SARS-CoV-2 (COVID-19) Diagnostics Test Kits Comprehensive Diagnostic Solutions Eurofins Technologies To Support the Fight Against COVID-19 Eurofins Technologies is a fast growing global provider of diagnostic technologies and industry-leading ELISA-based instruments in the field of bioanalytical testing for the food, feed, environmental, animal health, and clinical diagnostics industries. The Gold Standard Diagnostics Group is part of the Eurofins Technologies group of companies. Eurofins Technologies is an international business line of Eurofins Scientific. Eurofins Scientific Eurofins Scientific through its subsidiaries is the world leader in food, environment, pharmaceutical and cosmetic products testing and in agroscience CRO services. It is also one of the global independent market leaders in testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and for supporting clinical studies. In addition, Eurofins is one of the key emerging players in specialty esoteric and molecular clinical diagnostic testing in Europe and the USA. As one of the most innovative and quality-oriented international groups in its industry, Eurofins is ideally positioned to support its clients’ increasingly stringent quality and safety standards and the increasing demands of regulatory authorities and healthcare practitioners around the world. Eurofins Scientific in numbers: Gold Standard Diagnostics Group The Gold Standard Diagnostics Group, including Novatec Immundiagnostica GmbH, Virotech Diagnostics GmbH and Gold Standard Diagnostics Inc., is a group of specialized diagnostic technologies companies who develop, manufacture and distribute a portfolio 200 000 of diagnostic test kits and instrumentation to clinical laboratories worldwide. 55 000 staff 900 laboratories 50 countries analytical methods Novatec and Virotech are based in the Frankfurt am Main area, Germany. GSD Inc. is headquartered in Davis, California. Fast Development of Diagnostic Test Kits Scientic Excellence Multiple SARS-CoV-2 Market experience Devoted Workforce (COVID-19) Diagnostic Assays 2 COMPREHENSIVE SOLUTIONS I GSD SARS-COV-2 CATALOGUE GSD SARS-COV-2 CATALOGUE I COMPREHENSIVE SOLUTIONS 3 SARS-CoV-2 and COVID-19 Symptoms The Virus that caused a Global Pandemic Most people infected with the SARS-CoV-2 virus will experience mild to moderate respiratory illness and recover without requiring special treatment. Older people and those with underlying medical conditions (e.g. like cardiovascular disease, diabetes, and chronic respiratory disease) are more likely to develop serious illness. Infection dynamics and applicable testing methods Incubation Symptomatic Convalescent Non-infectious Patient Status Viral RNA IgM/IgA Serological Test LoD IgG RT-qPCR Test LoD 0 5 10 15 20 25 30 35 Days since infection Test methods and expected results: Negative Positive Antibody (total) Coronavirus disease (COVID-19) is an infectious disease caused by a newly discovered coronavirus called severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). PCR SARS-CoV-2 is predominantly transmitted by droplet infection via coughing or sneezing and through close contact with infected patients. Antigen (for symptomatic patients) The incubation period is in the median 5–6 days (and up to 14 days maximum). Source: Sethuraman, N.; Jeremiah, S.S.; Ryo, A.: Interpreting Diagnostic Tests for SARS-CoV-2. JAMA. 2020;323(22):2249-2251. Spike glycoprotein (S) Hemagglutinin-esterase dimer (HE) Structure of SARS-CoV-2 Membrane protein (M) Coronaviruses are enveloped, positive single-stranded Nucleoprotein (N) large RNA viruses that infect humans, but also a wide range of animals. Its four major structural proteins are the spike, nucleocapsid, envelope Genomic RNA and membrane proteins. Envelope small membrane protein (E) 4 THE VIRUS I GSD SARS-COV-2 CATALOGUE GSD SARS-COV-2 CATALOGUE I THE VIRUS 5 PCR Workflow In case of positive result: Mutation Variant Detection GSD SARS-CoV-2 (COVID-19) 4+ GSD (Multiplex) NovaType II SARS-CoV-2 4+ GSD (Multiplex) NovaType III SARS-CoV-2 Benefit from a complete molecular solution with high sensitivity and an efficient workflow ▪ Parallel discrimination between S gene wildtype - from sample to result. and mutations N501Y, E484K, and K417N ▪ Targets: 484E (WT); E484K (e.g. Beta/Gamma); ▪ Fast and reliable results with very high sensitivity E484Q (Kappa); L452R (Delta / Epsilon, Kappa) ▪ Substitutes time-consuming sequencing separate PP for RNaseP ▪ Targets: WT, K417N (Beta), E484K (e.g. Gamma), Sample Collection Real-Time PCR without extraction step N501Y (e.g. Alpha), seperate PP for RNaseP GSD NovaPrime® Direct SARS-CoV-2 (COVID 19) Full screening and identification Full screening and identification 1 2 solution on VOC‘s on multiple variants ▪ Simplified process: reduced cost, labour, and time ▪ Short TAT of one hour without compromising the high accuracy of PCR testing ▪ Targets: 2 targets N genes, Internal control ▪ Device compatibility: 5 channel RT PCR Thermocyclers Real-Time PCR 4+ GSD NovaType Select Assay Family: GSD NovaType Select Base + GSD NovaType Select kit of choice Choose from the NovaType Select assay panel the mutation combination that best fits your variant testing purposes Respiratory clinical samples: nasal, nasopharyngeal, oropharyngeal, saliva, gargling water 3 PCR Cycler Mutations covered by NovaType Select kits Variants I Mutations K417N K417T L452R T478K E484K P681R* P681H* Alpha X Alpha + E484K X X RNA Extraction Beta X X Gamma X X ▪ Agilent Technologies: AriaDxTM, AriaMxTM Delta X X X ▪ Bioneer: Exicycler™ 96 Real-Time Thermal Block 2 ▪ Bio-Rad: CFX96 TouchTM B.1.427 / B.1.429 X ® ▪ Roche Diagnostics: LightCycler 480 Instrument II Delta + K417N X X X X Eta X P.3 X X Kappa X X *NovaType Select assays for these mutations will be available soon RNA Extraction System Customized screening and identification solution for emerging variants GSD NovaPrime® SARS-CoV-2 (COVID 19) Device compatibility: KingFisher Flex, Allsheng Auto Pure 96, Tanbead ▪ Approximately 1 hour turnaround time Maelstrom 9600, Bioteke AU1001 96, ▪ Excellent performance with a 100 % NPA, PPA MGI MGISP 9600 ▪ Extraction/inhibition control included RT-PCR Thermocycler: 4 and/ or 5 channel ▪ Targets: 2 targets N genes, Internal control (e.g. AriaMxTM/AriaDxTM, ABI7500, LC480, QS5) ▪ Device compatibility: 4 and 5 channel RT PCR Thermo cyclers TM GSD NovaPrime® (e.g ABI7500, LC480 96, CFX96, QuantStudio5, AriaMx ) RNA Extraction Kit GSD NovaPrime® Plus SARS-CoV-2 (COVID 19) ▪ Detection of N501Y and/or E484K mutations in the spike protein ▪ Internal positive control to monitor successful extraction and amplification of sample material ▪ Targets: N-, S- and E genes, RNAseP gene, N501Y (e.g.Alpha), E484K (e.g. Beta/Gamma) ▪ Device compatibility: 5 channel RT PCR Thermocyclers TM, TM Simple execution and short extraction time (e.g. AriaMx AriaDx ) Automated extraction of genomic Abbreviations: PP Primer Probe WT Wildtype Virus VOC Variant of Concern VO Variant of Interest SARS-CoV-2 RNA with magnetic beads 6 PCR WORKFLOW I GSD SARS-COV-2 CATALOGUE GSD SARS-COV-2 CATALOGUE I PCR WORKFLOW 7 Real-Time PCR Assays Direct Real-Time RT-PCR: for SARS-CoV-2 Detection GSD NovaPrime® SARS-CoV-2 Direct RT-PCR This Real-Time RT-PCR assay is intended for the qualitative detection of SARS-CoV-2 from human nasopharyngeal swabs, eluted directly into deionised water without an additional RNA extraction process. The direct method is particularly useful to increase the capacity of SARS-CoV-2 testing and in those settings where recurrent, affordable, and faster testing is desirable. Main Features ▪ Direct RT-qPCR method: no need for viral RNA extraction kit or equipment ▪ Simplified process: reduced cost, labour, and time required to perform RT-PCR ▪ Short TAT of one hour without compromising the high accuracy of PCR testing ▪ Performance: Negative Percent Agreement: 98%; Positive Percent Agreement: 98% ▪ CE-IVD Real-Time PCR Assays Product Format Order No. Validated on GSD NovaPrime® 1 x 96 reactions PCOV6033 AriaDxTM/ AriaMxTM (Agilent Technologies), SARS-CoV-2 (CO- 4 x 96 reactions PCOV6034 ABI Prism® 7500 SDS/Fast SDS, Quantstudio™ 5 TM TM VID-19) 1 x 384 reactions PCOV6036 (Applied Biosystems ), CFX96 Touch (Bio-Rad) TM 2 x 384 reactions PCOV6037 Exicycler 96 Real-Time Quantitative Thermal Block (Bioneer), LightCycler® 480 Instrument II (Roche) Direct pathogen determination via Real-Time RT-PCR is the method of choice to detect GSD NovaPrime® 1 x 96 reactions PCOV6043 AriaDxTM/ AriaMxTM (Agilent Technologies) acute COVID-19 infections. Molecular methods allow for virus detection a few days after SARS-CoV-2 Direct 4 x 96 reactions PCOV6044 infection as well as in subclinical / asymptomatic infections. RT-PCR The kits need to be validated as required by local legislation for their intended use by authorized clinical testing laboratories. Real-Time RT-PCR: GSD NovaPrime® SARS-CoV-2 This Multiplex Real-Time RT-PCR is for the direct qualitative pathogen detection of SARS-CoV-2 genomic RNA in respiratory samples to aid in the diagnosis of COVID-19. Main Features ▪ Simultaneous detection of two target sequences in the N gene ▪ Approximately 1 hour turnaround time ▪ Specimen types: nasal wash/swab, nasopharyngeal wash/swab, oropharyngeal swab, BAL, pharynx gargle solution, and saliva. ▪ Excellent performance with a 100 % NPA, PPA ▪ Extraction/inhibition control included ▪ CE-IVD 8 REAL-TIME PCR ASSAYS I GSD SARS-COV-2 CATALOGUE GSD SARS-COV-2 CATALOGUE I REAL-TIME