Convenient sample collection for the CE-marked EUROIMMUN ELISAs for detection of

anti-SARS-CoV-2 antibodies (IgG)

Smooth integration into existing processes and automation solutions

For determination of the antibody status and collection of epidemiological data

COVID-19 diagnostics with

dried capillary blood

2

Benefits for your lab

Automated processing

All work steps can be automated. Completesample traceability is ensured at all timesdue to unique sample IDs.

All components from one manufacturer

EUROIMMUN offers all materials requiredfor complete DBS diagnostics. In this way,matching work processes are provided to-gether with complete service.

Benefits for the senders

Fast and easy blood collection

All required materials are included in theEUROIMMUN Blood Collection Set: alcoholpad, lancet, blood collection card and plas-ters. The blood collection cards can also bepurchased separately.

Easy shipment

The blood collection card with the DBS canbe sent to your lab by post using the stampedreturn envelope. No cooling required.

7. A physician ex-plains the test re-sult to the patient.

6. Your lab transmitsthe test result to thesender.

5. The sample is analysed using the EUROIMMUN ELISAs. 4. The sample is ex-

tracted from the DBS.

3. The DBS are punched out of the blood collection card.

2. Your lab receives the blood collection card for analysis.

1. Using the blood collection kit, the patient collects a blood sample from the fingertip. This can be doneconveniently at home or at a physician’s office.

Expand your customer range by offering dried blood spot analyses

The use of dried blood spots (DBS) as sample material reduces the blood collection to a quick prick into sthe fingertip, sparing patients the burdensome and stressful collection of venous blood. The blood spot is brought onto the blood collection card and after drying, it can be sent to the laboratory immediately. For instance, this allows companies to test all their employees in a fast and convenient way through their medical officer.

3

Sprinter XL

EUROIMMUNAnalyzer I-2P

EUROIMMUNAnalyzer I

EUROMappingToolEUROMappingTool

EUROMappingTool

EUROLabWorkstation ELISAEUROLabWorkstation ELISA

1 h

37 °CPanthera-Puncher™ 9

Date / Datum

Name

green: EUROIMMUN product, blue: Please get in touch with your EUROIMMUN contact for information on the PerkinElmer products

Note: The processing times given apply to the Anti-SARS-CoV-2 NCP ELISA (IgG).

EUROMappingTool

Loading of the extracts in sample tubes with unique ID

EUROIMMUN Analyzer I and Analyzer I-2P

Processing time: 3 h 10 min or 2 h 55 min

Sample throughput: 57 or 49 tests/hour

Sprinter XL

Processing time: 2 h 45 min

Sample throughout: 87 tests/hour

EUROLabWorkstation ELISA with

8 incubators

Direct loading of the 96-well plates withextracts from DBS

Parallel processing of up to 15 ELISAplates with 1,390 samples

Processing time: 5 h 37 min

Sample throughput: 245 tests/hour

or

or

Test resultT t lt

Sample analysis

Sample extraction

Punching

Blood collection card with unique ID

Automation solutions for every laboratory size

The blood collection cards and the EUROIMMUN ELISAs for detection of anti-SARS-CoV-2 antibodies arevalidated for fully automated processing on the EUROLabWorkstation ELISA. With every process step,the samples are clearly identified by barcodes. In this way, the laboratory information system (LIS)manages each patient sample from start to finish without any risks of mix-ups.

EUROIMMUN Medizinische Labordiagnostika AG · Seekamp 31 · 23560 Lübeck · Tel.: 0451 2032-0 · info@euroimmun.de · www.euroimmun.de

In a nutshell

Dried capillary blood (dried blood spots, DBS) is a convenient alternative to blood collection from veins.

Detection of anti-SARS-CoV-2 antibodies (IgG) using the established EUROIMMUN ELISAs with DBS samples is CE-marked. Automated processing is validated for the EUROLabWorkstation ELISA.

EUROIMMUN offers all required materials: Blood Collection Sets, ELISA kits and comprehensive solutions for ELISA automation. Automation solutions for the punching and extraction of DBS are offered in cooperation with PerkinElmer.

EUROIMMUN ELISAs for detection ofanti-SARS-CoV-2 antibodies

S1 domain of the spike proteinp p

Anti-SARS-CoV-2 ELISA (IgG, IgA)

Anti-SARS-CoV-2-QuantiVac ELISA (IgG)Anti-SARS-CoV-2-NCP ELISA (IgG, IgM)

Antigen with the strongest immune dominance inthe coronavirus family

Optimised specificity of the ELISA due to the use of a modified nucleocapsid protein (NCP) that only contains diagnostically relevant epitopes

S1 domain of the spike protein contains the immuno-logically relevant receptor binding domain (RBD)

RBD presents an important target antigen forvirus-neutralising antibodies

Antibodies against S1 / RBD are considered the most promising indicator for possible immunity

Excellent performance of the Anti-SARS-CoV-2ELISA (IgG) and good correlation with neutralisationassays confirmed in external studies

NEW! Also available for quantitative IgG determi-nation in standardised units:Anti-SARS-CoV-2 QuantiVac ELISA (IgG)

