Table 1:
Pre-analytical, analytical and post-analytical aspects of PD-L1 testing stratified by region
| Region | North America | Central & South America | Europe | Asia | Oceania | Africa and Middle East | World | |
|---|---|---|---|---|---|---|---|---|
| n=83 | n=25 | n=140 | n=61 | n=13 | n=22 | Comparison test | n=344 | |
|
| ||||||||
| PD-L1 testing status* | n=83 | n=20 | n=139 | n=59 | n=13 | n=20 | p†<0.0001 | n=334 |
| In house | 62 (75%) | 17 (85%) | 134 (96%) | 56 (95%) | 13 (100%) | 18 (90%) | 300 (90%) | |
| Send out | 21 (25%) | 3 (15%) | 5 (4%) | 3 (5%) | 0 | 2 (10%) | 34 (10%) | |
|
| ||||||||
| No. of sample types** | n=83 | n=20 | n=138 | n=59 | n=13 | n=19 | p†<0.0001 | n=332 |
| 1 | 2 (3%) | 5 (25%) | 5 (4%) | 5 (9%) | 1 (8%) | 6 (32%) | 24 (7%) | |
| 2 | 11 (13% | 11 (55%) | 21 (15%) | 22 (37%) | 1 (8%) | 1 (5%) | 67 (20%) | |
| 3 or more | 70 (84%) | 4 (20%) | 112 (81%) | 32 (54%) | 11 (84%) | 12 (63%) | 241 (73%) | |
| Sample types used** | ||||||||
| Biopsy | 80 (96%) | 20 (100%) | 138 (100%) | 57 (97%) | 13 (100%) | 16 (84%) | p†<0.0001 | 324 (98%) |
| Surgical | 80 (96%) | 15 (75%) | 128 (91%) | 55 (93%) | 11 (85%) | 16 (84%) | p†<0.0001 | 305 (92%) |
| Cell blocks | 73 (88%) | 4 (20%) | 116 (84%) | 32 (54%) | (92%) | 12 (63%) | p†<0.0001 | 249 (75%) |
| Cytology smear | 7 (8.4%) | 0 | 22 (16%) | 4 (6.8%) | 0 | 0 | 36 (11%) | |
|
| ||||||||
| Platform** | n=57 | n=19 | n=133 | n=54 | n=13 | n=18 | p†=0.07 | n=294 |
| Ventana | 31 (54%) | 14 (74%) | 95 (71%) | 42 (78%) | 10 (77%) | 9 (50%) | p†=0.10 | 201 (68%) |
| Dako | 29 (51%) | 10 (53%) | 48 (36%) | 35 (65%) | 1 (8%) | 10 (56%) | p†<0.0001 | 133 (45%) |
| Leica | 13 (23%) | 1 (5%) | 23 (17%) | 14 (26%) | 4 (31%) | 1 (6%) | p†=0.19 | 56 (19%) |
|
| ||||||||
| External QA** | n=59 | n=16 | n=134 | n=56 | n=13 | n=18 | p†=0.54 | n=296 |
| No | 8 (14%) | 5 (31%) | 23 (17%) | 11 (20%) | 1 (8%) | 4 (22%) | 52 (18%) | |
| Yes | 51 (86%) | 11 (69%) | 111 (83%) | 45 (80%) | 12 (92%) | 14 (78%) | 244 (82%) | |
| If Yes, | ||||||||
| Interlab validation | 28 (47%) | 6 (38%) | 39 (29%) | 29 (52%) | 5 (38%) | 7 (39%) | p†=0.04 | 114 (39%) |
| Formal external QA | 34 (58%) | 7 (44%) | 97 (72%) | 30 (54%) | 10 (77%) | 9 (50%) | p†=0.02 | 187 (63%) |
| Other | 2 (3%) | 1 (6%) | 2 (1 %) | 2 (4%) | 2 (15%) | 0 | p†=0.11 | 9 (3%) |
|
| ||||||||
| Training** | n=75 | n=21 | n=139 | n=60 | n=13 | n=21 | p†<0.0001 | n=329 |
| No | 23 (31%) | 5 (36%) | 9 (6%) | 8 (13%) | 0 | 7 (33%) | 52 (16%) | |
| Yes | 52 (69%) | 16 (64%) | 130 (94%) | 52 (87%) | 13 (100%) | 14 (67%) | 277 (84%) | |
| If yes, organized by | p†=0.02 | |||||||
| Companies | 28 (54%) | 10 (63%) | 91 (70%) | 43 (83%) | 11 (84%) | 8 (58%) | 191 (69%) | |
| IASLC | 5 (10%) | 2 (12%) | 11 (8%) | 7 (13%) | 1 (8%) | 3 (21%) | 29 (10%) | |
| Other societies | 19 (37%) | 4 (25%) | 28 (22%) | 2 (4%) | 1 (8%) | 3 (21%) | 57 (21%) | |
|
| ||||||||
| Guidelines used** | n=73 | n=21 | n=140 | n=59 | n=13 | n=20 | p†=0.07 | n=326 |
| No | 4 (5%) | 0 | 3 (2%) | 1 (2%) | 1 (8%) | 3 (15%) | 12 (4%) | |
| Yes | 69 (95%) | 21 (100%) | 137 (98%) | 58 (98%) | 12 (92%) | 17 (85%) | 314 (96%) | |
| If yes, | ||||||||
| Local or national | 53 (73%) | 5 (24%) | 95 (68%) | 36 (61%) | 7 (54%) | 6 (30%) | p†<0.0001 | 202 (62%) |
| IASLC | 26 (36%) | 18 (86%) | 78 (56%) | 34 (58%) | 9 (69%) | 15 (75%) | p†<0.0001 | 180 (55%) |
|
| ||||||||
| TAT** | p‡=0.0002 | |||||||
| Median | 1 –2 days | 2–3 days | 1 –2 days | 2–3 days | 1–2 days | 3–4 days | 1 –2 days | |
| Range | [1 ; ≤5] | [1 ; ≤5] | [1 ; ≤5] | [1 ; ≤5] | [1 ; ≤5] | [1 ; ≤5] | [1 ; ≤5] | |
|
| ||||||||
| Standardized report** | n=79 | n=19 | n=138 | n=58 | n=13 | n=18 | p†=0.53 | |
| No | 8 (10%) | 2 (11%) | 23 (17%) | 6 (10%) | 1 (8%) | 4 (22%) | 44 (14%) | |
| Yes | 71 (90%) | 17 (89%) | 115 (83%) | 52 (90%) | 12 (92%) | 14 (78%) | 281 (86%) | |
p†: Х2 or Fisher exact bilateral test; p‡: Mann-Whitney test; QA: quality assurance; TAT: turn-around time;
*
the numbers indicate participants whose lab offered clinical PD-L1 immunohistochemistry assessment;
**
the numbers indicate those of participants who responded to the specific question.