OraQuick HIV-1 2 rapid test kit Product Parameters vendors

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  • OraQuick ADVANCE Rapid HIV-1/2 Antibody Test | FDA

    2020-1-30 · Added labeling claim for the detection of HIV-2 antibodies in oral fluid and a change in the name of the device to OraQuick ADVANCE Rapid HIV-1/2 Antibody Test Approval Date: 6/22/2004 Product ...

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  • OraQuick ADVANCE Rapid HIV-1/2 Antibody Test

    2015-1-30 · • The OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test is a single-use, qualitative immunoassay to detect antibodies to Human Immunodeficiency Virus Type 1 and 2 (HIV-1/2) in oral fluid, venipuncture whole blood, fingerstick whole blood, and plasma specimens. • For in vitro diagnostic use. • This is a restricted device.

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  • oraquick hiv test, oraquick hiv test Suppliers and ...

    Product: OraQuick HIV 1/2 Rapid Antibody Test . WHO reference number: PQDx 0159-055-00 . OraQuick HIV 1/2 Rapid Antibody Test with product codes . 5x4-0010, 5x4-0012, 5x4-0014 5x4-0015. and . 5X4-0062. manufactured in Thailand for . OraSure Technologies, Inc., Rest-of-World regulatory version, was accepted for the WHO list of prequalified in ...

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  • WHO Prequalification of In Vitro Diagnostics PUBLIC

    Page 2 of 20 mix. Kit controls for OraQuick® HIV-1/2 Rapid Antibody Test are available separately. These serve to demonstrate that the test is maintaining adequate performance. Test kit contents: Component 100 tests (product code 5x4-0010) 500 tests (product code 5x4-0012) Pouch containing 1 test device, 1 desiccant, 1

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  • WHO Prequalification of In Vitro Diagnostics PUBLIC

    2012-6-29 · OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test Customer Letter Dear Customer, Thank you for deciding to use the OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test. The sale, distribution, and use of this product is restricted as described in the product insert. By purchasing this device, you are doing so as an agent

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  • OraQuick ADVANCE Rapid HIV-1/2 Antibody Test

    2021-7-7 · The OraQuick ® HIV Self-Test (HIVST) is a point-of-care rapid antibody test. It detects antibodies for both HIV-1 and HIV-2, enabling individuals to find out their HIV status with a simple oral swab in as little as 20 minutes. The simplicity of the product makes it ideal for testing in a range of locations, including in the privacy of one’s ...

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  • Rapid Infectious Disease Products - OraSure

    OraQuick HIV 1/2 Rapid Antibody Test with product codes 5x4-0010 and 5x4-0012, manufactured in Thailand for OraSure Technologies, Inc. , rest-of-world regulatory version , was accepted for the WHO list of prequalified in vitro diagnostics and was listed on 8 April

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  • WHO Prequalification of In Vitro Diagnostics PUBLIC

    Page 2 of 22 Intended use: OraQuick HIV-1/2 Rapid Antibody Test is a qualitative, in vitro immunoassay. It detects antibodies to the human immunodeficiency virus types 1 and 2 (HIV-1/2) in human oral fluid, whole blood, serum or plasma. The assay is read visually, and is intended for the

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  • OraQuick ADVANCE HIV Test - OraSure Technologies

    2021-5-12 · The OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test detects antibodies to HIV-1 and HIV-2 in 20 minutes. Provides results in 20 minutes enabling patients to learn their status in a single visit and allows HIV positive patients to be connected to care immediately. Approved for oral fluid, plasma, fingerstick or venipuncture whole blood specimens.

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  • OraSure Technologies OraQuick™ Advance™ Rapid

    HIV Testing anytime, anywhere, made easy. The OraQuick™ ADVANCE™ Rapid HIV-1/2 Antibody Test is an easy-to-use rapid HIV test that offers several specimen types - oral fluid, fingerstick whole blood, venipuncture whole blood and plasma. Yielding accurate results in as little as 20 minutes. Manufacturer: OraSure Technologies 10010079.

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  • WHO | OraQuick HIV self-test

    Technical Specifications Series document TSS1 Human Immunodeficiency Virus (HIV) rapid - diagnostic tests for professional use and/or self- testing. 2. 1Dossier assessment and laboratory evaluation for the OraQuick HIV 1/2 Self-Test were adapted from the professional use product, OraQuick HIV 1/2 Rapid Antibody Test prequalified in 2016. Please ...

