Figure 1
Flow chart of the study.
Table 1
Quality Control–POCT Atellica® vTLi.
| LEVEL 1 (13.0–29.1 ng/L) | |||||
|---|---|---|---|---|---|
| ng/L | First | Second | Third | Fourth | Fifth |
| Rep 1 | 18.2 | 19.0 | 17.6 | 19.6 | 19.9 |
| Rep 2 | 17.7 | 16.8 | 14.2 | 17.5 | 16.0 |
| Rep 3 | 16.3 | 17.2 | 15.6 | 16.8 | 15.5 |
| Rep 4 | 17.7 | 17.3 | 16.9 | 16.8 | 16. |
| Rep 5 | 16.9 | 17.0 | 15.6 | 17.9 | 15.6 |
| LEVEL 2 (22.6–51.5 ng/L) | |||||
| ng/L | First | Second | Third | Fourth | Fifth |
| Rep 1 | 30.5 | 30.4 | 32.2 | 26.7 | 31.3 |
| Rep 2 | 28.8 | 26.5 | 23.5 | 29.0 | 27.3 |
| Rep 3 | 32.6 | 31.2 | 29.1 | 29.0 | 22.8 |
| Rep 4 | 30.3 | 26.9 | 30.1 | 28.4 | 27.9 |
| Rep 5 | 30.2 | 28.2 | 24.2 | 27.3 | 27.6 |
| LEVEL 3 (238–499 ng/L) | |||||
| ng/L | First | Second | Third | Fourth | Fifth |
| Rep 1 | 288 | 264 | 258 | 335 | 284 |
| Rep 2 | 291 | 290 | 307 | 268 | 264 |
| Rep 3 | 290 | 252 | 289 | 305 | 288 |
| Rep 4 | 315 | 292 | 267 | 277 | 284 |
| Rep 5 | 292 | 291 | 256 | 284 | 271 |
[i] CV (Coefficient of variation): CV Level 1 = 7.5%; CV Level 2 = 8.7%; CV Level 3 = 6.7%.
Rep: replicate.
Table 2
Correlations between the assays, group of control samples (first phase).
| ASSAYS | R | P |
|---|---|---|
| Plasma POCT – VLTi a × Serum Cobas, troponin <5.0 | 0.462 | 0.009 |
| Plasma POCT – VLTia × Serum Cobas, troponin >5.0 | 0.645 | <0.0001 |
| Plasma POCT – VLTi a × Serum Cobas, troponin <52.0 | 0.526 | <0.0001 |
| Plasma POCT – VLTia × Serum Cobas, troponin >52.0 | 0.558 | 0.001 |
[i] r: Pearson correlation.
Table 3
Clinical parameters from the patients with chest pain, second phase of the study.
| VARIABLE | VALUES |
|---|---|
| Age, mean (SD) | 61 (16) |
| Sex, male (%) | 76 |
| Systemic Arterial Hypertension (%) | 60 |
| Diabetes Mellitus (%) | 35 |
| Dyslipidemia (%) | 53 |
| Smoking (%) | 0 |
| Previous Acute Myocardial Infarction (%) | 10 |
| Heart Score 1 point (n) | 6 |
| Heart Score 2 points (n) | 7 |
| Heart Score 3 points (n) | 11 |
| Heart Score 4 points (n) | 9 |
| Heart Score 5 points (n) | 8 |
| Heart Score 6 points (n) | 4 |
| Heart Score 7 points (n) | 2 |
| Heart Score 8 points (n) | 3 |
| Heart Score 9 points (n) | 1 |
Table 4
Rule in and Rule out from the patients of phase 2.
