Assessment of an ultra-sensitive IFNγ immunoassay prototype for latent tuberculosis diagnosis

Autor: Guy Gorochov, Laure Allard, Céline Dragonetti, Karim Dorgham, Amélie Guihot, Mylene Lesenechal, Camille Pease, Delphine Sterlin, Elyes Ben Salah
Přispěvatelé: Centre d'Immunologie et de Maladies Infectieuses (CIMI), Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU)-Centre National de la Recherche Scientifique (CNRS), BIOMERIEUX
Rok vydání: 2019
Předmět:
0301 basic medicine
medicine.medical_specialty
Paris
030106 microbiology
Clinical Biochemistry
Immunology
Interferon gamma release assay
Physical examination
Enzyme-Linked Immunosorbent Assay
Drug resistance
Sensitivity and Specificity
03 medical and health sciences
Interferon-gamma
0302 clinical medicine
[SDV.MHEP.MI]Life Sciences [q-bio]/Human health and pathology/Infectious diseases
Latent Tuberculosis
Internal medicine
medicine
Immunology and Allergy
Humans
Medical history
Latent tuberculosis infection
030212 general & internal medicine
interferon gamma release assay
Ultra sensitive
Immunoassay
medicine.diagnostic_test
Latent tuberculosis
business.industry
Tuberculin Test
medicine.disease
3. Good health
digital ELISA
[SDV.IMM]Life Sciences [q-bio]/Immunology
business
Indeterminate
Interferon-gamma Release Tests
Zdroj: European Cytokine Network
European Cytokine Network, John Libbey Eurotext, 2018, 29 (4), pp.136-181. ⟨10.1684/ecn.2018.0417⟩
ISSN: 1952-4005
1148-5493
DOI: 10.1684/ecn.2018.0417⟩
Popis: International audience; 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 developing 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 SiMoA assay 83.3% of the indeterminate samples became interpretable and could be classified as negative, whereas 74% of uncertain positive 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.
Databáze: OpenAIRE
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