ABSTRACT
Over the past two decades, the development of nucleic acid am-
plification technologies (NAATs) and molecular diagnostics has en-
hanced the detection, characterization, and monitoring of infectious
agents, which includes monitoring the emergence of drug resistance
worldwide. In developed regions such as Europe andNorth America,
molecular diagnostics is by now the standard of care for many ap-
plications but generally involves complex instrumentation operated
by highly skilled personnel in a centralized laboratory environment.
In developing countries, molecular diagnostics has proven to be
equally critical to providing appropriate health care, yet a great
need exists for technologies that enable molecular diagnostics to
be performed at the point of care (POC) in low-resource settings.1
Traditional pathogen identification and disease monitoring in low-
resource settings often involves simplemicroscopic tests (e.g., smear
tests for malaria and tuberculosis [TB]), but these tests suffer
from limited sensitivity and specificity. Culture-based methods can
increase sensitivity and specificity but are time consuming, highly
specialized, and expensive, thereby being often unsuitable for low-
resource settings. Rapid diagnostic tests based on lateral flow
immunoassays address the needs of low-resource settings and are
used increasingly. However, these immunoassays again suffer from
limited sensitivity and are often unable to distinguish new from
persistent infections. Thus, lateral flow-based diagnostic tests are
of limited utility in disease monitoring and in aiding treatment
decisions (e.g., for human immunodeficiency virus [HIV]). With the
advent of NAATs, the detection of pathogens, including those that
are unculturable and/or highly contagious, may become possible
in a timely, sensitive, and inexpensive manner.2 Moving molecular
diagnostics to the POC is advantageous for rapid pathogen diagnosis
and disease surveillance and to facilitate effective treatment and
containment, particularly concerning life-threatening disease or
disease outbreaks in both developed and developing countries.
