Editorial
Making IGRA testing easier: First performance report of QIAreach QFT for tuberculosis infection diagnosis
P. Miottoa,
, D. Golettib, L. Petroneb
Corresponding author
miotto.paolo@hsr.it
Corresponding author at: Emerging Bacterial Pathogens Unit, Div. of Immunology, Transplantation and Infectious Diseases, IRCCS San Raffaele Scientific Institute, Dibit 2, Building San Gabriele 1, Via Olgettina, 60, 20132 Milano, Italy.
Corresponding author at: Emerging Bacterial Pathogens Unit, Div. of Immunology, Transplantation and Infectious Diseases, IRCCS San Raffaele Scientific Institute, Dibit 2, Building San Gabriele 1, Via Olgettina, 60, 20132 Milano, Italy.
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Data transformation of TTR and IFN-γ of uncorrected and corrected TB2 values to a natural logarithmic scale showed a significantly high correlation (<span class="elsevierStyleItalic">r</span> = -0.913, <span class="elsevierStyleItalic">p</span> < 0.001 and <span class="elsevierStyleItalic">r</span> = -0.918, <span class="elsevierStyleItalic">p</span> < 0.001, respectively) between IFN-γ levels and TTR by linear regression analysis (Fig. 1.3 and 1.4). Corrected IFN-γ (Fig. 1.2) means IFN-γ levels with Nil subtraction. IFN-γ: interferon-γ; TB: tuberculosis.</p>" ] ] ] "autores" => array:1 [ 0 => array:2 [ "autoresLista" => "K. Fukushima, K. Akagi, A. Kondo, T. Kubo, N. Sakamoto, H. Mukae" "autores" => array:6 [ 0 => array:2 [ "nombre" => "K." "apellidos" => "Fukushima" ] 1 => array:2 [ "nombre" => "K." "apellidos" => "Akagi" ] 2 => array:2 [ "nombre" => "A." "apellidos" => "Kondo" ] 3 => array:2 [ "nombre" => "T." "apellidos" => "Kubo" ] 4 => array:2 [ "nombre" => "N." "apellidos" => "Sakamoto" ] 5 => array:2 [ "nombre" => "H." "apellidos" => "Mukae" ] ] ] ] ] "idiomaDefecto" => "en" "EPUB" => "https://multimedia.elsevier.es/PublicationsMultimediaV1/item/epub/S2531043721001513?idApp=UINPBA00004E" "url" => "/25310437/0000002800000001/v1_202201060713/S2531043721001513/v1_202201060713/en/main.assets" ] "itemAnterior" => array:19 [ "pii" => "S2531043721001240" "issn" => "25310437" "doi" => "10.1016/j.pulmoe.2021.05.011" "estado" => "S300" "fechaPublicacion" => "2022-01-01" "aid" => "1636" "copyright" => "Sociedade Portuguesa de Pneumologia" "documento" => "simple-article" "crossmark" => 1 "licencia" => "http://creativecommons.org/licenses/by-nc-nd/4.0/" "subdocumento" => "dis" "cita" => "Pulmonol. 2022;28:1-3" "abierto" => array:3 [ "ES" => true "ES2" => true "LATM" => true ] "gratuito" => true "lecturas" => array:1 [ "total" => 0 ] "en" => array:10 [ "idiomaDefecto" => true "cabecera" => "<span class="elsevierStyleTextfn">Comment</span>" "titulo" => "The COVID-19 impact on the scientific production on the 25 main death causes according to world region" "tienePdf" => "en" "tieneTextoCompleto" => "en" "paginas" => array:1 [ 0 => array:2 [ "paginaInicial" => "1" "paginaFinal" => "3" ] ] "contieneTextoCompleto" => array:1 [ "en" => true ] "contienePdf" => array:1 [ "en" => true ] "resumenGrafico" => array:2 [ "original" => 0 "multimedia" => array:8 [ "identificador" => "fig0001" "etiqueta" => "Fig. 1" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => true "mostrarDisplay" => false "figura" => array:1 [ 0 => array:4 [ "imagen" => "gr1.jpeg" "Alto" => 2393 "Ancho" => 3000 "Tamanyo" => 467806 ] ] "detalles" => array:1 [ 0 => array:3 [ "identificador" => "alt0001" "detalle" => "Fig. " "rol" => "short" ] ] "descripcion" => array:1 [ "en" => "<p id="spara001" class="elsevierStyleSimplePara elsevierViewall">The COVID-19 Impact on the Scientific Production on the 25 Main Death Causes according to World In Data. Available from: <span class="elsevierStyleInterRef" id="interref0001" href="https://ourworldindata.org/causes-of-death">https://ourworldindata.org/causes-of-death</span>.