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. 2023 Aug 4;42:193. doi: 10.1186/s13046-023-02743-9

Table 2.

Recommendation for a structured report

Clinical Data

- cancer diagnosis

- disease stage

- treatment at time of acquisition

Timing

- data (dd/mm) and time (hh/mm) of blood sample

- data (dd/mm) and time (hh/mm) of plasma separation

Tubes used

- K2/K3EDTA-containing tubes

- specialized blood collection tubes containing preservative agent

Result

- variants detected related to the clinical request

- VAF for each variants detected

- if a variant is not detected should be reported as “non-informative” or “not detected” rather than “negative”

Potential germline variants Potential pathogenic germline variants in genes associated with heritable cancer predisposition should be flagged with an alert for the clinician
Variants potentially associated with CHIP Variant identified in ctDNA assay is assumed to be present in the tumour but could be derived from leukocytes
Variant allele fractions for quantitative assays Variant type and/or genomic features detected by assay SNVs, small insertions/deletions, amplifications, copy number losses, gene fusions, MSI, TMB and LOH
Technology used for analysis

- Q-PCR

- dd-PCR

- Mass Spettrometry

- NSG

Kits used for the analysis IVD or IVD-R certificated kits should be used
Limit of detection In cases where input plasma DNA is limiting, a warning should be inserted in the report
Assay limitations ctDNA results have an amount of discordance with tumour testing. The report should communicate this potential discordance