@Article{ecn.2018.0417,
AUTHOR = {Elyes Ben Salah, Karim Dorgham, Mylène Lesénéchal, Camille Pease, Laure Allard, Céline Dragonetti, Guy Gorochov, Amélie Guihot, Delphine Sterlin},
TITLE = {Assessment of an ultra-sensitive IFNγ immunoassay prototype for latent tuberculosis diagnosis},
JOURNAL = {European Cytokine Network},
VOLUME = {29},
YEAR = {2018},
NUMBER = {4},
PAGES = {136--145},
URL = {http://www.techscience.com/ECN/v29n4/65402},
ISSN = {1952-4005},
ABSTRACT = {Worldwide there are about 1.7 billion individuals with latent tuberculosis infection (LTBI) and only
5% to 15% will develop active tuberculosis (TB). It is recommended to treat only those most at risk of develop
ing active TB to avoid problems of drug resistance. LTBI diagnosis involves reviewing the individual’s medical
history, physical examination, and biological tests. Interferon gamma release assays (IGRA) can yield “undetermi
nate” or “uncertain” results, which makes clinical management decisions difficult. We assessed an ultra-sensitive
immunoassay prototype based on single molecule array (SiMoA) technology to evaluate its overall performance,
and in particular, its performance for indeterminate and uncertain positive or negative samples, as classified by the
results from the current ELISA technique used for IFN quantification. We analyzed samples from hospitalized or
consulting patients and healthcare workers from three hospitals in Paris, previously classified as negative (n=30),
positive (n=35), uncertain negative (n=25), uncertain positive (n=31), or indeterminate (n=30). We observed that
with the SiMoAassay83.3%oftheindeterminatesamplesbecameinterpretable and could be classified as negative,
whereas 74%ofuncertainpositive samples were classified as positive. Most uncertain negative samples (72%) were
reclassified as uncertain positive (68%) or positive (4%). The results suggest that the ultra-sensitive SiMoA IFN
assay could represent a useful tool for the identification of true positive and negative samples among those giving
indeterminate or uncertain results with the TB IGRA assay currently used.},
DOI = {10.1684/ecn.2018.0417}
}