brochure pg version 017-2019-06-17 infectious serology...2019/06/17 · 04 pa g e aesku.group •...

AESKU.GROUP • INFECTIOUS SEROLOGY • VERSION 017-2019-06-17 01PAGE

INFECTIOUS SEROLOGY ....................................03

Diagnosis of Infectious Diseases with AESKULISA® and AESKUBLOTS® .....................03

AESKULISA®

FOR THE DIAGNOSIS OF INFECTIOUS DISEASES ................04

Prenatal Care with AESKULISA® .............................06

OVERVIEW .................................................................06

ELISA TESTING Kit Components ...................................................08 Kit Configuration ..................................................09

Laboratory Diagnosis of Borreliosis with AESKULISA® and AESKUBLOTS® ......................10

HIGHLIGHTS ..............................................................11

AESKUBLOTS® Borrelia-G/Borrelia-M ................. 12

OVERVIEW .................................................................15

IMMUNOBLOT TESTING Kit Components ...................................................16

PRODUCT HIGHLIGHTS ..............................................17

TABLE OF CONTENTS


Diagnosis of Infectious Diseases with AESKULISA® and AESKUBLOTS® Serology refers to the demonstration of specific antibodies in serum or plasma specimen. AESKULISA® and AESKUBLOTS® are widely adopted test formats particularly suited for reliable identification of IgA, IgG or IgM antibodies directed against a range of different pathogens.

The following pages provide an overview of AESKULISA® and AESKUBLOTS® for infectious disease diagnostics and summarize the most important highlights of the individual test systems.

INFECTIOUS SEROLOGY

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Immunoassays are important in routine laboratory services for identification of antibodies in serum or plasma specimen.

AESKULISA® (AESKU Enzyme Linked Immunosorbent Assay) is a test format particularly suited for qualitative and quantitative determination of specific IgA, IgG or IgM antibodies directed against a range of different pathogens.

The following AESKULISA® tests are available order to support the diagnosis of infectious diseases.

AESKULISA®

FOR DIAGNOSIS OF INFECTIOUS DISEASES

AESKULISA® for qualitative and quantitative demonstration of IgA, IgG or IgM antibodies directed against a range of different pathogens supporting reliable diagnosis of infectious diseases.

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RefNo.

Product Name

Pathogen Specific Antigens

Ig Class

Calibration/Standard Range

Equivocal Zone/Cut-off

AESKULISA® FOR THE DIAGNOSIS OF INFECTIOUS DISEASES

AESKULISA®

6012 Toxoplasma gondii IgG

Specific cell wall material from Toxoplasma gondii (Strain RH)

IgG qualitative/quantitative (1–100 IU/ml)

Equivocal: 8–12 IU/mlCut-off:10 IU/ml

6013 Toxoplasma gondii IgM

Specific cell wall material from Toxoplasma gondii (Strain RH)

IgM qualitative/ quantitative (1–100 U/ml)

Equivocal: 8–12 U/mlCut-off:10 U/ml

6022 Rubella Virus IgG

Purified and inactivated Rubella Virus (Strain HPV-77)

IgG qualitative/quantitative (1–100 IU/ml)

Equivocal: 8–12 IU/mlCut-off:10 IU/ml

6023 Rubella Virus IgM

Purified and inactivated Rubella Virus (Strain HPV-77)

IgM qualitative/quantitative (1–100 U/ml)

Equivocal:8–12 U/mlCut-off:10 U/ml

6032 Cytomegalovirus IgG

Purified and inactivated Cytomegalovirus (Strain AD-169)

IgG qualitative/quantitative (1–100 U/ml)


6033 Cytomegalovirus IgM

Purified and inactivated Cytomegalovirus (Strain AD-169)



6035 Cytomegalovirus gB IgG

Recombinant protein composed of immunogenic domains of HCMV gB



Prenatal Care with AESKULISA®

The presentation/exposure of antibodies directed against a variety of different pathogens, which can be harmful to the unborn child, is important for early disease diagnosis during pregnancy as well as immune status determination in preventive medical examinations.

