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The DPP Zika IgM System is intended for the presumptive qualitative detection of Zika virus IgM antibodies in human serum (plain or separation gel), potassium-EDTA plasma, potassium-EDTA venous whole blood, or fingerstick whole blood specimens, collected from individuals meeting the CDC Zika virus clinical criteria (e.g., a history of clinical signs and symptoms associated with Zika virus infection) and/or CDC Zika virus epidemiological criteria (e.g., history of residence in or travel to a geographic region with active Zika transmission at the time of travel, or other epidemiological criteria for which Zika virus testing may be indicated). Specimens from symptomatic patients or returning travelers from endemic areas should not be collected prior to 8 days after symptom onset or after potential exposure as a sample collected earlier may return a negative result. If testing is needed after day 8 and results are negative, testing must be repeated one week later. Positive results must be confirmed by following the latest CDC guidelines for the diagnosis of Zika virus infection. Results of this test are intended to be used in conjunction with clinical observations, patient history, epidemiological information, and other laboratory results. Zika IgM levels over the course of illness are not well characterized. Zika IgM levels are variable during the course of infection and may be detectable near day 4 post-onset of symptoms and persist up to approximately 12 weeks following initial infection. Negative results may be seen in specimens collected before day four post-onset of symptoms or after the window of detectable IgM closes and therefore do not preclude the possibility of Zika virus infection, past or present. The Chembio DPP Zika IgM System is not indicated for testing blood or plasma donors. The test cannot be visually interpreted by the operator and must be read on the DPP Micro Reader. DPP Zika IgM System Control Pack The Chembio DPP Zika IgM System Control Pack is an external quality control kit for use with the DPP Zika IgM System only. The performance characteristics of the DPP Zika IgM System Control Pack have not been established for any other assay or instrument different from the DPP Micro Reader. DPP Micro Reader The DPP Micro Reader is a reflectance reader used to obtain test results from DPP Zika IgM System. The DPP Micro Reader is necessary to minimize errors from direct visual interpretation; the results of DPP Zika IgM System cartridges must be read exclusively with the DPP Micro Reader.

Chembio' s DPP Zika IgM System is a qualitative immunochromatographic assay for the presumptive detection of IgM antibodies to Zika virus. The DPP Zika IgM System is composed of: - A single-use immunochromatographic test for the presumptive detection of ZIK V 1. IgM antibodies in human serum (plain or separation gel), potassium-EDTA plasma, potassium-EDTA venous whole blood, or fingerstick whole blood specimens. - 2. The DPP Micro Reader to minimize errors from direct visual interpretation.

The DiaSorin LIAISON® XL Zika Capture IgM II assay is intended for the presumptive qualitative detection of Zika virus IgM antibodies in human sera collected from individuals meeting CDC Zika virus clinical criteria (e.g., a history of clinical signs and symptoms associated with Zika virus infection) and/or CDC Zika virus epidemiological criteria (e.g., history of residence in or travel to a geographic region with active Zika transmission at the time of travel, or other epidemiological criteria for which Zika virus testing may be indicated). Specimens from symptomatic patients or returning travelers from endemic areas must be collected not earlier than day 8 after the onset of symptoms or risk of exposure, respectively. Positive results must be confirmed by following the latest CDC quidelines for the diagnosis of Zika virus infection. Results of this test are intended to be used in combination with clinical observations, patient history, epidemiological information, and other laboratory evidences. Zika IqM levels over the course of illness are not well characterized. IqM levels are variable, may be detectable near day 4 post onset of symptoms and persist up to approximately 12 weeks following initial infection. Negative results may be seen in specimens collected before day four post onset of symptoms or after the window of detectable IgM closes, and therefore do not preclude the possibility of Zika virus infection, past or present. This LIAISON® XL Zika Capture IgM II assay is not indicated for testing blood or plasma donors. The test has to be performed on the LIAISON® XL Analyzer. The DiaSorin LIAISON® XL Zika Capture IgM II Control Set is intended for use as assayed quality control samples to monitor the performance of the LIAISON® XL Zika Capture IgM II assay. The performance characteristics of the LIAISON® XL Zika Capture IgM II controls have not been established for any other assay or instrument platforms different from the LIAISON® XL.

