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 (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 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 PCR ASSAYS 9 Real-Time PCR Assays GSD NovaType III SARS-CoV-2 The NovaType III RT-PCR assay is the improved version of the NovaType II SARS-CoV-2 for SARS-CoV-2 Variant Detection assay in regard to parallel detection and discrimination of relevant mutations associated with SARS-CoV-2 variants: B.1.427 / B.1.429 (Epsilon) / B.1.617.2 (Delta), B.1.617.1 (Kappa) / B.1.617.3, B.1.351 (Beta) / P.1 (Gamma).

GSD NovaType Select SARS-CoV-2 GSD NovaType Select is a group of RT-PCR assays to discriminate variants of the SARS-CoV-2 virus. This assay family provides the opportunity to assemble a customized RT-PCR assay mutation panel from a basis kit including the enzyme mastermix, and a range of mutation specific sets including primer, probes and controls. The Select assays detect the following mutations: K417N, K417T, L452R, T478K, E484K, P681R, P618H.

Real-Time PCR Assays for Variant Detection

Product Format Order No. Validated on GSD NovaPrime® Plus 1 x 96 reactions PCOV6063 LightCycler® 480 Instrument II (Roche), TM TM SARS-CoV-2 4 x 96 reactions PCOV6064 AriaDx / AriaMx (Agilent Technologies)

GSD NovaType II 1 x 96 reactions PCOV6083T AriaDxTM/ AriaMxTM (Agilent Technologies) SARS-CoV-2 4 x 96 reactions PCOV6084T

GSD NovaType III 1 x 96 reactions PCOV6093T AriaDxTM/ AriaMxTM (Agilent Technologies) SARS-CoV-2 4 x 96 reactions PCOV6094T The rapid emergence of new SARS-CoV-2 variants represents a continuous challenge and GSD NovaType Select 1 x 96 reactions PBASE6101 AriaDxTM/ AriaMxTM (Agilent Technologies) underlines the need to identify, trace and track mutations. Base SARS-CoV-2

GSD NovaType Select 1 x 96 reactions PCOV417NT AriaDxTM/ AriaMxTM (Agilent Technologies) Real-Time RT-PCR for identification of variants: K417N/T SARS-CoV-2 ® GSD NovaType Select 1 x 96 reactions PCOVL452R3 AriaDxTM/ AriaMxTM (Agilent Technologies) GSD NovaPrime Plus SARS-CoV-2 L452R SARS-CoV-2 The CE-marked kit is a new Multiplex Real-Time RT-PCR assay intended for the qualitative GSD NovaType Select 1 x 96 reactions PCOV478K AriaDxTM/ AriaMxTM (Agilent Technologies) T478K SARS-CoV-2 detection of SARS-CoV-2 and the simultaneous discrimination of B.1.1.7 (Alpha), B.1.351 TM TM (Beta), and P.1 (Gamma) lineages in one reaction. GSD NovaType Select 1 x 96 reactions PCOV484K AriaDx / AriaMx (Agilent Technologies) E484K SARS-CoV-2 The kits need to be validated as required by local legislation for their intended use by authorized clinical testing laboratories. GSD NovaType II SARS-CoV-2

This Real-Time RT-PCR allows for the qualitative detection and discrimination of relevant mutations associated with SARS-CoV-2 variants: B.1.1.7 (Alpha), B.1.351 (Beta), and P.1 (Gamma).

10 REAL-TIME PCR ASSAYS I GSD SARS-COV-2 CATALOGUE GSD SARS-COV-2 CATALOGUE I REAL-TIME PCR ASSAYS 11 Automated RNA Extraction RNA Extraction Validated Instruments

for SARS-CoV-2 Detection To ease implementation and improve the extraction time, the GSD NovaPrime® IVD RNA Extraction AE1 and AE2 kits allow for an automated workflow. We offer our own RNA Extraction System, the GSD Auto-Pure 96 Purification System with the GSD NovaPrime® IVD RNA Extraction AE1 kit. The RNA test kits are also validated for use with multiple automation platforms.

