{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,22]],"date-time":"2026-10-22T09:43:53Z","timestamp":1792662233424,"version":"4.5.0"},"reference-count":29,"publisher":"Elsevier BV","license":[{"start":{"date-parts":[[2026,12,1]],"date-time":"2026-12-01T00:00:00Z","timestamp":1796083200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/tdm\/userlicense\/1.0\/"},{"start":{"date-parts":[[2026,12,1]],"date-time":"2026-12-01T00:00:00Z","timestamp":1796083200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/legal\/tdmrep-license"},{"start":{"date-parts":[[2026,9,29]],"date-time":"2026-09-29T00:00:00Z","timestamp":1790640000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":["clinicalkey.com","clinicalkey.com.au","clinicalkey.es","clinicalkey.fr","clinicalkey.jp","elsevier.com","sciencedirect.com"],"crossmark-restriction":true},"short-container-title":["Journal of Clinical Virology"],"published-print":{"date-parts":[[2026,12]]},"DOI":"10.1016\/j.jcv.2026.106013","type":"journal-article","created":{"date-parts":[[2026,9,30]],"date-time":"2026-09-30T15:18:50Z","timestamp":1790781530000},"page":"106013","update-policy":"https:\/\/doi.org\/10.1016\/elsevier_cm_policy","source":"Crossref","is-referenced-by-count":0,"special_numbering":"C","title":["Operational harmonisation of SARS-CoV-2 RT-qPCR quantification across heterogeneous laboratory systems using WHO International Standard\u2013traceable units"],"prefix":"10.1016","volume":"187","author":[{"given":"Rie","family":"Moriuchi","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Miyuki","family":"Nagano","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4306-332X","authenticated-orcid":false,"given":"So","family":"Fujiyoshi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jun","family":"Suzuki","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yoshiyuki","family":"Sugishita","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yoshikazu","family":"Ishii","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fumito","family":"Maruyama","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"78","reference":[{"key":"10.1016\/j.jcv.2026.106013_bib1","series-title":"Molecular Diagnostic Methods for Infectious Diseases, 3rd ed. CLSI document MM03","author":"Clinical and Laboratory Standards Institute","year":"2015"},{"key":"10.1016\/j.jcv.2026.106013_bib2","doi-asserted-by":"crossref","first-page":"9326","DOI":"10.3390\/ijms25179326","article-title":"RT-qPCR testing and performance metrics in the COVID-19 era","volume":"25","author":"Bustin","year":"2024","journal-title":"Int. J. Mol. Sci."},{"key":"10.1016\/j.jcv.2026.106013_bib3","doi-asserted-by":"crossref","first-page":"171","DOI":"10.1038\/s41579-020-00461-z","article-title":"Considerations for diagnostic COVID-19 tests","volume":"19","author":"Vandenberg","year":"2021","journal-title":"Nat. Rev. Microbiol."},{"key":"10.1016\/j.jcv.2026.106013_bib4","doi-asserted-by":"crossref","first-page":"987","DOI":"10.1515\/cclm-2020-1602","article-title":"Variability of cycle threshold values in an external quality assessment scheme for detection of the SARS-CoV-2 virus genome by RT-PCR","volume":"59","author":"Buchta","year":"2021","journal-title":"Clin. Chem. Lab. Med."},{"key":"10.1016\/j.jcv.2026.106013_bib5","series-title":"Association for Molecular Pathology, IDSA and AMP joint statement on the use of cycle threshold (Ct) values for clinical decision-making","author":"Infectious Diseases Society of America","year":"2021"},{"key":"10.1016\/j.jcv.2026.106013_bib6","doi-asserted-by":"crossref","first-page":"e685","DOI":"10.1093\/cid\/ciaa1199","article-title":"College of American Pathologists (CAP) microbiology committee perspective: caution must be used in interpreting the cycle threshold (Ct) value","volume":"72","author":"Rhoads","year":"2021","journal-title":"Clin. Infect. Dis."},{"key":"10.1016\/j.jcv.2026.106013_bib7","doi-asserted-by":"crossref","first-page":"496","DOI":"10.3390\/life11060496","article-title":"Use and misuse of Cq in qPCR data analysis and reporting","volume":"11","author":"Ruiz-Villalba","year":"2021","journal-title":"Life"},{"key":"10.1016\/j.jcv.2026.106013_bib8","doi-asserted-by":"crossref","first-page":"634","DOI":"10.1093\/clinchem\/hvaf043","article-title":"MIQE 2.0: Revision of the minimum information for publication of quantitative real-Time PCR Experiments Guidelines","volume":"71","author":"Bustin","year":"2025","journal-title":"Clin. Chem."