In a prospective multicenter study, 367 fecal samples from 300 patients with diarrhea were tested for Clostridium difficile-associated diarrhea (CDAD) with a new immunochromatography assay for toxins A and B (ICTAB), a real-time PCR on the toxin B gene, and the cell cytotoxicity assay. Twenty-three (6.2%) of the 367 fecal samples were positive by the cell cytotoxicity assay. With the cell cytotoxicity assay as the "gold standard," the sensitivity, specificity, positive predictive value, and negative predictive value for the ICTAB assay and real-time PCR were 91, 97, 70, and 99%, and 87, 96, 57 and 99%, respectively. In conclusion, both the ICTAB and the real-time PCR can be implemented as rapid screening methods for patients suspected of having CDAD.Clostridium difficile-associated diarrhea (CDAD) is the most important infectious cause of nosocomial diarrhea and pseudomembranous colitis. The enteropathogenicity depends on the production of enterotoxin A (308 kDa) and cytotoxin B (270 kDa). Several authors have suggested that all fecal samples for C. difficile from patients with diarrhea hospitalized for more than 72 h be investigated (3) irrespective of the physician's request, since length of hospitalization is simple to implement as an inclusion criterion. Conventional diagnostic methods for CDAD are the cell cytotoxicity assay and the enzyme immunoassays (EIA) to detect fecal toxins A (TcdA) and B (TcdB). The cell cytotoxicity assay is considered the "gold standard." However, with a turnaround time of more than 48 h, this method is laborious and time-consuming. Frequently, EIA are used because of their more rapid turnaround time. Rapid diagnosis of CDAD is important, since it may result in early treatment and prevention of nosocomial transmission.A new rapid immunochromatography test, the ImmunoCard Toxins A&B (ICTAB; Meridian), has recently been introduced. The ICTAB is a single-test enzyme immunoassay for the detection of TcdA and TcdB in fecal samples within 20 min. No sample pretreatment is required, and an internal procedure control is integrated in each card. The performance of this rapid assay was evaluated in comparison with an in-housedeveloped, real-time PCR using tcdB and the cell cytotoxicity assay. A positive PCR result for a fecal sample is indicative of the presence of a C. difficile strain capable of producing TcdB. Fecal samples from adult patients with diarrhea for whom there was a request for C. difficile diagnosis and samples from patients hospitalized for more than 72 h were included. All samples were stored within 6 hours after arrival at the laboratory at Ϫ20°C in two individual vials for subsequent testing by the cell cytotoxicity assay and real-time PCR at the LUMC. The ICTAB was performed in the Erasmus MC and the LUMC. All fecal samples were thawed only once for a specific test.The ICTAB was performed according to the respective manufacturer's instructions. Briefly, enzyme conjugate was added to specimen diluent before the addition of 25 l of the fecal sample or the control. After i...
Lyme neuroborreliosis (LNB) is a serious but treatable disease. The diagnosis of LNB poses a challenge to clinicians, and improved tests are needed. The C6-peptide ELISA is frequently used on serum but not on cerebrospinal fluid (CSF). Data on the sensitivity of the C6-peptide ELISA in CSF in patients suffering from LNB have been conflicting. Serum-CSF pairs from 59 LNB patients, 36 Lyme non-neuroborreliosis cases, 69 infectious meningitis/encephalitis controls and 74 neurological controls were tested in a C6-peptide ELISA. With the optimal cut-off of 1.1, the sensitivity of the C6-peptide ELISA for LNB patients in CSF was 95%, and the specificity was 83% in the Lyme non-neuroborreliosis patients, 96% in the infectious controls, and 97% in the neurological controls. These results suggest that the C6-peptide ELISA has a high sensitivity and good specificity for the diagnosis of LNB patients in CSF. The C6-peptide ELISA can be used on CSF in a clinical setting to screen for LNB.
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