSymdhJyXRghs0IEtpEDDeKnrvEmu1bmSpUIokJmyQSW0NYXjC3L9e3fvh68xBVS7NtTYdabHYQxVzlnBpOIFJPXqqI52h02196nfH6q_n_BvD9xlJQ |
| ContentType | Journal Article |
| DBID | CGR CUY CVF ECM EIF NPM 7X8 |
| DOI | 10.1177/00045632251350676 |
| DatabaseName | Medline MEDLINE MEDLINE (Ovid) MEDLINE MEDLINE PubMed MEDLINE - Academic |
| DatabaseTitle | MEDLINE Medline Complete MEDLINE with Full Text PubMed MEDLINE (Ovid) MEDLINE - Academic |
| DatabaseTitleList | MEDLINE MEDLINE - Academic |
| Database_xml | – sequence: 1 dbid: NPM name: PubMed url: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed sourceTypes: Index Database – sequence: 2 dbid: 7X8 name: MEDLINE - Academic url: https://search.proquest.com/medline sourceTypes: Aggregation Database |
| DeliveryMethod | no_fulltext_linktorsrc |
| Discipline | Medicine Chemistry |
| EISSN | 1758-1001 |
| ExternalDocumentID | 40500910 |
| Genre | Journal Article |
| GroupedDBID | --- .55 .GJ 0R~ 23M 35A 36B 4.4 53G 5GY 5I- 5I. 5RE 5VS 6J9 7X7 88E 88I 8AF 8AO 8CJ 8FE 8FG 8FH 8FI 8FJ 8R4 8R5 AACMV AACTG AAEWN AAGMC AAJIQ AAJOX AAKGS AAQXH AATBZ AAUAS AAWTL AAXOT AAXTJ AAYTG AAZBJ ABDWY ABHKI ABJCF ABJIS ABJZC ABLUO ABPGX ABUJY ABUWG ABVVC ABWRX ACFEJ ACFIC ACFMA ACFYK ACGBL ACGFO ACGFS ACGOD ACGZN ACGZU ACIWK ACJOP ACJTF ACLFY ACLHI ACPRK ACUAV ACXMB ADBBV ADEBD ADMPF ADNBR ADTBJ ADWAY AECGH AECVZ AEDTQ AEKYL AEMJX AENEX AEPTA AEWDL AEWLI AEXFG AFEGE AFFHD AFIEG AFKRA AFKRG AFNTS AGHKR AGPXR AGWFA AHDMH AHMBA AHOKE AI. AIGRN AIIQI AJABX AJEFB AJMMQ AJSCY AJUZI AJXAJ ALKWR ALMA_UNASSIGNED_HOLDINGS AMCVQ AOSDY ARTOV AYAKG AZQEC BBNVY BBRGL BENPR BES BGLVJ BHPHI BKIIM BPACV BPHCQ BVXVI BWJAD CAG CCPQU CF. CGR COF CORYS CQQTX CS3 CUTAK CUY CVF D1I D1J DB0 DC. DC0 DD- DE- DF0 DN0 DO- DWQXO EBS ECM EIF EJD EMOBN F5P FHBDP FYUFA GNUQQ H13 HCIFZ HMCUK HZ~ J5H J8X KB. LK8 M1P M2P M2Q M7P MV1 NPM O9- P.B P.C P2P PDBOC PHGZM PHGZT PJZUB PPXIY PQGLB PQQKQ PROAC PSQYO Q1R Q2X ROL RWL RXW S0X SAUOL SCNPE SFC SHG SPQ SPV TAE TRM UKHRP VH1 WH7 X6Y X7M ZXP 7X8 |
| ID | FETCH-LOGICAL-c294t-51966bb7555f50329a44edef0b854ea1297c3dc29b736596e08e1a9de647ba8f2 |
| IEDL.DBID | 7X8 |
| ISICitedReferencesCount | 0 |
| ISICitedReferencesURI | http://www.webofscience.com/api/gateway?GWVersion=2&SrcApp=Summon&SrcAuth=ProQuest&DestLinkType=CitingArticles&DestApp=WOS_CPL&KeyUT=001506756500001&url=https%3A%2F%2Fcvtisr.summon.serialssolutions.com%2F%23%21%2Fsearch%3Fho%3Df%26include.ft.matches%3Dt%26l%3Dnull%26q%3D |
| ISSN | 1758-1001 |
| IngestDate | Thu Oct 02 22:36:39 EDT 2025 Wed Oct 29 02:16:21 EDT 2025 |
| IsPeerReviewed | true |
| IsScholarly | true |
| Issue | 6 |
| Keywords | SHBG free testosterone immunoassay |
| Language | English |
| LinkModel | DirectLink |
| MergedId | FETCHMERGED-LOGICAL-c294t-51966bb7555f50329a44edef0b854ea1297c3dc29b736596e08e1a9de647ba8f2 |
| Notes | ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23 |
| ORCID | 0000-0002-7342-8724 0000-0002-0684-9318 0000-0003-4352-3410 0000-0002-1584-4965 0000-0001-5159-3238 |
| PMID | 40500910 |
| PQID | 3218156280 |
| PQPubID | 23479 |
| ParticipantIDs | proquest_miscellaneous_3218156280 pubmed_primary_40500910 |