},{"key":"10.1016\/j.jcv.2026.106013_bib9","doi-asserted-by":"crossref","DOI":"10.1016\/j.jcv.2022.105242","article-title":"Harmonization of SARS-CoV-2 reverse transcription quantitative PCR tests to the first WHO international standard for SARS-CoV-2 RNA","volume":"154","author":"Sahoo","year":"2022","journal-title":"J. Clin. Virol."},{"key":"10.1016\/j.jcv.2026.106013_bib10","doi-asserted-by":"crossref","DOI":"10.1016\/j.jcv.2022.105352","article-title":"Converting to an international unit system improves harmonization of results for SARS-CoV-2 quantification: results from multiple external quality assessments","volume":"158","author":"Buchta","year":"2023","journal-title":"J. Clin. Virol."},{"key":"10.1016\/j.jcv.2026.106013_bib11","doi-asserted-by":"crossref","DOI":"10.1016\/j.jiac.2025.102694","article-title":"Development of traceable international standard materials using sequence-customized lentivirus, modeled on SARS-CoV-2 nucleic acid amplification tests, and validation through a pilot external quality assessment","volume":"31","author":"Itano","year":"2025","journal-title":"J. Infect. Chemother."},{"key":"10.1016\/j.jcv.2026.106013_bib12","doi-asserted-by":"crossref","first-page":"2009","DOI":"10.1007\/s00216-020-02490-2","article-title":"PCR inhibition in qPCR, dPCR and MPS-mechanisms and solutions","volume":"412","author":"Sidstedt","year":"2020","journal-title":"Anal. Bioanal. Chem."},{"key":"10.1016\/j.jcv.2026.106013_bib13","series-title":"PCR troubleshooting and optimization: The essential guide","article-title":"Difficult templates and inhibitors of PCR","author":"Gallup","year":"2011"},{"key":"10.1016\/j.jcv.2026.106013_bib14","doi-asserted-by":"crossref","first-page":"242","DOI":"10.1016\/j.jiac.2021.10.027","article-title":"A study of quality assessment in SARS\u2011CoV\u20112 pathogen nucleic acid amplification tests performance: results from an external quality assessment survey of clinical laboratories in the Tokyo Metropolitan Government external quality assessment program in 2020","volume":"28","author":"Ishii","year":"2022","journal-title":"J. Infect. Chemother."},{"key":"10.1016\/j.jcv.2026.106013_bib15","doi-asserted-by":"crossref","first-page":"633","DOI":"10.1016\/j.jiac.2024.01.016","article-title":"External quality assessment survey for SARS-CoV-2 nucleic acid amplification tests in clinical laboratories in Tokyo, 2021","volume":"30","author":"Sugishita","year":"2024","journal-title":"J. Infect. Chemother."},{"key":"10.1016\/j.jcv.2026.106013_bib16","series-title":"Design of molecular proficiency testing\/external quality assessment, 3rd ed. CLSI guideline MM14","author":"Clinical and Laboratory Standards Institute","year":"2025"},{"key":"10.1016\/j.jcv.2026.106013_bib17","doi-asserted-by":"crossref","first-page":"588","DOI":"10.1080\/10408363.2024.2335202","article-title":"The European organisation of external quality assurance providers in laboratory medicine (EQALM) Statement: guidelines for publishing about interlaboratory comparison studies (PubILC)","volume":"61","author":"Buchta","year":"2024","journal-title":"Crit. Rev. Clin. Lab. Sci."},{"key":"10.1016\/j.jcv.2026.106013_bib18","unstructured":"World Health Organization, Second International Standard for SARS-CoV-2 RNA for nucleic acid amplification technique\u2013based assays (WHO\/BS\/2023.2459), 2023. https:\/\/www.who.int\/publications\/m\/item\/who-bs-2023.2459 (accessed 2 March 2026)."},{"key":"10.1016\/j.jcv.2026.106013_bib19","series-title":"Collaborative study to evaluate the proposed 6th WHO International Standard for hepatitis C virus (HCV) RNA for nucleic acid amplification technique-based assays (WHO\/BS\/2019.2358)","author":"World Health Organization","year":"2019"},{"key":"10.1016\/j.jcv.2026.106013_bib20","doi-asserted-by":"crossref","first-page":"77","DOI":"10.1016\/j.yamp.2023.07.004","article-title":"Quantitative viral load monitoring: How far are we from commutable results?","volume":"6","author":"Parikh","year":"2023","journal-title":"Adv. Mol. Pathol."},{"key":"10.1016\/j.jcv.2026.106013_bib21","doi-asserted-by":"crossref","DOI":"10.1016\/j.ijmm.2025.151656","article-title":"From crisis to routine\u2014Standardization of SARS-CoV-2 genome detection by enhanced EQA schemes in a scientific pandemic network","volume":"319","author":"Kammel","year":"2025","journal-title":"Int. J. Med. Microbiol."