Paul-Ehrlich-Institut

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Reference Material

Ref­er­ence Ma­te­ri­al

The Paul-Ehrlich-Institut provides reference materials for in vitro diagnostic medical devices (IVD) and reference materials for immunoglobulin preparations. IVD are materials of the Paul-Ehrlich-Institut as well as materials produced by the Paul-Ehrlich-Institut on behalf of the WHO.

Reference Material / Pipetting in the laboratory with Eppendorf tubes (Source: Jantakorn Kok/Shutterstock.com)

Definition

Reference material means a material of sufficient homogeneity of which one or more features are specified so that they can be used to calibrate measuring instruments, to assess measuring methods or to determine their values. This material is analysed together with the testing material in a series of measurements. The traceability to international units, if any, must be given. All reference materials must be clearly identifiable and labeled. When handling reference materials, especially in refrigerated or frozen storage, care should be taken to ensure that labels are not damaged.

Updated: 12.05.2022

Biological Reference Material (WHO)

Bi­o­log­i­cal Ref­er­ence Ma­te­ri­al (WHO)

Hepatitis B Virus Genotype Panel for NAT-based Assays, 1st WHO International Reference Panel, 2009
(#5086/08)

Product Code
#5086/08

Description
Hepatitis B Virus Genotype Panel for NAT-based Assays, 1st WHO International Reference Panel, 2009

Instructions for Use (IFU)
IFU HBV genotype panel for NAT assays

Report on the international ring study
ECBS Report HBV genotype panel for NAT assays

Source Materials and Sequences
5086/08 Sequences of the samples 1-15 and phylogenetic trees

Special Requirements
Infectious/lyophilized (no dry-ice shipment)

Price per unit
300 €

Hepatitis B Virus Genotype Panel for HBsAg-based Assays, 1st WHO International Reference Panel, 2011
(#6100/09)

Product Code
#6100/09

Description
Hepatitis B Virus Genotype Panel for HBsAg-based Assays, 1st WHO International Reference Panel, 2011

Instructions for Use (IFU)
IFU HBV genotype panel

Report on the international ring study
ECBS Report HBV genotype panel for HBsAgAssays

Source Materials and Sequences
6100/09 Source materials
6100/09 Sequences of the Samples 4

Special Requirements
Infectious/lyophilized (no dry-ice shipment)

Price per unit
300 €

Hepatitis E Virus RNA for NAT-based assays, 1st International Standard 2011
(#6329/10)

Product Code
#6329/10

Description
Hepatitis E Virus RNA for NAT-based assays, 1st International Standard 2011

Instructions for Use (IFU)
IFU HEV RNA

Report on the international ring study
ECBS Report HEV RNA

Source Materials and Sequences
not available

Special Requirements
Infectious/lyophilized (no dry-ice shipment)

Price per unit
100 €

Publication

Baylis SA, Hanschmann KM, Blümel J, Nübling CM, HEV Collaborative Study Group (2011): Standardization of hepatitis E virus (HEV) nucleic acid amplification technique-based assays: an initial study to evaluate a panel of HEV strains and investigate laboratory performance.
J Clin Microbiol 49: 1234-1239.
Online-Abstract

Hepatitis D Virus RNA for NAT-based Assays, 1st WHO International Standard, 2013
(#7657/12)

Product Code
#7657/12

Description
Hepatitis D Virus RNA for NAT-based Assays, 1st WHO International Standard, 2013

Instructions for Use (IFU)
IFU HDV RNA

Report on the international ring study
ECBS Report HDV RNA

Source Materials and Sequences
not available

Special Requirements
Infectious/lyophilized (no dry-ice shipment)

Price per unit
100 €

Bacterial Reference Panel Transfusion Relevant Bacterial Reference, 1st WHO International Repository of Platelet Strains
(#8483/13)

