FIND evaluation update: SARS-CoV-2 molecular diagnostics

FIND evaluation update: SARS-CoV-2 molecular diagnostics

On 19 February 2020, FIND launched an expression of interest (EOI) for test developers of in vitro diagnostics (IVDs) that detect SARS-CoV-2 nucleic acid (molecular tests). The EOI closed on 9 March 2020. Over 200 submissions were received.

Applications were reviewed according to the following scoring criteria. The tests selected for the first round of independent evaluation are listed below. Additional tests will be included in subsequent rounds, including automated tests for use on closed/proprietary systems. Results of the evaluations will be posted in the coming weeks.

Scoring criteria Max score
Limit of detection 3
Regulatory status 2
Type of organization 1
Quality management system 1
Other products available in low- and middle-income countries 3

Manual (open) PCR tests included in the round 1 evaluation:

Company Assay Country of manufacturer Target Regulatory status
altona Diagnostics RealStar® SARS-CoV-2 RT-PCR Kit 1.0 Germany E gene and S gene CE-IVD
Atila Biosystems Inc. Atila iAMP® COVID Detection Kit USA ORF1ab and N region RUO
Beijing Wantai Pharmacy Enterprise Co. Ltd Wantai SARS-CoV-2 RT-PCR Kit China ORF1ab and N gene RUO
BGI Health (HK) Co. Ltd Real-time fluorescent RT-PCR kit for detecting 2019-nCoV China ORF1ab China EUA
bioMérieux S.A. SARS-COV-2 R-GENE® France N gene and RdRp gene RUO
BIONEER Corporation AccuPower® SARS-CoV-2 Real-Time RT-PCR Kit Rep. of Korea E gene and RdRp gene CE-IVD
BODITECH Med Inc. ExAmplar COVID-19 real-time PCR kit (L) Rep. of Korea E gene and RdRp gene CE-IVD
CerTest Biotec S.L. VIASURE SARS-CoV-2 Real Time PCR Detection Kit Spain ORF1ab gene and N gene CE-IVD
DAAN Gene Co., Ltd. of Sun Yat-sen University Detection Kit for 2019 Novel Coronavirus (2019-nCoV) RNA (PCR-Fluorescence Probing) China ORF1ab and N gene China EUA
EUROIMMUN AG EURORealTime SARS-CoV-2 Germany ORF1ab gene and N gene RUO
GeneFirst Limited The Novel Coronavirus (2019-nCoV) Nucleic Acid Test Kit United Kingdom ORF1ab gene and N gene RUO
KH Medical Co. Ltd RADI COVID-19 Detection Kit (RV008) Rep. of Korea ORF1ab gene and S gene CE-IVD
PerkinElmer Inc. PerkinElmer® SARS-CoV-2 Realtime RT-PCR Assay China ORF1ab gene and N gene CE-IVD
Primerdesign Ltd Primerdesign Ltd COVID-19 genesig Real-Time PCR assay England S and RdRp genes USA FDA-EUA, CE-IVD
R-Biopharm AG RIDA GENE SARS-CoV-2 RUO (PG6815RUO) Germany E gene RUO
Sansure Biotech Inc. Novel Coronavirus (2019-nCoV) Nucleic Acid Diagnostic Kit China ORF1ab gene and N gene CE-IVD
SD BIOSENSOR, INC. STANDARD M nCoV Real-Time Detection kit Rep. of Korea RdRp and E gene Korea EUA, CE-IVD
Seegene, Inc. Allplex 2019-nCoV assayS Rep. of Korea E, RdRp and N genes Korea EUA, CE-IVD
Shanghai Kehua Bio-engineering Co., Ltd SARS-CoV-2 Nucleic Acid Test China ORF 1ab, N and E genes RUO
ThermoFisher Scientific TaqMan™ SARS-CoV-2 Assay Kit v2 USA ORF1ab, S and N RUO
Vela Diagnostics ViroKey SARS-CoV-2 RT-PCR Test Singapore ORF1ab RUO

CE-IVD – conformité européenne (EU certification)-in vitro diagnostics
EUA – Emergency Use Authorization
RUO – Research Use Only

More information

For questions relating to the evaluation of molecular tests, please contact our Emerging Threats team.

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