TABLE 3.
Detailed performance characteristics for assays and products calibrated to WHO IS, detect GT1-8, and used IC for RNA extraction
| Assay name | Manufacturer/provider | Target site | LoD (IU/mL) | LLoQ (IU/mL) | ULoQ (IU/mL) | Regulation | RNA extraction method | Detection equipment (cycler) | Comments |
|---|---|---|---|---|---|---|---|---|---|
| EurobioPlex HDV | Eurobio Scientific | HDAg | 10 | 562 | 3.16E+08 | CE-IVD | m2000sp | CFX96 | |
| RoboGene HDV RNA Quantification Kit 2.0 | Roboscreen GmbH | HDAg | 6 | 60 | 1.00E+08 | CE-IVD | Instand Virus RNA/DNA Kit | Several options | |
| HDV QNP 2.1 Real-Time PCR Kit | Iontec | Proprietary | 400 | 1000 | 1.00E+10 | CE-IVD | Fluorion i12, i24/i12 Kit | Several options | *no information on GT8 |
| AltoStar HDV RT-PCR Kit 1.5 | altona Diagnostics | Proprietary | <10* | 100* | 1.00E+06 | RUO** | AltoStar AM16r | CFX96 | *Still under verification. **The kit is CE-IVDR ready |
| RealStar HDV RT-PCR Kit 1.0 | altona Diagnostics | Proprietary | RUO | Several options | Several options | LoD depend on extraction/detection method | |||
| SYSTAAQ HDV Real-time PCR Kit | SYSTAAQ | Proprietary | 10 | 10 | 8.00E+06 | RUO | Several options | Not specified | LoD depend on extraction/detection method |
| HDV RNA, Quantitative Real-Time PCR | Quest Diagnostics | Proprietary | 5 | 40 | 1.00E+07 | LDT | MagNA Pure 96 | ABI 7500 | |
| Pflüger (LDT) | Ribozyme | 3.9 | 10 | 1.00E+08 | LDT | cobas 6800 | cobas 6800 | ||
| Olivero (LDT) | Ribozyme | 9.2 | 10 | 1.00E+06 | LDT | EZ1 Advanced XL | CFX96 QX200 |
Abbreviations: CE-IVD, conformité européenne in vitro diagnostic; GT, genotype; HDAg, hepatitis D antigen; IC, internal control; IVDR, in vitro diagnostic regulation; LDT, laboratory-developed test; LLoQ, lower limit of quantitation; LoD, limit of detection; RT-PCR, real-time PCR; RUO, research use only; ULoQ, upper limit of quantitation; WHO IS, World Health Organization International Standard.