A Macroprolactin Level Today May Keep Health Care Cost and the Surgical Knife at Bay

Henry, R; Bowden, Sasigarn A

doi:10.1177/0009922814529017

Clin Pediatr (Phila)

2014

DOI: 10.1177/0009922814529017

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A Macroprolactin Level Today May Keep Health Care Cost and the Surgical Knife at Bay

R Henry

Sasigarn A Bowden

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2022

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“…A PEG precipitation procedure has been validated for the detection of macroprolactinaemia by comparison with the reference gel filtration chromatography technique [14]. However, individual cases of macroprolactinaemia and case series continue to be reported indicating that laboratory testing for macroprolactinaemia is not universal and that interference by macroprolactin in prolactin assays remains a problem and continues to cause clinical confusion [15][16][17]. It is therefore important to consider what more could be done by all parties involved to solve the problem.…”

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confidence: 99%

Interference by macroprolactin in assays for prolactin: will the In Vitro Diagnostics Regulation lead to a solution at last?

Fahie-Wilson¹,

Cobbaert

Horvath

et al. 2022

Clinical Chemistry and Laboratory Medicine (CCLM)

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Cross reactivity with high molecular weight complexes of prolactin known as macroprolactin is a common cause of positive interference in assays for serum prolactin. All prolactin assays currently available are affected with 5–25% of results indicating hyperprolactinaemia falsely elevated due to macroprolactinaemia – hyperprolactinaemia due to macroprolactin with normal concentrations of bioactive monomeric prolactin. Macroprolactinaemia has no pathological significance but, if it is not recognised as the cause, the apparent hyperprolactinaemia can lead to clinical confusion, unnecessary further investigations, inappropriate treatment and waste of healthcare resources. Macroprolactinaemia cannot be distinguished from true hyperprolactinaemia on clinical grounds alone but can be detected by a simple laboratory test based on the precipitation of macroprolactin with polyethylene glycol. Laboratory screening of all cases of hyperprolactinaemia to exclude macroprolactinaemia has been advised as best practice but has not been implemented universally and reports of clinical confusion caused by macroprolactinaemia continue to appear in the literature. Information provided by manufacturers to users of assays for prolactin regarding interference by macroprolactin is absent or inadequate and does not comply with the European Union Regulation covering in vitro diagnostic medical devices (IVDR). As the IVDR is implemented notified bodies should insist that manufacturers of assays for serum prolactin comply with the regulations by informing users that macroprolactin is a source of interference which may have untoward clinical consequences and by providing an estimate of the magnitude of the interference and a means of detecting macroprolactinaemia. Laboratories should institute a policy for excluding macroprolactinaemia in all cases of hyperprolactinaemia.

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mentioning

confidence: 99%

Interference by macroprolactin in assays for prolactin: will the In Vitro Diagnostics Regulation lead to a solution at last?

Fahie-Wilson¹,

Cobbaert

Horvath

et al. 2022

Clinical Chemistry and Laboratory Medicine (CCLM)

View full text Add to dashboard Cite

show abstract

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A Macroprolactin Level Today May Keep Health Care Cost and the Surgical Knife at Bay

Cited by 1 publication

References 11 publications

Interference by macroprolactin in assays for prolactin: will the In Vitro Diagnostics Regulation lead to a solution at last?

Interference by macroprolactin in assays for prolactin: will the In Vitro Diagnostics Regulation lead to a solution at last?

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