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Analyte Depleted Serum

Why choose BBI Serum? 

Our specific analyte depleted, pooled normal human serum/plasma has levels below that of the most sensitive test methods. Our range of analyte depleted, normal human serum products use well defined, optically clear 0.2µm filtered off the clot serum or processed plasma as base material. The range is specifically designed for critical applications where a highly demanding specification is required.  

Superior performance  

Our streamlined range of analyte depleted serum products offers superior performance, with analyte levels below the limit of detection for most assays. Serum/plasma products are sourced from US licenced plasma collection facilities. The material is shipped to BBI for processing where BBI uses a range of proprietary methodologies including ligand affinity techniques to reduce the specified analyte content to very low levels.  

After processing, the material is 0.2µm filtered and stored pending fill. The processed material is tested using state-of-the-art methods defined by the analyte to check that the specification has been reached. The material is filled under laminar flow into defined aliquots and stored frozen in clear plastic bottles. The base serum protein concentration is, where necessary, returned to a normal level. 

Please contact our Customer Services Team directly to discuss your requirements on tel:+44 (0) 1495 363000 or alternatively you can submit an enquiry here.

Serum and Plasma FAQs

Our team are here to help! If you can’t find the answer you are looking for contact us

BBI supplies the following human serum and plasma products:

Pooled normal human serum and plasma for use as calibrator/control bases and product testing
Pooled specific disease state plasma used for calibrators/controls for immunology products
Analyte depleted serum and plasma used as negative base for calibrators/controls

Plasma and serum are both the liquid portion of blood that remains once the cells are removed.

Plasma is the liquid that is formed when the cellular components are removed, and clotting is prevented with the addition of an anticoagulant. There may be residual anticoagulant remaining in
the plasma.

Serum is the liquid that remains after the blood has been allowed to clot, then the cellular components are removed. It does not contain fibrinogens as these are removed as part of the blood clot. The
resulting serum will not contain any anticoagulant.

Typical volumes depend on the specific product however in general individual unit volumes for Disease state plasma range between 1ml samples and up to 1L however generally these are available as 200-
240ml remnants and 850-950ml units with samples of 1-5ml. Depleted serums and pooled normal human serums are available in lots of up to 50L.

Disease state serums and plasmas are collected as remnants and as plasmapheresis units, the availability is specific to the analyte. Please contact your account manager for details.

Specific immunoassays are normally used to determine the levels of the analytes. These are specified on the Certificate of Analysis. In some cases it is possible to offer an alternative method to those
stated, please contact your account manager for details. In certain cases, the materials are tested by LC-MS (Liquid chromatography mass spectroscopy).

Plasma and serum samples can normally be provided however to ensure that the product is likely to meet the requirement it is essential to agree the titre requirement and testing methodology as well
as any other specifications prior to sampling. Units of the bulk can be held for a maximum of 3 months pending sample approval.

These products are processed at our ISO13485 accredited site in Sittingbourne.. The specific methodologies are proprietary to BBI however a general depletion methodology can be provided after execution of a Non-disclosure agreement.

Serums and plasmas should be stored below -15°C and the use of dry ice is recommended for shipping. Repeated freeze-thaw cycles should be avoided as this can cause the material to become “cloudy” due
to residual Fibrinolysis.

This is product specific and is described in the Certificate of Analysis of each individual product. Normally the product is supplied 0.2µm filtered and tested for bioburden however this is not always
the case for Disease state plasma units.

BBI’s Serum and plasma is collected at hospitals and blood banks worldwide, specific sources can be used if requested however bespoke collections can take additional time to facilitate. Most Pooled
normal human serum and plasma and depleted serum are from US sourced paid blood donations.

Most of our products are screened for the current World Health Organisation (WHO) list of recognised infectious agents (https://www.who.int/bloodsafety/ScreeningDonatedBloodforTransfusion.pdf) and the results are listed on the product C of A, however as they are derived from human materials they should be treated as potentially hazardous and only handled in laboratories with appropriate biological containment facilities. Some Disease State Plasma products may be positive for specific infectious agents which will be reported on the product Certificate of Analysis. These materials should be handled in laboratories with appropriate biological containment facilities.

All our serum and plasma products will be dispatched directly from our Sittingbourne facility. Our terms are “FCA” meaning it is the customers responsibility to ensure the package is delivered safely.
We use an air courier service and we will make a charge for this service or pass the shipping charges forward.

