Table 3 Presence of scored elements in analyzed reports versus elements required by guidelines/standards
Element | Present for tissue testing | Present for liquid biopsy testing | Required by Belgian standards (13, 15, 16, 20) | Required by international guidelines (14, 17, 41, 42) | ||
|---|---|---|---|---|---|---|
REPORTS | Visited labs N = 4 | ESP labs N = 86 | G&T labs N = 47 | Visited labs N = 4 | ||
Administrative elements | ||||||
Requesting physician: name | 4 (100%) | 77 (90%) | 47 (100%) | 4 (100%) | ✓ | ✓ |
Requesting physician: address | 4 (100%) | 67 (78%) | 42 (89%) | 4 (100%) | ✓ | ✓ |
Patient: name | 4 (100%) | 79 (92%) | 47 (100%) | 4 (100%) | ✓ | ✓ |
Patient: address | 2 (50%) | 10 (12%) | 1 (2%) | 3 (75%) | ||
Patient: date of birth | 4 (100%) | 78 (91%) | 46 (98%) | 4 (100%) | ✓ | ✓ |
Patient: gender | 4 (100%) | 71 (83%) | 40 (85%) | 4 (100%) | ✓ | |
Name report authorizer | 4 (100%) | 76 (88%) | 40 (85%) | 4 (100%) | ✓ | ✓ |
Signature report authorizer | 3 (75%) | 63 (73%) | 41 (87%) | 3 (75%) | ✓ | |
Request date | 2 (50%) | 48 (56%) | 32 (68%) | 3 (75%) | ✓ | |
Sample collection date | 4 (100%) | 61 (71%) | 46 (98%) | 3 (75%) | ✓ | ✓ |
Sample arrival date | 3 (75%) | 56 (65%) | 45 (96%) | 3 (75%) | ✓ | ✓ |
Report validation date | 4 (100%) | 74 (86%) | 42 (89%) | 3 (75%) | ✓ | ✓ |
Page nr/total pages | 2 (50%) | 55 (64%) | 43 (91%) | 2 (50%) | ✓ | ✓ |
Concise titles of the analysis | 2 (50%) | 55 (64%) | 45 (96%) | 2 (50%) | ✓ | |
Clinical information | ||||||
Patient history | 4 (100%) | 76 (88%) | 44 (94%) | 4 (100%) | ✓ | ✓ |
Planned line of therapy | 0 (0%) | 3 (3%) | 6 (13%) | 2 (50%) | ✓ | |
Reason for testing | 2 (50%) | 68 (79%) | 21 (45%) | 3 (75%) | ✓ | ✓ |
Sample characteristics | ||||||
Sample type | 4 (100%) | 80 (93%) | 38 (81%) | 4 (100%) | ✓ | ✓ |
Sample number | 3 (75%) | 83 (97%) | 46 (98%) | 3 (75%) | ✓ | |
% neoplastic cells | 4 (100%) | 77 (90%) | 46 (98%) | NA | ✓ | |
ml blood analyzed | NA | NA | NA | 1 (25%) | ||
Method description | ||||||
IVD/LDT | 2 (50%) | 16 (19%) | 6 (13%) | 1 (25%) | ✓ | |
DNA extraction method | 1 (25%) | 35 (41%) | 26 (55%) | 3 (75%) | ✓ | |
Variant analysis method | 4 (100%) | 80 (93%) | 47 (100%) | 4 (100%) | ✓ | ✓ |
Pre-analytical conditions | 2 (50%) | 8 (9%) | 2 (4%) | 0 (0%) | ✓ | ✓ |
Sensitivity testing method | 4 (100%) | 69 (80%) | 44 (94%) | 4 (100%) | ✓ | |
Overview alterations tested | 2 (50%) | 79 (92%) | 43 (91%) | 3 (75%) | ✓ | ✓ |
Reference sequence | 2 (50%) | 44 (51%) | 7 (15%) | 1 (25%) | ✓ | ✓ |
Results | ||||||
Mutation status | 4 (100%) | 86 (100%) | 47 (100%) | 4 (100%) | ✓ | ✓ |
Concentration extracted DNA | 0 (0%) | 8 (9%) | 9 (19%) | 1 (25%) | ||
VAF | 1 (25%) | 26 (30%) | 15 (32%) | NA | ||
Disclaimer result validity | 1 (25%) | 1 (1%) | 1 (2%) | 3 (75%) | ||