Search Results

The OraQuick Ebola Rapid Antigen Test is an in vitro diagnostic single-use immunoassay for the qualitative detection of antigens within the Ebolavirus genus but does not differentiate between these viruses. Testing with the OraQuick Ebola Rapid Antigen Test must only be performed when public health authorities have determined the need for this test. Testing for Ebola Virus Disease (EVD) must be performed in accordance with current guidelines provided by the appropriate public health authorities that address appropriate biosafety conditions, interpretation of test results, and coordination of testing, results and patient management with public health authorities. The OraQuick Ebola Rapid Antigen Test is intended for use with specimens from: - individuals with epidemiological risk factors with signs and symptoms of EVD or - . recently deceased individuals with epidemiological risk factors who are suspected to have died of EVD. EVD is a nationally notifiable condition and must be reported to public health authorities in accordance with local, state, and federal regulations. The OraQuick Ebola Rapid Antigen Test is intended for use with venipuncture whole blood and fingerstick whole blood specimens as an aid in diagnosis of EVD in patients suspected of and with signs or symptoms consistent with EVD who have epidemiological risk factor(s) for Ebolavirus exposure (e.g., contact with a known or suspected case, travel to a geographic location at a time when Ebolavirus transmission was known or suspected to have occurred). Performance of the device with Ebolavirus positive fingerstick whole blood was established in a non-human primate model. The OraQuick Ebola Rapid Antigen Test is intended for use with cadaveric oral fluid collected from recently deceased individuals with epidemiological risk factors who are suspected to have died of EVD. Cadaveric oral fluid should be collected directly with the device or collected with oral swabs in viral transport media. The OraQuick Ebola Rapid Antigen Test is intended as an aid in the determination of EVD as the cause of death to inform decisions on safe handling of cadavers to prevent disease transmission. The OraQuick Ebola Rapid Antigen Test results are presumptive, definitive identification of EVD requires performing additional testing and confirmation procedures in consultation with public health and/or other authorities to whom reporting is required. Negative results were observed in individuals with low levels of circulating virus, therefore negative results do not preclude infection with viruses within the Ebolavirus genus. The level of Ebolavirus antigens that would be present in EVD clinical specimens from individuals with early systemic infection is unknown. Test performance of the OraQuick Ebola Rapid Antigen Test is associated with the level of Ebolavirus antigens in the patient; therefore, the test is not intended for use in an asymptomatic population for massscreening purposes (e.g., as the sole means of EVD control at airports or bordercrossings) or for testing of individuals at risk of exposure without observable signs of infection. The OraQuick Ebola Rapid Antigen Test is intended for use by experienced personnel who have documented device specific training offered by OraSure Technologies Inc., training in the correct use of recommended personal protective equipment (PPE) and expertise in infectious disease diagnostic testing, including the safe handling of clinical specimens potentially containing Ebolavirus. The test is intended for use by laboratory professionals or healthcare workers who have demonstrated availability of biosafety equipment, access to patient containment facilities, and established procedures (e.g., SOP) for coordinating testing, results and patient management with public health authorities consistent with state, local and federal recommendations and guidelines.

