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Bartels Legionella Urinary Antigen ELISA Test is intended as an adjunct to culture for the presumptive diagnosis of past or current Legionnaires' Disease by qualitative detection of Legionella pneumophila Serogroup 1 antigen in human urine.

Bartels Legionella Urinary Antigen ELISA Test is an enzyme-linked immunoassay intended for the qualitative detection of Legionella pneumophila Serogroup 1 antigen in human urine. The kit consists of microelisa stripwells with lid, positive and negative control reagents, conjugate, wash concentrate, colorimetric substrate (2 components) and stop solution. Sufficient materials are provided to perform 96 analyses. The microelisa wells have been pre-coated with purified rabbit antibodies to Legionella pneumophila Serotype 1 (capture antibody). An undiluted urine specimen (100 µL), or positive or negative controls (100 µL each) are each placed in a single microelisa well followed by the addition of 50 uL of Conjugate (horseradish peroxidase-conjugated rabbit antibodies to L. pneumophila). The loaded microelisa plate is then covered with the lid and incubated for 48 to 52 minutes at 34-37°C followed by 4 cycles of wash/aspiration using diluted Wash Solution (manual or automated wash procedure). Colorimetric substrate (tetramethyl benzidine/H2O2 100 µL/well) is then added and incubated for 10 to 12 minutes at 34-37℃ followed by the addition of Stop Solution (1M Phosphoric acid, 100 uL/well). The stopped plate is then read on a microelisa plate reader at 450 nm against an air blank. For a test to be considered valid, the Negative Control must have an optical density (OD) value of less than 0.100 and the Positive Control must be greater than the Positive Cutoff (pco). The pco is equal to 4X the O.D. value of the Negative Control value. Any specimen with an O.D. value ≥ the pco is considered positive. Any specimen with an O.D. value < the pco is considered negative. Alternatively, the results can be visually read. For this purpose, a visual interpretation card, and written instructions, are provided in the kit for interpretation of results. Any well that produces definite yellow color is considered to be positive.

Bartels Clostridium difficile Toxin A Enzyme Immunoassay (EIA) is intended for the qualitative detection of Clostridium difficile Toxin A in human fecal specimens as an aid in the diagnosis of Clostridium difficile -associate diseases.

The Bartels Clostridium difficile Toxin A EIA is a rapid method for the diagnosis of Clostridium difficile toxin A in human fecal samples, to be used as an aid in the detection of Clostridium difficile-associated disease. Microwell strips are coated with mouse IgG to Clostridium difficile toxin A, which selectively captures Clostridium difficile toxin A if present in a stool sample. Irrelevant specimen debris, including non-toxigenic strains of Clostridium difficile, is washed away. Rabbit immunoglobulins to Clostridium difficile toxin A and peroxidase-labeled goat anti-rabbit antibodies are added to the well concurrently in a coincubation step. During incubation, the rabbit anti- Clostridium difficile toxin A binds to captured toxin A. Peroxidase-labeled anti-rabbit antibodies bind to rabbit antitoxin, forming an antitoxin-conjugate complex. Unbound anti-toxin and conjugate are washed away. Solution 3 and Solution 4 are then added and color is produced if the antitoxin-conjugate complex, which possesses the enzyme for the substrate (HRP), is present. This color production is quantified spectrophotometrically and compared to negative and positive controls for determination of the presence of Clostridium difficile toxin A.

The Bartels CINAkit™ CMV Antigenemia Test is intended for use as an aid in the diagnosis of Cytomegalovirus (CMV) infection by the rapid direct qualitative detection of CMV pp65 antigen in human blood leukocytes by indirect immunofluorescence (IF). This product is not intended to be used for testing (i.e. screening) blood or plasma donors.

BARTELS CINAKIT CMV Antigenemia is an indirect immunofluorescence test that allows detection of Human Cytomegalovirus antigen in leukocytes from peripheral blood. The test uses a monoclonal antibody pool (1C3, AYM-1) which recognizes the 65-68kDa lower matrix structural phosphoprotein (pp) (protein kinase, pp65, present in the nucleus of cells. The antibody pool (blended antibodies) recognizes two epitopes on the protein. Leukocytes are prepared from whole blood by dextran sedimentation and centrifugation; slides are prepared, fixed in formalin and permeabilized on detergent (NP40). Staining is accomplished with primary murine monoclonal antibodies to the pp65 antigen and F(Ab-)2 fluorescein-conjugated anti-mouse immunoglobulin secondary antibody. The slides are read using a fluorescence microscope.