[저자] Lize Cuypers, Jannes Bode, Kurt Beuselinck, Lies Laenen, Klaas Dewaele, Reile Janssen, Arnaud Capron, Yves Lafort, Henry Paridaens, Bertrand Bearzatto, Mathieu Cauchie, Aline Huwart, Jonathan Degosserie, Olivier Fagnart, Yarah Overmeire, Arlette Rouffiange, Ilse Vandecandelaere, Marine Deffontaine, Thomas Pilate, Nicolas Yin, Isabel Micalessi, Sandrine Roisin, Veronique Moons, Marijke Reynders, Sophia Steyaert, Coralie Henin, Elena Lazarova, Dagmar Obbels, François E Dufrasne, Hendri Pirenne, Raf Schepers, Anaëlle Collin, Bruno Verhasselt, Laurent Gillet, Stijn Jonckheere, Philippe Van Lint, Bea Van den Poel, Yolien Van der Beken, Violeta Stojkovic, Maria-Grazia Garrino, Hannah Segers, Kevin Vos, Maaike Godefroid, Valerie Pede, Friedel Nollet, Vincent Claes, Inge Verschraegen, Pierre Bogaerts, Marjan Van Gysel, Judith Leurs, Veroniek Saegeman, Oriane Soetens, Merijn Vanhee, Gilberte Schiettekatte, Evelyne Huyghe, Steven Martens, Ann Lemmens, Heleen Nailis, Kim Laffineur, Deborah Steensels, Elke Vanlaere, Jérémie Gras, Gatien Roussel, Koenraad Gijbels, Michael Boudewijns, Catherine Sion, Wim Achtergael, Wim Maurissen, Luc Iliano, Marianne Chantrenne, Geert Vanheule, Reinoud Flies, Nicolas Hougardy, Mario Berth, Vanessa Verbeke, Robin Morent, Anne Vankeerberghen, Sébastien Bontems, Kaat Kehoe, Anneleen Schallier, Giang Ho, Kristof Bafort, Marijke Raymaekers, Yolande Pypen, Amelie Heinrichs, Wim Schuermans, Dominique Cuigniez, Salah Eddine Lali, Stefanie Drieghe, Dieter Ory, Marie Le Mercier, Kristel Van Laethem, Inge Thoelen, Sarah Vandamme, Iqbal Mansoor, Carl Vael, Maxime De Sloovere, Katrien Declerck, Elisabeth Dequeker, Stefanie Desmet, Piet Maes, Katrien Lagrou, Emmanuel André
[Category] COVID19(2023년), MERS, SARS, 진단,
[Article Type] Article
[Source] PMC
Abstract
From early 2020, a high demand for SARS-CoV-2 tests was driven by several testing indications, including asymptomatic cases, resulting in the massive roll-out of PCR assays to combat the pandemic. Considering the dynamic of viral shedding during the course of infection, the demand to report cycle threshold (Ct) values rapidly emerged. As Ct values can be affected by a number of factors, we considered that harmonization of semi-quantitative PCR results across laboratories would avoid potential divergent interpretations, particularly in the absence of clinical or serological information. A proposal to harmonize reporting of test results was drafted by the National Reference Centre (NRC) UZ/KU Leuven, distinguishing four categories of positivity based on RNA copies/mL. Pre-quantified control material was shipped to 124 laboratories with instructions to setup a standard curve to define thresholds per assay. For each assay, the mean Ct value and corresponding standard deviation was calculated per target gene, for the three concentrations (10 7 , 10 5 and 10 3 copies/mL) that determine the classification. The results of 17 assays are summarized. This harmonization effort allowed to ensure that all Belgian laboratories would report positive PCR results in the same semi-quantitative manner to clinicians and to the national database which feeds contact tracing interventions.
Keywords: PCR; RNA copies/mL; SARS-CoV-2; infectivity; semi-quantitative reporting.
All Keywords
【저자키워드】 SARS-CoV-2, Infectivity, PCR, RNA copies/mL, semi-quantitative reporting., 【초록키워드】 pandemic, Infection, viral shedding, Contact tracing, database, Laboratory, RNA, Asymptomatic, cycle threshold, Factors, threshold, information, serological, Concentration, standard curve, target gene, Standard deviation, clinician, indications, effort, PCR assay, National, SARS-CoV-2 test, positive PCR result, Course, resulting, affected, calculated, determine, absence, to define, category, driven by, the mean, semi-quantitative, Leuven, National Reference Centre, semi-quantitative PCR, 【제목키워드】 Test, Reporting, harmonization, Belgium, SARS-CoV-2 PCR, Result,
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2020년 초부터 SARS-CoV-2 테스트에 대한 높은 수요는 무증상 사례를 포함한 여러 테스트 징후에 의해 주도되었으며, 그 결과 대유행을 퇴치하기 위해 PCR 분석이 대규모로 출시되었습니다. 감염 과정에서 바이러스 발산의 역학을 고려할 때 주기 임계값(Ct) 값을 보고하라는 요구가 빠르게 나타났습니다. Ct 값은 여러 요인의 영향을 받을 수 있으므로 실험실 전반에 걸친 반정량적 PCR 결과의 조화는 특히 임상 또는 혈청학적 정보가 없는 경우 잠재적인 다양한 해석을 피할 수 있다고 생각했습니다. NRC(National Reference Center) UZ/KU Leuven은 검사 결과 보고를 조화롭게 하기 위한 제안을 작성하여 RNA 사본/mL에 따라 양성 범주를 4가지로 구분했습니다. 사전 정량화된 대조 물질은 분석당 임계값을 정의하기 위해 표준 곡선을 설정하라는 지침과 함께 124개 실험실로 배송되었습니다. 각 분석에 대해, 분류를 결정하는 3가지 농도(10 7 , 10 5 및 10 3 사본/mL)에 대해 표적 유전자당 평균 Ct 값 및 해당 표준 편차를 계산했습니다. 17개의 분석 결과가 요약되어 있습니다. 이러한 조화 노력을 통해 모든 벨기에 실험실에서 양성 PCR 결과를 동일한 반정량적 방식으로 임상의와 접촉 추적 중재를 제공하는 국가 데이터베이스에 보고할 수 있었습니다.
{{ 키워드: }} PCR; RNA 카피/mL; 사스 코로나바이러스 2; 감염성; 반 정량적 보고.