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Nationwide Harmonization Effort for Semi-Quantitative Reporting of SARS-CoV-2 PCR Test Results in Belgium.

Lize CuypersJannes BodeKurt BeuselinckPiet MaesKlaas DewaeleReile JanssenArnaud CapronYves LafortHenry ParidaensBertrand BearzattoMathieu CauchieAline HuwartJonathan DegosserieOlivier FagnartYarah OvermeireArlette RouffiangeIlse VandecandelaereMarine DeffontaineThomas PilateNicolas YinIsabel MicalessiSandrine RoisinVeronique MoonsMarijke ReyndersSophia SteyaertCoralie HeninElena LazarovaDagmar ObbelsFrançois E DufrasneHendri PirenneRaf SchepersAnaëlle CollinBruno VerhasseltLaurent GilletStijn JonckheerePhilippe Van LintBea Van den PoelYolien Van der BekenVioleta StojkovicMaria-Grazia GarrinoHannah SegersKevin VosMaaike GodefroidValerie PedeFriedel NolletVincent ClaesInge VerschraegenPierre BogaertsMarjan Van GyselJudith LeursVeroniek SaegemanOriane SoetensMerijn VanheeGilberte SchiettekatteEvelyne HuygheSteven MartensAnn LemmensHeleen NailisKim LaffineurDeborah SteenselsElke VanlaereJérémie GrasGatien RousselKoenraad GijbelsMichael BoudewijnsCatherine SionWim AchtergaelWim MaurissenLuc IlianoMarianne ChantrenneGeert VanheuleReinoud FliesNicolas HougardyMario BerthVanessa VerbekeRobin MorentAnne VankeerberghenSébastien BontemsKaat KehoeAnneleen SchallierGiang HoKristof BafortMarijke RaymaekersYolande PypenAmelie HeinrichsWim SchuermansDominique CuigniezSalah Eddine LaliStefanie DriegheDieter OryMarie Le MercierKristel Van LaethemInge ThoelenSarah VandammeIqbal MansoorCarl VaelMaxime De SloovereKatrien DeclerckElisabeth DequekerStefanie DesmetPiet MaesKatrien LagrouEmmanuel André
Published in: Viruses (2022)
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.
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