AAS1 N

Modifi ed nucleocapsid protein

EI_2606_I_UK_A05, 02/2021

Patent applicationpublished

Order information

Category Test system Function Order number

DBS

Blood collection setCE-marked set with EUROIMMUN branding, incl. all materials for easyblood collection from the fingertip

ZV 9701-0101

Blood collection boxCE-marked blank box without EUROIMMUN branding, incl. all materials foreasy blood collection from the fingertip

ZV 9702-0101

EUROIMMUN Blood Collection Card (100 units)

Cards for blood collection for subsequent analysis in the laboratory ZV 9711-01100

ELISA

Anti-SARS-CoV-2 ELISA (IgG)

Detection of IgG antibodies against the S1 domain of the SARS-CoV-2 spike protein

EI 2606-9601 G

Anti-SARS-CoV-2 QuantiVac ELISA(IgG)

Detection of specific IgG antibodies against the S1 antigen of SARS-CoV-2by means of a 6-point calibration curve

EI 2606-9601-10 G

Anti-SARS-CoV-2 NCP ELISA (IgG)Detection of IgG antibodies against the nucleocapsid protein of SARS-CoV-2

EI 2606-9601-2 G

Automa-

tion

PerkinElmer Panthera-Puncher 9 Automatisches Ausstanzen der DBS in bis zu 9 96-Well-Platten 2081-0010*

PerkinElmer DBS Puncher Automatisches Ausstanzen der DBS in bis zu 2 96-Well-Platten 1296-071*

PerkinElmer JanusAutomatisches Versetzen der DBS mit ExtraktionslösungAutomatische Überführung der Extrakte in 96-Well-Platten

AJMDT01*

EUROLabWorkstation ELISA Automatische Abarbeitung der ELISA-Kits im Hochdurchsatz YG 0851-0101

EUROMappingTool Übersetzung der Platten-Barcodes in Barcodes für Probenröhrchen YG 9730-0101

EUROIMMUN Analyzer I/I-2P

Automatische Abarbeitung der ELISA-Kits

YG 0014-0101YG 0015-0101

Sprinter XL 160/240 ELISAYG 0033-0101-3YG 0033-0101-23

* PerkinElmer product

EUROIMMUN Medizinische Labordiagnostika AG · Seekamp 31 · 23560 Lübeck (Germany) · Phone: +49 451 2032-0 · info@euroimmun.de · www.euroimmun.com

Infection diagnosticsAutoimmune diagnostics Allergy diagnostics Antigen detection Molecular genetic diagnostics Automation

For further information on the blood collection procedure visit

https://www.euroimmun.com/bloodcollection

1. Use the lancet to puncture the side of the fi ngertip.

2. Allow the blood droplet to fall into one of the marked circles without touching the card. Repeat the procedure for the

remaining circles. Each circle should be fi lled as completely as possible.

3. Leave the blood droplets to dry at room temperature for 3 to 4 hours.

4. Place the blood collection card into the plastic pouch together with the desiccant and post it within two days.

3-4h

Application

1 Test instruction

1 Blood collection card

1 Gauze swab

2 Plasters

2 Alcohol pads

2 Sterile lancets

1 Sealable plastic pouch with desiccant

1 Mailing envelope

Content

The blood collection set is a collection and mailing set for dried capillary blood samples for use in appropriate in vitro diagnostic

tests. It is suitable either for personal use in a home-use environment, or for blood collection performed by a healthcare profes-

sional.

Intended purpose

For quick and simple blood collection from the fi ngertip without venous puncture

CE-marked for use by patients or medical professionals

Simple storage and mailing of dried blood spots (DBS) without cooling

Samples are suited for automated further processing and analysis using ELISA and blot

Now also available as blood collection box, without EUROIMMUN branding, for your individual design

Blood collection set – Analytics with dried blood spots (DBS)

Only for

INFORMATION!

To perform the proce-

dure, please only follow

the test instruction of

the blood collection set

(ZV_9701_A_INT_C01).

Blood collection set, with EUROIMMUN branding

Order no. ZV 9701-0101

Blood collection box, without EUROIMMUN branding

Order no. ZV 9702-0101

EUROIMMUN Medizinische Labordiagnostika AG · Seekamp 31 · 23560 Lübeck (Germany) · Phone: +49 451 2032-0 · info@euroimmun.de · www.euroimmun.com

Infection diagnosticsAutoimmune diagnostics Allergy diagnostics Antigen detection Molecular genetic diagnostics Automation

ZV_9701_I_UK_B03, 02/2021

* ANVISA-registered

Area Indication / parameter Test system Order number DBS as sample material

Allergy diagnostics 55 different allergens EUROLINE Atopy Screen (IgE) DP 3790 EFor research use onlyin the sense of EU Directive 98 / 97 / EC

Antigen

diagnostics

Dengue virus Dengue Virus NS1 ELISA EQ 266a - 9601 - 1For research use only*in the sense of EU Directive 98 / 97 / EC

