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Premier Toxins A&B is a qualitative enzyme immunoassay for the detection of Clostridium difficile toxin A and toxin B in stool from patients with antibiotic associated diarrhea. Premier Toxins A&B is intended for use as an aid in diagnosis of C. difficile associated disease.

Premier Toxins A&B is an enzyme immunoassay for the direct detection of Clostridium difficile toxin A and toxin B in stool samples. Breakaway microwells are coated with toxin specific monoclonal and polyclonal antibodies. Diluted patient specimens and HRP-conjugated anti-toxin A and B polyclonal antibodies are added to microwells. If either toxin is present in the diluted patient samples, HRP-conjugated toxin polyclonal antibodies (specific for both toxins) complexes are formed which remain in the microwells after washing. After a final washing step, a substrate / chromagen (urea peroxide and tetramethylbenzidine) is added to the wells. Any bound conjugate converts the substrate / chromagen to a blue color. Addition of acid (Stop Solution) converts the blue to a vellow color.

The Immunocard STAT! STEC O157 is a rapid test for the detection of antigens from shiga toxin producing E. coli O157 as an aid in the diagnosis of E. coli O157:H7 infection. The test can be used to directly test stool specimens, or confirmatory stool cultures grown in MacConkey broth or sorbitol MacConkey (SMAC) plates.

Stool or culture material are prepared / diluted and added to the sample port of the device. The sample mobilizes gold particles, coated with monoclonal antibody specific for the O157 lipopolysacchride, and migrates along the membrane through the Test and Control zones. The test zone contains immobilized monoclodal antibody specific for an epitope common to shiga toxin producing E. coli. After ten minutes the Test and Control zones are observed for the presence of red/purple lines across the membrane surface. If a shiga toxin producing E. coli O157 is present in the sample, a complex is formed between the capture antibody, the shiga toxin producing E. coli O157, and the monoclonal antibody-gold conjugate which can be seen visually as a red/purple line in the Test zone. No red/purple line in the Test zone indicates a negative result. The Control line serves as a procedural control, to assure that the sample has migrated the appropriate distance along the membrane.

The PREMIER™ TYPE SPECIFIC HSV-1 IgG ELISA TEST is to be used in the testing of human serum specimens from individuals for whom the qualitative presence of detectable IgG antibody to herpes simplex virus type 1 is warranted; specifically, when used in conjunction with the Premier™ Type Specific HSV-2 IgG ELISA Test in the screening of sexually active adults. This test is indicated for individuals at risk for a sexually transmitted HSV infection. For example, this test can clarify when an individual with symptoms suggestive of genital herpes has genital HSV-1 infection. The PREMIER™ TYPE SPECIFIC HSV-1 IgG ELISA TEST is not recommended for use in a pediatric population. The performance characteristics of this device have not been established for testing patients with HSV-1 associated meningitis and encephalitis, prenatal and neonatal screening, the testing of immunosuppressed patients, or the detection of early stages of HSV seroconversion.

The Premier™ Type Specific HSV-1 IgG ELISA Test is an in vitro diagnostic medical device is intended for the qualitative detection of IgG antibody to herpes simplex virus type 1 in human serum by the enzyme-linked immunosorbent assay (ELISA) method. The Premier™ Type Specific HSV-1 IgG ELISA Test is comprised of the following items: - Antigen-Coated ELISA Plate: One 96-well plate comprised of twelve 8-well strips with breakaway wells, each well coated with affinity purified HSV-1 glycoprotein G (gG-1). - IgG Specimen Diluent: One bottle containing 30 ml of a lavender colored dilution buffer with sodium azide. - Conjugate: One bottle containing 15 ml of a pink colored solution of alkaline phosphatase-labeled antihuman IgG (Caprine) with sodium azide. - Substrate Buffer: One bottle containing 30 ml of a blue colored buffer solution with sodium azide. - p-NPP Tablets: One foil pack containing 6 tablets of p-nitrophenyl phosphate (p-NPP). - Stopping Reagent: One bottle containing 30 ml of a colorless solution of 1.5 N sodium hydroxide (NaOH). - Positive Control and Negative Control: One vial of each containing 200 ul of serum (human) with sodium azide. - Reference Serum: One vial containing 400 ul of serum (human) with sodium azide. - 20X Wash Solution: One bottle containing 60 ml of a green colored solution with detergent and sodium azide. - ELISA Plate Sealer: One acetate sheet with contact adhesive. - Resealable Storage Bag: One plastic sealable bag. - ELISA Worksheet: One worksheet for recording data. When the Premier™ Type Specific HSV-1 IgG ELISA Test is employed, diluted patient serum is incubated with purified herpes simplex virus type 1 glycoprotein (gG1) bound to the ELISA plate wells. If antibodies to the herpes simplex virus type 1 are present, they bind to the antigen and do not rinse off. Subsequently when enzyme-labeled antihuman IgG is added to the reaction site it binds to the immobilized IgG antibodies. After washing and the addition of a chromogenic substrate and stopping reagent, specimens containing antibodies to the herpes simplex virus type 1 produce a color endpoint reaction which can be read with a standard ELISA plate reader.