Product Code
#8483/13

Description

  • Staphylococcus epidermidis PEI-B-P-06
  • Streptococcus pyogenes PEI-B-P-20
  • Escherichia coli PEI-B-P-19
  • Klebsiella pneumoniae PEI-B-P-08

Instructions for Use (IFU)
IFU Bacteria Reference Panel

Report on the international ring study
ECBS Report Bacteria Reference Panel

Source Materials and Sequences
not available

Special Requirements
Infectious/deep frozen (dry-ice shipment)

Price per unit
1 panel 300 €
2 panels 190 €
3 panels 175 €

Mycoplasma DNA for NAT-based assays designed for generic mycoplasma detection, 1st International Standard
(#8293/13)

Product Code
#8293/13

Description
Mycoplasma DNA for NAT-based assays designed for generic mycoplasma detection, 1st International Standard

Instructions for Use (IFU)
IFU Mykoplasma DNA

Report on the international ring study
ECBS Report Mycoplasma DNA

Source Materials and Sequences
not available

Special Requirements
Infectious/lyophilized (no dry-ice shipment)

Price per unit
100 €

Hepatitis E virus RNA genotype panel for NAT-based assays, 1st International Standard
(#8578/13)

Product Code
#8578/13

Description
Hepatitis E virus RNA genotype panel for NAT-based assays, 1st International Standard

Instructions for Use (IFU)
IFU HEV RNA reference panel

Report on the international ring study
ECBS Report HEV RNA reference panel

Source Material and Sequences
not available

Special Requirements
Infectious/lyophilized (no dry-ice shipment)

Price per unit
300 €

Bacterial Strains for Red Blood Cell Concentrates
(#11167/16, #11180/20, #11181/20, #11182/20, #11183/20)

Product Code
#11167/16, #11180/20, #11181/20, #11182/20, #11183/20

Description

  • Pseudomonas fluorescens PEI-B-P-77 (#11167/16)
  • Listeria monocytogenes PEI-B-E-199 (#11180/20)
  • Serratia liquefaciens PEI-B-E-184 (#11181/20)
  • Yersinia enterocolitica PEI-B-E-105 (#11182/20)
  • Yersinia enterocolitica PEI-B-E-176 (#11183/20)

Instructions for Use (IFU)
IFU RBC Reference Bacteria

Report on the international ring study
ECBS Report on Red Blood Cell Transfusion-Relevant Bacterial Reference Strains

Source Materials ans Sequences
not available

Special Requirements
Infectious/deep frozen (dry-ice shipment)

Price per unit
100 €

Repository of Platelet-Transfusion Relevant Bacteria Reference Strains - Enlargement
(#11162/16, #11163/16, #11164/16, #11165/16, #11166/16, #11167/16, #11168/16, #11169/16, #11170/16, #11171/16)

Product Code
#11162/16, #11163/16, #11164/16, #11165/16, #11166/16, #11167/16, #11168/16, #11169/16, #11170/16, #11171/16

Description

  • Bacillus cereus PEI-B-P-57 (spore suspension) (#11162/16)
  • Bacillus thuringiensis PEI-B-P-07 (spore suspension) (#11163/16)
  • Enterobacter cloacae PEI-B-P-43 (#11164/16)
  • Morganella morganii PEI-B-P-91 (#11165/16)
  • Proteus mirabilis PEI-B-P-55 (#11166/16)
  • Pseudomonas fluorescens PEI-B-P-77 (#11167/16)
  • Serratia marcescens PEI-B-P-56 (#11168/16)
  • Staphylococcus aureus PEI-B-P-63 (#11169/16)
  • Streptococcus bovis PEI-B-P-61 (#11170/16)
  • Streptococcus dysgalactiae PEI-B-P-71 (#11171/16)

Instructions for Use (IFU)
IFU Bacteria Reference Panel - Enlargement

Report on the international ring study
ECBS Report Bacteria Reference Panel - Enlargement

