Editorial
Developments in immunological technologies leading to improvements in
point-of-care diagnostic testing
Volker Gurtler
a
, Charles Pavia
b,
⁎
a
School of Applied Sciences, Building 223, Level 1, Bundoora Campus, RMIT University, PO Box 71, Bundoora, 3083 Australia
b
Department of Biomedical Sciences, New York College of Osteopathic Medicine, New York Institute of Technology, Old Westbury, NY 11568, United States
abstract article info
Available online 30 May 2011 Rapid and accurate point of care testing is of great concern, especially in terms of detecting infectious disease
outbreaks in developing countries having high population burdens. While numerous detection systems are
currently available, care must be taken in choosing those that are reliable and have proven acceptable levels of
sensitivity and specificity, based on adequate laboratory and pre-clinical trial testing. Two papers in the
current issue show significant advances in technology that could bring Point-of-Care Diagnostic Testing closer
to reality for cholera and environmental mycobacteria.
© 2011 Elsevier B.V. All rights reserved.
Effective strategies designed to control the spread of many
infectious diseases, that could lead to a massive outbreak, have relied
wholly or partly on reactive measures implemented in response to the
detection of the first few recognizable clinical cases. Such measures,
however, may depend heavily on the most readily available detection
system that would be typically based on culture, serology or
molecular techniques. In this regard, a vital niche would be filled if
assays for microorganisms fulfilled regulatory requirements for point-
of-care testing in developing countries because this would overcome
some of the problems associated with the lack of facilities and funding
in these countries. In the aftermath of natural disasters such as the
earthquake in Haiti, that occurred in October 2010, and the floods in
India (July, 2010) these problems are exacerbated and further
highlight the advantages point-of-care testing could make to issues
such as cholera outbreaks, as well as other water- or food-borne
outbreaks. In most developed countries and possibly in some
developing countries, rapid testing for certain infectious diseases is
currently available and has been for several years. Examples of these
include the rapid group A streptococcus antigen test for pharyngitis,
urine antigen tests for pneumococcal pneumonia (Murdoch et al.,
2001) and Legionnaires disease, and testing of saliva fluid for HIV type
1 and 2 antibodies (Holguín et al., 2009). Results from such tests have
shown good specificity and sensitivity, can usually be obtained within
30 min and are easy to use and do not require sophisticated laboratory
facilities or highly trained staff. Accordingly, they fulfil the re-
quirements for rapid and effective point-of-care testing.
Currently, there are scores of commercial serology tests being sold
in high-burden countries without international guidelines recom-
mending their use or efficacy. Some are laboratory-based tests,
whereas others are rapid dipstick tests, which could fill a vital niche
for a point-of-care test. WHO has responded by issuing a negative
policy recommendation – the first of its kind for the organization – on
the usefulness of current commercially available tuberculosis detec-
tion systems (Morris, 2011).
Two papers in this issue of J Microbiol Methods have developed
technologies leading to improvements in point-of-care diagnostic
testing including immunological data from patient specimens (Stavri
et al., in press) or from cultured isolates (Yu et al., in press). One paper
(Yu et al., in press) describes a ready to use point-of-care test that
improves on the readily available dipstick technology by attaching V.
cholerae O1 and O139 serogroup specific monoclonal antibodies
raised against lipopolysaccharides to functionalize colloidal gold
nanoparticles for dual detection in gold nanoparticle biosensors. The
other one uses superparamagnetic amine and carboxyl terminated
particles to purify antibodies to specific antigens from environmental
mycobacteria as the basis of an ELISA for environmental mycobacteria.
Both these assays have applications in developing countries. The
assay for V. cholerae would have been of great benefit during the cholera
outbreaks after the Haitian earthquake. There are no immunological
tests for environmental mycobacteria, so this paper is timely when put
in to the context of the proposed WHO guidelines—it may be that such
new technology is required for TB immunological testing also, especially
in light of the fact that, apart from the United States and remote areas of
the world (where routine BCG vaccination is not done or available), BCG
vaccination done elsewhere precludes the use of PPD skin testing for the
initial screening for possible exposure or infection with the tubercle
bacillus. In conclusion these two papers show significant advances in
technology that will bring Point-of-Care Diagnostic Testing closer to
reality. In addition, with the success of reactive disease control strategies
being shown already to depend on the timing of early testing of a
Journal of Microbiological Methods 86 (2011) 275–276
⁎ Corresponding author. Tel.: + 1 516 686 3778; fax: + 1 516 686 3832.
E-mail address: cpavia@nyit.edu (C. Pavia).
0167-7012/$ – see front matter © 2011 Elsevier B.V. All rights reserved.
doi:10.1016/j.mimet.2011.05.015
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Journal of Microbiological Methods
journal homepage: www.elsevier.com/locate/jmicmeth