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  • June 12, 2020 - FDA

    2020-6-13 · Company: Cellex Inc. Indication: Qualitative detection of IgM and IgG antibodies against SARS- CoV-2 in serum, plasma (EDTA or citrate), or venipuncture whole

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  • qSARS-CoV-2 IgG/IgM Rapid Test - A SAGES

    2020-4-1 · Designed in response to the COVID-19 pandemic, the qSARS-CoV-2 IgG/IgM Rapid Test is the first FDA approved assay of its kind. The test qualitatively detects IgG and IgM immunoglobulins against SARS-CoV-2 present in venipuncture whole blood, serum, or plasma (EDTA or …

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  • Rapid COVID-19 Testing Kit | Coronavirus Test Kits ...

    2020-4-7 · Cellex, a medical diagnostics company with U.S. headquarters and labs in Research Triangle Park, has launched a new antibody test for detecting COVID-19 infection. The company’s qSARS-COV-2 IgG/IgM Rapid Test is permitted for distribution and use under the public health emergency guidance issued by the U.S. Food and Drug Administration.

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  • Q.E.D rapid alcohol test - Quest Diagnostics

    2021-4-29 · In this partnership, biotechnology company Cellex is developing a rapid COVID-19 antigen test, while Gauss has created a consumer-friendly app for you to see your results within 15 minutes. Cellex’s test has not yet received FDA Emergency Use Authorization, but if it does, it will be one of the fastest tests on the market, using Gauss’s app to scan and return the rapid results.

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  • Cellex Cleared to Market Covid-19 Antibody Test | NC

    2020-3-16 · The COVID-19 Corona Virus IgM/IgG Rapid Test is an in vitro diagnostic test solely for the qualitative determination of COVID-19’s IgM and IgG antibodies in human whole blood, serum, plasma and fingertip blood. The test kit is based on immunoassay technology. The test devices contain:

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  • Coronavirus Test Kits: Compare Price, Type, and More

    IDENTIFY POTENTIALLY CONTAGIOUS PATIENTS WITH OR WITHOUT SYMPTOMS IN 15 MINUTES. Patient-friendly, supervised self-collected Nasal swab minimizes health worker exposure. For professional use only. High performance rapid test enables immediate treatment or isolation measures to minimize transmission. Accessible, easy-to-deploy, large-scale testing ...

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  • CoVid-19 Rapid Test - Rethink My Healthcare

    2021-6-23 · The Rapid fFN test is a safe, reliable, and non-invasive test that can help providers determine a pregnant woman’s risk of delivering preterm. The use of fetal fibronectin (fFN) testing can help reduce unnecessary admissions and hospitalizations and help direct care and resources to patients who need it most.

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  • Panbio COVID-19 Ag Rapid Test Device | Abbott Point

    2021-6-3 · These EXSISERS modules enable non-invasive live staining, efficient cell enrichment using fluorescence-activated cell sorting (FACS) or magnetic cell separation system (MACS), and convenient ...

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  • Cellex, INC. qSARS-CoV-2 IgG/IgM Rapid Test

    2021-6-25 · The Cellex, Inc. qSARS-CoV-2 IgG/IgM Rapid Test, which has received an Emergency Use Authorization (EUA) from the U.S Food and Drug Administration (FDA), is indicated for the qualitative detection and differentiation of IgM and IgG antibodies against SARS-CoV-2 in serum, plasma (EDTA or citrate), or venipuncture whole blood from individuals suspected of COVID-19 by a healthcare provider.

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  • qSARS-CoV-2 IgG/IgM Rapid Test - A SAGES

    2020-4-1 · Authors: Diane Bronikowski, Nova Szoka, MD Cellex Inc received FDA approval for qSARS-CoV-2 IgG/IgM Rapid Test on April 1, 2020. Designed in response to the COVID-19 pandemic, the qSARS-CoV-2 IgG/IgM Rapid Test is the first FDA approved assay of its kind. The test qualitatively detects IgG and IgM immunoglobulins against SARS-CoV-2 present in venipuncture whole […]

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  • Cellex Cleared to Market Covid-19 Antibody Test | NC

    2020-4-7 · Cellex, a medical diagnostics company with U.S. headquarters and labs in Research Triangle Park, has launched a new antibody test for detecting COVID-19 infection.. The company’s qSARS-COV-2 IgG/IgM Rapid Test is permitted for distribution and use under the public health emergency guidance issued by the U.S. Food and Drug Administration.

