Comparison of Premier CAMPY Enzyme Immunoassay (EIA), ProSpecT Campylobacter EIA, and ImmunoCard STAT! CAMPY Tests with Culture for Laboratory Diagnosis of Campylobacter Enteric Infections

Abstract

Campylobacter enteritis is a food-borne or waterborne illness caused almost exclusively by Campylobacter jejuni and, to a lesser extent, by Campylobacter coli. These organisms produce indistinguishable clinical diseases and together represent the second most common cause of bacterial diarrhea in the United States and the leading cause of enteric infection throughout the world. The conventional approach to the laboratory diagnosis of Campylobacter enteritis is based on the recovery of the organism from a stool specimen, which requires the use of a specialized medium incubated at 42°C for several days in an artificially created microaerophilic environment. Recently, several commercially available enzyme immunoassays (EIAs) have been developed for the direct detection of C. jejuni and C. coli in stool specimens. This study compared conventional culture with three EIA methods, the Premier CAMPY EIA (Meridian Bioscience, Cincinnati, OH), the ProSpecT Campylobacter EIA (Remel, Lenexa, KS), and the ImmunoCard STAT! CAMPY test (Meridian Bioscience, Cincinnati, OH), for the detection of C. jejuni and C. coli in 485 patient stool samples. Discordant results were arbitrated by using an in-house, real-time PCR assay that was developed and validated by a public health reference laboratory. Following analyses of the discrepant specimens by PCR, the sensitivity and specificity of both the Premier CAMPY and ProSpecT Campylobacter EIAs were 99.3% and 98%, respectively, while the ImmunoCard STAT! CAMPY test had a sensitivity of 98.5% and a specificity of 98.2%. By use of the PCR test as the reference standard, culture detected 127 of 135 Campylobacter-positive stool specimens, yielding a sensitivity of 94.1%. These results showed that the three EIAs evaluated in this study provide a rapid and reliable alternative for the laboratory diagnosis of enteric infections with C. jejuni and C. coli and that conventional culture may no longer be recognized as the "gold standard" for diagnosis.

Accurate detection ofCampylobacterspp. antigens by immunochromatography and enzyme immunoassay in routine microbiological laboratory

“…The new generation of the EIA tested has been improved compared with the previous type, which only had a sensitivity of 69% and a specifi city of 87% compared with culture [6]. Considering the present results for all fresh and frozen samples and culture "gold standard", sensitivity and specifi city of the current product are 96.8% (95% CI, 88.5-99.8%) and 97.2% (95% CI, 95.4-98.4%), respectively, which is in the range of data reported for other, similar assays [11,[15][16][17].…”

“…Furthermore, our data for the ICA also are comparable to those published for a different ICA, the immunoCard STAT! Assay [7,10,11]. Like the ICA evaluated by us, the immunoCard STAT!…”

Immunological Methods for the Detection of Campylobacter spp. - Current Applications and Potential Use in Biosensors

“…The limit of detection is 10 6-7 CFU per ml -1 , and according to the manufacturer's literature, this assay had a sensitivity of 97% and specificity of 96% in a study of 2,073 samples (Table 1). High specificity and sensitivity for this EIA were reported by Granato et al (2010). Another microplate EIA, Ridascreen Campylobacter (R-Biopharm AG, Germany), also uses monoclonal antibodies but does not appear to perform as well as the manufacturer's claims (Bessede et al, 2011;Tissari et al, 2007).…”

“…In another study, culture-based methods were less sensitive than PCR and the ProSpecT assay (Granato et al, 2010).…”

“…CAMPY (Meridian Bioscience, Inc.), uses the same monoclonal antibody as the PREMIER CAMPY assay. The capturing of the target bacteria is by an antibody colloidal complex and the assay has similar specificity to the EIA assays, but with a sensitivity of 10 7 CFU per ml -1 (Bessede et al, 2011;Granato et al, 2010). The Xpect Campylobacter assay (Remel Inc.) is a rapid assay equivalent to the ImmunoCard STAT!…”