Specific stability trials are not carried out on serum and plasma products. In general, it is the responsibility of the client to determine the stability using the specific assay linked to their application.
As human Serum and plasma products are generally considered to be stable for at least 5 years when stored frozen.

Technical information and product specifications can be found in the product-specific Certificate of Analysis and the Product Information Sheet. If any further technical information is required, this can be requested by emailing technicalsupport@bbisolutions.com.

In the unlikely event of having an issue with the product performance we will endeavour to find a satisfactory resolution. In the first instance contact your account manager who will advise on the
course of action to resolve any issue.

Refer to our website, contact your account manager or contact technical support (technicalsupport@bbisolutions.com). Your inquiry will then be routed to the most appropriate department.

Uses of Analyte Depleted Serum 

Analyte depleted serum is used for number of defined applications within the IVD industry but is often also useful in research and development applications. To define the linearity of an assay dose response curve it is important to be able to measure an analyte below the reference range (the normal concentration of the analyte in the matrix). 

In IVD methods the normal biological matrix for measurement of analytes is blood serum or blood plasma. Performing these measurements with a base that does not contain the wider biological components in the measuring systems can lead to inaccurate results due to the unique components of serum such as albumin (a binding protein) immunoglobulins and other plasma proteins. To avoid these inaccuracies and to record results that are as close as possible (commutable) with the patient sample requires the use of a depleted serum. The other potential use is in serological applications where the assay is not detecting the analyte but the host immune response. Here a low-level base will give a negative response across all assay specificities such as infectious disease, autoimmune and allergy assays. 

There are many analytes in serum/plasma samples that give a clinician information about the status of a patient these range from small molecules such as Vitamin D and hormones like oestrogen and testosterone through to complex peptides and proteins. Each of these potentially could require a specific depleted serum for the above applications.  

At BBI we have focused on the provision of three main groups of depleted serum product; firstly small molecule depleted where the small molecule can be removed by the use of charcoal or other absorbing materials which may remove multiple analytes, examples include Vitamin D depleted and Thyroxine (T4) depleted. 

Secondly the specific protein depleted serum, in this case immunoaffinity or specific ligand affinity methods can be used to deplete the serum, examples include CRP depleted, NSE depleted and TBG depleted. For this group of products, it is sometimes important to be able to add back the analyte in question to perform linearity studies. For products manufactured using immunoaffinity depletion often antibodies can leach from the immunoaffinity gel and be left in the serum, these can confound the spike of analytes and BBI has developed a method for avoiding this issue.  

The third group is where we have provided material depleted of a whole class of proteins, here the only example is our immunoglobulin depleted serum. This material has been successfully used as a negative base in serological assays and can be useful in the assessment of vaccines. 

Our Serum is made to meet your specific requirements 

BBI depleted serum products are almost exclusively made to order as each assay LOD can vary however we hold stock of some of the more common depleted serums. It should be noted here that a customisation service can be offered to prepare depleted serums that are not listed however there is a minimum order value for this service. 

BBI depleted serum uses pooled normal human serum or pooled normal human processed serum produced from plasma as a base. This is then depleted using a defined methodology and then the material is formulated. This formulation can is normally an adjusted base buffer and correction of the protein concentration after depletion followed by 0.2µm filtration. Materials are then tested using a range of different analyte assays for example defined immunoassays or Liquid Chromatography/Mass spectrometry methods (LCMS/MS) to establish that the limit of detection for the assay has been met. In some cases, this can be below ng/ml. Material is aliquoted and provided frozen it is shipped on dry ice. 

 

 

 

 

 

 

 

 

 

 

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BBI Solutions Brands

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The acquisition of DIARECT in June 2020 and their world leading recombinant autoimmune antigen capability immediately enhances BBI’s portfolio and position as a ‘complete’ immunoassay reagent supplier. This further enhances BBI’s position as the world’s largest diagnostics components company with a market leading antigen portfolio.

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Maine Biotechnology Services brings 27 years of knowledge, experience, process development, and project management to our customers to ensure the best possible antibodies for any application. As antibody development goals in the biotechnology and pharmaceutical industry have evolved the acquisition of MBS will help BBI further meet and exceed our customers needs.

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