Background
Methods
HTLV IVDs
IVDs | Method | Indg/Sandh | Manufacturer | Codei |
---|---|---|---|---|
For primary detection test | ||||
Architect rHTLV I/II | CLIAa | Sand | Abbott Japan | A |
Alinity i rHTLV I/II | CLIA | Sand | Abbott Japan | B |
Elecsys HTLV-I/II | ECLIAb | Sand | Roche Diagnostics | C |
Lumipulse HTLV-I/II | CLEIAc | Sand | Fujirebio | D |
Lumipulse Presto HTLV-I/II | CLEIA | Sand | Fujirebio | E |
Serodia HTLV-I | PAd | - | Fujirebio | F |
ESPLINE HTLV-I/II | ICAe | - | Fujirebio | G |
HISCL HTLV-I | CLEIA | Ind | Sysmex | H |
UD1 | CLEIA | Sand | Sysmex | I |
UD2 | CLEIA | Sand | Non-disclosure | J |
For confirmatory/discriminatory test | ||||
INNO-LIA HTLV-I/II Score | LIAf | - | Fujirebio |
HTLV-positive/negative reference panels for evaluation of HTLV IVDs
Results
Estimation of the diagnostic specificity of 10 HTLV IVDs in primary detection test/screening
Estimation of the diagnostic sensitivity of 10 HTLV IVDs in primary detection test/screening
No | IVDs for primary detection test | INNO-LIA HTLV-I/II Score | ||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
A | B | C | D | E | F | G | H | I | J | Confirmation | Discrimination | Result | ||||||
gag p19 I/II | gag p24 I/II | env gp46 I/II | env gp21 I/II | gag p19-I | env gp46-I | env gp46-II | ||||||||||||
S/CO | S/CO | COI | COI | COI | D.F.a | Decision | COI | COI | COI | |||||||||
1 | 103.55 | 92.10 | 320.7 | > 50.0 | > 50.0 | 2048 | Positive | > 100.0 | > 100.0 | 239.893 | 3 + | 2 + | 2 + | 2 + | 2 + | 3 + | ± | HTLV-I |
2 | 156.38 | 141.75 | 335.0 | > 50.0 | > 50.0 | 8192 | Positive | > 100.0 | > 100.0 | 289.531 | 2 + | 2 + | - | 3 + | 2 + | 3 + | ± | HTLV-I |
3 | 17.63 | 17.06 | 58.1 | 27.9 | 23.4 | 64 | Positive | 3.6 | 49.9 | 6.386 | 1 + | ± | 1 + | 1 + | 1 + | ± | - | HTLV-I |
4 | 46.50 | 43.95 | 178.2 | > 50.0 | > 50.0 | 512 | Positive | 6.8 | > 100.0 | 6.034 | 1 + | - | 1 + | 2 + | - | 1 + | - | HTLV-I |
5 | 119.41 | 107.43 | 283.5 | > 50.0 | > 50.0 | 2048 | Positive | 23.8 | > 100.0 | 55.062 | 2 + | 1 + | 3 + | 2 + | 1 + | ± | - | HTLV-I |
6 | 76.57 | 73.74 | 294.0 | > 50.0 | > 50.0 | 2048 | Positive | 85.3 | > 100.0 | 170.378 | 3 + | 3 + | 1 + | 3 + | ± | 3 + | ± | HTLV-I |
7 | 73.14 | 67.73 | 292.2 | > 50.0 | > 50.0 | 1024 | Positive | 13.8 | > 100.0 | 33.105 | 1 + | 1 + | 1 + | 2 + | ± | 1 + | - | HTLV-I |
8 | 51.17 | 49.42 | 15.0 | 42.4 | 48.8 | 64 | Positive | 4.5 | 39.4 | 11.979 | 1 + | - | 2 + | 1 + | ± | ± | - | HTLV-I |
9 | 54.26 | 51.43 | 130.7 | > 50.0 | > 50.0 | 256 | Positive | 15.5 | > 100.0 | 39.815 | 2 + | 1 + | 2 + | 2 + | 2 + | ± | ± | HTLV-I |
