European Multicenter Evaluation of Commercial Enzyme Immunoassays for Detecting Norovirus Antigen in Fecal Samples

Gray, Jim; Kohli, Évelyne; Ruggeri, Franco Maria; Vennema, Harry; Sánchez-Fauquier, Alicia; Schreier, E.; Gallimore, Christopher; Iturriza‐Gómara, Miren; Giraudon, H.; Pothier, Pierre; Bartolo, Ilaria Di; Inglese, N.; Bruin, Erwin de; Veer, Bas van der; Moreno, Sílvia; Montero, Vanessa; Llano, M; Höhne, Marina; Diedrich, Sabine

doi:10.1128/cvi.00214-07

Cited by 90 publications

(53 citation statements)

References 22 publications

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“…Of these, one sample showed inhibition of the PCR and was excluded. Of the remaining 537 samples, 98 (18.2%) were PCR-positive and 60 (11.2%) were positive by the RQN assay (Table 1) and 96%, which are more consistent with our findings for the RQN assay [7][8][9][10]. The difference between Apostel's and our RQN assay sensitivity results may be explained by differences between the two patient populations, the prevalent viral genotypes in these populations and the stage of infection at which sampling took place.…”

Section: Introductionsupporting

confidence: 81%

Evaluation of a rapid immunochromatographic test for the detection of norovirus in stool samples

Bruins

Wolfhagen

Schirm

et al. 2010

Eur J Clin Microbiol Infect Dis

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Worldwide noroviruses are an important cause of gastroenteritis and are major agents of both sporadic as well as epidemic infection. Because of the rapid transmission of the virus, early detection is essential. Until recently the available test methods for the detection in stool were enzyme immunoassays and real time reverse transcription PCR (RT-PCR), which both take several hours to perform. We evaluated the rapid immunochromatographic test RIDA®QUICK Norovirus for the detection of norovirus in stool of patients with acute gastroenteritis. This test is easy to perform and read and only takes 20 minutes. The sensitivity and specificity compared to RT-PCR results and the positive and negative predictive values were 57.1%, 99.1%, 93.3% and 91.2% respectively. The rapid test is useful for quick screening, but a negative result should be followed up by RT-PCR . 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 61 62 63 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 61 62 63 64 65 2 AbstractWorldwide noroviruses are an important cause of gastroenteritis and are major agents of both

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Section: Introductionsupporting

confidence: 81%

Evaluation of a rapid immunochromatographic test for the detection of norovirus in stool samples

Bruins

Wolfhagen

Schirm

et al. 2010

Eur J Clin Microbiol Infect Dis

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“…Current EIAs are based on polyclonal or monoclonal antibodies raised against a panel of different virus-like particles (VLPs). Previous studies have demonstrated that the sensitivity and specificity of NoV EIAs vary with the diagnostic goal (outbreak or sporadic cases) and test design (19), which raises questions about their usefulness for routine screening of samples.…”

mentioning

confidence: 99%

Diagnostic Accuracy and Analytical Sensitivity of IDEIA Norovirus Assay for Routine Screening of Human Norovirus

Costantini

Grenz

Fritzinger³

et al. 2010

J Clin Microbiol

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Noroviruses (NoVs) are recognized as the leading cause of epidemic and sporadic acute gastroenteritis. Early detection of NoV is crucial to control the spread of the disease. In this study, we evaluated the diagnostic accuracy, analytical sensitivity, and analytical reactivity of the IDEIA Norovirus assay (an enzyme immunoassay [EIA]) in a prospective and retrospective study design. A total of 557 prospectively collected fecal samples and a panel of 97 archived fecal samples, including 21 different GI and GII genotypes, were tested by conventional reverse transcription-PCR (RT-PCR)/bidirectional sequencing, real-time RT-PCR, and electron microscopy. The sensitivity and specificity of the EIA were 57.6% and 91.9%, respectively. The sensitivity for detecting NoV in fecal samples from outbreaks improved from 44.1% when three samples were tested to 76.9% when five samples per outbreak were tested. The EIA was able to detect strains from 7 GI and 11 GII genotypes. The analytical sensitivity of the EIA was 3.1 ؋ 10 6 and 1.6 ؋ 10 7 virus particles g ؊1 of fecal sample for NoV GI and GII strains, respectively. Most GII samples positive by EIA had a threshold cycle (C T ) of <26.5, and 50% of the GII samples negative by EIA had a C T of >25.6, suggesting that, although strains from genotypes GI.8, GII.10, and GII.16 were not detected, the low sensitivity of the EIA is primarily caused by low virus concentration. In conclusion, the current EIA may be of use as a rapid screening test during a norovirus outbreak investigation when multiple fecal samples are available; however, sporadic samples should be tested by molecular methods.

