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. 2023 Aug 28;81(2):637–650. doi: 10.1097/HEP.0000000000000584

TABLE 2.

Comprehensive list of published methods (LDTs) and RNA quantitation kits

Assay name Manufacturer/provider Type Source of data Reference(s) Technique Calibrated to WHO international standard
EurobioPlex HDV Kit EBX 004 Eurobio Scientific Commercial kit Le Gal (2017) 48 qPCR Yes
RoboGene HDV RNA Quantification Kit 2.0 Roboscreen GmbH Commercial kit Wang (2018); IFU/website (2020) 37,49 qPCR Yes
AltoStar HDV RT-PCR Kit 1.5 altona Diagnostics GmbH Commercial kit Supplier qPCR Yes
RealStar® HDV RT-PCR Kit 1.0 RUO altona Diagnostics GmbH Commercial kit Supplier qPCR Yes
AmpliSens HDV-FRT Federal Budget Institute of Science Commercial kit IFU/website qPCR Yes
Fluorion HDV QNP 2.1 Real-Time PCR Kit Iontec Commercial kit IFU/website qPCR Yes
SYSTAAQ HDV Real-Time PCR Kit SYSTAAQ Commercial kit IFU/website qPCR Yes
LIPSGENE HDV Kit VL-Diagnostics GmbH commercial kit IFU/website qPCR Yes
Bosphore HDV Quantification-Detection Kit v1 Anatolia Geneworks commercial kit IFU/website qPCR No
genesig Real-time PCR Detection Kit for HDV Primerdesign Commercial kit Supplier qPCR No
HDV Real-TM Qual Real-time PCR Test Sacace Biotechnologies Commercial kit IFU/website qPCR No
LightMix Kit HDVa TibMolBiol/Roche commercial kit IFU/website qPCR No
HDV Real-time RT-PCR Kit Creative Biogene commercial kit IFU/website qPCR Unknown
HDV Quantitation Real-Time PCR kit Dia.Pro Diagnostic Bioprobes s.r.l Commercial kit IFU/website qPCR Unknown
ViroReal Kit HDVa Ingenetix Commercial kit IFU/website qPCR Unknown
HDV Real-Time RT-PCR Kit Liferiver Commercial kit IFU/website qPCR Unknown
Hepatitis Delta virus One-Step RT-qPCR Kita NZYTech Commercial kit IFU/website qPCR Unknown
PCRmax LtdTM qPCR test Hepatitis Delta PCRmax Commercial kit IFU/website qPCR Unknown
Hepatitis Delta Virus by Quantitative PCR ARUP LDT Website qPCR Yes
HDV RNA, Quantitative Real-Time PCR Quest Diagnostics LDT Website/coauthor qPCR Yes
NA (LDT) LDT LeGal (2005) 50,51 qPCR No
NA (LDT) LDT Tseng (2008) 52 qPCR No
NA (LDT) LDT Hofmann (2010) 53 qPCR No
NA (LDT) LDT Mederacke (2010) 54 qPCR No
NA (LDT) LDT Schaper (2010) 22 qPCR No
NA (LDT) LDT Ferns (2012) 55 qPCR No
NA (LDT) LDT Scholtes (2012) 56 qPCR No
NA (LDT) LDT Shang (2012) 57 qPCR No
NA (LDT) LDT Katsoulidou (2013) 58 qPCR No
NA (LDT) LDT Kodani (2013) 59 qPCR No
NA (LDT) LDT Botelho-Souza (2014) 60 qPCR No
NA (LDT) LDT Karatayli (2014) 61 qPCR No
NA (LDT) LDT Coller (2018) 62 qPCR Yes
NA (LDT) LDT Pflüger (2021) 63 qPCR Yes
NA (LDT) LDT Olivero (2022) 64 ddPCR/qPCR Yes
NA (LDT) LDT Xu (2022) 65 ddPCR
a

No longer available.

Abbreviations: ddPCR, droplet digital PCR; IFU, instructions for use; LDT, laboratory-developed test; qPCR, quantitative PCR; RT-PCR, real-time PCR; RUO, research use only; WHO, World Health Organization.