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Laboratory Services: Phadia LabCommunity and Quality Club for your Laboratory's Needs

Brought to you by ThermoFisher Scientific

Services

Our Comprehensive Offerings Provide Support beyond the Bench

At Thermo Fisher Scientific, we believe that your laboratory’s needs are our top priority. From customer service and technical support, to remote diagnostics and external monitoring of Phadia™ Laboratory Systems, our goal is to partner with your laboratory to help support your staff, ordering clinicians and patients.

Services and Support

Phadia LabCommunity Makes Remote Support Possible for Your Laboratory

For most clinical laboratories, the risk of lost or corrupted data—and the time and costs associated with re-running assays—is a great concern. With Phadia LabCommunity, your laboratory can take advantage of remote troubleshooting, productivity in your laboratory and support to help protect the integrity of your data.

Features of Phadia LabCommunity Include:

  • Encrypted remote data collection to facilitate service and support
  • Automatic removal of sensitive data before data collection
  • Remote assistance and trouble-shooting
  • Automatic reporting of Quality Club proficiency testing results

Compare Your Laboratory's Performance with Quality Club

Maintaining the integrity of test results is of utmost importance for any clinical laboratory. Quality Club, an international quality assessment program for ImmunoCAPTM Specific IgE, ImmunoCAPTM Total IgE, ImmunoCAPTM ECP as well as EliATM autoimmune disease assays, is available for all laboratories that operate Phadia Laboratory systems. Through a system of monthly reports, participating laboratories can evaluate their testing procedures to help maintain reliable, accurate ImmunoCAP and EliA assay results. With a membership of over 1,500 laboratories in more than 60 countries, Quality Club helps set the standard for diagnostic testing with Phadia Laboratory Systems.

Quality Club makes assessing the performance of your laboratory easy. Members receive a program kit containing reagents and materials to use over 4 months. Process the test samples according to the provided schedule, then register your results on the Quality Club website each month.


You will receive:

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Detailed, confidential monthly reports to help you monitor laboratory performance  

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12-month summary reports to assess long-term performance
 

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Priority access to local and international support teams for direct, hands-on assistance

Special Allergen Service (SAS) and customized products

Keeping your laboratory on the cutting edge of allergy research

At times, your laboratory may need to test for rare allergens, antigens, or those not yet commercially available. Through SAS, Thermo Fisher Scientific offers:

  • Rare allergen and customized ImmunoCAP
  • Requests on coupling of new allergens
  • Test service for sensitization to drug allergens, rare allergens, and allergens not available in your territory
  • Monitoring of occupational allergen sensitization for businesses
  • Immunogenicity testing for Biological Drugs and Biosimilars

Based on 50 years of experience in antibody measurements and in vitro testing, we develop customized applications using our technologies and products to meet the specific needs of industrial customers. Current applications include, but are not limited to:

  • Development of over 150 ImmunoCAP products between 1991 and 2017 for IgE antibody analyses on personnel working with enzymes
  • Development of over 20 drug ImmunoCAP for isotype specific immunogenicity testing in clinical trials
  • Special ImmunoCAP Allergen Component developed and used for measurements of IgE, IgG and IgG4 antibodies in clinical trials

Research use only ImmunoCAP and test service

Rare allergen and customized ImmunoCAP

Many rare allergens are available as SAS off-list Research Use Only (RUO) products. It is also possible to request Customized ImmunoCAP for specific IgE, IgG and IgG4 analysis.

SAS off-list research use only drug allergens:

Availability  Drug ImmunoCAP Product
SAS products available for purchase

Cellulase

Dextran

Penicillin MD

Peroxidase

Polyhexanide

Protamine

Atracurium

Bacitracin

Mepivacaine

Methylprednisolone

Propyphenazone

Rocuronium

SAS products available for test service

Cefamandole

Cefotaxime

Cefoxitin

Cefuroxime

SAS provides test service for sensitization to a range of drug allergens, rare allergens, and allergens not available in your territory.

