Product category: Equipment and systems for HIV determination units, Controls / Standards / Calibrators - Infect. immunology
QUALITY CONTROL PANELS OF SERA
Performance Panels are panels of human sera intended for use in control serological assays. Each Performance Panel consists of a thoroughly characterized series of serum collected from different individuals. The sera members of Performance Panels represent the full reactivity range of the assay, including negative reactivity. Each panel also contains a comprehensive datasheet with testing results from a variety of commercially available test kits. Performance Panels are used to challenge test kits performance, sensitivity, and specificity. The HIV-panels are supplied for incoming control of test kits within the frame of National Project “Zdorovie” (Health), Russia. Performance Panels can be used to evaluate and validate new test methods, new equipment, demonstrate lab proficiency, and train laboratory personnel. As the performance panels represent the Russian collection of sera containing markers of infectious diseases and containing no such markers, they can be helpful for international users during for the test kits characteristics investigation.
These panels were developed under the requirements specification the Tarasevich State Institute of Standardization and Control of Medical Biological Preparations. Each taken separately performance panel of sera was recognized as Immunobiological Standard and has specific branch standard number.
CONTROL AND QUALIFICATION PANELS OF SERA CONTROL SERA - EXTERNAL RUN CONTROLS
Control Panels are panels of human sera intended for use in external control and testing the work standards of clinical diagnostic laboratories. Control Panels are used to demonstrate serological lab proficiency. Control Panels can also be used to challenge test kits performance, sensitivity, and specificity, to evaluate and validate new test methods, new equipment, show up the mistakes occurred during ELISA test kits performance, correct these mistakes, and train laboratory personnel.
Control Panels are included in the program of The Federal System of External Quality Assessment of Federal Service of Surveillance in Healthcare and Social Development (Roszdravnadzor), Russia and local EQA programs.
Each Control Panel contains 4 or 5 positive members and 2-4 negative members. All sera are thoroughly characterized by a range of commercially available test kits.
Qualification panels have similar intended use to that of the Control panels. The sera included into the control panel are differentiated to positive and negative. The sera included into the qualification panel are also differentiated to positive and negative and additionally positive sera are ranged in the order of marker concentration increasing.
Each Qualification Panel contains 4 positive members, which represent serial dilutions of human serum and 1 negative member.
Control sera are intended for laboratory external run control and monitoring of ELISA test kits performance inside clinical laboratory.
Laboratory external run control set consists of equal members representing the preparations lyophilized from inactivated human sera. Each external run control contains certain infectious disease marker, e.g. viral antigen, antibodies to viral antigen.
Medical Biological Union, Ltd. (MBU) is one of the first privately held biotechnological companies in Russia. MBU works in the Health Science field. The company is focused on the development and realization of science-intensive projects resulting in commercialisation of novel products and technologies in the area of pharmaceutics, diagnostics, surgery, and personalized medicine to enhance a quality of human life and an availability of medical care. Researches and developments of MBU are aimed at making facilities and methods of reliable high quality diagnostics of human diseases.