Extraction & Analysis Workflow

The RNA isolation process of the GSD NovaPrime® IVD RNA Extraction kits is based on the well-established Boom method and uses magnetic beads for the extraction of nucleic acids from human swab samples.

1 Lysis and inactivation of viral particles High RNA recovery rates resulting in an adequate sensitivity

Binding and purification of viral RNA 2 Followed by multiple washing steps to obtain high quality, ultrapure RNA for subsequent analysis

3 Elution of purified viral RNA from magnetic beads

4 Analysis with GSD NovaPrime® SARS-CoV-2 (COVID-19) RT-PCR In order to specifically detect virus particles in human clinical swabs, the virus itself as well as the respective RNA need to be isolated prior to real-time RT-PCR analysis by approved clinical analytical kits. RNA Extraction Kits Product List

® GSD NovaPrime RNA Extraction kits Product Format Order No. Validated on

Our RNA Extraction kits are designed for the automated isolation of high-quality RNA GSD NovaPrime® IVD 1 x 96 reactions 5524401101 GSD Auto-Pure 96 from viral particles from human respiratory specimens. Its components are optimised for RNA Extraction AE1 20 x 96 reactions 5524401201 KingFisher Flex (Thermo Fisher Scientific) Maelstrom 9600 (TANBead) 100 x 96 reactions 55244011100 RNA extraction and removal of potential inhibitors from these sample materials. AU1001-96 (BioTeke) Auto-Pure 96 (Hangzhou Allsheng)

Main Features GSD NovaPrime® IVD 20 x 96 reactions 5524411020 GSD Auto-Pure 96 RNA Extraction AE1 RTU 100 x 96 reactions 5524411100 KingFisher Flex (Thermo Fisher Scientific) ▪ Magnetic bead technology for automated extraction of genomic SARS-CoV-2 RNA Maelstrom 9600 (TANBead) ▪ Respiratory samples from clinical specimens: nasal, nasopharyngeal, oropharyngeal, AU1001-96 (BioTeke) BAL, gargle Auto-Pure 96 (Hangzhou Allsheng) ▪ Easy implementation and short extraction time GSD NovaPrime® IVD 1 x 96 reactions 5524400901 MGISP-960 (MGI Tech) RNA Extraction AE2 ▪ High sensitivity and efficiency in overall workflow 20 x 96 reactions 5524401401 100 x 96 reaction 55244013100 ▪ Validated on the most common automation platforms ® The kits need to be validated as required by local legislation for their intended use by authorized clinical testing laboratories. ▪ Ideal for the use in conjunction with GSD NovaPrime SARS-CoV-2 (COVID-19) assay Not available in the USA. ▪ CE-IVD Manufacturer of the GSD NovaPrime RNA Extraction kits: Eurofins GeneScan Technologies

12 RNA EXTRACTION I GSD SARS-COV-2 CATALOGUE GSD SARS-COV-2 CATALOGUE I RNA EXTRACTION 13 GSD Auto-Pure 96 Main Features

Nucleic Acid Purification System Simple, intelligent operation ▪ Built-in lighting LED lights ▪ Front cover can be opened for quick stop, convenient for reagent optimization ▪ Intelligent operation with self-inspection, power protection function ▪ 8-plate position automatic identification design. No manual adjustment required Multiple pollution control ▪ Drip-proof plate design with software control magnetic beads drying mode, to prevent the liquid splashing in the experiment process ▪ Disposable consumables can eliminate the cross contamination between holes and batches. Built-in disinfection function Extension Internet ▪ Can be controlled by phone app software to check the running status of the instrument in real time - remote monitoring High quality and rapid extraction ▪ GSD Auto-Pure 96 can process 96×1ml samples simultaneously ▪ Maximum sample size: 10ml ▪ Open software design ▪ Room temperature + 5°C~120°C, accurate temperature control ▪ Single machine can do program editing ▪ Software has complete functions and is suitable for all kinds of magnetic bead reagents ▪ Diverse binding and magnetic absorption modes Reliable structure and stable operation GSD Auto-Pure 96 Nucleic Acid Purification System is an automatic extraction and ▪ GSD Auto-Pure 96 adopts lead screw drive to realize lifting movement with high purification system for DNA/RNA, proteins and cells. It can absorb, transfer and release precision magnetic beads by magnetic rod and magnetic rod sleeve to separate magnetic beads ▪ Patent structure design with center rotary table and samples. Combined with different kinds of magnetic bead nucleic acid extraction kits, ▪ Patent design for automatic loading and unloading structure of magnetic rod tip comb, it can operate 1-96 samples or simultaneously and extract DNA and RNA rapidly, in 30- which guarantee stability and liability (success rate>99.99%) 60 minutes.

