Paul-Ehrlich-Institut

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Reference Material

Ref­er­ence Ma­te­ri­al

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

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: 21.11.2019

PEI Serological Reference Material

PEI Sero­log­i­cal Ref­er­ence Ma­te­ri­al

  • HCV core Ag (129096/12) / 3200 IU/ml / Volume 0,5 ml
  • CMV-IgG (136616/17) 46.4 IU/ml / Volume 1,0 ml
  • anti-HBe (129095/12) 120 IU/ml / Volume 0,5 ml
  • HBeAg (129097/12) 100 IU/ml / Volume 0,5 ml

All Reference Material is infectious Dangerous Good and needs Shipment on Dry-Ice.

Contact

Phone +49 (0) 6103 77 7005
Email: pei-ivd@pei.de

Updated: 21.11.2019

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PEI NAT-Reference Material

PEI NAT-Ref­er­ence Ma­te­ri­al

Contact

Testing Laboratoy PEI-IVD
Phone: +49 (0)6103 77 3309
Email: sigrid.hanitsch@pei.de

Updated: 21.11.2019

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PEI Immunglobulin Preparations

PEI Im­mun­glob­u­lin Prepa­ra­tions

Reference CMV-IgG (12/1996), 110 U/ml
Reference VZV-Ig, 25 U/ampoule (no datasheet available)

Contact

Product Testing of Immunological Biomedicines
Phone: +49 6103 77 2252
Email: standard-igg@pei.de

Updated: 21.11.2019

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WHO Biological Reference Material

WHO Bi­o­log­i­cal Ref­er­ence Ma­te­ri­al

Bacterial Strains for Red Blood Cell Concentrates

Code Number
11167/16, 11180/20, 11181/20, 11182/20, 11183/20

Type of Standard
1st WHO International Repository, 2019

  • 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)

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

Instructions for Use (IFU)
IFU RBC Reference Bacteria

International Collaborative Study Report
ECBS Report on Red Blood Cell Transfusion-Relevant Bacterial Reference Strains

Handling Charge
100 €

With an order of at least four strains the handling charge will be reduced to 80 € per strain.

Repository of Platelet-Transfusion Relevant Bacterial Reference Strains

Code Number
8483/13

Type of Standard
1st WHO International Repository, 2013

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

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

Instructions for Use (IFU)
IFU Bacteria Reference Panel

International Collaborative Study Report
ECBS Report Bacteria Reference Panel

Handling Charge
1 panel (1 x 4 strains) 300 €
2 panels (2 x 4 strains) 380 €
3 panels (3 x 4 strains) 520 €

Repository of Platelet-Transfusion Relevant Bacteria Reference Strains - Enlargement

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

Type of Standard
WHO International Repository - Enlargement, 2016

  • 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)

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

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

International Collaborative Study Report
ECBS Report Bacteria Reference Panel - Enlargement

Handling Charge
100 €
With an order of at least four strains the handling charge will be reduced to 80 € per strain.

Standard for Detection of Antibodies to Hepatitis B Virus e-Antigen (anti-HBe)

Code Number
129095/12

Type of Standard
1st WHO International Standard, 2013

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

Instructions for Use (IFU)
IFU anti-HBe

International Collaborative Study Report
ECBS Report anti-HBe

Handling Charge
100 €

Hepatitis B Virus e-Antigen Standard (HBeAg)

Code Number
129097/12

Type of Standard
1st WHO International Standard, 2013

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

Instructions for Use (IFU)
IFU HBeAg

International Collaborative Study Report
ECBS Report HBeAg

Handling Charge
100 €

Hepatitis B Virus (HBV) Genotype Panel for HBsAg Assays

Code Number
6100/09

Type of Standard
1st WHO International Reference Panel, 2011

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

Instructions for Use (IFU)
IFU HBV genotype panel

International Collaborative Study Report
ECBS Report HBV genotype panel for HBsAgAssays

Handling Charge
300 €

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

Hepatitis B Virus (HBV) Genotype Panel for NAT Based Assays

Code Number
5086/08

Type of Standard
1st WHO International Reference Panel, 2009

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

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

International Collaborative Study Report
ECBS Report HBV genotype panel for NAT assays