Source Materials and Sequences
not available

Special Requirements
Infectious/deep frozen (dry-ice shipment)

Price per unit
100 €

Chikungunya Virus RNA for NAT-based Assays, 1st WHO International Standard, 2017
(#11785/16)

Product Code
#11785/16

Description
Chikungunya Virus RNA for NAT-based Assays, 1st WHO International Standard, 2017

Instructions for Use (IFU)
IFU-Chikungunya Virus RNA Standard

Report on the international ring study
ECBS Report Chikungunya Virus RNA Standard

Source Materials and Sequences
not available

Special Requirements
Infectious/lyophilized (no dry-ice shipment)

Price per unit
100 €

Zika virus RNA for NAT-based assays 1st International Standard, 2016
(#11468/16)

Product Code
#11468/16

Description
Zika virus RNA for NAT-based assays 1st International Standard, 2016

Instructions for Use (IFU)
IFU Zika Virus RNA

Report on the international ring study
ECBS Report Zika Virus RNA

Source Materials and Sequences
not available

Special Requirements
Infectious/lyophilized (no dry-ice shipment)

Price per unit
100 €

Updated: 11.05.2022

Serological Reference Material (WHO)

Sero­log­i­cal Ref­er­ence Ma­te­ri­al (WHO)

Anti-hepatitis B virus "e" antigen (anti-HBe), 1st International Standard 2013
(#129095/12)

Product Code
#129095/12

Description
Anti-hepatitis B virus "e" antigen (anti-HBe), 1st International Standard 2013

Instructions for Use (IFU)
IFU anti-HBe

Report on the International Ring Study
ECBS Report anti-HBe

Source Materials and Sequences
not available

Special Requirements
Infectious/lyophilized (no dry-ice shipment)

Price per unit
100 €*

* for orders from Germany plus VAT

Hepatitis C Virus Core Antigen (HCV core Ag), for HCV core antigen assays 1st WHO International Standard, 2014
(#129096/12)

Product Code
#129096/12

Description
Hepatitis C Virus Core Antigen (HCV core Ag), for HCV core antigen assays 1st WHO International Standard, 2014

Instructions for Use (IFU)
IFU HCV core Ag

International Collaborative Study Report
ECBS Report HCV core Ag

Source Materials and Sequences
not available

Special Requirements
Infectious/lyophilized (no dry-ice shipment)

Price per unit
100 €*

* for orders from Germany plus VAT

Hepatitis B virus "e" antigen (HBeAg), 1st International Standard 2013
(#129097/12)

Product Code
#129097/12

Description
Hepatitis B virus "e" antigen (HBeAg), 1st International Standard 2013

Instructions for Use (IFU)
IFU HBeAg

Report on the International Ring Study
ECBS Report HBeAg

Source Materials and Sequences
not available

Special Requirements
Infectious/lyophilized (no dry-ice shipment)

Price per unit
100 €*

* for orders from Germany plus VAT

anti-CMV-IgG
(#136616/17)

Product Code
#136616/17

Description
anti-CMV-IgG

Instructions for Use (IFU)
IFU anti-CMV IgG

International Collaborative Study Report
ECBS Report anti-CMV IgG

Source Materials ans Sequences
not available

Special Requirements
Infectious/lyophilized (no dry-ice shipment)

Price per unit
100 €*

* for orders from Germany plus VAT

Updated: 11.05.2022

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NAT Reference Material (PEI)

NAT Ref­er­ence Ma­te­ri­al (PEI)

PEI Reference Preparation HIV-1 RNA
(#3441/04)

Product Code
#3441/04

Description
PEI Reference Preparation HIV-1 RNA

Instructions for Use (IFU)
PEI Reference Preparation HIV-1 RNA (#3441/04)

Report on the International Ring Study
not available

Source Materials and Sequences
not available

Special Requirements
Infectious/lyophilized (no dry-ice shipment)

Price per Unit
20,00 €

PEI Reference Preparation HCV RNA
(#3443/04)

