Nationwide quality assurance of high-throughput diagnostic molecular testing during the SARS-CoV-2 pandemic: role of the Belgian National Reference Centre

Janssen, Reile; Cuypers, Lize; Laenen, Lies; Keyaerts, Els; Beuselinck, Kurt; Janssenswillen, Sunita; Slechten, Bram; Bode, Jannes; Wollants, Elke; Van Laethem, Kristel; Rector, Annabel; Bloemen, Mandy; Sijmons, Anke; de Schaetzen, Nathalie; Capron, Arnaud; Van Baelen, Kurt; Pascal, Thierry; Vermeiren, Céline; Bureau, Fabrice; Vandesompele, Jo; De Smet, Pieter; Uten, Wouter; Malonne, Hugues; Kerkhofs, Pierre; De Cock, Jo; Matheeussen, Veerle; Verhasselt, Bruno; Gillet, Laurent; Detry, Gautier; Bearzatto, Bertrand; Degosserie, Jonathan; Henin, Coralie; Pairoux, Gregor; Maes, Piet; Van Ranst, Marc; Lagrou, Katrien; Dequeker, Elisabeth; André, Emmanuel

doi:10.1186/s12985-024-02308-y

Virology Journal

Table 1 Overview of the assays used for SARS-CoV-2 detection, antibody detection and genotyping at the NRC UZ/KU Leuven and at the UZ Leuven hospital. The assays currently in use are marked in bold

From: Nationwide quality assurance of high-throughput diagnostic molecular testing during the SARS-CoV-2 pandemic: role of the Belgian National Reference Centre

