NADAL Shigella dysenteriae, rapid test

General information about this test: NADAL Gonorrhea Test is a rapid chromatographic immunoassay for qualitative detection of Gonorrhea in female cervical swab and male urethral swab specimens. NADAL Gonorrhea Test is aimed to aid diagnosis of gonococcal infection and is intended for professional use only. Reagents and material supplied: 10 NADAL Gonorrhea test cassettes (individually packed) Provided additional material according to 93/42/EEC: 10 sterile female cervical swabs CE 0086 10 extraction tubes 10 dropper tips Reagent A (Ethanol, 10-20% w/w; Sodium hydroxide, 0.2- 0.5% w/w) Reagent B (MOPSO sodium salt, 2-5% w/w; Sodium azide <0.1%) 1 reagent holder 1 package insert Test time : 10 min Performance characteristics: The NADAL Gonorrhea Test shows no cross-reactivity with the following microorganisms: (10 7 CFU/test): Acinetobacter calcoaceticus, Acinetobacter spp, Enterococcus faecalis, Enterococcus faecium, Staphylococcus aureus, Escherichia coli, Pseudomona aeruginosa, Gardnerella vaginalis, Salmonella choleraesius, Candida albicans, Proteus vulgaris, Proteus mirabilis, Chlamydia trachomatis, Група B/C Streptococcus, Hemophilus influenzae, Klebsiella pneumoniae, Proteus mirabili . The specificity and sensitivity data for NADAL Gonorrhea Test were evaluated with specimens obtained from patients of STD clinics and subsequent comparison with the results obtained with culture methods. For Female Cervical Swab Specimens Relative sensitivity: 91.5% * Relative specificity: 96.1% * Accuracy: 93.9% * * 95% Confidence Interval For Male Urethral Swab Specimens: Relative sensitivity: 89.2% * Relative specificity: 96.5% * Accuracy: 92.7% * * 95% Confidence Interval Results reproducibility: >99% Test principles: The NADAL Gonorrhea Test is a qualitative lateral flow immunoassay for the detection of gonorrhea antigens in female cervical swab and male urethral swab specimens. In the case of positive result, the gonorrhea antigens eventually present in the sample first react with gonorrhea antibodies which are coated onto particles, further the so formed complex moves along the membrane by capillary action and reacts with specific antibodies present on test line and generate a colored line in the test (T) region of the cassette.A colored line in the control line region (C) serving as a procedural control should always appear. It indicates that the proper volume of specimen has been added and membrane wickinghas occurred. Clinical significance: Gonorrhea is a sexually transmitted disease caused by the bacterium Neisseria gonorrhoeae . The transmission is not restricted to vaginal sex, infection with Neisseria gonorrhoeae can occur during anal and oral sex too, causing respectively severe sore throat and inflammation of anus and rectum – a condition called proctitis. In females, it can infect the vagina, causing irritation with discharge (vaginitis). Neisseria gonorrhoeae also infects urethra, causing urethritis with burning, painful urination and discharge, increased urinary frequency and urinary discomfort. The spread of this bacterium to the fallopian tubes and abdomen is also possible. In this case severe lower-abdominal pain and fever occur. In women, gonorrhea is a common cause of pelvic inflammatory disease (PID). PID can lead to internal abscesses and long-lasting, chronic pelvic pain. PID can damage the fallopian tubes enough to cause infertility or increase the risk of ectopic pregnancy. On average, the first symptoms of gonorrhea appear 3 to 5 days after sexual intercourse with an infected individual, however, this period can be as long as 2 weeks.