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  • OraQuick ADVANCE Rapid HIV-1/2 Antibody Test

    2012-6-29 · OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test Customer Letter Dear Customer, Thank you for deciding to use the OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test. The sale, distribution, and use of this product is restricted as described in the product insert. By purchasing this device, you are doing so as an agent

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  • Herpes HSV1/2 Blood Test - Rapid STD Test Kit

    2019-3-25 · The OraQuick ® HIV‐1/2 Rapid Antibody Test is WHO prequalified for use with oral fluid, whole blood, serum or plasma. The matrix of the sample (i.e. plasma rather than an oral crevicular fluid sample) was not a crucial factor in this investigation, as we were not investigating specificity or sensitivity.

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  • Re‐reading of OraQuick HIV‐1/2 rapid antibody test

    2013-1-30 · 1 COMPLEXITY: MODERATE NAME AND INTENDED USE The OraQuick® Rapid HIV-1 Antibody Test is a single-use, qualitative immunoassay to detect antibodies to Human Immunodeficiency Virus Type 1 (HIV-1) in fingerstick whole blood specimens. The OraQuick® Rapid HIV-1 Antibody Test is intended for use as a point -of-care test to aid in the diagnosis of infection with HIV -1.

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  • Read this package insert completely before ... - oraquick.org

    Dec 01, 2019 · HIV test accuracy, results and further testing Are HIV tests If you used a self-testing kit at home, a positive HIV test result must always be . Rapid test kit for COVID-19 – IgG/IgM Antibody Detection Kit (Colloidal Gold) virus (HIV) testing medically necessary for screening persons for HIV infection, The OraQuick HCV Rapid ...

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  • Hiv Screen Test Kit Sg Test Results | Jal Innovations ...

    Oraquick Advance HIV Test Kit- Ph. 152 likes. OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test Kit Detection is the first step in prevention. Stop the spread of HIV one simple test at a time.

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  • OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test

    2021-5-12 · OraQuick ® HIV Self-Test. The OraQuick ® HIV Self-Test (HIVST) is a point-of-care rapid antibody test. It detects antibodies for both HIV-1 and HIV-2, enabling individuals to find out their HIV status with a simple oral swab in as little as 20 minutes. The simplicity of the product makes it ideal for testing in a range of locations, including ...

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  • OraQuick HIV Self-Test - OraSure Technologies

    Rapid HIV antibody tests represent a key development in the current diagnosis and management of HIV infection. The OraQuick ADVANCE Rapid HIV-1/2 antibody test (OraSure Technologies) has received US Food and Drug Administration approval on the basis of its performance characteristics and a subsequent Clinical Laboratory Improvement Amendments waiver based on its simplicity and accuracy.

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  • OraQuick ADVANCE Rapid HIV-1/2 antibody test

    HIV TEST, ORAQUICK ADV RAPID 1/2 (25TEST/BX) Features. The OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test detects antibodies to HIV-1 and HIV-2 in 20 minutes. Approved for oral fluid, plasma, fingerstick or venipuncture whole blood specimens. Complexity: Waived for Oral Fluid, Fingerstick Whole Blood and Venipuncture Whole Blood.

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  • Orasure Technologies 1001-0079 - McKesson Medical

    2015-3-25 · The OraQuick Advance Rapid HIV-1/2 Antibody Test is a manually performed, visually read, 20-minute immunoassay for the qualitative detection of antibodies to HIV-1/2 in oral fluid, human whole blood obtained from finger puncture, human whole blood obtained from venipuncture and plasma specimens. The OraQuick Advance Rapid Test is comprised of a

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  • OraQuick Rapid HIV Testing Procedures and Quality ...

    The OraQuick® HIV Self-Test is an in-vitro diagnostic medical device (IVD) that is used for self-testing of antibodies for HIV-1 and HIV-2 in oral fluid. This test is intended as an aid to detect antibodies to HIV-1 and HIV-2 from infected individuals. Technical specifications: Sensitivity: 100%. Specificity: 99.1%.

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  • Oraquick HIV self-test, Kit/50 - supply.unicef.org

    2016-3-4 · PRODUCT NAME: OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test Kit GENERAL USE: The OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test is a single-use, qualitative immunoassay to detect antibodies to Human Immunodeficiency Virus Type 1 (HIV-1) and Type 2 (HIV-2) in oral fluid, fingerstick, whole blood, venipuncture whole blood and plasma specimens.