| PATIENT | POCT VLTia T0 | POCT VLTia T1 | Plasma COBAS T0 | Plasma COBAS T1 | RULE IN | RULE OUT |
|---|---|---|---|---|---|---|
| 1 | 7 | 8 | 5 | 4 | X–Y | |
| 2 | 16 | 17 | 5 | 5 | X–Y | |
| 3 | 37 | 34 | 41 | 38 | X–Y | |
| 4 | 3 | 3 | 8 | 8 | X–Y | |
| 5 | 6 | 10 | 4 | 4 | X–Y | |
| 6 | 2 | 4 | 3 | 3 | X–Y | |
| 7 | 4 | 5 | 5 | 5 | X–Y | |
| 8 | 9 | 9 | 14 | 16 | X–Y | |
| 9 | 6 | 4 | 8 | 5 | X–Y | |
| 10 | 7 | 10 | 34 | 32 | X–Y | |
| 11 | 7 | 6 | 6 | 5 | X–Y | |
| 12 | 3 | 4 | 13 | 15 | X–Y | |
| 13* | 35 | 49 | 36 | 35 | X | Y |
| 14 | 13 | 14 | 9 | 9 | X–Y | |
| 15 | 8 | 9 | 27 | 28 | X–Y | |
| 16 | 3 | 3 | 28 | 33 | X–Y | |
| 17 | 47 | 43 | 12 | 12 | X–Y | |
| 18 | 4 | 5 | 6 | 6 | X–Y | |
| 19 | 2 | 1 | 12 | 11 | X–Y | |
| 20 | 4 | 5 | 3 | 4 | X–Y | |
| 21 | 11 | 10 | 7 | 7 | X–Y | |
| 22 | 5 | 7 | 3 | 4 | X–Y | |
| 23 | 5 | 5 | 23 | 26 | X–Y | |
| 24 | 48 | 177 | 40 | 123 | X–Y | |
| 25 | 1250 | 1250 | 249 | 275 | X–Y | |
| 26 | 4 | 5 | 13 | 12 | X–Y | |
| 27 | 6 | 6 | 7 | 7 | X–Y | |
| 28 | 13 | 11 | 14 | 12 | X–Y | |
| 29 | 6 | 5 | 19 | 17 | X–Y | |
| 30 | 6 | 3 | 6 | 7 | X–Y | |
| 31 | 15 | 14 | 45 | 44 | X–Y | |
| 32 | 12 | 81 | 49 | 67 | X–Y | |
| 33 | 5 | 9 | 9 | 14 | X–Y | |
| 34 | 100 | 462 | 86 | 185 | X- Y | |
| 35 | 11 | 9 | 3 | 3 | X–Y | |
| 36 | 49 | 52 | 45 | 38 | X–Y | |
| 37 | 15 | 15 | 15 | 15 | X–Y | |
| 38 | 3 | 3 | 5 | 6 | X–Y | |
| 39 | 7 | 6 | 7 | 6 | X–Y | |
| 40 | 10 | 8 | 22 | 21 | X–Y | |
| 41 | 4 | 6 | 4 | 4 | X–Y | |
| 42 | 14 | 14 | 19 | 18 | X–Y | |
| 43 | 3 | 5 | 8 | 7 | X–Y | |
| 44 | 5 | 6 | 13 | 13 | X–Y | |
| 45 | 6 | 5 | 8 | 9 | X–Y | |
| 46 | 1 | 1 | 8 | 9 | X–Y | |
| 47 | 7 | 9 | 10 | 10 | X–Y | |
| 48 | 6 | 5 | 22 | 22 | X–Y | |
| 49 | 4 | 5 | 7 | 8 | X–Y | |
| 50 | 5 | 4 | 3 | 3 | X–Y | |
| 51 | 4 | 3 | 10 | 9 | X–Y |
[i] *Patient 13: discordant; X: laboratorial stratification of POCT VLTia; Y: laboratorial stratification of Plasma COBAS, according to the chest pain protocol.
Table 5
Correlations between the assays, second phase of the study (clinical).
| ASSAYS | r T0 | p T0 | r T1 | p T1 |
|---|---|---|---|---|
| Whole blood POCT Atellica® vTLi × plasma hs-cTnT Cobas® | 0.926 | <0.0001 | 0.927 | <0.0001 |
| Whole blood POCT Atellica® vTLi × Serum Cobas | 0.956 | <0.0001 | 0.957 | <0.0001 |
| Whole blood Plasma Cobas × Serum Cobas | 0.995 | <0.0001 | 0.994 | <0.0001 |
| Whole blood POCT Atellica® vTLi × Plasma Atellica IM 1300 | 0.964 | <0.0001 | 1.000 | <0.0001 |
| Whole blood POCT Atellica® vTLi × Serum Atellica IM 1300 | 0.999 | <0.0001 | 0.982 | <0.0001 |
| Plasma Atellica IM 1300 × Serum Atellica IM 1300 | 0.926 | <0.0001 | 1.000 | <0.0001 |
[i] T0: until 3 h since the beginning of the symptoms; T1: Time 1: after 1 h since the symptoms have been detected.
Supplementary Table 1
Analytical specifications reported by the manufacturers.
| TnI – ATELLICA vTLi – PLASMA | TnI – ATELLICA vTLi – TOTAL BLOOD | TnT – COBAS 602 – SERUM | |
|---|---|---|---|
| Blanc limit (LoB) | 0.55 ng/L | 0.55 ng/L | 2.36 ng/L |
| Detection limit (LoD) | 1.2 ng/L | 1.6 ng/L | 2.85 ng/L |
| Quantification limit (LdQ) | 2.1 ng/L | 3.7 ng/L | 2.92 ng/L |
| Overall Percentil 99 | 22.9 ng/L | 22.9 ng/L | 14 ng/L |