Determination of biological variation of α-fetoprotein and choriogonadotropin (β chain) in disease-free patients with testicular cancer

Trapé, Jaume; Franquesa, Josefina; Sala, María; Domènech, Montserrat; Montesinos, J.; Catot, Sílvia; Buxó, J; Casado, Esther; Fígols, Cristina; Harillo, Sílvia; Galobart, Judit; Bella, M Di

doi:10.1515/cclm.2010.343

Cited by 7 publications

(3 citation statements)

References 11 publications

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“…The TEa was selected based on the biological variation. 5 The results suggested significant variations in the detected values of AFP across different platforms (P , .05).…”

Section: Comparability Of the Analytical Results Of Afpmentioning

confidence: 91%

“…Although analytical performance specifications based on direct or indirect clinical outcomes are highly recommended for the assessment of betweenmethod comparability, these can be affected by current measurement quality, characteristics of the investigated population, and health care setting. 9 Therefore, the desirable TEa value was based on biological variation, which is a more general approach to recommending analytical specifications 5,10 : each instrument platform was compared with 2 times the average CV of the average measured values of all samples on the 5 instrument platforms to assess the comparability of analytical results.…”

Section: Discussionmentioning

confidence: 99%

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Commutability of Reference Materials for α-Fetoprotein in Human Serum

Yue¹,

Zhang²,

Xu³

et al. 2017

Archives of Pathology &Amp; Laboratory Medicine

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- Our results suggested that the Beijing Center for Clinical Laboratories and Beijing Controls and Standards Biotechnology materials were commutable across all 5 instrument platforms, whereas the Bio-Rad quality controls were limited by the concentration of AFP and the instrument platforms used. Caution needs to be taken in using water to dilute the World Health Organization 72/225 reference material because its commutability is limited to high concentrations.

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“…The TEa was selected based on the biological variation. 5 The results suggested significant variations in the detected values of AFP across different platforms (P , .05).…”

Section: Comparability Of the Analytical Results Of Afpmentioning

confidence: 91%

Section: Discussionmentioning

confidence: 99%

Commutability of Reference Materials for α-Fetoprotein in Human Serum

Yue¹,

Zhang²,

Xu³

et al. 2017

Archives of Pathology &Amp; Laboratory Medicine

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“…논문에 수록된 BV값을 선택하였다 [14][15][16][17][18][19][20][21][22][23][24]. 선택된 BV값과 CD값 을 Westgard 홈페이지의 BV 데이터베이스 [6]와 비교하여 Table 2에 정리하였다.…”

Section: Shinae Yu Et Al • CD In Diagnostic Immunoassayunclassified

Establishment of Critical Difference for Diagnostic Immunoassays

Moon

Shin

et al. 2022

J Lab Med Qual Assur

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Background: Critical difference (CD) is a significant difference between sequential laboratory results in a patient and is a major parameter for comparative evaluation of quantitative clinical laboratory tests, and how significant the difference is should be set by the laboratory itself. In this study, we established the criteria for CD that can be referenced in each laboratory for diagnostic immunoassays. Methods: We targeted 17 major diagnostic immunoassays as follows: alphafetoprotein (AFP), cancer antigen 125 (CA125), cancer antigen 15-3 (CA15-3), cancer antigen 19-9 (CA19-9), carcinoembryonic antigen (CEA), prostatespecific antigen (PSA), free PSA, tri-iodothyronine (T3), thyroxine (T4), free T4, thyroglobulin, thyroid-stimulating hormone (TSH), estradiol (E2), folliclestimulating hormone (FSH), luteinizing hormone (LH), testosterone, and prolactin. According to Clinical and Laboratory Standards Institute EP31, we investigated acceptance criteria for CD based on clinical outcomes, clinician's questionnaire, biological variation, published professional recommendations, goals set by accrediting agencies, and general capability in the Korean Association of External Quality Assessment Service. Results: We selected the acceptance criteria for CD as follows: 6.0% for total PSA and TSH based on well-designed clinical study's outcomes; 20.0% for AFP, CA19-9, CEA, and free PSA, 10.0% for T3, 14.3% for T4, 12.5% for free T4, 16.9% for thyroglobulin, 22.2% for E2, 22.9% for FSH, 20.0% for LH, 10.0% for testosterone, and 25.0% for prolactin based on clinician's questionnaire; 8.4% for CA125 and 10.2% for CA15-3 based on general capability. Conclusions: Applying the acceptance criteria for CD from this study may help assess the comparability of the quantitative tests in routine laboratory practice.

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