10 | 67.95 | 64.61 | 100.2 | > 50.0 | > 50.0 | 256 | Positive | 5.1 | > 100.0 | 40.375 | 1 + | 1 + | 2 + | 2 + | ± | 2 + | - | HTLV-I |
11 | 61.10 | 59.17 | 41.9 | > 50.0 | > 50.0 | 128 | Positive | 12.8 | > 100.0 | 51.587 | 2 + | 1 + | 3 + | 1 + | ± | 2 + | - | HTLV-I |
12 | 108.69 | 102.12 | 286.7 | > 50.0 | > 50.0 | 1024 | Positive | 43.3 | > 100.0 | 114.827 | 2 + | 1 + | 1 + | 3 + | 2 + | 3 + | - | HTLV-I |
13 | 111.35 | 103.79 | 153.4 | > 50.0 | > 50.0 | 512 | Positive | 32.6 | > 100.0 | 39.667 | 2 + | 1 + | 3 + | 2 + | 2 + | 3 + | - | HTLV-I |
14 | 71.64 | 72.32 | 146.3 | > 50.0 | > 50.0 | 1024 | Positive | 10.2 | > 100.0 | 20.430 | 2 + | ± | 1 + | 2 + | 1 + | 2 + | - | HTLV-I |
15 | 117.15 | 110.85 | 311.5 | > 50.0 | > 50.0 | 4096 | Positive | 50.3 | > 100.0 | 147.137 | 3 + | 2 + | 2 + | 3 + | 3 + | 3 + | - | HTLV-I |
16 | 2.99 | 2.78 | 1.1 | 3.7 | 1.5 | 0 | Positive | 0.0 | 2.2 | 0.205 | ± | - | - | ± | - | - | - | HTLV |
17 | 25.70 | 23.20 | 107.3 | 23.9 | 29.5 | 256 | Positive | 8.1 | 79.1 | 14.375 | 2 + | 2 + | 2 + | 2 + | - | 2 + | - | HTLV-I |
18 | 40.27 | 38.15 | 56.7 | 45.2 | 42.6 | 128 | Positive | 9.5 | 74.2 | 9.735 | 1 + | - | 2 + | 2 + | 1 + | 1 + | - | HTLV-I |
19 | 36.10 | 36.02 | 45.0 | > 50.0 | 37.0 | 256 | Positive | 35.2 | 62.8 | 45.865 | 2 + | 1 + | 1 + | 2 + | 2 + | - | - | HTLV-I |
20 | 59.80 | 56.40 | 103.3 | > 50.0 | > 50.0 | 256 | Positive | 12.8 | > 100.0 | 17.582 | 1 + | ± | 2 + | 2 + | 1 + | 1 + | - | HTLV-I |
21 | 81.13 | 75.12 | 112.1 | > 50.0 | > 50.0 | 512 | Positive | 8.2 | > 100.0 | 21.974 | 2 + | ± | 1 + | 2 + | 2 + | 1 + | - | HTLV-I |
22 | 12.07 | 11.87 | 56.2 | 21.6 | 22.5 | 128 | Positive | 6.5 | 52.2 | 4.381 | 2 + | ± | 2 + | 2 + | - | 2 + | - | HTLV-I |
23 | 50.77 | 48.20 | 139.9 | > 50.0 | > 50.0 | 512 | Positive | 14.7 | > 100.0 | 12.135 | 2 + | - | 1 + | 2 + | 2 + | ± | - | HTLV-I |
24 | 3.46 | 3.41 | 7.7 | 2.9 | 1.7 | 0 | Positive | 4.7 | 3.5 | 0.542 | ± | - | - | 1 + | 1 + | - | - | HTLV-I |
25 | 2.72 | 2.68 | 53.3 | 6.5 | 6.1 | 32 | Positive | 19.4 | 13.7 | 2.509 | 2 + | - | 1 + | 2 + | ± | ± | - | HTLV-I |
26 | 58.14 | 57.77 | 65.6 | > 50.0 | > 50.0 | 256 | Positive | 7.7 | > 100.0 | 16.409 | 2 + | - | - | 2 + | - | - | - | HTLV |
27 | 98.19 | 88.51 | 237.5 | > 50.0 | > 50.0 | 1024 | Positive | 26.6 | > 100.0 | 28.569 | 2 + | ± | 2 + | 2 + | 2 + | 2 + | - | HTLV-I |
28 | 106.43 | 98.42 | 182.1 | > 50.0 | > 50.0 | 1024 | Positive | 68.4 | > 100.0 | 107.693 | 2 + | 2 + | 2 + | 2 + | 2 + | 3 + | ± | HTLV-I |
29 | 104.05 | 94.04 | 325.5 | > 50.0 | > 50.0 | 2048 | Positive | 35.0 | > 100.0 | 61.918 | 2 + | 1 + | 2 + | 3 + | - | 2 + | - | HTLV-I |
