TECHLAB C. DIFF QUIK CHEK COMPLETE

1 TECHLAB C. diff quik chek COMPLETE ENGLISH p. 3 A Rapid Membrane Enzyme Immunoassay for the Simultaneous Detection of Clostridium difficile Glutamate Dehydrogenase Antigen and Toxins A and B in Fecal Specimens Catalog No. T30525C (25 Tests) or T30550C (50 Tests)ESPA OL p g. 9 Inmunoensayo enzim tico r pido de membrana para la detecci n simult nea del ant geno glutamato deshidrogenasa de Clostridium difficile y de toxinas A y B en muestras fecales N. de cat logo T30525C (25 ensayos) o T30550C (50 ensayos)DEUTSCH s. 15 Ein Membranenzymimmunoassay-Schnelltest f r den gleichzeitigen Nachweis des Clostridium difficile-Antigens Glutamatdehydrogenase sowie Toxin A und B in Stuhlproben Katalog-Nr. T30525C (25 Tests) bzw. T30550C (50 Tests)FRANCAISE p. 21 Dosage immunoenzymatique membranaire rapide pour la d tection simultan e de l antig ne glutamate d shydrog nase Clostridium difficile et des toxines A et B dans les chantillons de selles Num ro de Catalogue T30525C (25 Tests) ou T30550C (50 Tests) E TINA str.

2 27 Rychl membr nov enzymov imunoanal za pro sou asnou detekci antigenu glutam t dehydrogen zy a toxin A a B Clostridium difficile ve vzorc ch stolice Katalogov slo T30525C (25 testy) nebo T30550C (50 test )DANSK s. 33 En hurtig membran-enzym-immunassay til samtidig p visning af Clostridium difficile-antigenet glutamatdehydrogenase samt toksin A og B i f cespr ver Katalog nr. T30525C (25 test) eller T30550C (50 test) . 39 Clostridium difficile A B . T30525C (25 ) T30550C (50 )MAGYAR 45. o. Gyors membr n enzim immunoassay a Clostridium difficile glutam t-dehidrogen z antig n, valamint az A s a B toxin egyidej kimutat sra sz kletmint kban Katal gussz.

3 : T30525C (25 teszt) vagy T30550C (50 teszt)ITALIANO p. 51 Un dosaggio immunoenzimatico rapido a membra per il rilevamento simultaneo dell antigene glutammato deidrogenasi e delle tossine A e B di Clostridium difficile in campioni fecali N. di catalogo T30525C (25 test) o T30550C (50 test)NEDERLANDS p. 57 Een snel membraanenzymimmuno-assay voor de gelijktijdige detectie van Clostridium difficile-glutamaatdehydrogenase-antigen en de toxinen A en B in fecale monsters Catalogusnr. T30525C (25 testen) of T30550C (50 testen)NORSK s. 63 En hurtig membranenzymimmunanalyse for samtidig p visning av Clostridium difficile glutamatdehydrogenase-antigen og toksin A og B i avf ringspr ver Katalognr. T30525C (25 tester) eller T30550C (50 tester)SVENSKA sid. 69 En snabb immunoanalys av membranenzym f r samtidigt p visande av Clostridium difficileglutamatdehydrogenasantigen och toxinerna A och B i feacesprover Katalognr.

4 T30525C (25 tester) eller T30550C (50 tester)T RK E syf. 75 Clostridium difficile Glutamat Dehidrojenaz Antijeni ile A ve B Toksinleri Saptamas i in H zl Bir Membran Enzimi Ba kl k Testi Katalog No. T30525C (25 Test) ya da T30550C (50 Test)РУССКИЙ с. 81 Мембранный иммуноферментный экспресс-анализ для одновременного обнаружения антигенов глутаматдегидрогеназы и токсинов А и В Clostridium difficile в пробах фекалий No по каталогу: T30525C (25 тестов) или T30550C (50 тестов)PORTUGU S p. 87 Um Ensaio Imunoenzim tico R pido de Membrana para a Dete o Simult nea de Clostridium difficile, Ant geno glutamato desidrogenase e Toxinas A e B em Amostras Fecais Specimens Cat logo N. T30525C (25 Testes) ou T30550C (50 Testes)U. S. Patents #5,965,375 and #8,343,726 TECHLAB C. diff quik chek COMPLETE 3 ENTECHLAB C.

5 diff quik chek COMPLETE INTENDED USEThe TECHLAB C. diff quik chek COMPLETE test is a rapid membrane enzyme immunoassay for the simultaneous detection of Clostridium difficile glutamate dehydrogenase antigen and toxins A and B in a single reaction well. The test detects C. difficile antigen, glutamate dehydrogenase, as a screen for the presence of C. difficile and confirms the presence of toxigenic C. difficile by detecting toxins A and B in fecal specimens from persons suspected of having C. difficile disease. The test is to be used as an aid in the diagnosis of C. difficile disease. As with other C. difficile tests, results should be considered in conjunction with the patient treatment with antibiotics, many patients develop gastrointestinal problems ranging from mild diarrhea to severe pseudomembranous colitis.