The LIAISON® XL Zika Capture IqM II assay is an automated immunoassay utilizing chemiluminescent (CLIA) detection technology for the detection of human IgM antibodies against Zika Virus in patient sera. The LIAISON® XL Zika Capture IgM II assay consists of the components described in the following tables. Magnetic Particles (2.4 mL): Magnetic particles coated with a mouse monoclonal antibody to human IgM diluted in phosphate buffer containing BSA, surfactant, and <0.1% sodium azide. Specimen Diluent (28.0 mL): Buffer containing BSA, surfactant, 0.2% ProClin® 300, and an inert yellow dye. Assay Buffer (28.0 mL): Buffer containing BSA, surfactant, and 0.2% ProClin® 300 Number of tests: 100 ZIKV-M Reagent Integral Composition: Calibrator 1 Lyophilized 2 vials: Human serum/defibrinated plasma containing Zika virus IgM, phosphate buffer, BSA, surfactant, 0.18% ProClin® 300, and <0.1% sodium azide. Reconstitute with 2.0 mL of distilled or deionized water. Calibrator 2 Lyophilized 2 vials: Human serum/defibrinated plasma containing Zika virus IgM, phosphate buffer, BSA, surfactant, 0.18% ProClin® 300, and <0.1% sodium azide. Reconstitute with 2.0 mL of distilled or deionized water. ZIKV-M Conjugate Lyophilized 1 vial: Recombinant Zika virus NS1 antigen conjugated to an isoluminol derivative diluted in buffer containing BSA, surfactant, and 0.2% ProClin® 300. Reconstitute with 5.0 mL of distilled or deionized water. Additional components provided not on the ZIKV-M Reagent Integral ZIKV-C Reagent Integral Composition: Magnetic Particles (2 X 28.0 mL): Magnetic particles coated with a mouse monoclonal antibody to human IgG diluted in phosphate buffer containing BSA, surfactant, and <0.1% sodium azide. Specimen Diluent (2 X 28.0 mL): Buffer containing BSA, surfactant, 0.2% ProClin® 300, and an inert yellow dye. Assay Buffer (28.0 mL): Buffer containing BSA, surfactant, and 0.2% ProClin® 300 Number of tests: 100 Additional components provided, not on the ZIKV-C Reagent Integral: Calibrator 1 1 vial x 0.9 mL: Human serum/defibrinated plasma containing Zika virus IgG, < 0.3% ProClin® 300, and < 0.1% sodium azide. Calibrator 2 1 vial x 0.9 mL: Human serum/defibrinated plasma containing Zika virus IgG, < 0.3% ProClin® 300, and < 0.1% sodium azide. ZIKV-C Conjugate Lyophilized 1 vial: Recombinant Zika virus NS1 antigen conjugated to an isoluminol derivative diluted in buffer containing BSA, surfactant, and 0.2% ProClin® 300. Reconstitute with 5.0 mL of distilled or deionized water. Materials required but not provided (system related): LIAISON® XL Analyzer LIAISON® Wash/System Liquid (REF 319100) LIAISON® XL Waste Bags (REF X0025) LIAISON® XL Cuvettes (REF X0016) LIAISON® XL Starter Kit (REF 319200) LIAISON® XL Disposable Tips (REF X0015) LIAISON® XL Zika Capture IgM II Control Set (REF 317151) Additional required materials (assay related): LIAISON® XL Zika Capture IgM II Control Set (REF 317151)

The ADVIA Centaur® Zika test is for in vitro diagnostic use in the qualitative detection of IgM antibodies to the Zika virus in human serum and plasma (potassium EDTA or lithium heparin) specimens using the ADVIA Centaur XP and ADVIA Centaur XPT systems. The ADVIA Centaur Zika test is intended for the presumptive clinical laboratory diagnosis of Zika virus infection. The test is intended for use only in individuals (children, adolescents and adults, including pregnant women) with clinical signs and symptoms consistent with Zika virus infection, and/or meeting the CDC Zika virus epidemiological criteria (history of residence in or travel to a geographic region with active Zika transmission at the time of travel, or other epidemiological criteria for which Zika virus testing may be indicated). Positive results must be confirmed by following the latest CDC guidelines for the diagnosis of Zika virus infection. Results of this test are intended to be used in conjunction with clinical observations, patient history, epidemiological information, and other laboratory evidence to make patient management decisions. Zika IgM levels are variable over the course of the infection, and may be detectable near day 4 post onset of symptoms and persist up to approximately 12 weeks following initial infection. Negative results may be seen in specimens collected before day 4 post onset of symptoms or after the window of detectable IgM closes, and therefore do not preclude the possibility of Zika virus infection, past or present. The ADVIA Centaur Zika test is not indicated for testing blood or plasma donors.