</p>" ] ] ] "autores" => array:1 [ 0 => array:2 [ "autoresLista" => "Felipe Eduardo Valencise, Matheus Negri Boschiero, Camila Vantini Capasso Palamim, Fernando Augusto Lima Marson" "autores" => array:4 [ 0 => array:2 [ "nombre" => "Felipe Eduardo" "apellidos" => "Valencise" ] 1 => array:2 [ "nombre" => "Matheus Negri" "apellidos" => "Boschiero" ] 2 => array:2 [ "nombre" => "Camila Vantini Capasso" "apellidos" => "Palamim" ] 3 => array:2 [ "nombre" => "Fernando Augusto Lima" "apellidos" => "Marson" ] ] ] ] ] "idiomaDefecto" => "en" "EPUB" => "https://multimedia.elsevier.es/PublicationsMultimediaV1/item/epub/S2531043721001240?idApp=UINPBA00004E" "url" => "/25310437/0000002800000001/v1_202201060713/S2531043721001240/v1_202201060713/en/main.assets" ] "en" => array:13 [ "idiomaDefecto" => true "cabecera" => "<span class="elsevierStyleTextfn">Editorial</span>" "titulo" => "Making IGRA testing easier: First performance report of QIAreach QFT for tuberculosis infection diagnosis" "tieneTextoCompleto" => true "paginas" => array:1 [ 0 => array:2 [ "paginaInicial" => "4" "paginaFinal" => "5" ] ] "autores" => array:1 [ 0 => array:4 [ "autoresLista" => "P. Miotto, D. Goletti, L. Petrone" "autores" => array:3 [ 0 => array:4 [ "nombre" => "P." "apellidos" => "Miotto" "email" => array:1 [ 0 => "miotto.paolo@hsr.it" ] "referencia" => array:2 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">a</span>" "identificador" => "aff0001" ] 1 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">*</span>" "identificador" => "cor0001" ] ] ] 1 => array:3 [ "nombre" => "D." "apellidos" => "Goletti" "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">b</span>" "identificador" => "aff0002" ] ] ] 2 => array:3 [ "nombre" => "L." "apellidos" => "Petrone" "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">b</span>" "identificador" => "aff0002" ] ] ] ] "afiliaciones" => array:2 [ 0 => array:3 [ "entidad" => "Emerging Bacterial Pathogens Unit, Div. of Immunology, Transplantation and Infectious Diseases, IRCCS San Raffaele Scientific Institute, Milano, Italy" "etiqueta" => "a" "identificador" => "aff0001" ] 1 => array:3 [ "entidad" => "Translational Research Unit, National Institute for Infectious Diseases “Lazzaro Spallanzani”-IRCCS, Rome, Italy" "etiqueta" => "b" "identificador" => "aff0002" ] ] "correspondencia" => array:1 [ 0 => array:3 [ "identificador" => "cor0001" "etiqueta" => "⁎" "correspondencia" => "Corresponding author at: Emerging Bacterial Pathogens Unit, Div. of Immunology, Transplantation and Infectious Diseases, IRCCS San Raffaele Scientific Institute, Dibit 2, Building San Gabriele 1, Via Olgettina, 60, 20132 Milano, Italy." ] ] ] ] "textoCompleto" => "<span class="elsevierStyleSections"><p id="para0001" class="elsevierStylePara elsevierViewall">Tuberculosis (TB), with around 1.4 million deaths, is one of the most important leading killer for infectious diseases in the world. Moreover, a quarter of the world population is estimated to live with TB infection (TBI).