The OraQuick Ebola Rapid Antigen Test is a manually performed, visually read immunoassay for the qualitative detection of Ebola virus in human venipuncture whole blood, fingerstick whole blood and cadaveric oral fluid. The OraQuick Ebola Rapid Antigen Test is comprised of both a single-use test device and a vial containing a pre-measured amount of a buffered developer solution. The single-use test devices consist of a plastic housing that protects the assay test strip with the reagents. The assay strip can be viewed through the test device result window. The test result window has indicated zones for the Ebolavirus specific Test Line and the Control Line of the test. The test consists of a sealed pouch with two separate compartments for each of the following two components: - 1. OraQuick Ebola Rapid Antigen Test - 2. Developer Vial The OraQuick Ebola Rapid Antigen Test further contains the following materials for the sample processing: - 1. Test Stand - 2. Micropipettes capable of pipetting 20ul of sample The OraQuick Ebola Rapid Antigen Test kit must be used with the OraQuick Ebola Rapid Antigen Test Kit Controls and a Visual Reference Panel (available separately). The OraQuick Ebola Rapid Antigen Test Kit Controls contain: - 1. One Ebola positive control vial (orange capped) - 2. One Ebola negative control vial (white capped) The positive control contains 0.25mL of Ebola recombinant VP40 equivalent to a moderate positive result and is diluted in a defibrinated pool of normal human plasma negative for Ebolavirus. The negative control contains 0.25 mL of defibrinated pool of normal human plasma negative for Ebolavirus. The controls do not contain infectious Ebolavirus material. The OraQuick Ebola Visual Reference Panel (VRP) is intended to assist new operators in becoming proficient at reading specimens with antigen levels near the limit of detection of the device. The devices in the VRP do not contain any infectious material. The VRP contains three Quick Ebola Rapid Antigen Test devices that have been designed to represent reading intensities representative of - 1. A test result near the limit of detection (LoD) - 2. A low positive test result - 3. A negative test result Additional materials required but not provided include 1. Timer

The Compound W® Freeze Off™ Plantar Wart Removal System is indicated for over-the-counter treatment of common and plantar warts.

The Compound W® Freeze Off™ Plantar Wart Removal System is a cryosurgical system for the treatment of common warts and plantar warts. It consists of: - A canister filled with a liquid mixture of the compressed gases dimethyl O ether, propane and isobutane - 12 Disposable Applicators O - 1 Pumice Stone o - o 12 Foot Comfort Pads - 1 Reusable Activator that releases the cryogen into the applicator O - An illustrated description of how to use the product with common and o plantar warts This device is a portable cryosurgical system comprised of a canister containing cryogen and an applicator that is saturated with cryogen and then applied tan the wart to be treated.

The Histofreezer® Wart Removal System is indicated for over-the-counter treatment of common warts and plantar warts.

The Histofreezer® Wart Removal System is a cryosurgical system for the treatment of warts. It consists of: A canister filled with a liguid mixture of the compressed gases dimethyl ether, propane 0 and isobutane o Custom applicators O An illustrated description of how to use the product

The OTI Benzodiazepines Intercept® MICRO-PLATE EIA is intended for use by clinical laboratories in the qualitative determination of benzodiazepines in oral fluid collected with the Intercept® Oral Fluid Drug Test Oral Specimen Collection Device using a 1.0 ng/mL cutoff. FOR IN VITRO DIAGNOSTIC USE. The OTI Benzodiazepines Intercept® MICRO-PLATE EIA provides only a preliminary analytical test result. A more specific alternative chemical method should be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry/mass spectrometry (GC/MS/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drugs of abuse test result, particularly when a preliminary, positive result is observed.

The OT1 Benzodiazepines Intercept® MICRO-PLATE EIA is a competitive micro-plate immunoassay for the detection of benzodiazepines in oral fluid collected with the Intercept® Oral Fluid Drug Test Oral Specimen Collection Device. Specimen or standard is added to an EIA well in combination with an enzyme-labeled hapten derivative. In an ELA well containing an oral fluid specimen positive for benzodiazepines, there is a competition between the drug and the enzymelabeled hapten to bind the antibody fixed onto the EIA wells are then washed, substrate is added, and color is produced. The absorbance measured for each well at 450 mm is inversely proportional to the amount of benzodiazepines present in the specimen or calibrator/control. Because currently there are no SAMHSA assigned cutoffs for benzodiazepines testing using oral fluid, OTI recommends a cutoff of 1.0 ng/mL when testing oral fluid collected with the Intercept® Oral Fluid Drug Test Oral Specimen Collection Device. This cutoff is within the limit of detection by the OTI Benzodiazepines Intercept® MICRO-PLATE EIA.

The UPlink™ Oral Fluid Drug Test is a rapid immunoassay intended for use with the UPlink™ Analyzer for the qualitative detection of opiates in oral fluid using a 40 ng/mL cutoff. FOR IN VITRO DIAGNOSTIC USE. The UPlink™ Test System provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drugs of abuse test result, particularly when a preliminary, positive result is observed.

