OraQuick HIV-1 2 rapid test kit Product Parameters manufacture

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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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  • WHO Prequalification of In Vitro Diagnostics PUBLIC

    According to the claim of the manufacturer, “ 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(EDTA) . The assay is read visually, and is intended for the detection of such antibodies from

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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 Prequalification of In Vitro Diagnostics PUBLIC

    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 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

    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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  • WHO Prequalification of In Vitro Diagnostics PUBLIC

    OraQuick HIV 1/2 Rapid Antibody Test codes . 5x4-0010 and 5x4with product 0012, - manufactured by 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 2016. Intended use: OraQuick® HIV-1/2 Rapid Antibody Test is a qualitative, in vitro immunoassay.

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  • Rapid Infectious Disease Products - OraSure

    2021-6-7 · 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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  • WHO Prequalification of In Vitro Diagnostics PUBLIC

    OraQuick HIV Self-Test with product codes 5X4-1000, 5X4-1001 and 5X4-2001 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 20 July 2017 . Summary of WHO prequalification assessment for . OraQ uick HIV 1/2 Self-Test1

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  • OraQuick Instructions Package Insert - OraQuick HIV 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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  • OraQuick ADVANCE HIV Test - OraSure

    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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  • China Oraquick Hiv Test, China Oraquick Hiv Test ...

    About 25% of these are pathological analysis equipments, 25% are tracheal cannula. A wide variety of oraquick hiv test options are available to you, There are 4 oraquick hiv test suppliers, mainly located in Asia. The top supplying country or region is China, which supply 100% of oraquick hiv test respectively.

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  • ORAQUICK RAPID TEST DISTRIBUTION PROTOCOL

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

    Blood and Oral fluid test. CLIA waived, FDA approved. 1 kit contains: 20 test devices... 155.95. Add to Cart. ORAQUICK ADV HIV 1-2 RAPID Test Kit. SKU : MUR-01L7425. (25 Tests) OraQuick HIV Test Kit, first oral fluid rapid HIV test. OraQuick ADVANCE HIV-1/2 Antibody Test. FDA approved...

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  • (PDF) EVALUATION OF ORAQUICK® HIV-1/2 AS

    The OraQuick® HIV-1/2 Rapid OMT-based test detected a total of 14 positive samples, of which 13 were true positives and 1 was a false positive; thus the sensitivity and positive predictive value of 93% and 92.86% respectively. Equally, of the 1506 negative samples confirmed by the gold standard, 1505 samples were detected HIV-negative by ...

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  • Hiv 1 2 Rapid Test Kit Suppliers, Manufacturer ...

    Alibaba offers 91 Hiv 1 2 Rapid Test Kit Suppliers, and Hiv 1 2 Rapid Test Kit Manufacturers, Distributors, Factories, Companies. There are 51 OEM, 49 ODM, 14 Self Patent. Find high quality Hiv 1 2 Rapid Test Kit Suppliers on Alibaba.

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

    Oraquick HIV self-test, Kit/50. 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. Between 2 to 30 °C.

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

    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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  • HIV FAQ | OraQuick Home HIV Test

    The OraQuick test uses oral fluid to check for HIV-1 and HIV-2. It can give you results in about 20 minutes, and if you follow the instructions carefully the OraQuick oral fluid test can detect 91.7 percent of people who are infected with HIV, and 99.9 percent of people who are not infected with HIV. Because the test is a 'screening' test, it ...

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  • Oraquick Advance HIV Test Kit- Ph - Home | Facebook

    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 | 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

    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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  • 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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  • 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 ...

    Get Price
  • OraQuick HIV Self-Test - OraSure

    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

    2016-3-4 · The OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test Kit Controls individual components should be used only by qualified personnel trained in laboratory procedures and familiar with their potential hazards. Specific warnings are given in the instructions for use. The absence of a specific warning should not be interpreted as an indication of safety.

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  • SAFETY DATA SHEET OraQuick ADVANCE Rapid HIV-1/2

    2019-3-1 · Methods. 444 OraQuick ® HIV ‐1/2 rapid antibody tests were conducted using commercial plasma from two HIV ‐positive donors and HIV ‐negative plasma (high‐reactive n = 148, weak‐reactive n = 148 and non‐reactive n = 148) and incubated them for six months under four conditions (combinations of high and low temperatures and humidity). Devices were re‐read daily for one week, weekly ...

