Table 2.
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 |