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Despite the great progress made in prevention
and treatment, infectious diseases endure to affect
the humankind. While traditional pathogen-detection
techniques, like culture, have proven their credibility
over time, they are often slow and sometimes insensitive.
Immunoassay methods have been used for many
decades in the detection of antigen from infectious
agents and immune response; newer methods have
increased the speed of detection. However, serological
laboratory diagnosis of infectious diseases
is perpetrated with numerous types of elementary
glitches. The main basis of the serological tests is
to detect the immune response of the patient to the
probable infectious agent. Hence, it neither detect
the disease directly nor the cause of the disease.
The immune response varies from person to person
and it may hamper the diagnostic accuracy of the
serological tests, because immune system in each
person is unique and polyclonal. The response varies
among individuals because of the variability of the
genetic background; as a result the measurability
of antibodies made in response can be forecasted.
Moreover, antigenic variants leading to diverse serotypes
also play an important role. Therefore, all these
basic problems challenge a diagnostician in order to
select appropriate investigations for diagnosis, their
interpretation and in standardizing serological tests.
Hence, it might lead to wrong decisions and the
ultimate sufferer will be the patient. There has been
an increase in awareness among the clinical and
reference laboratories as well as among the companies
of commercial test kits. Keeping in the view the
problems, it prompted the U.S. National Committee
for Clinical Laboratory Standards (NCCLS) to create
specific guidelines that address ”the generic problems
of preparation and characterization of antigens
and antibodies, testing using these reagents, and
understanding the results.” These approved guidelines
were made public in December 1994.
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