NADAL CRP, test cassettes

General information about the test: The NADAL C. difficile GDH Ag Test is a rapid chromatographic immunoassay for the qualitative detection of Clostridium difficile glutamate dehydrogenase ( C. difficile GDH) antigens in human faecal specimens. The test is intended for use as an aid in the diagnosis of Clostridium difficile infection and is designed for professional use only. Reagents and materials supplied: 10 NADAL C. difficile GDH Ag test cassettes 10 specimen collection tubes with buffer 1 package insert Test time: 10 min Performance characteristics: NADAL C. difficile GDH Ag Test shows no cross-reactivity with other microorganisms occasionally present in human faeces ( E.Coli , Campylobacter spp , Helicobacter pylori , Salmonella spp , Shigella spp , Listeria spp , Staphylococcus aureus , Yersinia spp etc ). Stool samples from patients were tested using NADAL C. difficile GDH Ag Test and two commercially available immunoassays ( C. DIFF QUIK CHEK COMPLETE , Techlab and Wampole C. Diff Chek TM-60, Techlab). Sensitivity: >99% and specificity: >99% Sensitivity: >95% and specificity: >99% Test principles: The NADAL C. difficile GDH Ag Test is a qualitative lateral flow immunoassay for the detection of C. difficile GDH antigens in human faecal samples. First, the anti-GDH antibodies eventually present in the sample (in the case of positive result) react with colored particles-bound antigens pre-dried on the internal test strip, further the samples move along the membrane by capillary action and specific antibodies present on test line react with the mixture conjugate and generate a colored line in the test (T) region of the cassette. A green line should always appear in the control line region (C). This serves as a procedural control, indicating that the proper volume of specimen has been added and membrane-based immunological reactions have taken place. Clinical significance: Clostridium difficile is anaerobic gram-positive spore-forming bacterium – a feature that enables it to persist in patients and physical environments for long periods of time. Infection with C. difficile takes place by fecal-oral route. C. difficile is the main pathogen related to cases of antibiotics associated diarrhea and/or pseudomembranous colitis in hospitalized patients. Colonic microflora of a healthy adult is resistant to C. difficile infection. When the normal colonic flora is compromised resistance to C. difficile is lost . Such conditions might occur after treatment with broad-spectrum antibiotics such as penicillins, cephalosporins and clindamycin. C. difficile releases two high-molecular-weight toxins – A and B. They cause the clinical manifestations of C. difficile infection – ranging from mild self-limited watery diarrhea to fulminant pseudomembranous colitis, toxic megacolon and death.