INFECTIOUS SEROLOGY LINE OVERVIEW

RefNo.

Product Name


Ig Class




AESKULISA®

6045 Herpes Simplex Virus 1 (gG1) IgG

Affinity purified glyco-protein gG1 of HSV 1

IgG qualitative/ quantitative (1–100 U/ml)


6048 Herpes Simplex Virus 2 (gG2) IgG

Affinity purified glyco-protein gG2 of HSV 2

IgG qualitative/ quantitative (1–100 U/ml)


6051 Varicella-Zoster Virus IgA

Glycoprotein of Varicella-Zoster Virus (Strain Ellen)

IgA qualitative/ quantitative (1–100 U/ml)


6052 Varicella-Zoster Virus IgG


IgG qualitative/ quantitative (10–1000 mlU/ml)

Equivocal: 50–100 mIU/mlCut-off: 75 mIU/ml

6053 Varicella-Zoster Virus IgM




6062 Parvovirus B19 IgG

Virus-like Particles (VLPs) composed of recom-binant VP2 produced in baculovirus-infected insect cells

IgG qualitative/ quantitative (1–100 IU/ml)

Equivocal:4–6 IU/mlCut-off: 5 IU/ml

6063 Parvovirus B19 IgM

Virus-like Particles (VLPs) composed of recom-binant VP2 produced in baculovirus-infected insect cells


Equivocal:4–6 U/mlCut-off: 5 U/ml

NEW

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Test Principle

Reaction is based on specific interaction of antibodies with their corresponding antigen:

• Wells of the AESKULISA® microtiter plates are coated with pathogen specific antigens.

• If antibodies in patient’s sample are present, they bind to the fixed antigen.

• A secondary antibody, which has been conjugated with the enzyme horseradish peroxidase (HRP), binds to any formed immune complex.

• A clear substrate is converted into a colored product by the conjugated HRP.

• The signal intensity of the reaction product is propor-tional to the antibody activity in the sample and measured photometrically.

Kit Components

Interchangeable Reagents

• Washing solution, substrate and stop solution can be used for all AESKULISA® immunoassays.

• The sample buffer of the AESKULISA® IgA and IgG tests can be used for all AESKULISA® IgA and IgG immunoassays (REF 6xxx).

• The sample buffer of the AESKULISA® IgM tests contains Rf absorbent and can be used for all AESKULISA® IgM immunoassays (REF 6xxx).

ELISA TESTING

Kit Configuration

Conjugates Calibrators Quality Controls

+

Interchangeable Reagents

Antigen Coating 12 x 8 Wells MTP IgA IgG IgM 4 x Calibrators + Control − Control

Sample Buffer

IgA + IgG

Sample Buffer IgM

IgA

IgG

IgM Wash Buffer TMB Stop

Solution

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Laboratory Diagnosis of Borreliosis with AESKULISA® and AESKUBLOTS®

A two-step approach is generally recommended for laboratory confirmation of borreliosis by initially using a screening test with subsequent confirmation of positive and borderline test results, e. g. immu-noblot analysis. Therefore, our product portfolio is composed of sensitive AESKULISA® immunoassays and specific AESKUBLOTS® for the complete serological diagnosis of borreliosis.

RefNo.

Product Name


Ig Class




AESKULISA®

3802 Borrelia-G Purified antigens from all relevant Borrelia species, additionally spiked with recombinant VlsE


Equivocal: 12–18 U/mlCut-off: 15 U/ml

3803 Borrelia-M Purified OspC and recombinant Borrelia specific p41i fragment

IgM qualitative/quantitative (0–300 U/ml)

Equivocal: 12–18 U/mlCut-off: 15 U/ml

PRODUCT HIGHLIGHTS

Highlights of AESKULISA® Immunoassays for the Diagnosis of Infectious Diseases

Consistent processing of IgA, IgG and IgM AESKULISA® immunoassays

Short incubation times (30 min – 30 min – 30 min)

Uniform incubation temperatures

Ready-to-use, colored, barcoded and interchangeable reagents

Quantification of the pathogen-specific IgA, IgG and IgM antibody activity

Standardized to international standard preparations, if available

Excellent diagnostic efficiency

High precision and linearity

CE marked

AESKU.GROUP • INFECTIOUS SEROLOGY • VERSION 017-2019-06-17

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Immunoblots are important in routine laboratory services, particularly for the confirmation of positive screening test

results.