Product Code
#3443/04

Description
PEI Reference Preparation HCV RNA

Instructions for Use (IFU)
PEI Reference Preparation HCV RNA (#3443/04)

Report on the International Ring Study
not available

Source Materials and Sequences
not available

Special Requirements
Infectious/lyophilized (no dry-ice shipment)

Price per Unit
20,00 €

PEI Reference Preparation HBV DNA
(#3620/05)

Product Code
#3620/05

Description
PEI Reference Preparation HBV DNA

Instructions for Use (IFU)
PEI Reference Preparation HBV DNA (#3620/05)

Report on the International Ring Study
not available

Source Materials and Sequences
not available

Special Requirements
Infectious/lyophilized (no dry-ice shipment)

Price per Unit
20,00 €

PEI Control Reagent HEV RNA
(#12585/18)

Product Code
#12585/18

Description
PEI Control Reagent HEV RNA

Instructions for Use (IFU)
PEI Controll Reagent HEV RNA (#12585/18) (German)

Report on the International Ring Study
not available

Source Materials and Sequences
not available

Special Requirements
Infectious/lyophilized (no dry-ice shipment)

Price per Unit
20,00 €

PEI Reference Preparation WNV RNA (Lineage 1)
(#13299/19)

Product Code
#13299/19

Description
PEI Reference Preparation WNV RNA (Lineage 1)

Instructions for Use (IFU)
PEI Reference Preparation WNV RNA, Lineage 1 (#13299/19)

Report on the International Ring Study
not available

Source Materials and Sequences
not available

Special Requirements
Infectious/lyophilized (no dry-ice shipment)

Price per Unit
100,00 €

PEI Reference Preparation WNV RNA (Lineage 2)
(#13300/19)

Product Code
#13300/19

Description
PEI Reference Preparation WNV RNA (Lineage 2)

Instructions for Use (IFU)
PEI Reference Preparation WNV RNA, Lineage 2 (#13300/19)

Report on the International Ring Study
not available

Source Materials and Sequences
not available

Special Requirements
Infectious/lyophilized (no dry-ice shipment)

Price per Unit
100,00 €

Updated: 11.05.2022

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Ordering

Or­der­ing

The purchase of our reference material is limited to 5 standards (panels) per year for each preparation (exeption: HEV panel is limited to 2 panels per year).

Order Form for WHO and PEI Reference Material

Shipment

The reference material is shipped in accordance with ADR and IATA and the rules of dangerous goods regulations "UN3373, Biological Substance Category B” and, if necessary, “UN1845" for dry ice.

If the customer commissions a forwarding company to ship the reference material, the Paul-Ehrlich-Institut (PEI) will not be invoiced for the shipping costs.

When reference material is shipped at ambient temperature, we offer certified packaging material in accordance with the packaging instruction PI 650 and charge it to you.

Please obtain a quote for shipping costs from your shipping company in advance.

If you do not have a customer account with a shipping company that transports dangerous goods and cannot issue a pick-up order, we are happy to assist you in arranging a shipping company.

It is in the responsibility of the customer to obtain all necessary import permits or other approvals required for delivery and, in particular, customs clearance (import). The Paul-Ehrlich-Institut must be kept informed of any changes to local legislation.

Payment

Please follow the payment instruction on your invoice:

  • Paul-Ehrlich-Institut (PEI) accepts payments in euros only.
  • Unfortunately, payment by credit card is not yet possible at the Paul-Ehrlich-Institut. However, you are welcome to use services such as PayPal for example, because there you can define your credit card as payment method for your bank transfer.
  • For new customers, advance payment is required with the first order. You will receive an invoice for advance payment.
  • An advance payment is required for customers outside the European Economic Area (EEA). You will receive an invoice for advance payment.
  • Please do not pay before you receive the invoice.

Contact

Email: refmat@pei.de

Updated: 11.05.2022

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