The PREMIER™ TYPE SPECIFIC HSV-2 IgG ELISA TEST is to be used in the testing of human serum specimens from individuals for whom the qualitative presence of detectable IgG antibody to herpes simplex virus type 2 is warranted; specifically, when used in conjunction with the Premier™ Type Specific HSV-1 IgG ELISA in the screening of sexually active adults. This test is indicated for individuals at risk for a sexually transmitted HSV infection or disease (STD), For example, this test is to be used to screen samples from patients with or without clinical history of herpes and can clarify when an individual with symptoms suggestive of genital herpes has genital HSV-2 infection. The PREMIER™ TYPE SPECIFIC HSV-2 IgG ELISA TEST is not recommended for use in a pediatric population. The performance characteristics of this device have not been established for prenatal and neonatal screening, the testing of patients with other HSV associated diseases and immunosuppressed patients, or the detection of early stages of HSV seroconversion.

The Premier™ Type Specific HSV-2 IgG ELISA Test is an in vitro diagnostic medical device is intended for the qualitative detection of IgG antibody to the herpes simplex virus type 2 in human serum by the enzyme-linked immunosorbent assay (ELISA) method. The Premier™ Type Specific HSV-2 IgG ELISA Test is comprised of the following items: 1. Antigen-Coated ELISA Plate: One 96-well plate comprised of twelve 8-well strips with breakaway wells, each well coated with affinity purified HSV-2 glycoprotein G (gG-2). 2. IgG Specimen Diluent: One bottle containing 30 ml of a lavender colored dilution buffer with sodium azide. 3. Conjugate: One bottle containing 15 ml of a pink colored solution of alkaline phosphatase-labeled antihuman IgG (Caprine) with sodium azide. 4. Substrate Buffer: One bottle containing 30 ml of a blue colored buffer solution with sodium azide. 5. p-NPP Tablets: One foil pack containing 6 tablets of p-nitrophenyl phosphate (p-NPP). 6. Stopping Reagent: One bottle containing 30 ml of a colorless solution of 1.5 N sodium hydroxide (NaOH). 7. Positive Control and Negative Control: One vial of each containing 200 ul of serum (human) with sodium azide. 8. Reference Serum: One vial containing 400 ul of serum (human) with sodium azide. 9. 20X Wash Solution: One bottle containing 60 ml of a green colored solution with detergent and sodium azide. 10. ELISA Plate Sealer: One acetate sheet with contact adhesive. 11. Resealable Storage Bag: One plastic sealable bag. 12. ELISA Worksheet: One worksheet for recording data. When the Premier™ Type Specific HSV-2 IgG ELISA Test is employed, diluted patient serum is incubated with purified herpes simplex virus type 2 glycoprotein (gG2) bound to the ELISA plate wells. If antibodies to the herpes simplex virus type 2 are present, they bind to the antigen and do not rinse off. Subsequently when enzyme-labeled antihuman IgG is added to the reaction site it binds to the immobilized IgG antibodies. After washing and the addition of a chromogenic substrate and stopping reagent, specimens containing antibodies to the herpes simplex virus type 2 produce a color endpoint reaction which can be read with a standard ELISA plate reader.