While screening tests are usually based on complex antigen mixtures for sensitive detection of heterogeneous antibody pop-ulations, confirmation tests are often used for determination of antigen specific antibodies.

The AESKUBLOTS® Borrelia-G and Borrelia-M are particularly suited for the qualitative demonstration of specific anti-bodies directed against a wide range of different Borrelia antigens.

As a consequence, the complete serological diagnosis of borreliosis can be performed in a recommended two-step approach by initially using our sensitive AESKULISA® and subsequent confirma-tion of positive and borderline test results using our specific AESKUBLOTS®.

AESKUBLOTS® Borrelia-G/Borrelia-MFOR THE DIAGNOSIS OF BORRELIOSIS

The AESKUBLOTS® Borrelia-G and Borrelia-M allow identification of antibodies directed against specific Borrelia antigens to support reliable diagnosis of Borreliosis.


Pathogen Specific Antigens Coated on Test Strips

p100 Late phase IgG marker and IgM marker

VlsE Variable major protein (VMP)-like sequence, expressed; early phase IgG marker

p58 Late phase IgG marker

p41 Flagellin protein

p39 Borrelia membrane protein A (BmpA); early phase marker

OspA Outer surface protein A

OspC Outer surface protein C; early phase IgM marker

p18 Decorin binding protein A (DbpA); late phase IgG marker

Ref No.

Product Name

Tests /Kit

Pathogen Specific AntigensCoated on Test Strips

Ig Class

Calibration

AESKUBLOTS® FOR THE DIAGNOSIS OF BORRELIOSIS

AESKUBLOTS®

4006 Borrelia-G 24 Tests p100, VlsE, p58, p41, p39, OspA, OspC, p18

IgG Qualitative Test

4007 Borrelia-M 24 Tests p100, VlsE, p58, p41, p39, OspA, OspC, p18

IgM Qualitative Test

OVERVIEW

AESKUBLOTS® Borrelia-G/Borrelia-M

Test Principle

Test based on the specific interaction of antibodies with corresponding antigen:

• The AESKUBLOTS® test strips are coated with a range of different pathogen specific antigens.

• If the specific antibodies are present in the patient’s sample, they bind to the coated antigen.

• A secondary antibody, conjugated with the enzyme horseradish peroxidase (HRP), binds to any formed immune complex.

• A clear substrate is converted by HRP into a colored and insoluble product.

• Results of diagnostic lines are evaluated regarding the intensity of the cut-off control.

Highlights of AESKUBLOTS® Borrelia-G/Borrelia-M

Demonstration of antigen specific Borrelia IgG or IgM antibodies

Cut-off and conjugate control to demonstrate test run validity

Simple manual use, minimal laboratory equipment required

Software solution AESKU.SCAN

Semi-automated analysis in combination with HELMED® BLOT

Automated analysis by use of HELIA® analyzer

CE marked

Use of highly purified antigens to guarantee excellent diagnostic efficiency

Quality assured handling through specific color codes and numbered tests strips

AESKU.GROUP • INFECTIOUS SEROLOGY • VERSION 017-2019-06-17

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Kit Components

IMMUNOBLOT TESTING PRODUCT HIGHLIGHTS

IMPRINTPublisherAESKU.GROUP GmbH & Co. KGMikroforum Ring 2-355234 WendelsheimGermany

Managing Director: Dr. Torsten MatthiasDistrict Court Mainz HRA41796

Telephone: +49-6734-9622-0Telefax: +49-6734-9622-2222

E-Mail: [email protected]: www.aesku.com

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Last UpdateJune 17, 2019

brochure pg version 017-2019-06-17 infectious serology...2019/06/17 · 04 pa g e aesku.group •...

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