Multichem® Third-Party Quality Controls

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Technopath Manufacturing Ltd is an ISO 13485 accredited manufacturer of Plasma Components, Quality Controls, Calibrators and Proficiency Sera for IVD. The company has particular expertise in test consolidation, analyte stabilisation and platform optimisation.  As might be assumed given the similarity in name, TECHNOPATH Distribution Ltd and Technopath Manufacturing Ltd were once parts of the same organisation. We are now separate companies whereby Technopath Manufacturing Ltd manufacture the Multichem range of Clinical Chemistry QC products, and TECHNOPATH Distribution Ltd then take over from that point and supply directly to end user customers, managing the LOT sequester programs and all customer related support elements.

The Multichem® Clinical Chemistry & Immunoassay Quality Controls are true third-party quality controls not linked to any platform provider, thereby meeting the requirements of ISO15189 and complying with the recommended guidelines from CPA/UKAS.

All of the Multichem® quality control products are manufactured using a uniquely stabilised human matrix that eliminates the need for the high levels of preservatives used in other commercially available controls. These preservatives when used in conjunction with bovine based products can adversely affect the accuracy and reproducibility of test methods.  The Multichem® range is human based and hence mimics the performance of patient samples, thereby minimising any such matrix effects.

The Multichem® product range includes fully test consolidated solutions for both chemistry and immunoassay.  Designed to complement and support Multichem® Quality Controls, the IAMQC QC Software provides Laboratory Managers and Biomedical Scientists with a range of QC software tools to analyse their QC results in real-time.

At TECHNOPATH, we introduced a LOT Sequester Management Program; whereby each of our customers is allocated a specific LOT for an agreed defined period reducing the requirement to run up new LOT’s on a more frequent basis.

With an extensive list of analytes included in the Multichem product range – quality, choice and flexibility is optimised for all customers. For convenience, we have outlined the range of third party QC products in the relevant testing disciplines;

The core cardiac assessment product is the Multichem® hsTn QC for high sensitive troponin assays (includes Troponin I and T). This product provides a high level of stability and confidence in your testing at the low concentrations that are relevant for today’s cardiac assessment strategies. This product can be used as a stand-alone product or in conjunction with the consolidated immunoassay products; Multichem® IA Plus or Multichem® IA, that include a wide range of cardiac markers.

The flagship chemistry product is Multichem® S Plus (S for Serum). Multichem S Plus consolidates over 100 analytes in to a single product. We also offer Multichem® S, which omits Rheumatoid Factor and C-Reactive Protein from the consolidated list of analytes.

In addition to the two main consolidated products, we offer Multichem® NB; QC for pediatric testing of Bilirubin levels, Multichem® AE; QC for ammonia and ethanol and Multichem® CSF, QC for cerebral spinal fluid testing.

Multichem® D-Dimer provides QC material to assess the precision of assays involved in patient testing that informs the diagnosis of thrombotic events.
The leading diabetes product is Multichem® A1c, third party QC for haemoglobin A1c. The haemoglobin A1c test, also called HbA1c or glycosylated haemoglobin, is an important blood test that shows how well a patient’s diabetes is being controlled.

Ovarian reserve testing has increased in popularity over the past few years as a screening test used in conjunction with fertility testing. Multichem® AMH provides third party QC for Anti-Mullerian Hormone testing. In addition, our consolidated immunoassay controls also offer a broad number of fertility analytes – see the Multichem® IA Plus product for more information.

Our flagship immunoassay product is Multichem® IA Plus. Multichem IA Plus consolidates over 90 analytes in to a single product.  We also offer Multichem® IA, which omits CA 19-9, CA 15-3 and CA 125 from the consolidated list of analytes.  In addition to the two consolidated controls, we offer Multichem® IA Speciality, providing extended open vial stability for peptide hormones, in addition to tri-level utility for BNP, PTH, ACTH, PCT and CT.

Multichem® P (P for protein) is specifically designed as a supplementary QC product for immunoproteins to be used in conjunction with our clinical chemistry QC. This product offers elevated concentrations for immunoprotein. Users can use this in conjunction with levels 1, 2 or 3 of Multichem® S Plus or Multichem® S, each of which already include multiple concentrations for immunoproteins.

Multichem® WBT (WBT for Whole Blood Transplant), provides tri-level QC to monitor the precision of laboratory testing procedures for Cyclosporine, Tacrolimus and Sirolimus assays.

Our leading urine chemistry control is Multichem® U. This product provides a single product to cover the majority of standard urine chemistry assays, including Microalbumin, which some other QC manufacturers provide a separate QC product for.

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