The Premier Platinum HpSA enzyme immunoassay (EIA) is an in vitro qualitative procedure for the detection of Helicobacter pylori antigens in human stool. Test results are intended to aid in the diagnosis of H. pylori infection, and to monitor response during and post-therapy in adult patients. Accepted medical practice recommends that testing by any current method, to confirm eradication, be done at least four weeks following completion of therapy.

The Premier Platinum HpSA test utilizes polyclonal anti-H. pvlori capture antibody adsorbed to microwells. Diluted patient samples and a peroxidase conjugated polyclonal antibody are added to the wells and incubated for one hour at room temperature. A wash is performed to remove unbound material. Substrate is added and incubated for ten minutes at room temperature. Color develops in the presence of bound enzyme. Stop solution is added and the results are interpreted visually or spectrophotometrically.

The Premier Cryptosporidium enzyme immunoassay (EIA) is an in vitro qualitative procedure for the detection of Cryptosporidium antigens in stool. Test results are intended to aid in the diagnosis of Cryptosporidium infection.

The assay is a conventional microwell sandwich enzyme immunoassay, utilizing polyclonal capture and monoclonal detection antibodies.

The Premier Giardia enzyme immunoassay (EIA) is an in vitro qualitative procedure for the detection of Giardia antigens in human stool. Test results are intended to aid in the diagnosis of Giardia infection (giardiasis).

The Premier Giardia test utilizes polyclonal anti-Giardia capture antibody adsorbed to microwells.

The Premier Platinum HpSA enzyme immunoassay (EIA) is an in vitro qualitative procedure for the detection of Helicobacter pylori antigens in human stool. Test results are intended to aid in the diagnosis of H. pylori infection in adult symptomatic patients.

The Premier Platinum HpSA test utilizes polyclonal anti-H. pylori capture antibody adsorbed to microwells. Diluted patient samples and a peroxidase conjugated polyclonal antibody are added to the wells and incubated for one hour at room temperature. A wash is performed to remove unbound material. Substrate is added and incubated for ten minutes at room temperature. Color develops in the presence of bound enzyme. Stop solution is added and the results are interpreted visually or spectrophotometrically.

Para-Pak SPINCON is for the concentration of eggs, larvae, and protozoa from preserved fecal specimens. Specimens preserved in 10% Formalin, Sodium Acetate Formalin (SAF), and ECOFIX may be used with the system.

Para-Pak SPINCON involves passing a surfactant treated, preserved stool specimen through a preliminary screen by gravity flow. The surfactant helps to break down fecal aggregates, thus freeing parasites. The specimen is then forced by centrifugation through a series of two screens with successively smaller mesh. The series of screens, not present in other devices, trap stool debris, yet allow even the larger parasites to pass through. This second filtration step eliminates the need for organic solvent extraction of the stool specimen. The resulting pellet may be examined for the presence of parasites by standard wet mount procedures. SPINCON Devices: 200/500 SPINCON Caps: 200/500 SPINCON Preliminary Funnel Screens: 200/500 Para-Pak Surfactant: 33ml

The ImmunoCard STAT! Rotavirus Immunoassay is a rapid in vitro qualitative procedure for the detection of rotavirus antigen in human stool. The test can be used to aid in the diagnosis of rotavirus associated gastroenteritis. For use to detect the presence of rotavirus in stool specimens from patients with loose stools, diarrhea, gastroenteritis, or suspected to be infected with rotavirus.

The ImmunoCard STAT! Rotavirus assay system is a membrane based immunogold assay for rotavirus. Each kit contains the following components: ImmunoCard STAT! Rotavirus devices(30), Positive Control (1.8ml), Sample Diluent (10.5ml), Transfer Pipets (30). In brief, 1/15 diluted stool enters the sample application pad and migrates through the conjugate pad. Monoclonal antibody (conjugated to colloidal gold particles) contained in the pad is dissolved in the specimen and travels onto the nitrocellulose membrane. The nitrocellulose membrane contains two "capture" zones. The first holds polyclonal antibody to rotavirus, and the second has polyclonal anti-mouse IgG. The first zone serves as the test line, indicating the presence of rotavirus. The second zone acts as a procedural control and verifies that the sample has migrated sufficiently into the device to permit a valid test result to be read in the first (test) zone. The final absorbent pad acts as a reservoir and draws the sample through the test strip.