UPlinkTM is the trademark name for a new, rapid, onsite testing technology. The basis for the test is Up-Converting Phosphor Technology (UPT). UPT particles are small nanospheres composed of rare earth metals that are labeled with antibodies against targeted drugs of abuse. Similar particles have been used for decades in display screens such as televisions or fluorescent light bulbs. Different from the particles used in televisions, UPT particles are excited by infrared light and up-convert the energy to give a visible emission. This is an anti-stokes shift that does not exist in nature. In addition, just like current display screens, UPT particles are available in different colors to allow multiplexing and do not fade or photobleach. The UPlink™ Test, in conjunction with the UPlink™ Analyzer and oral fluid collection device, is a lateral flow, panel immunoassay for the rapid qualitative measurement of opiates in oral fluid. The UPlinkTM collection device gathers the oral fluid sample for analysis from the mouth and into a test cassette, The UPlink™ Analyzer measures the intensity of the signal line(s) on the cassette and converts it to a qualitative result(s). The test consists of a protective cassette housing containing a lateral flow strip of plastisbacked nitrocellulose that has been impregnated with test and reference lines. Phosphor particles conjugated with analyte-specific antibodies are dried into a pad adjoined to the nitrocellulose strip and in physical contact with both the strip and an overlying absorbent pad. With addition of the oral fluid sample to the cassette, the phosphor-antibody complexes move with the sample by capillary action to contact the test line. When opiates are present in the oral fluid sample, the drug with the phosphorantibody conjugate during flow and the phosphor-antibody-drug complexes will not bind further to the analyte derivative on the test line. As a result, subsequent excitation of the URink™ Analyzer will not produce a signal. If no drug is present in the sample, phosphor-antibody complexes will bind to the test line, giving a high signal strength at the test line is inversely proportional to the amount of opiates present in the sample. The assay reference band is not influenced by the presence or absence of drug in the oral fluid, and therefore, will be present in all reactions. The UP oral fluid collection device consists of a cellulose sponge donut contained in aplastic housing with a removable handle. The collector is used to continuously swab the mouth between the cheek and gum for 1 to 2 minutes. As sample is collected, the cellulose sponge expands, ensuring that an adequate amount of sample is obtained in each collection. The collection device is inserted into the an accquate and pushed down to crack a small ampoule of buffer, followed by removal of the handle so the test cassette can be inserted into the UPIinkTM Analyzer. The UPIink™ Analyzer is a portable instrument containing a laser source that interrogates the test strip for signals produced by the test and reference lines. Detection of a signal for the reference line indicates the validity of the test. The intensity of the signal for the test line is indirectly proportional to the concentration of the analyte. The test strip's lot specific calibration curve is contained in a barcode on each cassette. By its use the instrument converts the measured signal into a positive or negative result that is displayed to the user.

The Intercept™ Oral Fluid Drug Test Oral Specimen Collection Device is intended for use in the collection, preservation, and transport of oral specimens. Oral specimens collected with the Intercept™ Oral Specimen Collection Device can be used to detect cocaine and cocaine metabolites, cannabinoids, phencyclidine, amphetamine, methamphetamine, opiates, barbiturates and methadone with the OraSure Technologies Intercept™ MICRO-PLATE EIAs.

The Intercept™ Oral Fluid Drug Test Oral Specimen Collection Device consists of a treated absorbent cotton fiber pad affixed to a nylon stick (Collection Pad) and a preservative solution in a plastic container (Specimen Vial). The Collection Pad is impregnated with a mixture of common salts and gelatin, creating a hypertonic environment which produces an osmotic gradient across the buccal and gingival mucosae. The Pad is placed in contact with the gingival mucosa (between the lower cheek and gum) which enhances the flow of mucosal transudate onto the absorptive cotton fibers of the Pad. Following the collection period, the Collection Pad is removed from the mouth and placed into a Specimen Vial. The vial contains a preservative solution which serves to inhibit the growth of oral microorganisms recovered on the Collection Pad. The vial is sealed with a plastic cap and transported to a laboratory for processing and testing.