Table 1 Performance values obtained during the collaborative study.
Protocol | End point PCR | SYBR Green real-time PCR | Hydrolysis probe real-time PCR | Significance of the difference between protocols | ||||||
|---|---|---|---|---|---|---|---|---|---|---|
p1 | p9 | p4 | p5 | p6 | p2 | p3 | p7 | p8 | ||
Number of laboratories involved | 6 | 6 | 6 | 5 | 4 | 6 | 6 | 4 | 6 | |
Number of samples analyzed and retained | 474 | 472 | 473 | 393 | 393 | 474 | 474 | 316 | 473 | |
Number of indeterminate resultsa,b | 2 A (2 AB) | 4 A (2 AB) | 7 A (4 AB) | 6 A (0 A) | 18 B (16 C) | 5 A (1 AB) | 5 A (4 AB) | 3 A (0 AB) | 9 AB (8 BC) | P < 0.001 (P < 0.001) |
Negative Accord (NA)b,c | 181 (180) | 183 (179) | 187 (183) | 154 (154) | 146 (130) | 171 (171) | 192 (191) | 128 (128) | 163 (161) | — |
Positive Accord (PA)b,c | 223 (221) | 229 (231) | 230 (227) | 194 (189) | 192 (191) | 230 (226) | 236 (232) | 156 (153) | 221 (220) | — |
Negative Deviation (ND)b,c | 53 (55) | 43 (44) | 45 (48) | 34 (40) | 35 (37) | 46 (50) | 40 (44) | 28 (31) | 55 (56) | — |
Positive Deviation (PD)b,c | 17 (18) | 17 (19) | 11 (15) | 11 (11) | 19 (35) | 27 (27) | 6 (7) | 4 (4) | 34 (37) | — |
Diagnostic Sensitivity % (SE)b,c | 80.8 (80.1) | 84.3 (83.6) | 83.6 (82.5) | 85.0 (82.8) | 84.0 (83.6) | 83.3 (81.9) | 85.5 (84.1) | 84.8 (83.2) | 80.1 (79.7) | P = 0.71 (P = 0.88) |
Diagnostic Specificity % (SP)b,c | 91.4 ABCD (90.9 AB) | 92.4 ABCD (90.4 AB) | 94.4 AC (92.4 AB) | 93.3 ABC (93.3 AB) | 88.5 ABD (78.8 C) | 86.4 BD (86.4 AC) | 97.0 C (96.6 B) | 97.0 C (97.0 B) | 82.6 D (81.6 C) | P < 0.001 (P < 0.001) |
Diagnostic accuracy % (AC)b,c | 85.2 AB (84.6 ABC) | 87.7 AB (86.4 AB) | 88.2 A (86.7 AB) | 88.5 A (87.3 ACD) | 85.9 AB (81.6 ABC) | 84.6 AB (83.8 ABC) | 90.3 A (89.2 B) | 89.9 A (88.9 D) | 81.2 B (80.5 CD) | P = 0.02 (P < 0.001) |
Concordance level (%)b | 96.8 A | 93 C | 96.8 A | 93.7 C | 74.6 D | 88.5 B | 93.2 C | 97.7 A | 93.5 C | P < 0.001 |
Positive deviation (PD)rate (%)b,c | 8.6 ABC (9.1 AB) | 8.5 ABC (9.6 AB) | 5.6 BC (7.6 AB) | 6.7 ABC (6.7 AB) | 11.5 ACD (21.2 C) | 13.6 AD (13.6 AC) | 3.0 B (3.5 B) | 3.0 B (3.0 B) | 17.3 D (18.7 C) | P < 0.001 (P < 0.001) |
Negative deviation (ND) rate %b,c | 19.2 (19.9) | 15.7 (16.1) | 16.4 (17.5) | 14.9 (17.5) | 15.4 (16.2) | 16.7 (18.1) | 14.5 (15.9) | 15.2 (16.8) | 19.9 (20.3) | P = 0.716 (P = 0.89) |