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Table 1. Test characteristics for HDV-RNA determinatio.
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The authors report an update to the data for the AltoStar® HDV RT-PCR Kit 1.5 assay presented in Table 1. According to the official CE-IVDR instructions for use, the corrected data are as follows:
Table 1.
Test characteristics for HDV-RNA determinatio.
| Name of test | Manufacturer | LOD | LLOQ | Linear range | Genotypes | Certification |
|---|---|---|---|---|---|---|
| Robogene® HDV RNA Quantification kit 2.0 | Roboscreen GmBH | 6 UI/mL | 60 UI/mL | 5 – 1 × 108UI/mL | 1−8 | CE |
| AltoStar® HDV RT-PCR | Altona Diagnostics | 1,12 UI/mL | 10 UI/mL | 10– 108UI/mL | 1−8 | CE |
| EurobioPlex HDV qRT-PCR EBX-004 | Eurobio Scientific | 100 UI/mL | 100 UI/mL | 102–108UI/mL | 1−8 | CE |
| Bosphore® HDV Quantification-Detection kit | Anatolia Geneworks | 45 copies/mL | 100 copies/mL | 102–108copies/mL | 1−8 | CE |
| Lightmix HDV kit | Roche Diagnostics | 10 copies/mL | 10 copies/mL | 101–106copies/mL | 1 | RUO |
| DiaPro HDV RNA quantification kit | Diagnostic Bioprobes | 100 copies/mL | 100 copies/mL | 102–107copies/mL | 1−8 | CE |
| HDV Genesig standard kit | Primerdesign Ltd | 100 copies/mL | Not avail. | 102–107copies/mL | 1−8 | RUO |
| HDV Realtime PCR kit | Vircell Microbiologists | 23 UI/mL | 40 UI/mL | 40 – 4 × 108UI/mL | 1−8 | CE |
CE: European conformity; LLOQ: Lower Limit Of Quantification; LOD: Limit Of Detection; Not avail.: No available; RUO: Research Use Only; UI: International Units; HDV: hepatitis D virus.
AltoStar® HDV RT-PCR Kit 1.5; Altona Diagnostics GmbH; LoD: 1,12 UI/mL; LLOQ: 10 UI/mL; lineal range: 10–1 × 10 8 UI/mL; genotypes: 1–8; certification: CE.
The authors would like to apologise for any inconvenience caused.