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  • Expiration Date: 2 years from Effective Date SAFETY DATA ...

    2019-3-1 · 2.2. Sample preparation. The OraQuick ® HIV‐1/2 Rapid Antibody Test is WHO prequalified for use with oral fluid, whole blood, serum or plasma. The matrix of the sample (i.e. plasma rather than an oral crevicular fluid sample) was not a crucial factor in this investigation, as we were not investigating specificity or sensitivity.

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  • Re-reading of OraQuick HIV-1/2 rapid antibody test

    SHORT REPORT Re-reading of OraQuick HIV-1/2 rapid antibody test results: quality assurance implications for HIV self-testing programmes Victoria Watson1§, Russell J Dacombe1, Christopher Williams2, Thomas Edwards2, Emily R Adams2, Cheryl C Johnson3,5, Miriam N Mutseta4, Elizabeth L Corbett5,6, Frances M Cowan1,7, Helen Ayles5,8, Karin Hatzold4, Peter MacPherson6,9 and Miriam …

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  • Re‐reading of OraQuick HIV‐1/2 rapid antibody test

    2020-1-3 · 42 specimens was tested by either the OraQuick Advance test or the Clearview HIV-1/2 Stat-Pak test, one specimen (speci-men I) was found to be reactive. The Multispot HIV-1/HIV-2 test detected HIV-1 antibody in 7 of the 42 specimens (spec-imens F, I, …

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  • OraSure OraQuick ADVANCE Rapid HIV Test Kit - MFI

    The OraSure OraQuick ADVANCE Rapid HIV Test Kit detects HIV-1 and HIV-2 antibodies in as little as 20 minutes. 99% accurate with 99.9% specificity from 'real world' data, each unit is designed with the goal of stopping the spread of HIV one test at a time. Compatible with …

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  • Control Kit - OraQuick ADVANCE Rapid HIV-1/2 Antibody

    2018-10-8 · - OraQuicli mmmmw Kit Controls RapU HI V- 1/2 Antibody Test Read this package insert and the OraQuicP ADVANCE Rapid HIV-112 Antibody Test Kit package insert completely before using the product ...

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  • HIV 1/2 Rapid Test - Rapikit

    Delayed re-reading of used OraQuick ® HIV-1/2 rapid antibody tests is not currently a valid methodological approach to quality assurance and monitoring as we observed a high incidence (29%) of true non-reactive tests changing to false weak-reactive and therefore its use may overestimate tr …

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  • Re-reading of OraQuick HIV-1/2 rapid antibody test

    2019-3-5 · rapid test has bearing for both clinical and public health considerations. 3. SUDS HIV-1 test is the first such test approved by the US Food and Drug Administration (FDA). It, however, must be performed by a trained laboratory technician. In November 2002, the FDA approved the OraQuick HIV-1 rapid test as a moderate complexity test, which has to be

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  • Report of a Pilot Study on Using OraQuick HIV-1/2 Rapid ...

    2017-8-25 · RESEARCH ARTICLE Open Access Field comparison of OraQuickW ADVANCE Rapid HIV-1/2 antibody test and two blood-based rapid HIV antibody tests in Zambia Dalila Zachary1,2*, Lawrence Mwenge1, Monde Muyoyeta1,3, Kwame Shanaube1,3, Albertus Schaap1,2, Virginia Bond1,4, Barry Kosloff1,3, Petra de Haas1,3 and Helen Ayles1,3 Abstract

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  • RESEARCH ARTICLE Open Access Field comparison of

    2021-7-26 · Hiv screen test kit nku student. A home blood test kit is included in the price of your health plan. BioSure's CE Marked HIV Self Testing Kit has everything you need to test at . Professionals as a screening test and an aid in the diagnosis of infection with HIV-1 or HIV-2 viruses. Any reactive specimen with the HIV 1/2 Rapid Test.

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  • Hiv Screen Test Kit Bw Test Strips | Jal Innovations ...

    2020-1-3 · 42 specimens was tested by either the OraQuick Advance test or the Clearview HIV-1/2 Stat-Pak test, one specimen (speci-men I) was found to be reactive. The Multispot HIV-1/HIV-2 test detected HIV-1 antibody in 7 of the 42 specimens (spec-imens F, I, …

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  • Assessment of Rapid Tests for Detection of Human ...

