Table 3.

Recommended data in a report on ALK testing by in situ hybridization

Clinical information
Patient identification
Identification of doctor making request
Dates of request and test
Identification of sample (case and block number)
Type of samplea
Anatomical origin
Gross specimen handling/molecular method
Date block received by laboratory
Block used for analysis
Probe used (supplier, approval by FDA or other agency)
Method of assessment (semi-quantitative, image analysis)
Threshold for positivity
Microscopy/molecular results
Number of nuclei assessed
Results
Positive (%)
Presence or absence of patterns indicating rearrangement (specify whether split or single)
Negative (% of translocated cells, if any)
Presence or absence of patterns indicating rearrangement
Inconclusive: Explanations for inconclusive answersb
Conclusion
Molecular test outcome and interpretation
Rearrangement associated with sensitivity
Name and signature of the pathologist(s) responsible for the investigation

^aFor example, bronchial–transbronchial biopsy, surgical specimen, core needle biopsy, transbronchial fine needle aspiration, effusion cytology or other

^bFor example, possible false-negatives due to low fraction of tumour cells or uncertain fixation time