High quality of SARS-CoV-2 molecular diagnostics in a diverse laboratory landscape through supported benchmark testing and External Quality Assessment

A two-step strategy combining assisted benchmark testing (entry controls) and External Quality Assessments (EQAs) with blinded simulated clinical specimens to enhance and maintain the quality of nucleic acid amplification testing was developed. This strategy was successfully applied to 71 diagnostic laboratories in The Netherlands when upscaling the national diagnostic capacity during the SARS-CoV-2 pandemic. The availability of benchmark testing in combination with advice for improvement substantially enhanced the quality of the laboratory testing procedures for SARS-CoV-2 detection. The three subsequent EQA rounds demonstrated high quality testing with regard to specificity (99.6% correctly identified) and sensitivity (93.3% correctly identified). Even with the implementation of novel assays, changing workflows using diverse equipment and a high degree of assay heterogeneity, the overall high quality was maintained using this two-step strategy. We show that in contrast to the limited value of Cq value for absolute proxies of viral load, these Cq values can, in combination with metadata on strategies and techniques, provide valuable information for laboratories to improve their procedures. In conclusion, our two-step strategy (preparation phase followed by a series of EQAs) is a rapid and flexible system capable of scaling, improving, and maintaining high quality diagnostics even in a rapidly evolving (e.g. pandemic) situation.</p

High quality of SARS-CoV-2 molecular diagnostics in a diverse laboratory landscape through supported benchmark testing and External Quality Assessment

A two-step strategy combining assisted benchmark testing (entry controls) and External Quality Assessments (EQAs) with blinded simulated clinical specimens to enhance and maintain the quality of nucleic acid amplification testing was developed. This strategy was successfully applied to 71 diagnostic laboratories in The Netherlands when upscaling the national diagnostic capacity during the SARS-CoV-2 pandemic. The availability of benchmark testing in combination with advice for improvement substantially enhanced the quality of the laboratory testing procedures for SARS-CoV-2 detection. The three subsequent EQA rounds demonstrated high quality testing with regard to specificity (99.6% correctly identified) and sensitivity (93.3% correctly identified). Even with the implementation of novel assays, changing workflows using diverse equipment and a high degree of assay heterogeneity, the overall high quality was maintained using this two-step strategy. We show that in contrast to the limited value of Cq value for absolute proxies of viral load, these Cq values can, in combination with metadata on strategies and techniques, provide valuable information for laboratories to improve their procedures. In conclusion, our two-step strategy (preparation phase followed by a series of EQAs) is a rapid and flexible system capable of scaling, improving, and maintaining high quality diagnostics even in a rapidly evolving (e.g. pandemic) situation.</p

Kunnen kinderen met bronchiolitis samen op een kamer verpleegd worden? Een prospectieve cohortstudie

Achtergrond Kinderen met bronchiolitis die zijn opgenomen in het ziekenhuis, worden meestal geïsoleerd en in RSV-positieve en RSV-negatieve cohorten verpleegd, om kruisbesmetting te voorkomen. Het is niet bekend of deze cohortisolatie zinvol is. Doel De incidentie en de ernst bepalen van kruisinfecties, gedefinieerd als detectie van een respiratoir virus gedurende of vlak na opname dat bij opname niet gevonden werd, bij kinderen die zijn opgenomen met bronchiolitis en samen op een kamer verpleegd worden, ongeacht de virale verwekker. Opzet Prospectief cohortonderzoek. Methode Aan dit onderzoek namen kinderen jonger dan 2 jaar deel die in de periode 2012-2016 werden opgenomen met bronchiolitis in Isala, Zwolle. Patiënten werden gezamenlijk op twee- tot vierpersoonskamers verpleegd. Neusspoelsels werden afgenomen bij opname, elke 4e dag van de opname en 5-7 dagen na ontslag; deze werden met PCR onderzocht op virale verwekkers. Onderzoekers en behandelaars waren niet op de hoogte van de uitslagen van de virale diagnostiek. De primaire uitkomstmaat was een kruisbesmetting tijdens opname. Resultaten Van de 218 geïncludeerde patiënten was 83,4% RSV-positief bij opname. Kruisbesmetting trad op bij 12,8%. Bij 3 van de 28 kruisbesmette patiënten werd hetzelfde virus gevonden bij een kamergenoot. Kruisbesmetting ging niet gepaard met een ernstiger ziektebeloop. Conclusie Kruisbesmettingen komen veel voor bij bronchiolitis, maar leiden niet tot ernstigere ziekteverschijnselen. Wanneer individuele contactisolatie wordt toegepast, heeft het verplegen van meerdere patiënten met bronchiolitis op dezelfde kamer, ongeacht de verwekker, geen nadelige gevolgen voor de patiënt

Room Sharing in Hospitalized Children With Bronchiolitis and the Occurrence of Hospital-Acquired Infections:A Prospective Cohort Study

OBJECTIVES: To determine the prevalence and severity of hospital-acquired infections (HAIs) in children hospitalized for bronchiolitis when patients share a room, irrespective of the causative virus. METHODS: A prospective cohort study during 4 winter seasons (2012-2016) was conducted in a Dutch general pediatric ward including otherwise healthy children <2 years of age hospitalized for bronchiolitis. Patients shared a 1-to-4-bed hospital room irrespective of virological diagnosis. The main outcome measures were HAIs assessed through multiplex polymerase chain reaction and disease severity. RESULTS: HAIs occurred in 28 of 218 included patients (12.8%), most frequently with rhinovirus (17 of 28; 60.7%). In 3 (10.7%) of 28 HAIs, the same virus was identified in roommates. Only 1 patient became cross-infected with respiratory syncytial virus, although this patient never shared a room with a patient infected with respiratory syncytial virus. HAI was not associated with more severe disease. The median length of hospitalization was 3.5 days (interquartile range [IQR] 1-6) compared with 3 days (IQR 2-6; P = .86); the number of PICU admissions was 0% versus 5.3% (P = .21); the median days of oxygen supplementation was 2.5 (IQR 1-4) versus 2 (IQR 1-4; P = .58); the median days of tube feeding was 2 (IQR 0-5) versus 2 (interquartile range: 0-5; P = .77); and the readmission rate was 0% versus 5.8% (P = .19) in patients with and without HAI, respectively. CONCLUSIONS: HAIs among patients with bronchiolitis are common but not associated with more severe disease. Room sharing with appropriate hygiene does not play a relevant role in the transmission of viruses between patients with bronchiolitis, regardless of the viruses involved. On the basis of these findings, we suggest that room sharing of patients with bronchiolitis is safe