Cross-reactivity in assays for prolactin and optimum screening policy for macroprolactinaemia
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Thomas P. Smith
,
Sinead Kelly
Abstract
Objectives
Macroprolactin cross-reacts in immunoassays for prolactin causing apparent hyperprolactinaemia (macroprolactinaemia) and consequent misdiagnosis and mismanagement of patients.
Methods
We determined the prevalence of macroprolactinaemia using prolactin immunoassays with reported “high” (Tosoh) or “low” cross-reactivity (Roche) with macroprolactin. We additionally modelled the effects of increasing the screening threshold on workload and sensitivity in the detection of macroprolactinaemia.
Results
A review of routine requests for prolactin received in a 12 month period identified 670 sera with hyperprolactinaemia (Tosoh assay). Treatment with polyethylene glycol (PEG) precipitation demonstrated normal levels of monomeric prolactin in 165 sera (24.6%) indicating macroprolactinaemia. In the macroprolactinaemic cohort, total prolactin levels were lower with the Roche assay (473 ± 132 mU/L; mean ± SD) compared to the Tosoh assay (683 ± 217 mU/L), p < 0.005. The prevalence of macroprolactinaemia was also lower with the Roche assay (6.2%). The number of samples that required screening for macroprolactinaemia fell by 14% when Roche gender specific total prolactin reference limits were applied. Use of a higher screening threshold (700 mU/L) reduced the screening workload considerably (Roche by 45%, Tosoh by 37%) however, the sensitivity of detection of macroprolactinaemia decreased markedly (Roche 90%, Tosoh 59%).
Conclusions
Macroprolactin interferes in both Tosoh and Roche prolactin immunoassays. Use of an assay with a relatively low cross reactivity with macroprolactin, e.g. Roche, will lead to a modest reduction in the screening workload. Increasing the screening threshold above the upper limit of the assay reference interval will also reduce the screening workload but leads to disproportionate increases in the number of cases of macroprolactinaemia which are missed.
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Research funding: Some reagents for this study were kindly provided by Roche Diagnostics.
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Author contributions: All authors have accepted responsibility for the entire content of this manuscript and approved its submission.
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Competing interests: Authors state no conflict of interest.
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Informed consent: Not Applicable.
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Ethical approval: Approval for this study was obtained from the Research Ethics Committee, St. Vincent’s University Hospital.
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© 2022 Walter de Gruyter GmbH, Berlin/Boston
Artikel in diesem Heft
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- Editorials
- Clinical Chemistry and Laboratory Medicine: enjoying the present and assessing the future
- Rethinking internal quality control: the time is now
- Review
- Multi-omics analysis from archival neonatal dried blood spots: limitations and opportunities
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- ‘Penelope test’: a practical instrument for checking appropriateness of laboratory tests
- Interference by macroprolactin in assays for prolactin: will the In Vitro Diagnostics Regulation lead to a solution at last?
- EFLM Paper
- Efficiency, efficacy and subjective user satisfaction of alternative laboratory report formats. An investigation on behalf of the Working Group for Postanalytical Phase (WG-POST), of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM)
- General Clinical Chemistry and Laboratory Medicine
- Cross-reactivity in assays for prolactin and optimum screening policy for macroprolactinaemia
- Repository of intra- and inter-run variations of quantitative autoantibody assays: a European multicenter study
- Stability of direct renin concentration and plasma renin activity in EDTA whole blood and plasma at ambient and refrigerated temperatures from 0 to 72 hours
- Comparison of four different immunoassays and a rapid isotope-dilution liquid chromatography-tandem mass spectrometry assay for serum folate
- Analytical quality specifications in semen analysis according to the state of the current methodologies
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Artikel in diesem Heft
- Frontmatter
- Editorials
- Clinical Chemistry and Laboratory Medicine: enjoying the present and assessing the future
- Rethinking internal quality control: the time is now
- Review
- Multi-omics analysis from archival neonatal dried blood spots: limitations and opportunities
- Opinion Papers
- ‘Penelope test’: a practical instrument for checking appropriateness of laboratory tests
- Interference by macroprolactin in assays for prolactin: will the In Vitro Diagnostics Regulation lead to a solution at last?
- EFLM Paper
- Efficiency, efficacy and subjective user satisfaction of alternative laboratory report formats. An investigation on behalf of the Working Group for Postanalytical Phase (WG-POST), of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM)
- General Clinical Chemistry and Laboratory Medicine
- Cross-reactivity in assays for prolactin and optimum screening policy for macroprolactinaemia
- Repository of intra- and inter-run variations of quantitative autoantibody assays: a European multicenter study
- Stability of direct renin concentration and plasma renin activity in EDTA whole blood and plasma at ambient and refrigerated temperatures from 0 to 72 hours
- Comparison of four different immunoassays and a rapid isotope-dilution liquid chromatography-tandem mass spectrometry assay for serum folate
- Analytical quality specifications in semen analysis according to the state of the current methodologies
- Reference Values and Biological Variations
- Short-term biological variation study of plasma hemophilia and thrombophilia parameters in a population of apparently healthy Caucasian adults
- First morning voided urinary gonadotropins in children: verification of method performance and establishment of reference intervals
- Derivation of sex and age-specific reference intervals for clinical chemistry analytes in healthy Ghanaian adults
- Cancer Diagnostics
- Serum free light chain analysis: persisting limitations with new kids on the block
- Cardiovascular Diseases
- Age partitioned and continuous upper reference limits for Ortho VITROS High Sensitivity Troponin I in a healthy paediatric cohort
- The predictive value of hemoglobin to creatinine ratio for contrast-induced nephropathy in percutaneous coronary interventions
- Infectious Diseases
- Health technology assessment to employ COVID-19 serological tests as companion diagnostics in the vaccination campaign against SARS-CoV-2
- Evaluation of a laboratory-based high-throughput SARS-CoV-2 antigen assay
- Presepsin levels in neonatal cord blood are not influenced by maternal SARS-CoV-2 infection
- Letters to the Editors
- How to evaluate fixed clinical QC limits vs. risk-based SQC strategies
- Reply to Westgard et al.: ‘Keep your eyes wide … as the present now will later be past’*
- Platelet phagocytosis by monocytes
- Early detection of Candida parapsilosis in peripheral blood as a result of a peripheral blood smear performed after cytographic changes on the Beckman Coulter UniCel DxH 800 hematology
- Pseudo-erythroblastosis on Sysmex XN hematology analyzers: a clue to Candida sepsis. Case report and literature review
- Covert poisoning with difenacoum: diagnosis and follow-up difficulties
- Comparison of Sebia Capillarys 3-OCTA with the Tosoh Bioscience HLC®-723G8 method for A1C testing with focus on analytical interferences and variant detection
