How comparable are total human chorionic gonadotropin (hCGt) tumour markers assays?
-
Carel J. Pretorius
,
Stephen du Toit
Abstract
Background
Total human chorionic gonadotropin (hCGt) tumour marker testing is regarded as an “off label” application for most commercial methods. We compared four assays in patients with a hCGt tumour marker request. We hypothesised that regression slopes would be altered and that outliers would be more common with tumour marker than with pregnancy samples if the detection of malignancy associated hCG molecular forms differed amongst assays. Further such systematic differences would be obvious and large enough to change clinical management decisions.
Results
We measured hCGt in 390 samples from 137 females and 253 males with a tumour marker request and 208 pregnancy controls with the following methods: Access Total βhCG, Architect Total-βhCG, Cobas hCG + β and Immulite HCG. The between method regressions determined on tumour marker and pregnancy samples were not significantly different. The outlier rates were similar for male and female tumour marker and the pregnancy groups: 1.6% (95% confidence interval [CI] 0%–3.1%), 2.2% (95% CI 0%–4.7%) and 2.9% (95% CI 0.6%–5.2%). The outliers were randomly distributed amongst the methods and we were confident that they would not adversely influence clinical decisions.
Conclusions
The hCGt results were clinically equivalent with no systematic difference amongst the four assays.
Author contributions: All the authors have accepted responsibility for the entire content of this submitted manuscript and approved submission.
Research funding: None declared.
Employment or leadership: None declared.
Honorarium: None declared.
Competing interests: The funding organisation(s) played no role in the study design; in the collection, analysis, and interpretation of data; in the writing of the report; or in the decision to submit the report for publication.
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©2020 Walter de Gruyter GmbH, Berlin/Boston
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- Editorial
- Progress in understanding the use of human chorionic gonadotropin as a tumor marker
- Reviews
- Biomarkers for prostate cancer: prostate-specific antigen and beyond
- Gut microbiome investigation in celiac disease: from methods to its pathogenetic role
- Opinion Papers
- Understanding and managing interferences in clinical laboratory assays: the role of laboratory professionals
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- Validation and verification of examination procedures in medical laboratories: opinion of the EFLM Working Group Accreditation and ISO/CEN standards (WG-A/ISO) on dealing with ISO 15189:2012 demands for method verification and validation
- Guidelines and Recommendations
- An updated protocol based on CLSI document C37 for preparation of off-the-clot serum from individual units for use alone or to prepare commutable pooled serum reference materials
- General Clinical Chemistry and Laboratory Medicine
- Highly accurate and explainable detection of specimen mix-up using a machine learning model
- Impact of delta check time intervals on error detection capability
- Effect of long-term frozen storage and thawing of stool samples on faecal haemoglobin concentration and diagnostic performance of faecal immunochemical tests
- A more accurate prediction to rule in and rule out pre-eclampsia using the sFlt-1/PlGF ratio and NT-proBNP as biomarkers
- Macro vitamin B12: an underestimated threat
- Evaluation of the primary biliary cholangitis-related serologic profile in a large cohort of Belgian systemic sclerosis patients
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