Pre-Analytic Guidelines: Specimen Handling Requirements

Need multiple seats for your university or lab? Get a quote
The page below is a sample from the LabCE course HER2 Testing in Breast Cancer. Access the complete course and earn ASCLS P.A.C.E.-approved continuing education credits by subscribing online.

Learn more about HER2 Testing in Breast Cancer (online CE course)
Pre-Analytic Guidelines: Specimen Handling Requirements

The HER2 clinical practice guidelines from CAP/ASCO apply to all IHC and FISH methodologies.
  • Rapid immersion of specimens in fixative is critical, and must occur within one hour of the biopsy or resection.
  • Excisional specimens should be fixed in 10% neutral buffered formalin (NBF) for 6 – 72 hours at room temperature.
  • For cases with negative HER2 results by IHC that were fixed outside these limits, confirmatory analysis by ISH is strongly recommended.
  • If HER2 FISH results are negative, and the fixation time is known to be longer or shorter, this should be noted.
  • If alternative fixative is used, the fixative must be validated against results for the same specimens fixed in 10% NBF.
  • The tissue handling requirements must be standardized and reported on every specimen.
  • If an alternative fixative is used, the laboratory's director is responsible for test performance.