Evaluation of third-generation ELISA and a rapid immunochromatographic assay for the detection of norovirus infection in fecal samples from inpatients of a German tertiary care hospital

Abstract

The analytical accuracy of the RIDASCREEN Norovirus 3rd Generation ELISA assay and the rapid immunochromatographic RIDAQUICK Norovirus assay were determined in comparison to PCR. In a prospective study 410 consecutive samples were collected from inpatients of a tertiary care hospital in Germany. All samples were tested with the two antigen detection assays, as well as with three different real-time reverse transcription PCR methods as the reference standard. A sample was considered true-positive if at least 2 out of 3 PCR methods yielded a positive signal (137 positive samples, >99% genogroup II). Compared with the PCR-based reference the overall diagnostic sensitivities of the ELISA and the immunochromatographic assay were 77% and 69% and the diagnostic specificities were 96% and 97% respectively. Both assays allow the rapid and economic screening of large numbers of samples and thus are useful diagnostic tools for the detection of suspected norovirus infections.

Rapid and sensitive detection of norovirus antibodies in human serum with a biolayer interferometry biosensor

“…There are NoV antibody-based lateral flow tests available for fast diagnosis, and they are used mainly for rapid screening of stool samples [24]. Stool samples are preferred due to the high virus content.…”

Characteristics and outcomes of patients diagnosed with norovirus gastroenteritis after allogeneic hematopoietic stem cell transplantation based on immunochromatography

“…Despite the difference in the backgrounds among these studies, the lower incidence of NV-GE in our report than in other reports suggests that some patients who are diagnosed as NV-GE by RT-PCR might be overlooked by IC [18-20, 22, 24, 27] because the IC kit was reported to have a lower sensitivity in patients who were diagnosed by RT-PCR. However, IC might have adequate sensitivity comparable to those of other methods for detecting a high viral load in the early phase of the disease, since there was no apparent NV outbreak during our study period [23]. Moreover, it is still unclear whether NA patients who are positive by RT-PCR but negative by IC have infectious potential and are clinically significant [13,31,32].…”

“…Although quantitative RT-PCR for the detection of viral RNA in stool specimens has been used to diagnose NV-GE after HSCT in recent studies [11,12,15,16], this method is not yet established as a standardized technique for widespread clinical use due to drawbacks such as its high cost and complicated techniques required [18]. On the other hand, several studies in other settings have demonstrated that immunochromatography (IC), which is based on the antigen-antibody reaction using a monoclonal antibody specific for virus-like particles, can be used to easily and rapidly detect NV antigen in stool samples by an inhouse laboratory with high specificity, albeit with slightly less sensitivity, and at lower cost than RT-PCR [19][20][21][22][23][24][25][26][27]. An IC kit has recently been marketed in Asia and Europe [1].…”

Microwave-accelerated bioassay technique for rapid and quantitative detection of biological and environmental samples

“…Enzyme-linked immunosorbent assay (ELISA) is the most common method used in health care and environmental industry for analyzing biological or environmental samples for specific proteins and autoantibodies, which can confirm the existence of a diseased state or microbial presence (Chen Gui 2011; Geginat et al 2012; Liu et al 2009; Mohammed and Aslan 2013a). Since its first publication in 1968, ELISA technique has been modified over the years to face new challenges of low assay sensitivity, assay linearity and cost efficiency (Aslan and Geddes 2008).…”

“…Since its first publication in 1968, ELISA technique has been modified over the years to face new challenges of low assay sensitivity, assay linearity and cost efficiency (Aslan and Geddes 2008). ELISAs can be used for qualitative detection (such as pregnancy test, in food industry to detect allergens) or quantitative (such as blood glucose level test, HIV test, entero-toxin of E. coli in feces and water samples (Geginat et al 2012). In this regard, colorimetric-based detection, which gives a visual conformation of the presence of an analyte of interest, is the most widely used detection technique for ELISA based systems (Dixit et al 2010).…”