Product specifications Additional items for Auto-Pure 96

Feature Product specification Article No. Product

Model Auto-Pure96 AS-17061-02 96-Deepwell plate, IT, for Auto-Pure96; 50 EA Throughput 1-96 AS-17061-03 96-Elution plate; IT; for Auto-Pure96; 100 EA Process volume 50-100 µl AS-17061-01 Magnetic tip comb; IT; for Auto-Pure96; 50 EA Consumables 96-deep well plate + 96 magnetic rod’s tip

14 RNA EXTRACTION SYSTEM I GSD SARS-COV-2 CATALOGUE GSD SARS-COV-2 CATALOGUE I RNA EXTRACTION SYSTEM 15 AriaMxTM AriaDxTM Real-time PCR System Real-time PCR System

The AriaMx Real-Time PCR system is a fully integrated qPCR solution for amplification, The AriaDx Real-Time PCR system is a fully integrated qPCR amplification, detection, and detection, and data analysis, combining a novel thermal cycler, an advanced optical data analysis system. The system’s modular design combines a state-of-the-art thermal system with LED excitation source, and comprehensive data analysis software. cycler, an advanced optical system with spectra-optimized LED cartridges, and data AriaMx has a closed-tube PCR detection format and can be used with many fluorescence analysis software. The instrument leverages a comprehensive software suite of on-board detection chemistries, including SYBR Green and EvaGreen dyes, and fluorogenic probe instrument diagnostics, giving you confidence that instrument failpoints are identified systems such as TaqMan. Functional reporting, more than 120 attributes, and built-in prior to running your assay. Experience total confidence with AriaDx’s blend of speed, diagnostics assist in troubleshooting. A modular and flexible design with intuitive touch- agility, and precision. screen interface improves productivity. For research use only. Main Features ▪ Blazing Fast Scan Times: < 3 sec. for all 6 channels Main Features ▪ Ready to Go: Factory Calibrated ▪ Usable with many fluorescence detection chemistries, including SYBR Green and ▪ Fast Assay Set Up: Intuitive touch screen interface EvaGreen dyes, and fluorogenic probe systems such as TaqMan ▪ Modular Optical Cartridges: 1-6 filter capability ▪ Combines a novel thermal cycler, an advanced optical system with LED excitation ▪ Low Maintenance and Lower Life Time Costs source, and comprehensive data analysis software ▪ On Board Self-diagnostics to keep your instrument running better ▪ Proprietary rapid hot-start enzymes and fastest industry high-resolution melt reagents ▪ Free Software package ▪ Intuitive operation with a touch screen interface ▪ 21 CFR part 11 compliant software ▪ Modular optics and open reagent platform for increased agility ▪ Multiplex capability with six filters for five plexing and two to five channels ▪ Tight & Accurate Thermal Control ▪ Validated for most applications and chemistries ▪ Intuitive open-source software and robust data analysis with proprietary algorithms ▪ Instrument validated on 100,000+ samples across 14 different assays

16 REAL-TIME PCR SYSTEM I GSD SARS-COV-2 CATALOGUE GSD SARS-COV-2 CATALOGUE I REAL-TIME PCR SYSTEM 17 ELISA Assays NovaLisa® SARS-CoV-2 (COVID-19) IgG, IgM, and IgA for SARS-CoV-2 Detection The NovaLisa® SARS-CoV-2 (COVID-19) IgG / IgM / IgA ELISA kits are intended for the qualitative detection of antibodies to SARS-CoV-2 virus in human serum. The assays are an ideal supplement for the direct pathogen detection and are a valuable tool for epidemiological studies. The ELISA kits demonstrate high sensitivity and specificity: antibodies were detected in all tested samples from patients PCR positive for SARS-CoV-2 12 days after symptom onset (100% sensitivity in this patient group). The specificity is >98%.* * Initial testing on more than 300 samples. Please refer to the product inserts for more details.