<a class="elsevierStyleCrossRef" href="#bib0001"><span class="elsevierStyleSup">1</span></a><span class="elsevierStyleSup">,</span><a class="elsevierStyleCrossRef" href="#bib0002"><span class="elsevierStyleSup">2</span></a> TBI is considered the reservoir of active TB, therefore, diagnosing and treating TBI is a crucial component of the End TB Strategy to achieve TB control.<a class="elsevierStyleCrossRef" href="#bib0003"><span class="elsevierStyleSup">3</span></a> So far, the diagnosis of TBI is based on tuberculin skin test and on interferon (IFN)-γ release assays (IGRAs) such as T-SPOT. TB and Quantiferon-TB Plus (QFT-Plus).<a class="elsevierStyleCrossRef" href="#bib0004"><span class="elsevierStyleSup">4</span></a> However, costs, complexity, and supply chain requirements hamper the implementation of current tests for TBI in decentralized settings. Therefore, there is an urgent need for accelerating the scale-up of such assays to inform test-and-treat algorithms for TBI.<a class="elsevierStyleCrossRef" href="#bib0005"><span class="elsevierStyleSup">5</span></a></p><p id="para0002" class="elsevierStylePara elsevierViewall">The QIAreach QFT test is a novel and simplified version of QFT-Plus. Indeed, it uses a single tube corresponding to the TB2 tube of the QFT-Plus. However, unlike QFT-Plus, the test provides a qualitative result through a fluorescence lateral flow reader, which is transportable, easy to use and does not need highly trained personnel.<a class="elsevierStyleCrossRef" href="#bib0006"><span class="elsevierStyleSup">6</span></a><span class="elsevierStyleSup">,</span><a class="elsevierStyleCrossRef" href="#bib0007"><span class="elsevierStyleSup">7</span></a> The assay time to result (TTR) is around 20 minutes. Therefore, the QIAreach QFT test has the potentials to be a point-of-care test.</p><p id="para0003" class="elsevierStylePara elsevierViewall">The paper of Fukushima et al<a class="elsevierStyleCrossRef" href="#bib0007"><span class="elsevierStyleSup">7</span></a> aimed to evaluate the accuracy of the QIAreach QFT test for the detection of TBI compared to the commercial QFT-Plus test in both immunocompetent and immunocompromised individuals. The authors evaluate the tests’ clinical performance in patients with active TB, used as a surrogate for TBI. Compared to QFT-Plus, which was used as reference standard, QIAreach QFT showed a 99% overall concordance and an optimal accuracy with 100% sensitivity and 98% specificity, similar to QFT-Plus 4. Interestingly, QIAreach QFT also scored positive in samples with IFN-γ level falling in the so-called uncertainty zone of the QFT-Plus.<a class="elsevierStyleCrossRef" href="#bib0008"><span class="elsevierStyleSup">8</span></a> IFN- γ level inversely correlated with TTR, suggesting that the TTR may be used as a surrogate marker for the IFN-γ concentrations. The QIAreach QFT test also scored positive in individuals with CD4 counts <200 cells/µl, thus showing potential for immunocompromised individuals.</p><p id="para0004" class="elsevierStylePara elsevierViewall">Multicenter studies are needed to validate these results, and to evaluate the QIAreach in immunocompromised individuals. Moreover, data on precision, repeatability and reproducibility, as well as costs analyses are needed to fully understand the potential of this platform. However, these optimal pilot performances, together with the technical advantages of the test (a single 1 mL of blood is needed), the short TTR, the portability and the multipurpose design of the platform allowing for diagnosing relevant diseases other than TB,<a class="elsevierStyleCrossRef" href="#bib0009"><span class="elsevierStyleSup">9</span></a> make the QIAreach QFT test a promising tool for TBI screening in peripheral settings for easier identification of people eligible for TB preventive therapy. This tool may be useful for TBI screening based on the new suggestions proposed by the WHO, and could support contact investigation to early identify individuals at risk for acquiring TBI also in high TB prevalence countries.