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  • COVID-19 Antibody Rapid Test Kit | Coronavirus IgM

    This COVID-19 Rapid Test Kit is suitable for the qualitative detection of SARS-CoV-2 IgM/IgG antibodies in human serum, plasma, or whole blood. Common signs of infection with SARS-CoV-2 include respiratory symptoms, fever, cough, shortness of breath, and dyspnea. In more severe cases, infection can cause pneumonia, severe acute respiratory ...

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  • FDA APPROVES RAPID ANTIBODY TEST KITS FOR

    2020-3-30 · This kit is PCR based. To date, FDA has approved 17 PCR based test kits for commercial use. As a safety precaution, the FDA shall require the product inserts or label of the Rapid Test Kits to state the following: “This product is strictly for medical professional use only and not intended for personal use. The administration of the test and ...

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  • Q.E.D rapid alcohol test - Quest Diagnostics

    The Corona rapid test kit Shows Up Coronavirus Between 3 To 7 Days After Infection – Before Symptoms Begin To Appear. These specially designed test kits are Rapid Chromatographic Immunoassays (configured Like a Home Pregnancy test) that are designed to detect IgM and IgG antibodies (for COVID-19 and SARS-CoV-2 detection) in the blood.

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  • Covid-19 Test Kit – Coronavirus Test Kit

    2021-3-1 · Objective There is a lack of evidence addressing several important human factors questions pertaining to the quality of supportive information provided by commercial manufacturers that can affect the adoption and use of lateral flow serology assays in practice. We aimed to: (1) identify and assess the quality of information that commercial manufacturers provided for their point-of-care tests ...

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  • Rapid point-of-care testing for COVID-19: quality of ...

    The COVID-19 IgM/IgG Rapid Test by BioMedomics, Inc. demonstrates a combined sensitivity and specificity of 100% and ~99% respectively, making it one of the most accurate and reliable tests in the world. There is a critical, global need for serology assays that can complement nucleic acid (PCR) tests for diagnosing COVID-19 infection.

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  • COVID-19 IgM/IgG Rapid Test – BioMedomics Inc.

    2021-6-3 · Truong et al. developed a cell-based reporter system, EXSISERS, that enables non-invasive quantification of the protein expression levels of exon-specific isoforms via intein-mediated protein ...

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  • COVID-19, Coronavirus, Rapid Test, Covisure IgM/iGG

    COVID-19 IgM/IgG Rapid Test. The W.H.P.M. Inc. COVID-19 IgM/IgG RapidTest is a rapid device for the presumptive qualitative indication of infection by the SARS-COV-2 virus (otherwise known as Coronavirus COVID-19). The key features of this device are: Provides Positive/Negative Results in 15 minutes. Works with fingerstick, whole blood, serum ...

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  • CoVid-19 Rapid Test - Rethink My Healthcare

    2020-3-16 · The COVID-19 Rapid Test Kit is an professional medical testing kit that can detect the presence of IgG and IgM antibodies in human blood. These two antibodies indicate if a person is infected with 2019-nCoV novel coronavirus (COVID-19) with results available after 15 minutes.

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  • Panbio COVID-19 Ag Rapid Test Device | Abbott Point

    Fast identification of potentially contagious individuals. Test results in 15 minutes. Deploy at large scale at point of care. Can be used in a wide variety of non-laboratory settings. No special/additional instruments required. Self-contained tube with 'break off' swab minimizes staff exposure. Extraction tube is fully enclosed for disposal.

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  • COVID-19 IgG/IgM Rapid Test Device offered by

    2021-6-2 · Antigen Rapid test or RT-qPCR test is recommended to identify acute COVID-19. The COVID-19 Viral Antigen Detection kit detects the Nucleocapsid (N) protein of the SARS-CoV-2 virus from naso- or oropharyngeal swabs, while the ProTect™ COVID-19 RT-qPCR kit is based on the direct molecular diagnostics of the virus RNA.

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  • Rapid and molecular tests for COVID-19 by Camtech™

    2016-6-30 · Introduction. The lateral flow assay (LFA) is a paper-based platform for the detection and quantification of analytes in complex mixtures, where the sample is placed on a test device and the results are displayed within 5–30 min. Low development costs and ease of production of LFAs have resulted in the expansion of its applications to multiple fields in which rapid tests are required.