Main Features

▪ Separate detection of IgG, IgM and IgA antibodies ▪ Advantages of the NovaTec reagent system ▪ Total incubation under 2 hours ▪ Compatible with diverse open platform ELISA analyzers ▪ CE-IVD

ELISA Assays Product List

Product Format Order No.

GSD NovaLisa® SARS-CoV-2 (COVID-19) Quantitative IgG 96 tests COVQ0970 Multiple immunoassays offered for the qualitative detection of IgG, IgA, and IgM antibodies NovaLisa® SARS-CoV-2 (COVID-19) IgG 96 tests COVG0940 to SARS-CoV-2 virus in human serum. Antibody testing provides information about past ® exposure to SARS-CoV-2, and could help identify donors of plasma from recovered patients NovaLisa SARS-CoV-2 (COVID-19) IgA 96 tests COVA0940 that can be transfused into COVID-19 patients as a potential treatment. NovaLisa® SARS-CoV-2 (COVID-19) IgM 96 tests COVM0940 In addition to the qualitative test, the GSD Group offers a quantitative IgG assay for the new CE marked serological assay is launched for the identification and quantification of antibodies to SARS-CoV-2. This ELISA kit can support vaccination campaigns by monitoring the antibody levels over time.

GSD NovaLisa® SARS-CoV-2 (COVID-19) quantitative IgG

Main Features ▪ Quantitative determination of antibodies to the SARS-CoV-2 spike (S) protein ▪ Trimeric SARS-CoV-2 Spike antigen ▪ Intended as an aid to evaluate patients immune status and determine efficacy ▪ Calibrators correlate to First WHO International Standards for SARS-CoV-2 ▪ Diagnostic sensitivity and specificity of 99.94% and 99.49% respectively ▪ Validated for serum, plasma, and finger prick (serum from capillary blood) samples

18 ELISA ASSAYS I GSD SARS-COV-2 CATALOGUE GSD SARS-COV-2 CATALOGUE I ELISA ASSAYS 19 ThunderBolt® The BoltTM Two-plate ELISA Analyzer One-plate ELISA Analyzer

The ThunderBolt® provides a reliable solution for laboratories needing automation of The BoltTM shares many features of the ThunderBolt®, but with a more customizable, the NovaLisa® SARS-CoV-2 (COVID-19) ELISAs. This 2-plate system with sliding racks lower throughput, cost-effective design. will simplify your laboratory experience and increase your productivity.

Main Features Main Features

▪ Slide-in racks with positive sample identification ▪ Modular design ▪ Simple workflow software that guides you through the process ▪ Simple workflow software that guides you through the process ▪ Designed to suit different laboratory demands ▪ Designed for niche, low throughput demand ▪ High sample loading capacity: 192 primary sample tubes ▪ Sample loading capacity: 96 primary sample tubes ▪ Capable of running many different protocols in a single batch ▪ Capable of running different protocols in a single batch ▪ On-board camera allows remote troubleshooting ▪ No disposable tips, minimal consumables, direct in-well dilution ▪ No disposable tips, minimal consumables, direct in-well dilution ▪ Occupies minimal bench space ▪ Occupies minimal bench space ▪ CE Marked ▪ CE Marked

Product Specifications Product Specifications

Product Order No. Product Order No.