Requests on Coupling of New Allergens through SAS Forum

Via SAS Forum, we receive and investigate requests for novel allergens and customized antigen couplings. Based on clinical history, other tests performed etc. we also invite for collaboration around development of new relevant allergenic sources and/or molecules.

Sample Collection and Handling for SAS

Occupational Allergy

A manufacturer’s occupational health services can rely on our unique ImmunoCAP system for assessing their staff for possible development of hypersensitivity to products or ingredients.

Customized, high-quality coupling service of protein-based substances to our ImmunoCAP platform are available for companies who:

  • Produce or develop enzymes or enzyme containing products
  • Produce substances which may cause allergy related occupational problems
  • Want to measure IgE, IgG, or IgG4 antibodies to allergens/antigens by immunological techniques


Test service is available at Thermo Fisher Scientific Service Laboratories and in partnership with commercial laboratories.

Immunogenicity Testing for Biological Drugs and Biosimilars

If your company develops biological drugs, needs to assess immunological responses, performs clinical studies in the field of allergy or autoimmunity, or wants to measure IgE, IgG, or IgG4 antibodies to drugs/antigens by immunological techniques, SAS can develop customized products to meet your need.

biological drugs

Fig 2. Immunoassay set-up for ImmunoCAP isotype measurements

Application lab

Serum Services offered by Thermo Fisher Scientific

Located in Freiburg, Germany and established as a service laboratory for autoimmune disease diagnostics, the application laboratory is primarily dedicated to provide support in accurately and comprehensively assessing the autoantibody constellations of particular serum samples and their diagnostic significance. As the determination of autoantibodies represents a valuable mosaic stone in the diagnosis of autoimmune disorders, EliA tests exist for the determination of a variety of autoantibody specificities which are of high diagnostic value due to their close clinical association with particular autoimmune diseases. Although these tests have excellent specificity, some samples tested in a routine laboratory may still require further analysis. Clinical diagnosis should only be made after a physical assessment, patient history and laboratory findings are evaluated together. The application laboratory evaluates special sera for purposes of: 1. Confirmation, 2. Service and 3. Clinical Trials.

1. Confirmation

To enable a correct and precise assessment of the autoantibody profile of serum samples an overall evaluation of additional supportive data is sometimes necessary. For this purpose, we offer a comprehensive investigation service which includes:

  • Investigation of the respective serum by various methods (see table below)
  • Comment on the data obtained by our internal investigation
  • On request, provision of a literature package about the issue of interest

2. Service

To make the determination of rare autoantibody parameters more advantageous and economical for customers, Thermo Fisher Scientific offers the determination of such parameters. Samples may be sent to the application lab for the determination of special autoantibody parameters which may be too costly or time-consuming to complete in house.

3. Clinical Trials

Collaboration with Thermo Fisher Scientific in setting up clinical trials is possible via the application lab. Conditions and details are discussed and agreed with both parties prior to commencement of the trial.


Methods available for investigation of serum samples

Parameters Methods Available
  Antinuclear Antibodies (ANA) 

EliA, determination of ANA subspecificities (Ro52 / Ro60, SmBB' / SmD, RNP-A / RNP-C / RNP70), IFA

(HEp-2), Western Blot (nuclear and cytoplasmic extract from HeLa cells)

  dsDNA 
  EliA, IFA (HEp-2, Crithidia luciliae), Farr RIA 
  AMA (M2) 
  IFA (rat kidney), EliA M2 
  LKM-1 Abs 
  IFA (rat liver / rat kidney) 
  Parietal cell Abs 
  EliA, IFA (rat stomach) 

 Tissue transglutaminase (tTG)

 IgA, IgG

 EliA Celikey, IFA Endomysium (esophagus)

 

  MPO / PR3 ANCA 
  EliA, IFA (Ethanol / Formalin / Methanol fixed granulocytes) 
  Tissue transglutaminase antibodies 
  EliA Celikey IgA / IgG, IFA (monkey esophagus) 
Contact

For detailed information about any of these services

Contact your sales representative