Handling Charge
300 €

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

Hepatitis C Virus Core Antigen (HCV core Ag) for HCV Core Ag Assays

Code number
129096/12

Type of Standard
1st WHO International Standard, 2014

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

Instructions for Use (IFU)
IFU HCV core Ag

International Collaborative Study Report
ECBS Report HCV core Ag

Handling Charge
100 €

Hepatitis D Virus (HDV) RNA for NAT Based Assays

Code Number
7657/12

Type of Standard
1st WHO International Standard, 2013

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

Instructions for Use (IFU)
IFU HDV RNA

International Collaborative Study Report
ECBS Report HDV RNA

Handling Charge
100 €

Hepatitis E Virus (HEV) RNA for NAT Based Assays

Code Number
6329/10

Type of Standard
1st WHO International Standard, 2011

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

Instructions for Use (IFU)
IFU HEV RNA

International Collaborative Study Report
ECBS Report HEV RNA

Handling Charge
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 E Virus (HEV) RNA Genotype Panel for NAT Based Assays

Code Number
8578/13

Type of Standard
1st WHO International Reference Panel, 2015

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

Instructions for Use (IFU)
IFU HEV RNA reference panel

International Collaborative Study Report
ECBS Report HEV RNA reference panel

Handling Charge
300 €
Orders are restricted to two panels per lab per year

Cytomegalovirus IgG Antibody Standard (anti-CMV IgG) for Serological Assays

Code Number
136616/17

Type of Standard
1st WHO International Standard, 2017

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

Instructions for Use (IFU)
IFU anti-CMV IgG

International Collaborative Study Report
ECBS Report anti-CMV IgG

Handling Charge
100 €

Chikungunya Virus RNA Standard for NAT Based Assays

Code Number
11785/16

Type of Standard
1st WHO International Standard, 2017

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

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

International Collaborative Study Report
ECBS Report Chikungunya Virus RNA Standard

Handling Charge
100 €

Standard for Mycoplasma DNA for NAT Based Assays Designed for Generic Mycoplasma Detection

Code Number
8293/13

Type of Standard
1st WHO International Standard, 2013

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

Instructions for Use (IFU)
IFU Mykoplasma DNA

International Collaborative Study Report
ECBS Report Mycoplasma DNA

Handling Charge
100 €

Zika Virus RNA for NAT Based Assays

Code Number
11468/16

Type of Standard
1st WHO International Standard, 2016

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

Instructions for Use (IFU)
IFU Zika Virus RNA

International Collaborative Study Report
ECDS Report Zika Virus RNA

Handling Charge
100 €

Contact

Email: whoccivd@pei.de

Updated: 13.01.2021

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).

PEI Serological Reference Material

Order List IVD Reference Material / Bestellliste für IVD Referenzmaterial

[Please always quote your VAT number when ordering IVD reference material]

PEI NAT Reference Material

Order form for PEI NAT Reference preparations / Bestellformular für PEI NAT Referenzmaterial

PEI Immunoglobulin Reference Material

Order List Immunglobulin-Preparations / Bestellliste Immunglobulinpräparate

WHO Biological Reference Material

To order WHO Biological Reference Materials, please complete and return the ordering form. If you are a new customer, please complete and return the Account Application Form.

Order Form for WHO Biological Reference Materials / Bestellformular WHO Referenzmaterial

Account Application Form for WHO Biological Reference Materials

Updated: 02.03.2021

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Shipment

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.

The delivery terms of the PEI are EWX (ex warehouse).

Consequently, the shipping fee is not part of your invoice or pre-payment invoice.

The contract for the shipment of the reference material needs to be concluded by the customer directly with the courier/shipping service provider . Therefore, the shipping costs must be settled by the customer directly with the courier/shipping service provider .

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 request an offer for the dispatch from your courier/shipping service provider 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.

Updated: 15.01.2020

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Payment

Pay­ment

Please follow the payment instruction on your invoice:

  • 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

Fee Collection Unit
Ms. Yanjiao Liu or Mr. Assadullah Ghauri
Email: Yanjiao.Liu@pei.de or Assadullah.Ghauri@pei.de
Phone: +49 (0) 6103 77 1713 or 1716

Updated: 09.04.2020

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