Retrospective analysis on confirmation rates for referred positive rotavirus samples in England, 2016 to 2017: implications for diagnosis and surveillance
Author(s)
Type
Journal Article
Abstract
Background
Rapid diagnostic tests are commonly used by hospital laboratories in England to detect rotavirus (RV), and results are used to inform clinical management and support national surveillance of the infant rotavirus immunisation programme since 2013. In 2017, the Public Health England (PHE) national reference laboratory for enteric viruses observed that the presence of RV could not be confirmed by PCR in a proportion of RV-positive samples referred for confirmatory detection.
Aim
We aimed to compare the positivity rate of detection methods used by hospital laboratories with the PHE confirmatory test rate.
Methods
Rotavirus specimens testing positive at local hospital laboratories were re-tested at the PHE national reference laboratory using a PCR test. Confirmatory results were compared to original results from the PHE laboratory information management system.
Results
Hospital laboratories screened 70.1% (2,608/3,721) of RV samples using immunochromatographic assay (IC) or rapid tests, 15.5% (578/3,721) using enzyme immunoassays (EIA) and 14.4% (535/3,721) using PCR. Overall, 1,011/3,721 (27.2%) locally RV-positive samples referred to PHE in 2016 and 2017 failed RV detection using the PHE reference laboratory PCR test. Confirmation rates were 66.9% (1,746/2,608) for the IC tests, 87.4% (505/578) for the EIA and 86.4% (465/535) for the PCR assays. Seasonal confirmation rate discrepancies were also evident for IC tests.
Conclusions
This report highlights high false positive rates with the most commonly used RV screening tests and emphasises the importance of implementing verified confirmatory tests for RV detections. This has implications for clinical diagnosis and national surveillance.
Rapid diagnostic tests are commonly used by hospital laboratories in England to detect rotavirus (RV), and results are used to inform clinical management and support national surveillance of the infant rotavirus immunisation programme since 2013. In 2017, the Public Health England (PHE) national reference laboratory for enteric viruses observed that the presence of RV could not be confirmed by PCR in a proportion of RV-positive samples referred for confirmatory detection.
Aim
We aimed to compare the positivity rate of detection methods used by hospital laboratories with the PHE confirmatory test rate.
Methods
Rotavirus specimens testing positive at local hospital laboratories were re-tested at the PHE national reference laboratory using a PCR test. Confirmatory results were compared to original results from the PHE laboratory information management system.
Results
Hospital laboratories screened 70.1% (2,608/3,721) of RV samples using immunochromatographic assay (IC) or rapid tests, 15.5% (578/3,721) using enzyme immunoassays (EIA) and 14.4% (535/3,721) using PCR. Overall, 1,011/3,721 (27.2%) locally RV-positive samples referred to PHE in 2016 and 2017 failed RV detection using the PHE reference laboratory PCR test. Confirmation rates were 66.9% (1,746/2,608) for the IC tests, 87.4% (505/578) for the EIA and 86.4% (465/535) for the PCR assays. Seasonal confirmation rate discrepancies were also evident for IC tests.
Conclusions
This report highlights high false positive rates with the most commonly used RV screening tests and emphasises the importance of implementing verified confirmatory tests for RV detections. This has implications for clinical diagnosis and national surveillance.
Date Issued
2020-10-29
Date Acceptance
2020-03-01
Citation
Eurosurveillance, 2020, 25, pp.1-8
ISSN
1025-496X
Publisher
European Centre for Disease Prevention and Control
Start Page
1
End Page
8
Journal / Book Title
Eurosurveillance
Volume
25
Copyright Statement
This article is copyright of the authors or their affiliated in-stitutions, 2020. This is an open-access article distributed under the terms of the Creative Commons Attribution (CC BY 4.0) Licence. You may share and adapt the material, but must give appropriatecredit to the source, provide a link to the licence and indicate if changes were made.
License URL
Sponsor
Medical Research Council (MRC)
National Institute for Health Research
GlaxoSmithKline Services Unlimited
Identifier
https://www.eurosurveillance.org/content/10.2807/1560-7917.ES.2020.25.43.1900375
Grant Number
MR/R015600/1
HPRU-2012-10080
3000862100
Subjects
Science & Technology
Life Sciences & Biomedicine
Infectious Diseases
GROUP-A ROTAVIRUS
ACUTE GASTROENTERITIS
VACCINE INTRODUCTION
IMPACT
AGE
Science & Technology
Life Sciences & Biomedicine
Infectious Diseases
NEISSERIA-GONORRHOEAE
GENOMIC EPIDEMIOLOGY
SUSCEPTIBILITY
THERAPY
TRANSMISSION
Rotavirus
diagnosis
rapid test
screening
surveillance
England
Humans
Infant
Public Health Surveillance
Retrospective Studies
Rotavirus
Rotavirus Infections
antibiotic resistance
antibiotic use
antimicrobial resistance
bacterial infections
epidemiology
gonorrhoea
modelling
molecular methods
multidrug resistance
point-of-care tests
sexually transmitted infections
Humans
Rotavirus
Rotavirus Infections
Retrospective Studies
Infant
England
Public Health Surveillance
0605 Microbiology
1117 Public Health and Health Services
1199 Other Medical and Health Sciences
Notes
eid: 1900375
Publication Status
Published
Article Number
43