2005
DOI: 10.1373/clinchem.2004.046086
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Biological Variation of Total Prostate-Specific Antigen: A Survey of Published Estimates and Consequences for Clinical Practice

Abstract: Background:The objectives of this study were to determine whether a single result for total prostate-specific antigen (tPSA) can be used confidently to guide the need for prostate biopsy and by how much serial tPSA measurements must differ to be significant. tPSA measurements include both analytical and biological components of variation. The European Group on Tumor Markers conducted a literature survey to determine both the magnitude and impact of biological variation on single, the mean of replicate, and ser… Show more

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Cited by 120 publications
(88 citation statements)
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“…In screening studies [4,6] or studies using stored sera [3,14] in which PSA samples are taken annually or biannually, the PSAV calculated by AE will be similar to that of LR. However, regular time intervals between PSA tests may not occur in clinical practice, particularly given recent recommendations to repeat an abnormal PSA before proceeding with invasive investigations [16,17]. In this population-based study, only 11.6% of men had at least 9 mo between each PSA, limiting the widespread usefulness of PSAV if strict time constraints are applied.…”
Section: Discussionmentioning
confidence: 96%
See 1 more Smart Citation
“…In screening studies [4,6] or studies using stored sera [3,14] in which PSA samples are taken annually or biannually, the PSAV calculated by AE will be similar to that of LR. However, regular time intervals between PSA tests may not occur in clinical practice, particularly given recent recommendations to repeat an abnormal PSA before proceeding with invasive investigations [16,17]. In this population-based study, only 11.6% of men had at least 9 mo between each PSA, limiting the widespread usefulness of PSAV if strict time constraints are applied.…”
Section: Discussionmentioning
confidence: 96%
“…Short-term variations in PSA are common [3,16,17] and, although factors such as infection and prostatic manipulation can artificially increase the PSA value [18], there is also an inherent biologic variability of PSA. A recent systematic review including 12 studies that examined PSA variability estimated the mean variation between tests to be 20% ($33% at 95% confidence interval) [17]. A true PSA of 4.5 ng/ml may therefore produce measured PSA results ranging from 3.0-6.0 ng/ml.…”
Section: Discussionmentioning
confidence: 99%
“…Finally, studies have shown that in patients with prostatic disease, there can be a 20-60% variability between PSA measurements. 2,30 Due to these potential sources of error, it is important to adhere to the National Academy of Clinical Biochemistry guidelines for the measurement of tumor markers. 2 These guidelines recommend that laboratories be aware of the possibility of analytical interferences, and that assay interferences should be considered whenever a tumor marker result does not agree with a patient's clinical picture.…”
Section: Discussionmentioning
confidence: 99%
“…by Söletormos et al [10] on behalf of the European Group on Tumor Markers. The CV I values from 13 studies varied between 2.1% and 22.9%.…”
Section: New Concept For Defining Permissible Performance Criteriamentioning
confidence: 99%