General information about this test:
NADAL® Shigella dysenteriae Test is a rapid chromatographic immunoassay for qualitative detection of Shigella dysenteriae type 1 in stool samples. NADAL® Shigella dysenteriae Test is aimed to aid diagnosis of shigellosis (bacillary dysentery) and is intended for professional use only.
Reagents and material supplied:
- 10 NADAL® Shigella dysenteriae test cassettes
- 10 specimen collection tubes with buffer
- 1 package insert
Test time: 10 min
Performance characteristics:
The NADAL® Shigella dysenteriae Test shows no cross-reactivity with the following common gastrointestinal microorganisms occasionally found in stool samples: E. coli O157:H7, Salmonella, H. pylori Staphylococcus aureus, Listeria monocytogene and Yersinia enterocolitica.
The specificity and sensitivity data for NADAL® Shigella dysenteriaeTest were confirmed by culture tests.
Sensitivity: >99%
Specificity: >99%
Test principles:
The NADAL® Shigella dysenteriae Test is a qualitative lateral flow immunoassay for the detection of S. dysenteriae antigens in human faecal samples. First, the anti-Shigella dysenteriae antibodies eventually present in the sample (in the case of positive result) react with antibodies bound to coloured particles 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) and serves as a procedural control, indicating that the proper volume of specimen has been added and membrane wicking has occurred.
Clinical significance:
Clinical syndromes in humans caused by infection with Shigella (S. dysenteriae, S. flexneri, S. boydii and S. sonnei) include diarrhoeal disease, fever and stomach cramps. Shigellosis is usually related to poor sanitation, contaminated water and foods and living in crowded conditions. First symptoms of shigellosis occur within 5-7 after infection. In societies characterized with poor hygiene habits, the most common Shigella serovars cause recurring problems and affect large population groups.