NADAL Influenza A/B, rapid test

General information about this test: NADAL Candida albicans Test is a rapid chromatographic immunoassay for qualitative detection of Candida albicans in vaginal swab specimens. NADAL Candida albicans Test is aimed to aid diagnosis of candidiasis ( C. albicans infection) and is intended for professional use only. Reagents and material supplied: 20 NADAL Candida albicans test cassettes (incl. disposable pipettes) Provided additional material according to 93/42/EEC: 20 swabs 20 extraction tubes 1 bottle Reagent 1 1 bottle Reagent 2 1 reagent holder 1 package insert Test time : 15 min Performance characteristics: The detection limit of the NADAL Candida albicans Test is 1.5 x 10 5 CFU/ml (determined with Candida albicans ATCC# 10231). The NADAL Candida albicans Test shows no cross-reactivity with the following microorganisms frequently found in the vaginal flora: Candida dubliniensis ATCC MYA-580 (1 x 10 7 микроорганизма/мл), Candida glabrata ATCC 15126 (1 x 10 7 ), Candida krusei ATCC 20405 (1 x 10 7 ), Candida oleophila ATCC28137 (1 x 10 7 ), Candida parapsilosis ATCC 10233 (1 x 10 7 ), Candida tropicalis ATCC 15114 (1 x 10 7 ), Chlamydophila pneumonia ATCC53592(1 x 10 7 ), Chlamydophila psittaci ATCC VR-1369(1 x 10 7 ), Chlamydia trachomatis ATCCVR-1500 (1 x 10 7 ), E. coli ATCC25922 (1 x 10 8 ), Gardnerella vaginalis ATCC 14018 (1 x 10 5 ), Lactobacillus ATCC 314(1 x 10 5 ), Mycoplasma hominis ATCC 15056 (1 x 10 3 ), Mycoplasma pneumonia ATCC 29342(1 x 10 7 ), Ureaplasma urealyticum ATCC27814(1 x 10 7 ). The specificity and sensitivity data for NADAL Candida albicans Test were evaluated with specimens obtained from 150 patients showing clinical symptoms and 150 women without any symptoms and subsequent comparison with the results obtained with culture methods. Relative sensitivity: 97.3% Relative specificity: 94.5% Overall aggreement: 96.0 % Test principles: The NADAL Candida albicans Test is a qualitative sandwich immunoassay aimed at detection of Candida albicans antigens in vaginal swab specimens. The test cassette contains a nitrocellulose membrane strip with immobilised mouse anti- Candida albicans antibodies in the test line region (T) and goat-anti-mouse antibodies which are immobilised in the control line region (C). In the case of positive result, the Candida albicans antigens eventually present in the sample first react withmouse anti- Candida albicans antibodies which are coupled with colloidal gold, thus forming antigen-antibody-colloidal gold complexes. Capillary forces drive the movement of the sample mixture along the membrane, it reaches the immobilised mouse anti- Candida albicans antibodies and sandwich antibody-antigen-antibody-colloidal gold complex is formed. If the tested sample contains a certain concentration of Candida albicans antigen, the formation of this sandwich complex will result in a visible colored line in the test line region of the membrane. If no Candida albicans antigen is present in the sample, no test line will appear in the test line region of the membrane. The remaining gold conjugates reach the control line region (C) of the nitrocellulose membrane where they form complexes with the immobilised anti-IgG antibodies on the membrane resulting in the formation of a coloured control line (C).A colored line in the control line region (C)serving as a procedural control should always appear. It indicates that the propervolume of specimen has been added and membrane wickinghas occurred. Clinical significance: Genital/vulvovaginal candidiasis (VVC), also known as "yeast infection" is a fungal infection caused by the diploid, dimorphic fungus (growing as yeast and hyphae) Candida albicans . C. albicans is present in small amounts in the microflora of mouth, vagina, digestive tract and on the skin, without causing infection or symptoms. However, if the natural balance of the flora is disturbed, overgrowth of the fungus may result in candidiasis. Vulvovaginal candidiasis is regarded relatively common infectious disease. Up to 75% of women have had ‘yeast infection’ at least once in their lifetime. Intake of broadspectrum antibiotics, hormonal changes during pregnancy or oestrogen uptake, illnesses like diabetes mellitus, immunodeficiency, iron deficiency anaemia or others increase the predisposition for infection. The most common symptoms of vulvovaginal candidiasis include, in particular, thick vaginal discharge, vaginal itching and burning, painful urination, pain with intercourse and redness around the vagina.