    Same-day test results mean . Members of the public who want a test but don't have any COVID-19 symptoms can book a rapid test at Hill House (Bishopsford Road, St.Helier) or at one of . Hiv test kit second focal. Stay home and skip your regularly scheduled visit for HIV and STI testing. Call your Request a free HIV self-test kit by contacting an ...

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  • Hiv Test Kit Hla Testing | Jal Innovations | ICare Rapid ...

    2017-4-19 · This would reflect the expected performance of the test for confirmed HIV positive samples based on a direct comparison with a currently accepted state-of-the-art device (e.g. third or fourth generation EIA) Third-generation EIA detect HIV-1/2 IgM and IgG antibody and are the relevant performance benchmark for antibody only rapid tests.

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  • OraQuick ADVANCE Rapid HIV-1/2 Antibody Test

    2018-3-15 · BIOLOGICAL PRINCIPLES OF THE TEST The OraQuick ADVANCE ® Rapid HIV-1/2 Antibody Test is a manually performed, visually read, 20 minute immunoassay for the qualitative detection of antibodies to HIV-1 and HIV-2 in human oral fluid, whole blood obtained from a finger puncture or a venipuncture, and plasma.

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  • Orasure Technologies OraQuick Advanc HIV 1/2

    Product Description. The OraQuick ADVANCE® HIV-1/2 Antibody Test is a single-use, qualitative immunoassay to detect antibodies to Human Immunodeficiency Virus Type 1 (HIV-1) and Type 2 (HIV-2) in oral fluid, fingerstick, whole blood, venipuncture whole blood and plasma specimens. The kit is intended for use as a point of care test to aid in ...

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  • OraQuick ADVANCE HIV Kit Controls - cliawaived.com

    OraQuick ADVANCE HIV Kit Controls. SKU. ORA-1001-0077. 69.95. (1 Kit, 3 Vials) The OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test Kit Controls are quality control reagents for use only with the OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test. Each Kit Control Box contains a package insert and three vials (one HIV-1 positive control, one HIV-2 ...

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  • HIV Test Kits | Buy HIV Rapid Test Kits | CLIAwaived

    2011-12-15 · OraQuick Advance rapid HIV test kits to community-based providers and healthcare institutions to provide HIV counseling and testing services. The District of Columbia will use the OraQuick rapid test because (1) it was the first rapid point-of-care HIV test approved by the U.S. Food and Drug Administration (FDA) and (2) it is the only oral

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  • ORAQUICK RAPID TEST DISTRIBUTION PROTOCOL

    2017-2-1 · 1 ABON™ HIV 1/2/O Tri-line HIV Rapid Test Device (Whole Blood/Serum/Plasma) Alere* USAID 2 Alere Determine™ HIV-1/2 Alere* Abbott Laboratories* USAID 3 Alere Determine™ HIV-1/2 Ag/Ab Combo Rapid Test Kit Alere* USAID 4 Aware™ HIV-1/2 BSP Calypte Biomedical* USAID 5 Bioline HIV 1/2 3.0 Standard Diagnostics USAID

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  • USAID List of Approved HIV Rapid Test Kits

    2014-6-19 · MATERIALS REQUIRED AND AVAILABLE AS AN ACCESSORY TO THE KIT OraQuick®HCV Rapid Antibody Test Kit Controls 1001-0182 Package contains: HCV Positive Control (1 vial, purple cap, 0.2 mL), HCV Negative Control (1 vial, white cap, 0.2 mL), and Package Insert OraQuick®HCV Visual Reference Panel 1001-0343 Package Contains: HCV Limit of Detection (1 ...

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  • OraQuick HCV Rapid Antibody Test Customer Letter

    performing quality assurance using the OraQuick Rapid HIV-1 Antibody test. The forms provided are examples and templates that can be adapted for local use, adding or deleting fields, as needed. The appendix includes the following: A. Government regulations B. Example training checklist for the OraQuick Rapid HIV-1 Antibody Test

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  • OraQuick ADVANCE HIV-1/2 Rapid Antib. test |

    McKesson CONSULT™ Pregnancy hCG Test (1) OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test (1) DCA 2000 (1) For ABX Micros 60 Hematology Analyzers (1) For ADVIA Centaur® System (1) For Acceava® H. pylori Test (1) For Advia® Centaur® Systems (4) For Array of Clinical Chemistry Analyzers (1) For AutoSCAN-4 System, WalkAway 40 Plus, WalkAway 96 ...

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