HIV: Page 2

FDA OK's new claim for Hologic's HIV assay
The Aptima HIV-1 Quant Dx is now the first dual-claim assay for both diagnosis and viral load monitoring in the U.S., Hologic said. First approved in late 2016 for viral load monitoring, the assay is a molecular diagnostic test that runs on the automated, sample-to-result Panther system. It uses a dual target approach against highly conserved regions in the HIV genome designed to deliver results across HIV-1 groups and subtypes, Hologic said.
November 19, 2020
2019 02 13 19 24 5396 Fda Logo V2 400
Truvian's COVID-19 antibody test cleared by FDA
The antibody test offers 98.4% sensitivity and 98.9% specificity, and has been tested and validated by healthcare professionals and scientists at the University of California, San Diego (UCSD) and the University of Chicago, according to the company. Furthermore, company evaluation suggests no cross-reactivity with HIV, influenza A and B, and several coronavirus strains, Truvian said.
July 29, 2020
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Thermo Fisher debuts infectious disease quality controls
The Thermo Scientific Mas Omni Infectious positive and negative quality controls are third-party, independent external controls used to assess the performance of serological assays for HIV types 1 and 2, hepatitis B and C, syphilis, and human T-cell leukemia virus types 1 and 2. Monitoring the assays' performance can streamline operations and may reduce spending without sacrificing quality, according to the company.
June 30, 2020
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Viro Research debuts test for chickenpox, shingles
ZosterGent is designed for lesion testing of at-risk patients suspected of having chickenpox or shingles, including immunosuppressed populations such as pregnant women or those with HIV, cancer, or organ transplants, according to the firm. Results are available in 20 minutes.
June 9, 2020
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Lab automation in steps | CDC touts HIV self-tests | Vitamin D falls flat -- again
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November 18, 2019
Free HIV self-tests boost diagnoses in CDC study
The Evaluation of Rapid HIV Self-testing Among MSM Project (eSTAMP) was designed to evaluate the effect of internet intervention and mailed HIV self-tests for men at risk. Two tests were used: OraQuick of oral fluids (OraSure Technologies) and the Sure Check HIV 1/2 finger-stick blood test (Chembio Diagnostics Systems).
November 18, 2019
2019 11 15 23 37 9903 Hiv 1 Virions Cdc 400
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Vela wins FDA clearance for HIV-1 genotyping NGS assay
The FDA said the approval is its first for an HIV drug resistance assay using NGS technology. The Sentosa SQ HIV-1 genotyping assay is meant for use only in patients with HIV-1 who are about to start or are already taking antiviral therapy, according to the FDA. It's not intended for diagnosing infection with HIV. The test results are intended to be used in conjunction with clinical observations, patient history, and other laboratory evidence to make patient management decisions, the FDA noted.
November 5, 2019
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Bay Area biotech gets NIH grant for Lyme disease test
The South San Francisco-based company says that its antibody detection by agglutination-PCR (ADAP) technology platform will power a test that is far more sensitive than standard testing today, enabling earlier detection of Lyme disease, as well as helping to distinguish it from other tick-borne illnesses. Enable is working with Tulane University and Columbia University on the Lyme disease test and with other partners to develop ADAP tests for HIV and type 1 diabetes.
July 11, 2019
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Mylan, Atomo 15-minute HIV self-test gets WHO backing
The test, which was developed using Atomo's AtomoRapid platform, detects HIV antibodies through a finger stick and delivers results within 15 minutes, according to the companies. Prequalification from the WHO means that a product meets certain criteria for safety, performance, and quality.
July 8, 2019
2019 07 09 16 17 7497 Hiv Virions Cdc 400
NIH funds creation of granuloma lab model for TB and HIV
Texas Biomed has a two-year study grant to create a model for granulomas, which are masses of macrophages, lymphocytes, and other cells that form in response to an infection with Mycobacterium tuberculosis. In people infected with HIV and TB, HIV is present in granulomas. The interaction is complex, and animal models haven't been up to the task of evaluation, Texas Biomed said in a statement.
June 27, 2019
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Avioq launches HIV profiling assay in Europe
The enzyme-linked immunosorbent assay (ELISA) was designed to confirm and differentiate antibodies for gene products of two HIV-1 groups -- group M, which causes most HIV globally, and group O, which has mostly been reported in parts of West and Central Africa -- and HIV-2 in human serum and plasma. According to the company, the test is also useful for differentiating new versus long-standing infection.
June 24, 2019
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GlaxoSmithKline recruits SpeeDx for antibiotics trials
SpeeDx markets in vitro testing products internationally that are aimed at minimizing the spread of treatment-resistant infections. Such products include ResistancePlus GC for Neisseria gonorrhoeae bacteria, which recently received the breakthrough device designation from the U.S. Food and Drug Administration (FDA), and ResistancePlus MG for detecting the emerging sexually transmitted infection Mycoplasma genitalium (Mgen). In a statement, the company said that it will use its existing molecular diagnostic tests as well as custom products to assist GlaxoSmithKline in ongoing trials and new product development.
June 23, 2019
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