<a class="elsevierStyleCrossRef" href="#bib0005"><span class="elsevierStyleSup">5</span></a><span class="elsevierStyleSup">,</span><a class="elsevierStyleCrossRef" href="#bib0010"><span class="elsevierStyleSup">10</span></a></p><p id="para0005" class="elsevierStylePara elsevierViewall">The further development and availability of tests for predicting the risk of progression from TBI to active disease will complete the portfolio for maximizing the impact of TB preventive treatment strategies.</p></span>" "pdfFichero" => "main.pdf" "tienePdf" => true "fechaRecibido" => "2021-07-29" "fechaAceptado" => "2021-07-29" "bibliografia" => array:2 [ "titulo" => "References" "seccion" => array:1 [ 0 => array:2 [ "identificador" => "cebibsec1" "bibliografiaReferencia" => array:10 [ 0 => array:3 [ "identificador" => "bib0001" "etiqueta" => "1" "referencia" => array:1 [ 0 => array:1 [ "referenciaCompleta" => "WHO. TB REPORT 2020. <a target="_blank" href="https://www.who.int/publications/i/item/9789240013131">https://www who int/publications/i/item/9789240013131</a> (2020)." ] ] ] 1 => array:3 [ "identificador" => "bib0002" "etiqueta" => "2" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "The global burden of latent tuberculosis infection: a re-estimation using mathematical modelling" "autores" => array:1 [ 0 => array:2 [ "etal" => false "autores" => array:2 [ 0 => "RM Houben" 1 => "PJ Dodd" ] ] ] ] ] "host" => array:1 [ 0 => array:2 [ "doi" => "10.1371/journal.pmed.1001976" "Revista" => array:4 [ "tituloSerie" => "PLoS Med" "fecha" => "2016" "volumen" => "13" "link" => array:1 [ 0 => array:2 [ "url" => "https://www.ncbi.nlm.nih.gov/pubmed/27327646" "web" => "Medline" ] ] ] ] ] ] ] ] 2 => array:3 [ "identificador" => "bib0003" "etiqueta" => "3" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => 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"link" => array:1 [ 0 => array:2 [ "url" => "https://www.ncbi.nlm.nih.gov/pubmed/31473271" "web" => "Medline" ] ] ] ] ] ] ] ] 4 => array:3 [ "identificador" => "bib0005" "etiqueta" => "5" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "Framework for the evaluation of new tests for tuberculosis infection" "autores" => array:1 [ 0 => array:2 [ "colaboracion" => "WHO" "etal" => false ] ] ] ] "host" => array:2 [ 0 => array:1 [ "Libro" => array:1 [ "fecha" => "2020" ] ] 1 => array:1 [ "WWW" => array:1 [ "link" => "https://www.who.int/publications/i/item/9789240007185" ] ] ] ] ] ] 5 => array:3 [ "identificador" => "bib0006" "etiqueta" => "6" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "Tests for tuberculosis infection: landscape analysis" "autores" => array:1 [ 0 => array:2 [ "etal" => false "autores" => array:6 [ 0 => "Y Hamada" 1 => "DM Cirillo" 2 => "A Matteelli" 3 => "A Penn-Nicholson" 4 => "MX Rangaka" 5 => "M Ruhwald" ] ] ] ] ] "host" => array:1 [ 0 => array:2 [ "doi" => "10.1183/13993003.00711-2017" "Revista" => array:3 [ "tituloSerie" => "Eur Respir J" "fecha" => "2021" "link" => array:1 [ 0 => array:2 [ "url" => "https://www.ncbi.nlm.nih.gov/pubmed/29025888" "web" => "Medline" ] ] ] ] ] ] ] ] 6 => array:3 [ "identificador" => "bib0007" "etiqueta" => "7" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "First clinical evaluation of the QIAreachTM QuantiFERON-TB for tuberculosis infection and active pulmonary disease" "autores" => array:1 [ 0 => array:2 [ "etal" => false "autores" => array:6 [ 0 => "K Fukushima" 1 => "K Akagi" 2 => "A Kondo" 3 => "T Kubo" 4 => "N Sakamoto" 5 => "H Mukae" ] ] ] ] ] "host" => array:1 [ 0 => array:1 [ "Revista" => array:2 [ "tituloSerie" => "Pulmonology" "fecha" => "2021" ] ] ] ] ] ] 7 => array:3 [ "identificador" => "bib0008" "etiqueta" => "8" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "Diagnostic accuracy of early secretory antigenic target-6-free interferon-gamma release assay compared to QuantiFERON-TB gold in- tube" "autores" => array:1 [ 0 => array:2 [ "etal" => true "autores" => array:6 [ 0 => "E Nemes" 1 => "D Abrahams" 2 => "TJ Scriba" 3 => "F Ratangee" 4 => "A Keyser" 5 => "L Makhethe" ] ] ] ] ] "host" => array:1 [ 0 => array:2 [ "doi" => "10.1093/cid/ciz034" "Revista" => array:6 [ "tituloSerie" => "Clin Infect Dis" "fecha" => "2019" "volumen" => "69" "paginaInicial" => "1724" "paginaFinal" => "1730" "link" => array:1 [ 0 => array:2 [ "url" => "https://www.ncbi.nlm.nih.gov/pubmed/30668657" "web" => "Medline" ] ] ] ] ] ] ] ] 8 => array:3 [ "identificador" => "bib0009" "etiqueta" => "9" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "Evaluation of SARS-CoV-2 total antibody detection via a lateral flow nanoparticle fluorescence immunoassay" "autores" => array:1 [ 0 => array:2 [ "etal" => true "autores" => array:6 [ 0 => "M Sibai" 1 => "D Solis" 2 => "K Röltgen" 3 => "BA Stevens" 4 => "KO Mfuh" 5 => "MK Sahoo" ] ] ] ] ] "host" => array:1 [ 0 => array:1 [ "Revista" => array:3 [ "tituloSerie" => "J Clin Virol" "fecha" => "2021" "volumen" => "139" ] ] ] ] ] ] 9 => array:3 [ "identificador" => "bib0010" "etiqueta" => "10" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "Implementing contact tracing for tuberculosis in Kyrgyz Republic and risk factors for positivity using QuantiFERON-TB Gold plus" "autores" => array:1 [ 0 => array:2 [ "etal" => true "autores" => array:6 [ 0 => "C Corbett" 1 => "A Kulzhabaeva" 2 => "T Toichkina" 3 => "G Kalmambetova" 4 => "S Ahmedov" 5 => "U Antonenka" ] ] ] ] ] "host" => array:1 [ 0 => array:2 [ "doi" => "10.1186/s12879-020-05465-x" "Revista" => array:5 [ "tituloSerie" => "BMC Infect Dis" "fecha" => "2020" "volumen" => "20" "paginaInicial" => "746" "link" => array:1 [ 0 => array:2 [ "url" => "https://www.ncbi.nlm.nih.gov/pubmed/33046016" "web" => "Medline" ] ] ] ] ] ] ] ] ] ] ] ] "agradecimientos" => array:1 [ 0 => array:4 [ "identificador" => "xack579687" "titulo" => "Acknowledgments" "texto" => "<p id="para0007" class="elsevierStylePara elsevierViewall">The work was supported by the Italian Ministry of Health, Ricerca Corrente, Linea 4.</p>" "vista" => "all" ] ] ] "idiomaDefecto" => "en" "url" => "/25310437/0000002800000001/v1_202201060713/S2531043721001951/v1_202201060713/en/main.assets" "Apartado" => array:4 [ "identificador" => "73042" "tipo" => "SECCION" "en" => array:2 [ "titulo" => "Editorial" "idiomaDefecto" => true ] "idiomaDefecto" => "en" ] "PDF" => "https://static.elsevier.es/multimedia/25310437/0000002800000001/v1_202201060713/S2531043721001951/v1_202201060713/en/main.pdf?idApp=UINPBA00004E&text.app=https://journalpulmonology.org/" "EPUB" => "https://multimedia.elsevier.es/PublicationsMultimediaV1/item/epub/S2531043721001951?idApp=UINPBA00004E" ]
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