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“…Advantages of EIA testing over PCR based assays include simplicity (no specialized equipment or skilled personnel required) and speed (rapid bed-side tests have been developed based on an EIA that promise results within 15 minutes). The EIAs use either monoclonal or polyclonal antibodies specific for a limited number of antigenically-distinct NoV genotypes, which can be problematic in the detection of antigenic variants or emerging genotypes (Gray et al, 2007). Knowledge of the local circulating NoV genotypes is helpful in evaluating the efficiency of the EIA in a particular setting (de Bruin et al, 2006).…”

Section: Detection Of Viruses In Humansmentioning

confidence: 99%

Scientific Opinion on an update on the present knowledge on the occurrence and control of foodborne viruses

2011

EFS2

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A review of the biology, epidemiology, diagnosis and public health importance of foodborne viruses was performed. Data needs to support a risk assessment were also identified. In addition possible control options and their anticipated impact to prevent or reduce the number of foodborne viral human infections were identified, including the scientific reasons for and against the establishment of food safety criteria and process hygiene criteria for viruses for certain food categories. Food may be contaminated by virus during all stages of the food supply chain, and transmission can occur by consumption of food contaminated during the production process (primary production, or during further processing), or contaminated by infected food handlers. Transmission of zoonotic viruses (e.g. HEV) can also occur by consumption of products of animal origin. Viruses do not multiply in foods, but may persist for extended periods of time as infectious particles in the environment, or in foods. At the EU-level it is unknown how much viral disease can be attributed to foodborne spread. The relative contribution of different sources (shellfish, fresh produce, food handler including asymptomatic shedders, food handling environment) to foodborne illness has not been determined. The Panel recommends focusing controls on preventive measures to avoid viral contamination rather than trying to remove/inactivate these viruses from food. Also, it is recommended to introduce a microbiological criteria for viruses in bivalve molluscs, unless they are labelled "to be cooked before consumption". The criteria could be used by food business operators to validate their control options. Furthermore, it is recommended to refine the regulatory standards and monitoring approaches in order to improve public health protection. Introduction of virus microbiological criteria for classification of bivalve molluscs production areas should be considered. A virus monitoring programme for compliance with these criteria should be risk based according to the findings of a sanitary survey. KEY WORDSFood borne viruses, Norovirus, Hepatitis, Microbiological criteria, molluscs, fresh produce. SUMMARYThe European Food Safety Authority (EFSA) asked the Panel on Biological Hazards to initiate a self tasking issue with the purpose to provide up-to-date information on the present knowledge on the occurrence and control of foodborne viruses. The BIOHAZ Panel carried out a review of the available information in the scientific literature with regards to the biology, epidemiology, diagnosis and public health importance of foodborne viruses. Where possible the review covered primary production, food harvesting, food processing, and storage/retail until consumption. Data needs to support a risk assessment were also identified. In addition possible control options and their anticipated impact to prevent or reduce the number of foodborne viral human infections were identified including the scientific reasons for and against the establishment of microbiological criteri...

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European Multicenter Evaluation of Commercial Enzyme Immunoassays for Detecting Norovirus Antigen in Fecal Samples

Cited by 90 publications

References 22 publications

Evaluation of a rapid immunochromatographic test for the detection of norovirus in stool samples

Evaluation of a rapid immunochromatographic test for the detection of norovirus in stool samples

Diagnostic Accuracy and Analytical Sensitivity of IDEIA Norovirus Assay for Routine Screening of Human Norovirus

Scientific Opinion on an update on the present knowledge on the occurrence and control of foodborne viruses

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