Third Party Quality Controls
Technopath Clinical Diagnostics is one of the largest manufacturers of liquid-ready quality controls globally in compliance with the highest quality standards. Multichem is our class leading third party test-consolidated QC product range. With an extensive list of analytes included in our Multichem product range – quality, choice and flexibility is guaranteed for all customers. For convenience, we have outlined our range of third party QC products in the relevant testing disciplines;
An extensive range of kit formats are currently available, providing greater customer flexibility and choice. As part of our commitment to meet customer requirements as testing menus increase, Technopath is committed to expanding its range of Quality Controls with new products regularly being added to the product offering available to end-users.
Multichem ID-COVID19 controls are the essential independent quality controls designed to test the precision of assays for antibodies IgG and IgM to SARS-CoV-2, to allow clinical laboratories to release patient results with confidence.
Our 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 our consolidated immunoassay products; Multichem IA Plus or Multichem IA, that include a wide range of cardiac markers.
Our flagship chemistry product is Multichem S Plus (S for Serum). Multichem S Plus consolidated 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.
Our 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 board number of fertility analytes – see the Multichem IA Plus page for more information.
Our flagship immunoassay product is Multichem IA Plus. Multichem IA Plus consolidated over 90 analytes in to a single product and can replace up to four competitor products in your lab. 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 1, 2 or 3 levels 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 competitors provide a separate QC product for.
Technopath’s Multichem ID range (ID for Infectious Disease) have been specifically optimised and validated to match assays commonly used for infectious diseases testing. The first two products brought to market include Multichem ID-B (B for Blue), a positive multi-marker QC, and Multichem ID-SeroNeg, a negative QC.
Multichem ID – powered by QConnect
Multichem ID controls can be used as part of the QConnect solution, developed by NRL, Australia. QConnect is your completely integrated and simplified QC solution. QConnect includes the Multichem ID product range, results management and reporting through IAMQC and EDCNet, control limits, Uncertainty of Measurement (MoU) reports, troubleshooting and the ability to liaise with other users.
EDCNet is an internet-based software program specifically designed for monitoring both serology and NAT QC results. EDCNet allows for the simple collection, management and analysis of QC data in real-time. Technopath provide instant access to EDCNet via IAMQC Peer software. For more information visit our informatics section.
Traditional QC approaches used to determine QC limits have been derived or modified from clinical chemistry and may not be applicable to serology. QConnect Limits, developed by NRL, utilise historical data by determining expected upper and lower values of results for each QC sample/assay combination.
Measurement of Uncertainty
To fulfil regulatory requirements with ease, you can access free annual MoU reports specific for your laboratory. NRL has developed a method for estimating and reporting MoU for quantitative assays based on a comparison of your laboratory’s QC results with those reported by other laboratories using the same QC sample/assay combination (peer group).
The NRL website provides you with a repository of information including frequently asked questions about the usage, storage, testing or troubleshooting of results obtained from your QC sample.
Technopath and NRL also supply a list of relevant literature about QC for infectious diseases testing including:
• Journal Publications
• Investigations and Case Studies
• Laboratory Standards and Requirements