BN™ II System Products and Assays Online Training

Upon successful completion of this course, you will be able to: Identify products that are used on the BN™ II System and how they are packaged List key information found on product lists and package insert sheets Describe how to access and identify assay protocol data using the Table of Assay Protocols Siemens Healthineers manufactures the reagents, standards, controls, buffer, and diluent used to run assays on the BN™ II System. Let’s look at how these products are packaged and identified, and the special features of the different types of products.     Siemens Healthineers manufactures more than 90 plasma protein products. Use the following resources to learn more about these products and their corresponding assays: Siemens Healthineers product lists Package insert sheets Table of Assay Protocols Let’s take a closer look at each resource.     Package Insert Sheets Learn about package insert sheets. Siemens Healthineers plasma protein products are packaged and handled in a variety of ways. Where do you find all of this information for the product you’re using? The Package Insert Sheet Reviewing the information on package insert sheets is the key to using products correctly. You’ll find that the sheets have a common format. Although all of the information is important, let’s focus on a few significant areas. See the Intended Use information or Specimen Handling if a reagent is intended for use with serum, plasma, urine, or cerebrospinal fluid samples See the Preparation of Reagents information to find instructions for reconstituting a reagent that is in the lyophilized form See the Materials Required but Not Provided information to ensure you have all the materials you need to perform the assay        Table of Assay Protocols Learn about the table of assay protocols. Base ImageHotspotsText BlocksImage FileThe range of measure at the dilution that is pre-programmed for that assay (which is listed in the Initial Sample Dil. column)The range of measure at the lowest dilution that is allowed for that assay (which is listed in the Minimum Sample Dil. column)The amount of protein that a given population is expected to haveFill volumes available: two fill volumes are available for some reagentsGuidelines to be used for reagent stability on the BN™ II System. These guidelines are also available in the package insert sheets. Also, refer to Remark #3Guidelines to be used for reagent stability on the BN™ System when reagent vials are fitted with BN™ II Evaporation StoppersThe amount of the diluted sample that is transferred from the dilution well to the reaction cuvette Congratulations. You’ve completed the BN™ II System Products and Assays Online Training course. Listed below are the key points that have been presented. Take time to review the material before you proceed to the final quiz. Identify Siemens Healthineers products used on the BN™ II System and how they are packaged Now you know that reagents are packaged in 5-mL vials, whereas standards and controls are packaged in 2-mL vials. And you know that all products have a unique six-digit number composed of an identifier number and a lot number. You've also learned that classical antisera are packaged with one vial per box, whereas vials of latex and supplemental reagents may be packaged individually or together in kits. List key information found on product lists and package insert sheets You’ve learned that product lists are a good place to look for catalog numbers, product descriptions, fill volumes, and number of tests per vial or kit. And now you know that package insert sheets contain key information that you need to correctly perform assays, such as indicated use, instructions for preparing reagents, required materials that are not provided, and sample preparation. Describe how to access and identify assay protocol data using the Table of Assay Protocols You’ve learned that the Table of Assay Protocols is a valuable resource for information, such as reference ranges of proteins, the on-board stability of reagents and controls, and the measuring range for various assays.   Siemens Healthineers plasma protein products include reagents used to quantitate plasma protein levels, as well as standards for calibrating assays and controls for verifying performance. Plasma protein reagents include: Classical antisera Latex reagents Supplemental reagents   These reagents are manufactured in 5-mL vials; however, the fill volumes range from 1.5 mL to 5 mL. To accommodate varying workloads, several reagents are available in two different fill volumes: 2-mL volume for 40 tests 5-mL volume for 120 tests   Plasma protein standards and controls are packaged in 2-mL vials. The fill volumes vary according to the product.   All Siemens Healthineers plasma protein products are labeled with a unique six-digit number. The first four digits (circled in red) represent the product identifier or name so, for example, the first four digits of every IgG vial will be the same. The last two digits (circled in blue) represent the lot number and will change with each new lot of product made.   The Siemens Healthineers plasma protein reagents contain high-titered antisera that consist of purified, specific antibodies specially tested and adjusted for optimal performance on the BN™ II System. There are three main types of reagents: Classical (serum-based) antisera, which have a clear appearance. Latex reagents, which have a milky appearance. Supplemental reagents, which are used with classical antisera and latex reagents for some assays to increase sensitivity. Let’s take a closer look at these.   Classical Antisera & Supplemental Reagents Learn about classical antisera & supplemental reagents. Classical antisera, such as those used to assay IgG, IgA, and IgM contain antibodies to the specific immunoglobulins being measured and are packaged in one vial per box. For some assays, a supplemental reagent is used with a classical antiserum to make the assay more sensitive. For example, in the IgA-sensitive assay, Supplemental reagent/precipitation is used with IgA antiserum to measure the immunoglobulin when it is present in a lower concentration. Supplemental reagent/precipitation is packaged separately, with one vial per box. Latex Reagents & Supplemental Reagents Learn about latex reagents & supplemental reagents. Latex-enhanced assays require two reagents: a latex reagent (antibodies bound to latex particles) and a supplemental reagent. Two examples of latex-enhanced assays are the Rheumatoid Factors assay and the High Sensitivity CRP assay. Reagents used to perform the Rheumatoid Factors assay—RF Reagent and RF Supplementary Reagent—are packaged together in a single kit. Depending on the size of kit, each kit contains three or four vials of latex reagent and three or four vials of supplemental reagent. The reagents paired in a kit must always be used together. In contrast, the latex reagent and supplemental reagent used to perform the High Sensitivity CRP assay are packaged separately—the lot numbers of these two reagents do not have to be paired. Siemens Healthineers plasma protein standards and controls are packaged in 2-mL vials. Standards are used to calibrate assays on the BN™ II System. Standards contain known concentrations of plasma proteins. Controls are run to ensure the accuracy of your test results. Like standards, controls also contain known (assayed) concentrations of plasma proteins. You can easily enter plasma protein assay values for each standard and control lot into the BN™ II System. The values are encoded in the barcode lines in the Table of Analytical Values sheet, which is packaged with each control and standard. Place this sheet on a flat surface, and use the system's barcode wand to scan the barcode lines. Or you can enter these values manually.   The BN™ II System uses three system liquids: buffer, diluent, and wash solution. N Reaction Buffer is packaged in a 5-L container (the N stands for nephelometer). For most assays, buffer is added to the reaction cuvette to optimize the conditions of the reaction.   N Diluent is also packaged in a 5-L container. It is used to make the dilutions for every sample, standard, and control that is processed. It is also added to the reaction cuvette for some assays.   Wash Solution is prepared by mixing BN™ II Additive with 5 L of distilled water. It is used to clean the probes and cuvettes. Also, wash solution is dispensed into the cuvettes when the analyzer enters standby or shutdown mode. To maintain quality, never pool old and new containers of buffer, diluent, standards, reagents, or controls.   Welcome to the BN™ II System Products and Assays Course. In this course, you’ll learn about the reagents, controls, and standards used on the BN™ II System and how these products are packaged. You’ll also become familiar with product lists and package insert sheets. The package insert sheets are shipped with each product, and they contain information that is critical to the proper handling of products and samples when you run plasma protein assays. Finally, you’ll be able to describe the general features of more than 40 assay protocols, which are found in the Table of Assay Protocols, one of our most valued resources.