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The information in this website is intended only for laboratory professionals. By entering this site, you are confirming that you are a laboratory professional.
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.
For most clinical laboratories, the risk of lost or corrupted data—and the time 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
Maintaining the integrity of test results is of utmost importance for any clinical laboratory. Quality Club, an international quality assessment program for ImmunoCAP™ Specific IgE, ImmunoCAP Total IgE, ImmunoCAP ECP™ as well as EliA™ 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:
Detailed, confidential monthly reports to help you monitor laboratory performance
12-month summary reports to assess long-term performance
Priority access to local and international support teams for direct, hands-on assistance
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
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 IMMUNOCAPTM 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
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.
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.
Fig 2. Immunoassay set-up for ImmunoCAP isotype measurements
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
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 fixed granulocytes) |
| Tissue transglutaminase antibodies |
EliA Celikey IgA / IgG, IFA (monkey esophagus) |
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.
Some products may not be available to you, and indications may differ from your original region's approved use.
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