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Objectives of the Model List of Essential In Vitro Diagnostics
The EDL outlines a group of IVDs that are recommended by WHO for use at various levels of a tiered national health care system. The EDL is not intended to be prescriptive with respect to the IVDs listed or the levels at which such IVDs can/should be used.
Rather country programs should make the ultimate decisions about which IVDs are selected and where they are implemented, based on the national or regional burden of disease, unmet needs, and priorities.
It is expected that the EDL will provide guidance and serve as a reference to Member States (including ministries of health, program managers, end-users such as laboratory managers, procurement officers, and reimbursement systems).
who are developing and/or updating lists of national essential IVDs for defining universal health coverage interventions, as well as selecting and implementing such IVDs?
It will also inform United Nations agencies and non-governmental organizations that support selection, procurement, supply, donations, or provision of IVDs. Finally, it will inform and guide the medical technology private sector on IVD priorities and the IVDs needed to address global health issues.
While the EDL provides a list of important tests required at various levels of the health care system, it is important to note that the EDL itself cannot have an impact without an integrated, connected, tiered laboratory system, with adequate human resources, training, laboratory infrastructure, and regulatory/quality assurance systems.
Impact also requires Member States to adopt and adapt the EDL and develop national and regional EDLs, as well as to implement the selection and supply mechanisms necessary to ensure access to the IVDs.
Scope of the first edition of the EDL
Based on the EDL selection criteria described below, the EDL consists of:
A group of general laboratory tests that can be used for routine patient care as well as for· the detection and diagnosis of a wide array of disease conditions – communicable and NCDs.
These IVDs are grouped by test discipline (e.g. clinical chemistry, serology, hematology, microbiology, and mycology) and specific test type (e.g. bilirubin, complete blood count, etc.).
IVDs are designed for the detection, diagnosis, and monitoring of each of the following WHO key· disease areas: HIV, TB, malaria, HBV/HCV, and HPV and syphilis. These IVDs are grouped by disease area and analyte tested.
The EDL does not list specific test brands but rather consists of IVDs described according to their biological targets.
Where specific products in categories of tests contained in the EDL have been prequalified by WHO or are recommended by a WHO disease program, a link is provided to that information, which is updated regularly.
EDL content and format
For each specific test listed in the first edition of the EDL, the following are described:
Test purpose: Purpose for which the test can be utilized.·
Assay format: The assay format or formats in which the test is generally· available, e.g. enzyme immunoassay, nucleic acid testing.
Specimen type: The types of specimens that can be used for the test.·
Facility level: The level of the tiered health care delivery system for which· the test is suggested, as described below.
Link to WHO guidance: If there is existing WHO guidance available on the test or· category of testing, a link is provided to the appropriate location on the WHO website.
WHO PQ or endorsed products: For each specific test for which there are brands of products· either prequalified by WHO or otherwise endorsed by WHO, a link is provided.
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