ThunderBolt® ELISA Analyzer 00300 The BoltTM ELISA Analyzer 00500

20 THUNDERBOLT I GSD COVID-19 CATALOGUE GSD SARS-COV-2 CATALOGUE I BOLT 21 Antigen Rapid Test Test procedure for SARS-CoV-2 Detection Nasopharyngeal Swab: Insert a sterile swab into the nostril of the patient, reaching the surface of the posterior nasopharynx. Swab over the surface of the posterior nasopharynx 5-10 times. Nasal Swab: Insert a sterilized swab into a nostril. Rotate the swab 5-10 times against the nasal wall and repeat in the second nostril.

Interpretation of results

Control Line (C)

Test Line (T)

Specimen Wells (S)

Positive Negative Invalid

The GSD NovaGen SARS-CoV-2 Ag Rapid Test is a rapid chromatographic immunoassay Accuracy of results for the qualitative detection of SARS-CoV-2 Nucleocapsid (N) Protein antigens present in respiratory samples. Specimen Nasopharyngeal Swab Nasal Swab

This lateral-flow test meets the WHO performance criteria for use in the global fight Sensitivity 93.40% 93.50% against COVID-19. Specificity 99.40% 99.30% Accuracy 97.90% 97.60%

GSD NovaGen SARS-CoV-2 Ag Rapid Test *Results compared with RT-PCR

Main Features

▪ Current mutant strains can be detected (UK, South Africa, Brazil) Antigen Rapid Tests ▪ Easy specimen collection: nasal and nasopharyngeal swabs ▪ Fast results in 15 minutes Product Format Order No. ▪ Intuitive visual interpretation GSD NovaGen SARS-CoV-2 Ag Rapid Test (NP swab) 20 tests CVAG408A ▪ High sensitivity and specificity GSD NovaGen SARS-CoV-2 Ag Rapid Test (Nasal swab) 20 tests CVAG408B ▪ Easy to perform: no special equipment needed *Not available in the US. ▪ CE-IVD marked

22 ANTIGEN RAPID TEST I GSD SARS-COV-2 CATALOGUE GSD SARS-COV-2 CATALOGUE I ANTIGEN RAPID TEST 23 Technical Support Ordering information To Simplify Lab Experience NovaTec Immundiagnostica GmbH Email: [email protected] Tel.: +49 6074 4876 0 Address: Waldstraße 23, A6, 63128 Dietzenbach, Germany

Real-Time PCR Assays GSD NovaPrime® SARS-CoV-2 (COVID-19) GSD NovaPrime® SARS-CoV-2 Direct RT-PCR GSD NovaPrime® Plus SARS-CoV-2 RT-PCR GSD NovaType II SARS-CoV-2 GSD NovaType III SARS-CoV-2 GSD NovaType Select Assay Family ELISA Assays NovaLisa® SARS-CoV-2 (COVID-19) IgG, IgA, IgM GSD NovaLisa® SARS-CoV-2 (COVID-19) quantitative IgG

Antigen Rapid Tests GSD NovaGen SARS-CoV-2 Ag Rapid Test

Gold Standard Diagnostics International Kft. Gold Standard Diagnostics Technical Support is dedicated to providing reliable, local, Email: [email protected] and quality service so that your laboratory never stops running. Address: Fóti út 56. 1047, Budapest, Hungary

Our Services RNA Extraction Kits 1. Program, install, and verify new protocols GSD NovaPrime® IVD RNA Extraction AE1 / AE1 RTU / AE2 2. Immediate phone and online support to instrument operators 3. Regular professional maintenance RNA Extraction Automation 4. On-site repair of instrumentation with guaranteed response time GSD Auto-Pure 96 Nucleic Acid Purification System

Your Solutions PCR Cyclers Aria MxTM, Aria DxTM Real-Time PCR Systems 1. Optimize the value of your current automation 2. Quick access to automation experts 3. Well-documented and traceable maintenance to ensure quality 4. Reduce downtime, and maximize your laboratory’s throughput

Contact Details Phone: +49 6074 48 76 186 Email: [email protected]

24 TECHNICAL SUPPORT I GSD COVID-19 CATALOGUE GSD SARS-COV-2 CATALOGUE I ORDERING INFORMATION 25 NTM018.0721-EN

www.goldstandarddiagnostics.com