Assay	Assay description		Device type		Instrument (manufacturer)			SARS-CoV-2 targets		Other targets		Instrument set-up		Instrument capacity (tests/24 h)		TAT (min)	Implementation date
A. Overview of assays used for SARS-CoV-2 detection
LDT Respiratory panel	NA extraction + qPCR		LDT		eMAG (BioMérieux) + QuantStudio Dx (TMO)			ORF1ab		IC and 28 other pathogens*		Open system (batch)		112		300	16–01-2020
LDT SARS-CoV-2 eMAG/ QuantStudio	NA extraction + qPCR		LDT		eMAG (BioMérieux) + QuantStudio Dx (TMO)			E		IC		Open system (batch)		576		240	31–01-2020
LDT SARS-CoV-2 Panther Fusion	NA extraction + qPCR		LDT		Panther Fusion (Hologic)			E, ORF1ab		IC		S2R system		750		150	17–02-2020
LDT SARS-CoV-2 KingFisher/ QuantStudio	NA extraction + qPCR		LDT		KingFisher Flex (TMO) + QuantStudio Dx (TMO)			E		IC		Open system (batch)		2160		240	04–03-2020
Xpert Xpress SARS-CoV-2	NA extraction + qPCR		CE-IVD (FDA EUA)		GeneXpert IV (Cepheid)			N2, E		IC		S2R system		96		60	07–05-2020
Aptima SARS-CoV-2 Assay	NA extraction + TMA		CE-IVD (FDA EUA)		Panther System (Hologic)			ORF1ab		IC		S2R system		750		210	08–06-2020
Alinity m SARS-CoV-2 Assay	NA extraction + qPCR		CE-IVD (FDA EUA)		Alinity m (Abbott)			N, RdRP		IC		S2R system		1000		140	14–10-2020
Xpert Xpress SARS-CoV-2/ Flu/ RSV	NA extraction + qPCR		CE-IVD (FDA EUA)		GeneXpert IV (Cepheid)			N2, E		IC; M1, PB2, PA gene (Influenza A); M1, NS1 gene (Influenza B); N gene (RSV)		S2R system		160		36	12–01-2021
Panbio COVID-19 Ag Rapid Test Device	Rapid chromatographic immunoassay		CE-IVD(FDA EUA)		Abbott			N protein		IC		N/A		N/A		15	26–01-2021
MagMAX Viral/Pathogen II Nucleic Acid Isolation Kit + TaqPath COVID-19 CE-IVD RT-PCR kit	NA extraction + qPCR		CE-IVD (FDA EUA)		Freedom EVO 150 (Tecan) + KingFisher Flex (TMO) + QuantStudio 7 Flex (TMO)			N, ORF1ab, S		IC		Open system (batch)		864		150	09–02-2021
Cobas SARS-CoV-2	NA extraction + qPCR		CE-IVD (FDA EUA)		Cobas Liat (Roche)			N, ORF1ab		IC		S2R system		72		20	17–10-2021
Cobas SARS-CoV-2 & Influenza A/B	NA extraction + qPCR		CE-IVD (FDA EUA)		Cobas Liat (Roche)			N, ORF1ab		IC; M1 gene (Influenza A); NS1 gene (Influenza B)		S2R system		72		20	10–12-2021
Xpert Xpress SARS-CoV-2/ Flu/ RSV plus	NA extraction + qPCR		CE-IVD (FDA EUA)		GeneXpert IV (Cepheid)			N2, E, RdRP		IC; M1, PB2, PA gene (Influenza A); M1, NS1 gene (Influenza B); N gene (RSV)		S2R system		160		36	21–01-2022
Alinity m Resp-4-plex assay	NA extraction + qPCR		CE-IVD (FDA EUA)		Alinity m (Abbott)			N, RdRP		IC; M1 gene (Influenza A); NS1 gene (Influenza B); M gene (RSV)		S2R system		1040		140	31–03-2022
Xpert Xpress SARS-CoV-2 plus	NA extraction + qPCR		CE-IVD (FDA EUA)		GeneXpert IV (Cepheid)			N2, E, RdRP		IC		S2R system		192		30	08–09-2022
B. Overview of assays used for SARS-CoV-2 antibody detection
SARS-CoV-2 IgG		CMIA		CE-IVD (FDA EUA)		Architect i2000 SR (Abbott)	N		N/A		S2R System		4800		30		29–04-2020
SARS-CoV-2 IgG II Quant		CMIA		CE-IVD (FDA EUA)		Architect i2000 SR (Abbott)	S		N/A		S2R system		4800		30		07–04-2021
SARS-CoV-2 IgG		CMIA		CE-IVD (FDA EUA)		Alinity I (Abbott)	N		N/A		S2R system		4800		30		08–02-2023
SARS-CoV-2 IgG II Quant		CMIA		CE-IVD (FDA EUA)		Alinity i (Abbott)	S		N/A		S2R system		4800		30		08–02-2023
C. Overview of assays used for SARS-CoV-2 genotyping
SARS-CoV-2 WGS		NA extraction + WGS		RUO		Freedom EVO 150 (Tecan) + KingFisher Flex (TMO) + MinION/ GridION (ONT)	complete SARS-CoV-2 genome		N/A		Open system (batch)		480		2880		03–02-2020
MagMAX Viral/ Pathogen II Nucleic Acid Isolation kit + TaqMan SARS-CoV-2 Mutation Research Panel		NA extraction + qPCR		RUO		Freedom EVO 150 (Tecan) + KingFisher Flex (TMO) + QuantStudio 5 (TMO)	S gene: 417KNT, 452LRQ, 484EKQ, 501NYT, 681PHR,		N/A		Open system (batch)		768		210		07–01-2021

CMIA (chemiluminescent microparticle immunoassay), EUA (emergency use authorization), FDA (Food and Drug Administration), IC (internal control), IVD (in vitro diagnostic medical device), LDT (lab-developed test), N/A (not applicable), NA (nucleic acid), ONT (Oxford Nanopore Technologies), RUO (Research Use Only), S2R (sample to result), TAT (turn-around-time), TMA (transcription-mediated amplification), TMO (Thermo Fisher Scientific), WGS (Whole Genome Sequencing). (*) Influenza A, influenza B, parainfluenza virus (PIV)-1, PIV-2, PIV-3, PIV-4, respiratory syncytial virus (RSV) A and B rhino-enterovirus, enterovirus D68, herpes simplex virus (HSV)-1, HSV-2, human metapneumovirus, adenovirus, bocavirus, parechovirus, human coronavirus (HCoV) 229E, HCoV HKU-1, HCoV NL63, HCoV OC43, MERS-CoV, SARS-CoV-1, cytomegalovirus (CMV), Mycoplasma pneumoniae, Coxiella burnetii, Chlamydia pneumoniae, Chlamydia psittaci, Streptococcus pneumoniae, Legionella pneumophila and Pneumocystis jirovecii.

Back to article page

ISSN: 1743-422X

Contact us

Submission enquiries: journalsubmissions@springernature.com