What question did this study set out to answer?

To evaluate the effects of an anti-estrogen receptor antibody recall on ER testing in breast cancer.

February 22, 2026

Anti-estrogen receptor (ER) antibody kit product recall audit: a lookback survey of ER staining in breast cancer

Key Points

To evaluate the effects of an anti-estrogen receptor antibody recall on ER testing in breast cancer.
Conducted a lookback survey of ER staining accuracy in biopsy and excision samples after recall issuance.
Analyzed data from >1500 breast core biopsies and >650 excisions.
Monitored the implications of light staining on therapeutic decisions.
Identified risks of false-negative results due to recall of CONFIRM anti-ER antibody.
Highlighted significant reliance on accurate immunohistochemistry for treatment decisions in breast cancer.

Abstract

Accurate estrogen receptor (ER) immunohistochemistry (IHC) is essential for therapeutic decision-making in breast cancer. Monash Medical Centre reports >1500 breast core biopsies (≈75% requiring ER testing) and >650 breast excisions annually (>90% requiring ER testing). In September 2025, the TGA issued a Class II recall for multiple lots of the CONFIRM anti-ER (SP1) rabbit monoclonal antibody due to unacceptable light staining, posing a risk of false-negative or low-positive ER results in weakly staining tumours.

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Anti-estrogen receptor (ER) antibody kit product recall audit: a lookback survey of ER staining in breast cancer

Key Points

Abstract

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