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

被引：14

作者：

Cuypers, Lize ^{[1
]}

Bode, Jannes ^{[1
]}

Beuselinck, Kurt ^{[1
]}

Laenen, Lies ^{[1
]}

Dewaele, Klaas ^{[1
]}

Janssen, Reile ^{[1
]}

Capron, Arnaud ^{[2
]}

Lafort, Yves ^{[2
]}

Paridaens, Henry ^{[3
]}

Bearzatto, Bertrand ^{[4
,5
]}

Cauchie, Mathieu ^{[6
]}

Huwart, Aline ^{[7
]}

Degosserie, Jonathan ^{[8
]}

Fagnart, Olivier ^{[9
]}

Overmeire, Yarah ^{[10
]}

Rouffiange, Arlette ^{[11
]}

Vandecandelaere, Ilse ^{[12
]}

Deffontaine, Marine ^{[13
]}

Pilate, Thomas ^{[14
]}

Yin, Nicolas ^{[15
]}

Micalessi, Isabel ^{[16
]}

Roisin, Sandrine ^{[17
]}

Moons, Veronique ^{[18
]}

Reynders, Marijke ^{[19
]}

Steyaert, Sophia ^{[20
]}

Henin, Coralie ^{[21
]}

Lazarova, Elena ^{[22
]}

Obbels, Dagmar ^{[23
]}

Dufrasne, Francois E. ^{[24
]}

Pirenne, Hendri ^{[25
]}

Schepers, Raf ^{[26
]}

Collin, Anaelle ^{[27
]}

Verhasselt, Bruno ^{[28
,29
]}

Gillet, Laurent ^{[30
]}

Jonckheere, Stijn ^{[31
]}

Van Lint, Philippe ^{[32
]}

van den Poel, Bea ^{[33
]}

van der Beken, Yolien ^{[34
]}

Stojkovic, Violeta ^{[35
]}

Garrino, Maria-Grazia ^{[36
]}

Segers, Hannah ^{[37
]}

Vos, Kevin ^{[38
]}

Godefroid, Maaike ^{[39
]}

Pede, Valerie ^{[40
]}

Nollet, Friedel ^{[41
]}

Claes, Vincent ^{[42
]}

Verschraegen, Inge ^{[43
]}

Bogaerts, Pierre ^{[44
]}

Van Gysel, Marjan ^{[45
]}

Leurs, Judith ^{[46
]}

机构：

[1] Univ Hosp Leuven, Dept Lab Med, Natl Reference Ctr Resp Pathogens, B-3000 Louvain, Belgium

[2] Sci Directorate Epidemiol & Publ Hlth, Epidemiol Infect Dis & Qual Serv Unit, B-1000 Brussels, Belgium

[3] Ctr Hosp Reg Citadelle, Clin Lab, B-4000 Liege, Belgium

[4] Clin Univ St Luc, Inst Expt & Clin Res IREC, Ctr Technol Mol Appliquees CTMA, Fed Testing Platform COVID 19, B-1200 Brussels, Belgium

[5] Univ Catholique Louvain UCLouvain, B-1200 Brussels, Belgium

[6] Europe Hosp, B-1180 Brussels, Belgium

[7] Clin Andre Renard, B-4040 Herstal, Belgium

[8] CHU UCL Namur, Dept Lab Med, Fed Testing Platform COVID 19, B-5530 Yvoir, Belgium

[9] St Jean Hosp Lab, B-1000 Brussels, Belgium

[10] Labo Nuytinck, Microbiol, B-9940 Anacura, Evergem, Belgium

[11] Lab Luc Olivier, Microbiol, B-5580 Fernelmont, Belgium

[12] Med Labo Bruyland, Microbiol, B-8500 Kortrijk, Belgium

[13] Ctr Hop Mouscron, Lab Clin Biol, B-7700 Mouscron, Belgium

[14] AZ Diest, Lab Med, Clin Lab, B-3290 Diest, Belgium

[15] Univ Bruxelles ULB, Univ Lab Brussel LHUB ULB, Lab Hosp Univ Bruxelles, Dept Microbiol, B-1000 Brussels, Belgium