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  • Lateral flow assays - National Institutes of Health

    2020-4-9 · The COVID-19 IgG/IgM Rapid Test detects IgM and IgG antibodies in a rapid test that gives results within 2 to 10 minutes. The test which is user friendly has the COVID-19 IgG/IgM Rapid Test Device (capillary kit), which is a qualitative membrane-based immunoassay for the detection of COVID-19 antibodies in whole blood, serum, or plasma.

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  • Optimization and evaluation of a non-invasive tool for ...

    2021-2-13 · Rapid diagnosis of SARS-CoV-2 during pandemic enables timely treatment and prevention of COVID-19. Evaluating the accuracy and reliability of rapid diagnostic testing kits is crucial for surveillance and diagnosis of SARS-CoV-2 infections in general population, injection drug users, multi-transfused populations, healthcare workers, prisoners, barbers and other high risk populations.

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  • COVID-19 IgG/IgM Rapid Test for antibodies detection

    2021-6-16 · DNA Genotek Inc., a subsidiary of OraSure Technologies, Inc. (NASDAQ: OSUR), focuses on providing high-quality biological sample collection products and end-to-end services for human genomics, microbiome and infectious disease applications. The Company's Oragene•Dx and ORAcollect•Dx product lines are the first and only FDA 510(k) cleared saliva-based DNA collection …

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  • BGI Local Laboratory Solution for Non-invasive

    The kit is widely used for rapid detection and outbreak control of COVID-19 in China. BGI is distributing its RT-PCR kits to more than 180 countries and regions around the world. With its high specificity, sensitivity and rapid response, it can effectively assist the diagnosis of disease and improve the diagnosis efficiency. Product Features.

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  • FDA APPROVES RAPID ANTIBODY TEST KITS FOR

    2020-3-30 · This kit is PCR based. To date, FDA has approved 17 PCR based test kits for commercial use. As a safety precaution, the FDA shall require the product inserts or label of the Rapid Test Kits to state the following: “This product is strictly for medical professional use only and not intended for personal use. The administration of the test and ...

    Get Price
  • Coronavirus (COVID-19) IgM/IgG Rapid Test Kit

    Coronavirus (COVID-19) IgM/IgG Rapid Test Kit (dual cassettes) Not for sale in the United States. International customers, please Contact your Local Distributor. 20 TESTS TOTAL. Suitable for the qualitative detection of SARS-CoV-2 (COVID-19) N-Protein IgM and IgG antibodies in human serum, whole blood, or finger prick samples. Video.

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  • COVID-19 Human IgM IgG Rapid Test - (DC0301) -

    2021-6-20 · COVID-19 Human IgM IgG Rapid Test provides a fast, convenient, and qualitative testing of human whole blood, serum and plasma for COVID-19 (SARS-CoV-2) IgM and IgG. (DC0301) - Products - …

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  • COVID-19 testing in Australia - information for health ...

    2021-6-25 · Tests for COVID-19 aim to detect the causative virus, SARS-CoV-2, or an immune response to SARS-CoV-2. Available evidence on the performance of COVID-19 tests mainly comes from symptomatic patients, and their clinical role in detecting asymptomatic carriers is unclear.

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  • Hemoglobin System | AccuQuik Test Kits

    2021-6-4 · This hemoglobin test can be used easily and quickly to determine levels of red blood cells. A small blood sample obtained by a small prick of the finger is required to measure red blood cell levels. The test kits contain all the instruments needed to draw one drop of blood safely at home or anywhere. Hemoglobin is a protein, which contains iron ...

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  • AtilaBiosystems – AtilaBiosystems

    Isothermal Molecular Diagnostic Assay Without RNA Extraction. Contact Us At: [email protected] LEARN MORE. HPV Test. The Simplest & Fastest High Risk HPV Screening & Genotyping In the World. LEARN MORE. NIPT. Ultra-high Multiplex Digital PCR Based Non-Invasive Prenatal Testing For Trisomy 21, 18, and 13. LEARN MORE.

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  • Yourgene Health plc - Home

    Non-Invasive Prenatal Testing (NIPT) Yourgene provides three complementary screening solutions to meet more of our lab customers', clinicians' and pregnant women's needs across different international locations. IONA ® Nx NIPT Workflow, the IONA ® test and Sage prenatal screen. Automated Gel Electrophoresis. Automated Gel Electrophoresis.

