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Pearl · 04 of 05

Fixation time matters for breast biomarker testing

When a breast biomarker result looks wrong, check fixation and ischaemia time first.

Established guidance for oestrogen receptor, progesterone receptor and HER2 testing on breast cancer specimens is prompt fixation in 10% neutral buffered formalin for roughly 6 to 72 hours, with the cold ischaemia time recorded. Under-fixation and over-fixation can both cause false-negative or unreliable staining.

If a result does not fit the morphology, check fixation and ischaemia time before repeating or reporting, and record both on the requisition.

  • Fix breast specimens promptly in 10% neutral buffered formalin.
  • Aim for 6 to 72 hours of fixation.
  • Record cold ischaemia and fixation times.
  • Question unexpected negative results against fixation history.

Why it matters

Pre-analytical errors are a common and avoidable cause of discordant biomarker results.

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