6 Many cases of the milder forms of gastrointestinal illness and most cases of pseudomembranous colitis are caused by toxigenic strains of Clostridium difficile (1). This organism is an opportunistic anaerobic bacterium that grows in the intestine once the normal flora has been altered by the antibiotic. Toxigenic strains of C. difficile carry the genes encoding the toxins while non-toxigenic strains do not carry the toxin genes. Disease onset is associated with the toxins that are produced by the toxigenic organism. The clinical symptoms associated with the disease are believed to be primarily due to toxin A, which is a tissue-damaging enterotoxin (2,3). C. difficile also produces a second toxin, designated toxin B. Toxin B, which has been referred to as the cytotoxin of the organism, is the toxin detected by the tissue culture assay currently used by many laboratories.

7 Toxigenic C. difficile strains produce both toxins, or only toxin B (4-7). The glutamate dehydrogenase of C. difficile is a good antigen marker for the organism in feces because it is produced in high amounts by all strains, toxigenic or non-toxigenic (8-10). The antigen can be detected in fecal specimens by using the C. diff quik chek COMPLETE test. A positive result in the test for the glutamate dehydrogenase of C. difficile confirms the presence of this organism in a fecal specimen; a negative result indicates the absence of the organism. A positive result in the test for toxins A and B confirms the presence of toxigenic C. OF THE TESTThe C. diff quik chek COMPLETE test uses antibodies specific for glutamate dehydrogenase and toxins A and B of C. difficile. The device contains a Reaction Window with three vertical lines of immobilized antibodies.

8 The antigen test line ( Ag ) contains antibodies against C. difficile glutamate dehydrogenase. The control line ( C ) is a dotted line that contains anti-horseradish peroxidase (HRP) antibodies. The toxins A and B test line ( Tox ) contains antibodies against C. difficile toxins A and B. The Conjugate consists of antibodies to glutamate dehydrogenase and antibodies to toxins A and B coupled to horseradish peroxidase. To perform the test, the sample is added to a tube containing a mixture of Diluent and Conjugate. The diluted sample-conjugate mixture is added to the Sample Well and the device is allowed to incubate at room temperature for 15 minutes. During the incubation, any glutamate dehydrogenase and toxins A and B in the sample bind to the antibody-peroxidase conju-gates. The antigen-antibody-conjugate complexes migrate through a filter pad to a membrane where they are captured by the immobilized glutamate dehydrogenase-specific and toxins A and B-specific antibodies in the lines.

9 The Reaction Window is subsequently washed with Wash Buffer, followed by the addition of Substrate. After a 10 minute incubation period, the Ag reaction is examined visually for the appearance of a vertical blue line on the Ag side of the Reaction Window. A blue line indicates a positive test. If the Ag is positive, then the Tox reaction should be examined visually for the ap-pearance of a blue line on the Tox side of the Reaction Window. A blue line indicates a positive test. A positive C reaction, indicated by a vertical dotted blue line under the C portion of the Reaction Window, confirms that the test is working properly and the results are PROVIDEDDEVM embrane Devices each pouch contains 1 deviceDiluent (22 mL per bottle) Buffered protein solution with graduated dropper assemblyREAGWASHWash Buffer (12 mL per bottle) Buffered solution with graduated dropper assemblyREAGSUBSS ubstrate ( mL per bottle) Solution containing tetramethylbenzidineENZCONJC onjugate ( mL per bottle) Mouse monoclonal antibody specific for glutamate de-hydrogenase coupled to horseradish peroxidase and goat polyclonal antibodies specific for toxins A and B coupled to horseradish peroxidase in a buffered protein solutionPositive Control (2 mL)

10 Antigen in a buffered protein solutionDisposable plastic transfer pipettes graduated at 25 L, 400 L and 500 LIVDFor in vitro diagnostic useMATERIALS AND EQUIPMENT REQUIRED BUT NOT PROVIDEDS mall test tubes ( , plastic Eppendorf tubes or glass tubes)Applicator sticks Timer Vortex mixerDisposable gloves for handling fecal samples Pipettor and tipsSHELF LIFE AND STORAGEThe expiration date of the kit is given on the label. Expiration dates for each component are listed on the individual labels. The kit should be stored between 2 C and 8 C. PRECAUTIONS1. Reagents from different kits should not be mixed or interchanged. Do not use a kit past the expiration Each component in the kit should be inspected for any signs of leakage. Upon arrival, inspect the kit to ensure that components are not frozen or warm to the touch due to improper shipping conditions.