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  • Current diagnostic tools for coronaviruses–From

    2020-8-3 · One of these tests is the COVID-19 IgM/IgG Rapid Test launched by Cellex Inc, which enables qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 within 15–20 min. 35 Another test is the DPP COVID-19 IgM/IgG test developed by Chembio Diagnostics, which can provide results in just 15 min using a simple finger-stick ...

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  • Evaluation of Loopamp™ Leishmania Detection Kit

    2021-4-26 · With reduced prevalence of visceral leishmaniasis (VL) in the Indian subcontinent (ISC), direct and field deployable diagnostic tests are needed to implement an effective diagnostic and surveillance algorithm for post-elimination VL control. In this regard, here we investigated the diagnostic efficacies of a loop-mediated isothermal amplification (LAMP) assay (Loopamp™ Leishmania …

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  • European Commission | Choose your language | Choisir

    The non-invasive MEGA test of SARS-CoV-2 Zalgen Labs, LLC ... Cellex qSARS-CoV-2 IgGIgM Cassette Rapid Test ... Bioeasy 2019-nCoV Ag Fluorescence Rapid Test Kit (Time-Resolved Fluorescence) Bioeasy 2019-nCoV Total Ab GICA Rapid Test Shenzhen Puruikang Biotech Co., Ltd ...

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  • Infectious Disease Controls for Serology Testing

    2021-4-13 · Cellex Cellex Rapid Test DiaSorin ... and assay procedures, different lots of the same test kit, and different lots of the control material . ... Non-reactive for: An unassayed quality control HAV-IgMHuman serum based 3 year shelf life at 2–8ºC 60 day open-vial …

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  • Coronavirus (COVID-19) IgM/IgG Rapid Test Kit

    Coronavirus (COVID-19) IgM/IgG Rapid Test Kit (dual cassettes) Not for sale in the United States. International customers, please Contact your Local Distributor. 20 TESTS TOTAL. Suitable for the qualitative detection of SARS-CoV-2 (COVID-19) N-Protein IgM and IgG antibodies in human serum, whole blood, or finger prick samples. Video.

    Get Price
  • Hemoglobin System | AccuQuik Test Kits

    2021-6-4 · This hemoglobin test can be used easily and quickly to determine levels of red blood cells. A small blood sample obtained by a small prick of the finger is required to measure red blood cell levels. The test kits contain all the instruments needed to draw one drop of blood safely at home or anywhere. Hemoglobin is a protein, which contains iron ...

    Get Price
  • In vitro diagnostics of coronavirus disease 2019 ...

    2021-4-1 · The Cellex qSARS-CoV-2 IgG/IgM Rapid Test (Cellex Inc., Durham, NC, USA) is also an LFIA for detecting anti-SARS-CoV-2 IgM and IgG. The performance of this test was assessed in 128 serum or plasma samples from 98 patients with COVID-19 confirmed by rRT-PCR and 70 negative serum or plasma samples collected before September 2019.

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  • Helix - Population Genomics

    2021-6-20 · COVID-19 Human IgM IgG Rapid Test provides a fast, convenient, and qualitative testing of human whole blood, serum and plasma for COVID-19 (SARS-CoV-2) IgM and IgG. (DC0301) - Products - …

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  • COVID-19 Human IgM IgG Rapid Test - (DC0301) -

    2020-3-19 · Roche plans to ship 400,000 of its cobas® SARS-CoV-2 tests for COVID-19 each week to labs authorized to run COVID-19 testing. Thermo Scientific also received authorization to distribute its real-time PCR (RT-PCR) diagnostic kits on Mar. 13 and plans to produce 5 …

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  • Recent Developments in COVID-19 Diagnostic Testing

    Additionally, there are no dangerous chemicals needed to run this kit to test water quality. With only one simple test procedure (using 3 reagents), Arsenic Quick is a must for any lab testing water quality, water testing professional, or service technician who values accurate, rapid results without sacrificing cost.

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  • Amazon.com: Arsenic Quick Test Kit: Health &

    2020-9-10 · In vivo non-invasive staining-free visualization of dermal mast cells in healthy, allergy and mastocytosis humans using two-photon fluorescence lifetime imaging

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