},{"key":"10.1016\/j.jcv.2026.106013_bib22","doi-asserted-by":"crossref","first-page":"898","DOI":"10.1515\/cclm-2024-1293","article-title":"Behind the scenes of EQA\u2014characteristics, capabilities, benefits and assets of external quality assessment (EQA): part V\u2014Benefits for stakeholders other than participants","volume":"63","author":"Buchta","year":"2025","journal-title":"Clin. Chem. Lab. Med."},{"key":"10.1016\/j.jcv.2026.106013_bib23","doi-asserted-by":"crossref","DOI":"10.1128\/jcm.01338-22","article-title":"Primary quantitative reference standards for viral nucleic acids should be developed using digital polymerase chain reaction instead of consensus testing","volume":"61","author":"Hayden","year":"2023","journal-title":"J. Clin. Microbiol."},{"key":"10.1016\/j.jcv.2026.106013_bib24","doi-asserted-by":"crossref","DOI":"10.1128\/cmr.00168-21","article-title":"Digital PCR applications in the SARS-CoV-2\/COVID-19 era: a roadmap for future outbreaks","volume":"35","author":"Nyaruaba","year":"2022","journal-title":"Clin. Microbiol. Rev."},{"key":"10.1016\/j.jcv.2026.106013_bib25","doi-asserted-by":"crossref","DOI":"10.1371\/journal.pbio.3000896","article-title":"Direct RT-qPCR detection of SARS-CoV-2 RNA from patient nasopharyngeal swabs without an RNA extraction step","volume":"18","author":"Bruce","year":"2020","journal-title":"PLoS Biol."},{"key":"10.1016\/j.jcv.2026.106013_bib26","doi-asserted-by":"crossref","DOI":"10.1038\/s41598-023-47645-0","article-title":"Optimization of extraction\u2011free protocols for SARS\u2011CoV\u20112 detection using a commercial rRT\u2011PCR assay","volume":"13","author":"Kang","year":"2023","journal-title":"Sci. Rep."},{"key":"10.1016\/j.jcv.2026.106013_bib27","doi-asserted-by":"crossref","first-page":"2825","DOI":"10.1007\/s00705-021-05165-0","article-title":"Evaluation of extraction\u2011free RT\u2011qPCR methods for SARS\u2011CoV\u20112 diagnostics","volume":"166","author":"Domnich","year":"2021","journal-title":"Arch. Virol."},{"key":"10.1016\/j.jcv.2026.106013_bib28","doi-asserted-by":"crossref","first-page":"829","DOI":"10.1093\/clinchem\/hvab052","article-title":"Efficiency correction is required for accurate quantitative PCR analysis and reporting","volume":"67","author":"Ruijter","year":"2021","journal-title":"Clin. Chem."},{"key":"10.1016\/j.jcv.2026.106013_bib29","doi-asserted-by":"crossref","first-page":"2904","DOI":"10.3390\/ijms27062904","article-title":"Understanding the qPCR standard curve: from assay validation to absolute quantification and variance PCR","volume":"27","author":"Kubista","year":"2026","journal-title":"Int. J. Mol. Sci."}],"container-title":["Journal of Clinical Virology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S1386653226001058?httpAccept=text\/xml","content-type":"text\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S1386653226001058?httpAccept=text\/plain","content-type":"text\/plain","content-version":"vor","intended-application":"text-mining"}],"deposited":{"date-parts":[[2026,10,22]],"date-time":"2026-10-22T09:33:22Z","timestamp":1792661602000},"score":1,"resource":{"primary":{"URL":"https:\/\/linkinghub.elsevier.com\/retrieve\/pii\/S1386653226001058"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,12]]},"references-count":29,"alternative-id":["S1386653226001058"],"URL":"https:\/\/doi.org\/10.1016\/j.jcv.2026.106013","relation":{},"ISSN":["1386-6532"],"issn-type":[{"value":"1386-6532","type":"print"}],"subject":[],"published":{"date-parts":[[2026,12]]},"assertion":[{"value":"Elsevier","name":"publisher","label":"This article is maintained by"},{"value":"Operational harmonisation of SARS-CoV-2 RT-qPCR quantification across heterogeneous laboratory systems using WHO International Standard\u2013traceable units","name":"articletitle","label":"Article Title"},{"value":"Journal of Clinical Virology","name":"journaltitle","label":"Journal Title"},{"value":"https:\/\/doi.org\/10.1016\/j.jcv.2026.106013","name":"articlelink","label":"CrossRef DOI link to publisher maintained version"},{"value":"article","name":"content_type","label":"Content Type"},{"value":"\u00a9 2026 The Author(s). Published by Elsevier B.V.","name":"copyright","label":"Copyright"}],"article-number":"106013"}}