[16] Inst Trop Med, Dept Clin Sci, Clin Reference Lab, B-2000 Antwerp, Belgium

[17] Ctr Hosp Univ Tivoli, Microbiol, B-7100 La Louviere, Belgium

[18] LKO LMC Med Lab, Microbiol, B-3800 St Truiden, Belgium

[19] AZ Sint Jan Brugge Oostende AV, Lab Med, B-8000 Brugge, Belgium

[20] AZ Maria Middelares, Clin Lab, B-9000 Ghent, Belgium

[21] Univ Libre Bruxelles, Fed Testing Platform COVID 19, B-1070 Brussels, Belgium

[22] Ctr Hosp Reg Haute Senne, Dept Biol Clin, B-7060 Soignies, Belgium

[23] Imelda, Clin Lab, B-2820 Bonheiden, Belgium

[24] Univ Mons, Fed Testing Platform COVID 19, B-7000 Mons, Belgium

[25] Synlab Lab Collard, Synlab Belgium, B-4020 Liege, Belgium

[26] Synlab Lab Heppignies, Synlab Belgium, B-6220 Heppignies, Belgium

[27] Vivalia, Site Marche Famenne, B-6900 Marche, Belgium

[28] Univ Ghent, Dept Lab Med, Fed Testing Platform COVID 19, B-9000 Ghent, Belgium

[29] Ghent Univ Hosp, B-9000 Ghent, Belgium

[30] Univ Liege, Fed Testing Platform COVID 19, B-4000 Liege, Belgium

[31] Jan Yperman Hosp, Lab Clin Biol, B-8900 Ieper, Belgium

[32] GZA Hosp, Clin Lab, B-2610 Antwerp, Belgium

[33] Gen Hosp Jan Portaels, Clin Lab, B-1800 Vilvoorde, Belgium

[34] Mil Hosp Queen Astrid, Mil Med Lab Capac, B-1120 Brussels, Belgium

[35] Ctr Hosp Bois Abbaye, Lab Serv, B-4100 Seraing, Belgium

[36] CHRSM, Clin Lab, Site Meuse, B-5000 Namur, Belgium

[37] AZ Glorieux, Clin Biol, B-9600 Ronse, Belgium

[38] RZ Heilig Hart Tienen, Clin Biol, B-3300 Tienen, Belgium

[39] Labo Maenhout, B-8790 Waregem, Belgium

[40] AZ Sint Elisabeth Zottegem, Lab Clin Biol, B-9600 Zottegem, Belgium

[41] Biogazelle NV, Diagnost Testing, B-9052 Zwijnaarde, Belgium

[42] ULB IBC, Inst Clin Biol, B-1170 Brussels, Belgium

[43] AZ St Blasius Dendermonde, B-9200 Dendermonde, Belgium

[44] CHU UCL Namur, Dept Lab Med, Mol Diagnost Ctr, B-5530 Yvoir, Belgium

[45] Gen Hosp Sint Maria Halle, B-1500 Halle, Belgium

[46] Practimed, B-3980 Tessenderlo, Belgium

[47] AZ Nikolaas, B-9100 St Niklaas, Belgium

[48] Vrije Univ Brussel, Univ Ziekenhuis Brussel, Dept Microbiol & Infect Control, B-1090 Brussels, Belgium

[49] AZ Delta, Clin Lab, Lab Med, B-8800 Roeselare, Belgium

[50] Ctr Med Anal, B-2200 Herentals, Belgium

来源：

VIRUSES-BASEL | 2022年 / 14卷 / 06期

关键词：

SARS-CoV-2; PCR; semi-quantitative reporting; RNA copies; mL; infectivity; REPLICATION; INFECTIVITY;

D O I：

10.3390/v14061294

中图分类号：

Q93 [微生物学];

学科分类号：

071005 ; 100705 ;

摘要：

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.

引用

页数：17

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