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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

    HIV tests are the most commonly used means of controlling and managing the spread of HIV. The HIV test most commonly used is the rapid HIV TEST kit. The best way to test for HIV is a rapid test in order to combat and control the HIV epidemic. These HIV tests look …

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  • Rapid STD Test Kits for home use including the

    2021-5-1 · Ab Test n OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test n Chembio HIV 1/2 STAT-PAK® n ®Chembio ... *From date of manufacture ORDERING INFORMATION PRODUCT CAT. NO. ... Ab Combo (x25) 7D2648 Determine ™ HIV-1/2 Ag/Ab Combo (x100) 7D2649 External Controls 7D2628 Fingerstick Sample Collection Kit (100 Sterile Safety Lancets, 100 Adhesive ...

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  • DETERMINE HIV-1/2 Ag/Ab COMBO - content.veeabb.com

    Item No. 0371651. Quickly and effectively providing results with the same test used by healthcare professionals, Oraquick is the first in-home HIV test kit. With no pricking or blood required to produce results, Oraquick answers the serious question about whether or not the HIV virus has been contracted by using a small sample from the mouth.

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  • OraQuick HIV Home Test Kit | Rite Aid

    2012-7-3 · The OraQuick(R) In-Home HIV Test can detect antibodies to both HIV-1 and HIV-2 with an oral swab, providing a confidential in-home testing option with results in as little as 20 minutes. It is the first rapid diagnostic test for any infectious disease that …

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  • OraSure Technologies, Inc.'s OraQuick: First Rapid,

    Find many great new & used options and get the best deals for Orasure ORAQUICK HIV Home Test Kit - Fast & Discreet at the best online prices at ebay!

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  • ORAQUICK Advance Rapid Antibody HIV 1/2 In Home

    Rapid Test HIV-1 & HIV-2, CLIA Waived For Whole Blood, Non-Waived For Serum & Plasma, Results in 15 Minutes, 25 test/kit Clearview HIV 1/2 STAT-PAK is a rapid qualitative screening test for the detection of antibodies to HIV-1 and HIV-2 in human whole blood, serum and plasma. Waived Test …

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  • HIV1&HIV2 RAPID TEST 25/BOX, WHOLE BLOOD CLIA

    2019-11-28 · Product Name Number of tests per kit Initial Sensitivity Final Specificity Manufacturer Analyte Specimen Type Anticipated Shelf life (months) Storage temperature ... 25228 Multispot HIV-1/HIV-2 Rapid Test 50 100% HIV-1 (serum) 100% HIV-1 (plasma) 100% HIV-2 (serum/plasma) 99.93% serum 99.91% plasma Bio-Rad Laboratories, Marnes

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  • HIV Test Kit - HIV Rapid Test Kit Latest Price ...

    2019-3-27 · and free HIV-1 p24 antigen. A 4th generation test that has the ability to identify HIV earlier than 2nd and 3rd generation antibody only tests.1 Detecting HIV earlier enables linkage to care sooner which may prevent onward transmission.2 6 1. Masciotra S, et al. Performance of the Alere Determine™ HIV-1/2 Ag/Ab Combo Rapid Test with specimens ...

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  • List of HIV Diagnostic test kits and equipments classified ...

    Premier Medical Corporation Ltd. Established in the year 1996 we “ Premier Medical Corporation Ltd.”. is a Manufacturer of the wide spectrum HIV Test Kit, HCV Test Kit, Malaria Test Kit, etc. We are manufacturing these products using premium grade raw material that is procured from the authentic vendors of the market.

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  • Rapid Test Kit OraQuick® In-Home HIV Home Test

    OraQuick® is an FDA-approved oral swab in-home test for HIV-1 and HIV-2 With OraQuick®, you have the comfort of getting your test results in the privacy of your own home Rapid Test Kit OraQuick® In-Home HIV Home Test Device H…

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  • OraQuick In-Home HIV Test - OraSure

    2021-5-12 · The OraQuick® In-Home HIV Test is the first and only oral fluid rapid over‑the‑counter (OTC) HIV test approved in the U.S. It can detect antibodies to both HIV‑1 and HIV‑2 with an oral swab, providing a confidential in‑home testing option with results in as little as 20 minutes. The test kit comes with extensive resources and support ...

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  • Near Patient Study of the OraQuick ADVANCE® HIV

    2021-3-23 · Currently only blood-based POC tests for HIV are licensed for use in Canada. The OraQuick ADVANCE® HIV-1/2 Rapid Antibody Test is a POC test developed by OraSure Technologies, Inc. to detect HIV antibodies in oral fluid and fingerstick blood samples.

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  • HIV 1/2 Rapid Test - Rapikit

    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 ...

    2019-3-5 · 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 ...

    One step anti-HIV 1+2 test strip and test cassette are direct binding screening testing devices for the presence of antibodies to HIV-1 and HIV-2 viruses in human serum, plasma or whole blood specimens. These HIV rapid tests are based on the principle of double antigen sandwich immunoassay. anti-HIV rapid test kits can be used for screening of ...

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