TY - JOUR
T1 - Critical review and meta-analysis of biological variation estimates for tumor markers
AU - Marques-Garcia, Fernando
AU - Boned, Beatriz
AU - González-Lao, Elisabet
AU - Braga, Federica
AU - Carobene, Anna
AU - Coskun, Abdurrahman
AU - Díaz-Garzón, Jorge
AU - Fernández-Calle, Pilar
AU - Perich, Maria Carmen
AU - Simon, Margarida
AU - Jonker, Niels
AU - Aslan, Berna
AU - Bartlett, William Alexander
AU - Sandberg, Sverre
AU - Aarsand, Aasne K.
AU - Task Group for the Biological Variation Database
N1 - © 2022 Walter de Gruyter GmbH, Berlin/Boston.
PY - 2022/3/4
Y1 - 2022/3/4
N2 - Objectives: Biological variation data (BV) can be used for different applications, but this depends on the availability of robust and relevant BV data. In this study, we aimed to summarize and appraise BV studies for tumor markers, to examine the influence of study population characteristics and concentrations on BV estimates and to discuss the applicability of BV data for tumor markers in clinical practice.Methods: Studies reporting BV data for tumor markers related to gastrointestinal, prostate, breast, ovarian, haematological, lung, and dermatological cancers were identified by a systematic literature search. Relevant studies were evaluated by the Biological Variation Data Critical Appraisal Checklist (BIVAC) and meta-analyses were performed for BIVAC compliant studies to deliver global estimates of within-subject (CVI) and between-subject (CVG) BV with 95% CI.Results: The systematic review identified 49 studies delivering results for 22 tumor markers; four papers received BIVAC grade A, 3 B, 27 C and 15 D. Out of these, 29 CVI and 29 CVG estimates met the criteria to be included in the meta-analysis. Robust data are lacking to conclude on the relationship between BV and different disease states and tumor marker concentrations.Conclusions: This review identifies a lack of high-quality BV studies for many tumor markers and a need for delivery of BIVAC compliant studies, including in different, disease states and tumor marker concentrations. As of yet, the state-of-the-art may still be the most appropriate model to establish analytical performance specifications for the majority of tumor markers.
AB - Objectives: Biological variation data (BV) can be used for different applications, but this depends on the availability of robust and relevant BV data. In this study, we aimed to summarize and appraise BV studies for tumor markers, to examine the influence of study population characteristics and concentrations on BV estimates and to discuss the applicability of BV data for tumor markers in clinical practice.Methods: Studies reporting BV data for tumor markers related to gastrointestinal, prostate, breast, ovarian, haematological, lung, and dermatological cancers were identified by a systematic literature search. Relevant studies were evaluated by the Biological Variation Data Critical Appraisal Checklist (BIVAC) and meta-analyses were performed for BIVAC compliant studies to deliver global estimates of within-subject (CVI) and between-subject (CVG) BV with 95% CI.Results: The systematic review identified 49 studies delivering results for 22 tumor markers; four papers received BIVAC grade A, 3 B, 27 C and 15 D. Out of these, 29 CVI and 29 CVG estimates met the criteria to be included in the meta-analysis. Robust data are lacking to conclude on the relationship between BV and different disease states and tumor marker concentrations.Conclusions: This review identifies a lack of high-quality BV studies for many tumor markers and a need for delivery of BIVAC compliant studies, including in different, disease states and tumor marker concentrations. As of yet, the state-of-the-art may still be the most appropriate model to establish analytical performance specifications for the majority of tumor markers.
KW - biological variation
KW - critical review
KW - meta-analysis
KW - tumor marker
UR - http://www.scopus.com/inward/record.url?scp=85124817530&partnerID=8YFLogxK
U2 - 10.1515/cclm-2021-0725
DO - 10.1515/cclm-2021-0725
M3 - Review article
C2 - 35143717
SN - 1434-6621
VL - 60
SP - 494
EP - 504
JO - Clinical Chemistry and Laboratory Medicine (CCLM)
JF - Clinical Chemistry and Laboratory Medicine (CCLM)
IS - 4
ER -