Vitamin D defi ciency 25-OH Vitamin D ELISA EQ 6411 - 9601For research use onlyin the sense of EU Directive 98 / 97 / EC

Autoimmune

diagnostics

Rheumatoid arthritis Anti-CCP ELISA (IgG) EA 1505 - 9601 GFor research use onlyin the sense of EU Directive 98 / 97 / EC

Coeliac disease Anti-Gliadin (GAF-3X) ELISA (IgG) EV 3011 - 9601 GFor research use onlyin the sense of EU Directive 98 / 97 / EC

Infection

diagnostics

Bordetella pertussis Anti-Bordetella pertussis Toxin ELISA (IgG) EI 2050 - 9601 GFor research use onlyin the sense of EU Directive 98 / 97 / EC

Borrelia

Anti-Borrelia-ELISA (IgM) EI 2132 - 9601 MFor research use onlyin the sense of EU Directive 98 / 97 / EC

Anti-Borrelia plus VlsE ELISA (IgG) EI 2132 - 9601 - 2 GFor research use onlyin the sense of EU Directive 98 / 97 / EC

Anti-Borrelia-EUROLINE-RN-AT (IgG / IgM) DN 2131 G / MFor research use onlyin the sense of EU Directive 98 / 97 / EC

Lyme ELISA (IgG / IgM) EI 2132-9601 - 24 OFor research use onlyin the sense of EU Directive 98 / 97 / EC

Chikungunya virus Anti-Chikungunya Virus ELISA (IgG / IgM) EI 293a - 9601 G / M For research use only*in the sense of EU Directive 98 / 97 / EC

Cytomegalovirus Anti-CMV ELISA (IgG / IgM) EI 2570 - 9601 G / MFor research use only*in the sense of EU Directive 98 / 97 / EC

Dengue virus

Anti-Dengue Virus Type 1-4 ELISA (IgM) EI 266a - 9601 - 1 MFor research use only*in the sense of EU Directive 98 / 97 / EC

Anti-Dengue Virus ELISA (IgG) EI 266b - 9601 GFor research use onlyin the sense of EU Directive 98 / 97 / EC

TBE virus Anti-TBE Virus ELISA “Vienna” (IgG) EI 2661 - 9601 - 9 GFor research use onlyin the sense of EU Directive 98 / 97 / EC

Measles virus

Anti-Measles Virus ELISA (IgG) EI 2610 - 9601 GFor research use onlyin the sense of EU Directive 98 / 97 / EC

Anti-Measles Virus NP ELISA (IgM) EI 2610 - 9601 - 4 MFor research use onlyin the sense of EU Directive 98 / 97 / EC

Mumps virus

Anti-Mumps Virus ELISA (IgG) EI 2630 - 9601 GFor research use onlyin the sense of EU Directive 98 / 97 / EC

Anti-Mumps Virus AT ELISA (IgG) EI 2630 - 9601 - 3 GFor research use onlyin the sense of EU Directive 98 / 97 / EC

Rubella virus

Anti-Rubella Virus ELISA (IgG / IgM) EI 2590 - 9601 G / MFor research use only*in the sense of EU Directive 98 / 97 / EC

Anti-Rubella Virus Glycoprotein ELISA (IgM) EI 2590 - 9601 - 2 MFor research use only*in the sense of EU Directive 98 / 97 / EC

SARS-CoV-2

Anti-SARS-CoV-2 ELISA (IgG) EI 2606-9601 G CE-marked

Anti-SARS-CoV-2 QuantiVac ELISA (IgG) EI 2606-9601-10 G CE-marked

Anti-SARS-CoV-2 NCP ELISA (IgG) EI 2606-9601-2 G CE-marked

Tetanus Anti-Tetanus Toxoid ELISA (IgG) EI 2060 - 9601 GFor research use onlyin the sense of EU Directive 98 / 97 / EC

Toxoplasma gondii

Anti-Toxoplasma gondii ELISA (IgG / IgM) EI 2410 - 9601 G / MFor research use only*in the sense of EU Directive 98 / 97 / EC

Avidity: Anti-Toxoplasma gondii ELISA (IgG) EI 2410 - 9601 - 1 GFor research use only*in the sense of EU Directive 98 / 97 / EC

Trypanosoma cruzi Anti-Trypanosoma cruzi ELISA (IgG) EI 2212 - 9601 GFor research use only*in the sense of EU Directive 98 / 97 / EC

Varizella zoster virus Anti-VZV ELISA (IgG) EI 2650 - 9601 GFor research use onlyin the sense of EU Directive 98 / 97 / EC

Zika virus Anti-Zika Virus ELISA (IgG / IgM) EI 2668 - 9601 G / MFor research use only*in the sense of EU Directive 98 / 97 / EC

EUROIMMUN test systems for DBS analytics

Analysis with EUROIMMUN test systems

According to

the individual

extraction

and test

instructionse.g. Anti-Borrelia EUROLINE-RN-AT

e.g. Anti-SARS-CoV-2 ELISA (IgG)

Punching and extraction of sample from blood collection card

Extraction and analysis