A manufacturer evaluation has been completed based on the information available thus far.The recommended staining protocol for the estrogen receptor clone 6f11 ready-to-use primary antibody is ihc protocol f, with recommended heat induced epitope retrieval using bond epitope retrieval solution 1 for 20 minutes.The customer information indicates that they are using hier with er2 for 30 minutes instead of the ifu recommendations.The ifu also contains the following information "the clinical interpretation of any positive or negative staining should be evaluated within the context of clinical presentation, morphology and other histopathological criteria.The clinical interpretation of any positive or negative staining should be complemented by morphological studies using proper positive and negative internal and external controls as well as other diagnostic tests." however, information received from the customer confirms that they do not use controls on all sections, only one control per rtu vial, which contains 200 tests.The facts so far, indicate that the estrogen receptor clone 6f11 ready-to-use primary antibody was not used in accordance with the manufacturer recommendations detailed in the instructions for use.Leica biosystems newcastle cannot assess the impact this may or may not have had on the quality of staining of the affected slides.A call is scheduled with the laboratory pathologist to further understand the issue and root cause, further details will be available following this.
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A complaint was received on the 3rd of october regarding false positive staining results.Between september 2022 and june 2023, 63 breast cancer cases were retested as the lab suspected false positive estrogen receptor results.The retesting resulted in a change in the interpretation of 40 cases, from positive to negative or at least a decrease in the % positive nuclei in tumour cells.At the time that this complaint was submitted, based on the initial information received regarding a lack of controls and not following the recommended protocol, it was determined that reporting was not required for this issue.Further information was received on the 11th of december 2023 and it was verified that 2 patients received inappropriate treatment (possibly surgery) on the basis of the results, this additional information triggered the need for reporting.The information received for patient 1 is outlined below: patient 1 born 1987 breast biopsy: grade iii non-specific infiltrative carcinoma, ki-67 80%, initially re60%+ rp- her2 0, er1 er2 controls and other platform: negative "undergoing neoadjuvant chemotherapy and has not had immunotherapy as recommended for this typology.After advice from (b)(6) hospital, we are not adding immunotherapy for the last cycles, because it already has a very good clinical response, and it is possible to have a complete histological response during surgery." medical affairs are due to have a call with the laboratory pathologist to discuss this case and determine root cause, a follow up report will be submitted following the scheduled call.Please note patient 2 details are outlined in 3004859032-2024-00002, and the initial report prior to patient details being available are detailed in 3004859032-2023-00001.
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A call was held on the 11th of january between medical affairs and the laboratory pathologists, no additional information was received regarding patient treatment or safety of the affected patient.The pathologists confirmed that they switched back to dako tests in q4 of 2023 and no longer use pa0009 from leica biosystems.Please note patient 2 details are outlined in 3004859032-2024-00002, and the initial report prior to patient details being available are detailed in 3004859032-2023-00001.
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