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Practical delta check limits for tumour markers in different clinical settings.
Yu, Shinae; Shin, Kyung-Hwa; Shin, Sunghwan; Lee, Hyeyoung; Yoo, Soo Jin; Jun, Kyung Ran; Shin, Hangsik; Kim, Sollip.
Afiliación
  • Yu S; Department of Laboratory Medicine, Haeundae Paik Hospital, Inje University College of Medicine, Busan, Republic of Korea.
  • Shin KH; Department of Laboratory Medicine and Biomedical Research Institute, Pusan National University Hospital, Busan, Republic of Korea.
  • Shin S; Department of Laboratory Medicine, Ilsan Paik Hospital, Inje University College of Medicine, Goyang, Republic of Korea.
  • Lee H; Department of Laboratory Medicine, International St. Mary's Hospital, College of Medicine, Catholic Kwandong University, Incheon, Republic of Korea.
  • Yoo SJ; Department of Laboratory Medicine, Sanggye Paik Hospital, Inje University College of Medicine, Seoul, Republic of Korea.
  • Jun KR; Department of Laboratory Medicine, Haeundae Paik Hospital, Inje University College of Medicine, Busan, Republic of Korea.
  • Shin H; Department of Digital Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.
  • Kim S; Department of Laboratory Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.
Clin Chem Lab Med ; 61(10): 1829-1840, 2023 09 26.
Article en En | MEDLINE | ID: mdl-36994761
OBJECTIVES: Few studies have reported on delta checks for tumour markers, even though these markers are often evaluated serially. Therefore, this study aimed to establish a practical delta check limit in different clinical settings for five tumour markers: alpha-fetoprotein, cancer antigen 19-9, cancer antigen 125, carcinoembryonic antigen, and prostate-specific antigen. METHODS: Pairs of patients' results (current and previous) for five tumour markers between 2020 and 2021 were retrospectively collected from three university hospitals. The data were classified into three subgroups, namely: health check-up recipient (subgroup H), outpatient (subgroup O), and inpatient (subgroup I) clinics. The check limits of delta percent change (DPC), absolute DPC (absDPC), and reference change value (RCV) for each test were determined using the development set (the first 18 months, n=179,929) and then validated and simulated by applying the validation set (the last 6 months, n=66,332). RESULTS: The check limits of DPC and absDPC for most tests varied significantly among the subgroups. Likewise, the proportions of samples requiring further evaluation, calculated by excluding samples with both current and previous results within the reference intervals, were 0.2-2.9% (lower limit of DPC), 0.2-2.7% (upper limit of DPC), 0.3-5.6% (absDPC), and 0.8-35.3% (RCV99.9%). Furthermore, high negative predictive values >0.99 were observed in all subgroups in the in silico simulation. CONCLUSIONS: Using real-world data, we found that DPC was the most appropriate delta-check method for tumour markers. Moreover, Delta-check limits for tumour markers should be applied based on clinical settings.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Biomarcadores de Tumor / Antígeno Prostático Específico Tipo de estudio: Observational_studies / Risk_factors_studies Límite: Humans / Male Idioma: En Revista: Clin Chem Lab Med Asunto de la revista: QUIMICA CLINICA / TECNICAS E PROCEDIMENTOS DE LABORATORIO Año: 2023 Tipo del documento: Article Pais de publicación: Alemania
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Biomarcadores de Tumor / Antígeno Prostático Específico Tipo de estudio: Observational_studies / Risk_factors_studies Límite: Humans / Male Idioma: En Revista: Clin Chem Lab Med Asunto de la revista: QUIMICA CLINICA / TECNICAS E PROCEDIMENTOS DE LABORATORIO Año: 2023 Tipo del documento: Article Pais de publicación: Alemania