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  • OEM, or Original Equipment Manufacturer, refers to an organisation that manufactures components or equipment used in another company's end product. When it comes to medical device OEM manufacturing, Universal Therapeutics collaborates closely with clients to tailor medical devices to meet specific client-defined requirements and design specifications. This collaborative approach ensures that the final medical devices are precisely aligned with the client's needs and standards, ultimately contributing to the advancement of healthcare technologies.

  • ODM stands for Original Design Manufacturer. In the context of medical devices and Universal Therapeutics, we as a manufacturer specialises in both designing and producing products, which are typically manufactured to be sold and marketed under the client's brand name. This approach allows progressive companies to bring products to market more quickly and efficiently without the need for extensive in-house design and development efforts.

  • Rapid diagnostic tests are serological tests that are designed for use where a preliminary screening test result is required and are especially useful in resource-limited settings.

  • • High quality, easy-to-use tests for use in resource-poor settings.

    • Quick and easy to perform and require little or no additional equipment.

    • Are designed for use with individuals or a limited number of samples, which makes them more economical than Enzyme-Linked Immunosorbent Assays (ELISA) in low throughput laboratories.

    • Possibility to store at room temperature for extended periods of time.

    • Same-day results allow timely treatment interventions.

  • Enzyme-Linked Immunosorbent Assays (ELISA) are highly sensitive and specific. They require sophisticated equipment that must be regularly maintained, constant electricity supply and skilled technicians. They are not suitable for small laboratories and are more suited for testing large number of samples daily, as well as in blood banks or for large-scale surveillance studies. RDTs are better for screening activities, emergency testing and in smaller laboratories with low number of tests per day.

  • A rapid diagnostic test (RDT) is an in vitro diagnostic medical device designed for qualitative or semi-quantitative analysis. It operates on the principle of immunochromatography, employing actions like lateral flow or agglutination to form antigen-antibody complexes specifically with the pathogen's antigen present in the provided sample. Various formats, including dipsticks, microfluidics, and cassettes, are frequently utilised, integrating the sample on a test card alongside specific reagents. These reagents facilitate the generation of results within approximately half an hour.

  • CGIA is founded on the principles of enzyme-linked immunosorbent assay (ELISA), monoclonal antibody technology, and immune chromatographic (CG) techniques. CGIA is simple, fast, and suitable for on-site detection and does not require complex operational skills or expensive equipment which is typically associated with ELISA, monoclonal antibody technology, and immune CG techniques.

  • A. Rapid antigen test:

    Rapid antigen tests detect the presence of specific viral antigens which indicates the current microbial infection. This test is commonly used for the detection of respiratory pathogens like the influenza virus, respiratory syncytial virus (RSV), and coronavirus.

    B. Rapid antibody test:

    A rapid antibody test is designed to detect the presence of a patient-generated antibodies that are produced in response to a specific infection. Typically, the test detects IgG and IgM antibody isotypes. IgM is an antibody that is produced early in the course of infection, while the IgG antibody emerges in the later stages of the infection. Positive test results are indicated when these antibodies are present in the blood sample, signalling an ongoing or past infection in the individual.

  • • Sensitivity is the ability of a test to correctly identify individuals with the disease or condition. A test with high sensitivity will have few false-negative results. The sensitivity of most tests is >95%.

    • Specificity is the ability of a test to correctly identify individuals without disease or condition. A test with high specificity will have few false-positive results. The specificity of most tests is >99%.

  • False-positive and false-negative results are terms used to describe errors in diagnostic testing, including rapid diagnostic tests. These terms refer to situations where the test outcome does not accurately reflect the true status of the individual being tested.

    A false-positive result occurs when a diagnostic test incorrectly indicates the presence of a condition or substance when it is not actually present, while a false-negative result occurs when a diagnostic test fails to detect the presence of a condition or substance that is actually present.

    To minimise false results, test kits with high sensitivity and specificity should be used. In some cases, additional confirmatory tests or clinical evaluation may be needed to validate or refute the results of a diagnostic test, especially if there is a concern about the accuracy of the initial result.