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The development of decision limits for the GH-2000 detection methodology using additional insulin-like growth factor-I and amino-terminal pro-peptide of type III collagen assays

The development of decision limits for the GH-2000 detection methodology using additional insulin-like growth factor-I and amino-terminal pro-peptide of type III collagen assays
The development of decision limits for the GH-2000 detection methodology using additional insulin-like growth factor-I and amino-terminal pro-peptide of type III collagen assays
The GH-2000 and GH-2004 projects have developed a method for detecting GH misuse based on measuring insulin-like growth factor-I (IGF-I) and the amino-terminal pro-peptide of type III collagen (P-III-NP). The objectives were to analyze more samples from elite athletes to improve the reliability of the decision limit estimates, to evaluate whether the existing decision limits needed revision, and to validate further non-radioisotopic assays for these markers. The study included 998 male and 931 female elite athletes. Blood samples were collected according to World Anti-Doping Agency (WADA) guidelines at various sporting events including the 2011 International Association of Athletics Federations (IAAF) World Athletics Championships in Daegu, South Korea. IGF-I was measured by the Immunotech A15729 IGF-I IRMA, the Immunodiagnostic Systems iSYS IGF-I assay and a recently developed mass spectrometry (LC-MS/MS) method. P-III-NP was measured by the Cisbio RIA-gnost P-III-P, Orion UniQ™ PIIINP RIA and Siemens ADVIA Centaur P-III-NP assays. The GH-2000 score decision limits were developed using existing statistical techniques. Decision limits were determined using a specificity of 99.99% and an allowance for uncertainty because of the finite sample size. The revised Immunotech IGF-I – Orion P-III-NP assay combination decision limit did not change significantly following the addition of the new samples. The new decision limits are applied to currently available non-radioisotopic assays to measure IGF-I and P-III-NP in elite athletes, which should allow wider flexibility to implement the GH-2000 marker test for GH misuse while providing some resilience against manufacturer withdrawal or change of assays
1942-7603
1-11
Holt, Richard I.G.
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Böhning, Walailuck
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Guha, Nishan
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Bartlett, Christiaan
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Cowan, David A.
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Giraud, Sylvain
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Bassett, E. Eryl
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Sönksen, Peter H.
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Böhning, Dankmar
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Holt, Richard I.G.
d54202e1-fcf6-4a17-a320-9f32d7024393
Böhning, Walailuck
e41681ae-1c18-42f9-96d2-e725d47dbeec
Guha, Nishan
1b8c142c-82be-4fd3-be11-90db4270c551
Bartlett, Christiaan
ed9cba27-96ef-419e-824b-fabab5c7cba8
Cowan, David A.
22bdafa8-cee8-481a-97d5-2687fcf325ca
Giraud, Sylvain
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Bassett, E. Eryl
fefd7f16-2045-4700-adaa-7cc6049933a4
Sönksen, Peter H.
e0c748c6-c924-4436-aacd-db754e636833
Böhning, Dankmar
1df635d4-e3dc-44d0-b61d-5fd11f6434e1

Holt, Richard I.G., Böhning, Walailuck, Guha, Nishan, Bartlett, Christiaan, Cowan, David A., Giraud, Sylvain, Bassett, E. Eryl, Sönksen, Peter H. and Böhning, Dankmar (2015) The development of decision limits for the GH-2000 detection methodology using additional insulin-like growth factor-I and amino-terminal pro-peptide of type III collagen assays. Drug Testing and Analysis, 1-11. (doi:10.1002/dta.1772).

Record type: Article

Abstract

The GH-2000 and GH-2004 projects have developed a method for detecting GH misuse based on measuring insulin-like growth factor-I (IGF-I) and the amino-terminal pro-peptide of type III collagen (P-III-NP). The objectives were to analyze more samples from elite athletes to improve the reliability of the decision limit estimates, to evaluate whether the existing decision limits needed revision, and to validate further non-radioisotopic assays for these markers. The study included 998 male and 931 female elite athletes. Blood samples were collected according to World Anti-Doping Agency (WADA) guidelines at various sporting events including the 2011 International Association of Athletics Federations (IAAF) World Athletics Championships in Daegu, South Korea. IGF-I was measured by the Immunotech A15729 IGF-I IRMA, the Immunodiagnostic Systems iSYS IGF-I assay and a recently developed mass spectrometry (LC-MS/MS) method. P-III-NP was measured by the Cisbio RIA-gnost P-III-P, Orion UniQ™ PIIINP RIA and Siemens ADVIA Centaur P-III-NP assays. The GH-2000 score decision limits were developed using existing statistical techniques. Decision limits were determined using a specificity of 99.99% and an allowance for uncertainty because of the finite sample size. The revised Immunotech IGF-I – Orion P-III-NP assay combination decision limit did not change significantly following the addition of the new samples. The new decision limits are applied to currently available non-radioisotopic assays to measure IGF-I and P-III-NP in elite athletes, which should allow wider flexibility to implement the GH-2000 marker test for GH misuse while providing some resilience against manufacturer withdrawal or change of assays

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Accepted/In Press date: 11 December 2014
Published date: 21 January 2015
Organisations: Primary Care & Population Sciences

Identifiers

Local EPrints ID: 379556
URI: http://eprints.soton.ac.uk/id/eprint/379556
ISSN: 1942-7603
PURE UUID: e4c31640-9884-4b6b-8099-685fa8f7071a
ORCID for Richard I.G. Holt: ORCID iD orcid.org/0000-0001-8911-6744
ORCID for Dankmar Böhning: ORCID iD orcid.org/0000-0003-0638-7106

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Date deposited: 23 Jul 2015 12:17
Last modified: 15 Mar 2024 03:39

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Contributors

Author: Walailuck Böhning
Author: Nishan Guha
Author: Christiaan Bartlett
Author: David A. Cowan
Author: Sylvain Giraud
Author: E. Eryl Bassett
Author: Peter H. Sönksen

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