As the Clinical Laboratory Director of a very prestigious hospital, you are responsible for the overall operation and administration of the laboratory, including the employment of competent qualified personnel. Even though you have the option to delegate some of your responsibilities, you remain ultimately responsible and must ensure that all the duties are properly performed and that applicable Clinical Laboratory Improvement Amendment (CLIA) regulations are met. It is your responsibility to ensure that your laboratory develops and uses a quality system approach to laboratory testing that provides rapid, accurate, and reliable patient test results.
Traditionally, viral diagnostic techniques, especially cell culture, are slow, expensive, and often peripheral to clinical decision-making, particularly when no therapeutic agents are available. The availability of antiviral therapeutic agents such as acyclovir, ganciclovir, foscarnet, cidofovir, antiretroviral drugs, neuraminidase inhibitors, and IFN-? that are effective for specific viral infections but expensive (and in some cases potentially toxic), has created an obvious need for specific viral diagnosis. However, your laboratory has a daily backlog (in hours and sometimes days) of patient samples that prevents the attending physician from making a diagnosis and ultimately treating the patient. Your administration’s patience is being tested because the “turn around” for sample analysis is too long and the “turn over” of hospital beds is slow – patients are not being treated and released in a timely fashion – and the cost to the hospital is increasing due to lack of coverage by insurance companies.
The trend for viral diagnostic testing is to accelerate the diagnostic process while keeping the associated costs low without compromising the accuracy of the diagnosis and/or the patient’s health. As the Clinical Laboratory Director, your task is to decrease the time and cost needed for 1) sample analysis, 2) viral detection, and 3) diagnosis.
In general, diagnostic tests can be grouped into 3 categories. Each of the 3 categories contains various diagnostic tests (not all inclusive) that you will use to evaluate and compare with your classmates.
1. Direct Examination of Specimen
a. Electron and Light Microscopy
b. Antigen detection immunofluorescence, ELISA, etc.
c. Molecular techniques for the direct detection of viral genomes
2. Indirect Examination
a. Cell Culture – cytopathic effect (CPE), haemadsorption, confirmation by neutralization, interference, immunofluorescence, etc.
b. Eggs pocks on CAM – haemagglutination, inclusion bodies
c. Animals disease or death confirmation by neutralization
3. Serology – Classical and Newer Techniques
b. Western blot
c. Complement fixation test
The title of your thread must begin with your choice to use one or more of the diagnostic techniques described and select 1 of the three categories listed above. Then, describe or argue your answer to support your reasoning for the technique(s) you selected against the following criteria: 1) sample analysis, 2) viral detection, and 3) diagnosis.