| PublicationCentury | 2000 |
| PublicationDate | 2025-11-01 |
| PublicationDateYYYYMMDD | 2025-11-01 |
| PublicationDate_xml | – month: 11 year: 2025 text: 2025-11-01 day: 01 |
| PublicationDecade | 2020 |
| PublicationPlace | England |
| PublicationPlace_xml | – name: England |
| PublicationTitle | Annals of clinical biochemistry |
| PublicationTitleAlternate | Ann Clin Biochem |
| PublicationYear | 2025 |
| SSID | ssj0002700 |
| Score | 2.4336288 |
| Snippet | BackgroundSerum free testosterone is commonly used as a parameter to evaluate testosterone exposure and is mostly calculated using mathematical approximations.... |
| SourceID | proquest pubmed |
| SourceType | Aggregation Database Index Database |
| StartPage | 493 |
| SubjectTerms | Adult Aged Chromatography, Liquid Female Humans Hyperandrogenism - blood Hyperandrogenism - diagnosis Hypogonadism - blood Hypogonadism - diagnosis Immunoassay - methods Male Middle Aged Sex Hormone-Binding Globulin - analysis Sex Hormone-Binding Globulin - metabolism Tandem Mass Spectrometry Testosterone - blood |
| Title | Variability in SHBG assays and the effect thereof on calculated estimates of free testosterone |
| URI | https://www.ncbi.nlm.nih.gov/pubmed/40500910 https://www.proquest.com/docview/3218156280 |
| Volume | 62 |
| WOSCitedRecordID | wos001506756500001&url=https%3A%2F%2Fcvtisr.summon.serialssolutions.com%2F%23%21%2Fsearch%3Fho%3Df%26include.ft.matches%3Dt%26l%3Dnull%26q%3D |
| hasFullText | |
| inHoldings | 1 |
| isFullTextHit | |
| isPrint | |
| link | http://cvtisr.summon.serialssolutions.com/2.0.0/link/0/eLvHCXMwpZ1LS8NAEMcXtaJefNRXfbGC1-Am2UdyEi3WXloKPujJsEkm0INJbarQb-9MktKTIHgJCXmQ7E52fruzO3_GbrIwTQ1o5YTobhwZm9ix6OYd10oQSLDge1klNmGGw2A8DkfNgFvZTKtctolVQ50WCY2R3_rki9BZB-Ju-umQahRFVxsJjXXW8hFlyKrNeJUt3KuXoKCHpBSmwm2imlXCpYplyJpdX2GLrX8nzMrT9Pb--477bLdhTH5fG8UBW4O8zba7S2m3NtsaNBH1Q_b-hp3lOlf3gk9y_tx_eOII1HZRcpunHPmQ13M-aHcGRcaLnGPF0vxVpFVOWTo-CFg5nspmAHxOYjWUf6HI4Yi99h5fun2n0VxwEi-UcweBTus4NkqpTAnfC62UkEIm4kBJsEgHJvFTvDY2vlahBhGAa8MUtDSxDTLvmG3k-PhTxrW1AfIfrbz1pBIJHphAJ9jhgSCWnumw62UpRvj9FKiwORRfZbQqxw47qasimtbJNyIETEGMc_aHu8_ZjkdyvdXSwQvWyvCPhku2mXzPJ-XsqjIW3A5Hgx98qMbk |
| linkProvider | ProQuest |
| openUrl | ctx_ver=Z39.88-2004&ctx_enc=info%3Aofi%2Fenc%3AUTF-8&rfr_id=info%3Asid%2Fsummon.serialssolutions.com&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=Variability+in+SHBG+assays+and+the+effect+thereof+on+calculated+estimates+of+free+testosterone&rft.jtitle=Annals+of+clinical+biochemistry&rft.au=Walravens%2C+Joeri&rft.au=Adaway%2C+Joanne&rft.au=Reyns%2C+Tim&rft.au=Narinx%2C+Nick&rft.date=2025-11-01&rft.eissn=1758-1001&rft.volume=62&rft.issue=6&rft.spage=493&rft_id=info:doi/10.1177%2F00045632251350676&rft_id=info%3Apmid%2F40500910&rft_id=info%3Apmid%2F40500910&rft.externalDocID=40500910 |
| thumbnail_l | http://covers-cdn.summon.serialssolutions.com/index.aspx?isbn=/lc.gif&issn=1758-1001&client=summon |
| thumbnail_m | http://covers-cdn.summon.serialssolutions.com/index.aspx?isbn=/mc.gif&issn=1758-1001&client=summon |
| thumbnail_s | http://covers-cdn.summon.serialssolutions.com/index.aspx?isbn=/sc.gif&issn=1758-1001&client=summon |