30 | 143.36 | 116.25 | 336.7 | > 50.0 | > 50.0 | 2048 | Positive | > 100.0 | > 100.0 | 242.534 | 2 + | 2 + | 2 + | 2 + | 2 + | 3 + | 1 + | HTLV-I |
31 | 109.65 | 100.68 | 272.5 | > 50.0 | > 50.0 | 2048 | Positive | 6.1 | > 100.0 | 112.804 | 2 + | 2 + | 2 + | 2 + | ± | 1 + | - | HTLV-I |
32 | 110.22 | 105.59 | 312.9 | > 50.0 | > 50.0 | 2048 | Positive | 11.8 | > 100.0 | 47.743 | 2 + | 2 + | ± | 2 + | - | 1 + | - | HTLV-I |
33 | 141.18 | 128.81 | 323.1 | > 50.0 | > 50.0 | 4096 | Positive | 61.2 | > 100.0 | 160.308 | 2 + | 2 + | 2 + | 3 + | 1 + | 3 + | ± | HTLV-I |
34 | 104.07 | 90.33 | 164.4 | > 50.0 | > 50.0 | 512 | Positive | 28.2 | > 100.0 | 22.931 | 2 + | - | 2 + | 2 + | 1 + | 2 + | - | HTLV-I |
35 | 142.34 | 129.40 | 304.5 | > 50.0 | > 50.0 | 8192 | Positive | 98.0 | > 100.0 | 101.134 | 2 + | 2 + | 2 + | 3 + | 2 + | 3 + | 1 + | HTLV-I |
36 | 123.75 | 111.83 | 336.8 | > 50.0 | > 50.0 | 4096 | Positive | 58.0 | > 100.0 | 227.879 | 2 + | 2 + | 2 + | 2 + | 2 + | 2 + | ± | HTLV-I |
37 | 134.56 | 125.49 | 194.8 | > 50.0 | > 50.0 | 512 | Positive | 11.5 | > 100.0 | 72.161 | 2 + | 1 + | - | 2 + | 1 + | - | - | HTLV-I |
38 | 93.86 | 87.15 | 326.8 | > 50.0 | > 50.0 | 4096 | Positive | 77.6 | > 100.0 | 158.547 | 2 + | 2 + | 2 + | 3 + | 2 + | 3 + | - | HTLV-I |
39 | 91.70 | 78.26 | 107.8 | > 50.0 | > 50.0 | 256 | Positive | 22.8 | > 100.0 | 51.753 | 1 + | 2 + | 2 + | 2 + | 1 + | 2 + | - | HTLV-I |
40 | 128.72 | 121.58 | 355.3 | > 50.0 | > 50.0 | 2048 | Positive | 5.2 | > 100.0 | 26.333 | 1 + | - | 2 + | 2 + | 1 + | - | - | HTLV-I |
41 | 103.66 | 92.73 | 80.3 | > 50.0 | > 50.0 | 256 | Positive | 1.8 | > 100.0 | 38.196 | 2 + | 1 + | 1 + | 2 + | 1 + | - | - | HTLV-I |
42 | 130.78 | 115.42 | 333.7 | > 50.0 | > 50.0 | 4096 | Positive | 69.7 | > 100.0 | 127.553 | 3 + | 2 + | 2 + | 3 + | 2 + | 3 + | ± | HTLV-I |
43 | 99.55 | 83.48 | 291.8 | > 50.0 | > 50.0 | 2048 | Positive | 72.4 | > 100.0 | 112.354 | 3 + | 2 + | 2 + | 2 + | 2 + | 2 + | - | HTLV-I |
44 | 40.07 | 38.19 | 230.3 | > 50.0 | > 50.0 | 512 | Positive | 9.0 | > 100.0 | 11.480 | 2 + | ± | 2 + | 2 + | - | 2 + | - | HTLV-I |
45 | 63.71 | 61.02 | 106.0 | > 50.0 | > 50.0 | 512 | Positive | 11.1 | > 100.0 | 15.413 | 2 + | ± | 2 + | 2 + | 2 + | 2 + | - | HTLV-I |
46 | 77.28 | 71.96 | 272.4 | > 50.0 | > 50.0 | 2048 | Positive | 83.0 | > 100.0 | 193.647 | 3 + | 3 + | 2 + | 2 + | 2 + | 2 + | - | HTLV-I |
IVDs | |||
---|---|---|---|
A, B, C, D, E, G, I | H | F, J | |
HTLV(-1) positive | 46 | 46 | 46 |
Test positive | 46 | 45 | 44 |
Positive agreement rate (%) | 100 | 97.8 | 95.7 |