TABLE 2.
Performance evaluation of Espline HTLV-I/II for different diagnostic situations
| HTLV-1 diagnosis | Clinical symptom | First antibody test | Confirmatory test | Additional test | Number of samples | IC positive | IC negative |
|---|---|---|---|---|---|---|---|
| Positive | ATL | CLEIA A+ | LIA+ | N/A a | 43 | 43 | 0 |
| CLIA+ | LIA+ | N/A | 30 | 30 | 0 | ||
| HAM | CLEIA A+ | LIA+ | N/A | 1 | 1 | 0 | |
| CLEIA B+ | LIA+ | N/A | 85 | 85 | 0 | ||
| CLIA+ | LIA+ | N/A | 40 | 40 | 0 | ||
| HU | CLEIA A+ | LIA+ | N/A | 1 | 1 | 0 | |
| Asymptomatic | PA+ | LIA+ | N/A | 47 | 47 | 0 | |
| CLEIA A+ | WB + | N/A | 130 | 130 | 0 | ||
| CLEIA C+ | WB+ | N/A | 70 | 70 | 0 | ||
| CLEIA A+ | LIA+ | N/A | 66 | 66 | 0 | ||
| CLEIA B+ | LIA+ | N/A | 68 | 68 | 0 | ||
| CLEIA C+ | LIA+ | N/A | 23 | 23 | 0 | ||
| CLEIA D+ | LIA+ | N/A | 99 | 99 | 0 | ||
| CLIA+ | LIA+ | N/A | 296 | 293 | 3 | ||
| CLEIA A+ | WB indeterminate | PCR+ | 47 | 47 | 0 | ||
| CLEIA C+ | WB indeterminate | PCR+ | 53 | 53 | 0 | ||
| CLEIA C+ | LIA indeterminate | PCR+ | 2 | 1 | 1 | ||
| CLEIA D+ | LIA indeterminate | PCR+ | 1 | 1 | 0 | ||
| CLIA+ | LIA indeterminate | PCR+ | 13 | 11 | 2 | ||
| Negative | Healthy | PA− | N/A | N/A | 40 | 0 | 40 |
| CLEIA D− | N/A | N/A | 60 | 0 | 60 | ||
| CLIA− | N/A | N/A | 1,000 | 6 | 994 | ||
| CLEIA B+ | LIA− | N/A | 19 | 0 | 19 | ||
| CLEIA C+ | LIA− | N/A | 4 | 1 | 3 | ||
| CLIA+ | LIA− | N/A | 451 | 205 | 246 | ||
| CLEIA A+ | LIA indeterminate | PCR− | 1 | 1 | 0 | ||
| CLEIA C+ | LIA indeterminate | PCR− | 4 | 0 | 4 | ||
| CLIA+ | LIA indeterminate | PCR− | 161 | 127 | 34 |
a
N/A, not applicable.