Table 2.
Technical and analytical characteristics of different highly sensitive Tg immunoassays.
Assay | Manufacturer | Method | Standardisation BCR 457 | Analytical sensitivity (manufacturers data) | Analytical sensitivity (literature data) | |||||
---|---|---|---|---|---|---|---|---|---|---|
LOD | LOQ | FS | LOD | LOQ | FS | Reference | ||||
Access Tg | Beckman Coulter (USA) | ICMA | Yes | 0.1 a | NQ | NQ | 0.01 | NQ | 0.1 | (13) |
EIASON TgCa | Iason (Austria) | ELISA | Yes | 0.01 | NQ | 0.02 | 0.01 | NQ | 0.02 | (12) |
ELECSYS Tg II | Roche | ECLIA | Yes | 0.04 | 0.1 | NQ | NA | NA | NA | NA |
KRYPTOR usTg | BRAHMS (Germany) | TRACE | Yes | 0.09 | NQ | 0.15 | NA | NA | NA | NA |
ECLIA, electrochemiluminescence immunoassay; FS, functional sensitivity; ICMA, immunochemiluminometric assay; LOD, limit of detection; LOQ, limit of quantification; NA, not available; NQ, not quoted; TRACE, time-resolved amplified cryptate emission.
Package insert reports the term ‘analytical sensitivity’.