The ADVIA Centaur Zika test consists of the components described in the following table: ADVIA Centaur Zika Ab Primary Reagent ReadyPack (included in Zika Ab assay kit), ADVIA Centaur Zika Ab Lite Reagent, ADVIA Centaur Zika Ab Solid Phase Reagent, ADVIA Centaur Zika Ab Ancillary Well Reagent, ADVIA Centaur Zika Ab Calibrators (included in Zika Ab assay kit), ADVIA Centaur Zika Ab High Calibrator, ADVIA Centaur Zika Ab Low Calibrator, ADVIA Centaur Zika Ab Controls (included in Zika Ab QC kit), ADVIA Centaur Zika Ab Negative Control, ADVIA Centaur Zika Ab Low Calibrator, ADVIA Centaur Zika IgM Primary Reagent ReadyPack (included in Zika IgM assay kit), ADVIA Centaur Zika IgM Lite Reagent, ADVIA Centaur Zika IgM Solid Phase Reagent, ADVIA Centaur Zika IgM Ancillary Well Reagent, ADVIA Centaur Zika IgM Calibrators (included in Zika IgM assay kit), ADVIA Centaur Zika IgM High Calibrator, ADVIA Centaur Zika IgM Low Calibrator, ADVIA Centaur Zika IgM Controls (included in Zika IgM QC kit), ADVIA Centaur Zika IgM Negative Control, ADVIA Centaur Zika IgM Low Calibrator. The methodology is an Antibody capture immunoassay using chemiluminescence detection.

The ZIKV Detect 2.0 IgM Capture ELISA is intended for the qualitative detection of Zika virus IgM antibodies in human sera for the presumptive clinical laboratory diagnosis of Zika virus infection. The assay is intended for use only in patients with clinical signs and symptoms consistent with Zika virus infection, and/or CDC Zika virus epidemiological criteria (e.g., history of residence in or travel to a geographic region with active Zika transmission at the time of travel, or other epidemiological criteria for which Zika virus testing may be indicated). Assay results are for the presumptive detection of IgM antibodies to Zika virus (ZIKV). Positive results must be confirmed by following the latest CDC guidelines for the diagnosis of Zika virus infection. Results of this test are intended to be used in conjunction with clinical observations. patient history, epidemiological information, and other laboratory evidence to make patient management decisions. Zika IgM levels are variable over the course of the infection, and may be detectable near day four post onset of symptoms and persist up to approximately 12 weeks following initial infection. Negative results may be seen in specimens collected before day four post onset of symptoms or after the window of detectable IgM closes, and therefore do not preclude the possibility of Zika virus infection, past or present. This assay is not indicated for testing blood or plasma donors.

The ZIKV Detect IgM Capture ELISA is a sandwich-type immunoassay. The test kit includes microtiter wells coated with anti-human IgM antibodies, ZIKV IgM Negative, and IgM Positive controls, ZIKV Sample Dilution Buffer, ZIKV Recombinant Antigen (Zika Ag) for IgM, Cross-reactive Control Antigen (CCA) for ZIKV IgM and normal cell antigens (NCA), secondary antibodies targeting the flavivirus antigens. The test kit also contains a HRPlabeled ZIK V-specific monoclonal antibody and tetramethylbenzidine (TMB) substrate which are used to detect ZIKV IgM antibodies in the wells. The ZIKV Detect 2.0 IgM Capture ELISA contains sufficient reagents for one plate of 96 wells (12 x 8 strips) for human IgM targeting Zika virus. This is sufficient for testing a maximum of 28 unknown samples for human IgM, with controls included in duplicate.