Syphilis

Health Canada grants approval for MedMira's HIV and syphilis test
By LabPulse.com staff writers
Regulatory body Health Canada has granted approval to MedMira's point-of-care test for HIV and syphilis.
December 27, 2024
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NowDiagnostics submits FDA de novo request for OTC syphilis test
By LabPulse.com staff writers
NowDiagnostics has submitted a de novo authorization request to the U.S. Food and Drug Administration (FDA) for its First to Know over-the-counter (OTC) syphilis test.
January 10, 2024
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Biolytical Laboratories nabs Health Canada authorization for HIV-1/2 syphilis antibody test
By LabPulse.com staff writers
The test detects HIV-1, HIV-2, and syphilis antibodies using a sample and fingerprick, delivering results in one minute or less.
March 27, 2023
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Chembio Diagnostics obtains FDA CLIA waiver for HIV-syphilis testing system
By LabPulse.com staff writers
More than 200,000 CLIA-waived point-of-care testing sites in the U.S. can now use the system to detect HIV and syphilis, Richard Eberly, Chembio’s president and CEO, said in a statement.
February 24, 2023
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CDC awards Chembio $3.2M for development of syphilis POC test
By LabPulse.com staff writers
Under the contract, Chembio will develop a syphilis test and confirm assay based on its Dual Path Platform (DPP) technology and DPP Micro Reader II. The assay will be designed to simultaneously and separately detect treponemal and nontreponemal IgM and IgG antibodies.
September 5, 2022
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FDA reports syphilis testing kit may generate false positives
By LabPulse.com staff writers
The FDA said false-positive results have been observed in some individuals for at least five months following vaccination.
December 20, 2021
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COVID-19 highlights need for at-home STI testing
By Leah Sherwood
It has been widely reported that the COVID-19 pandemic has caused declines in rates for different screening exams, and the same holds for STI screenings, according to the authors, led by Ellen Kersh, PhD, of the U.S. Centers for Disease Control and Prevention (CDC).
October 25, 2021
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FDA clears Beckman Coulter's automated microplate system for blood banking
By LabPulse.com staff writers
The PK7400 system is a high-throughput single analyzer designed for large laboratories and blood donor and plasma centers. It can process up to 300 samples per hour, the company noted.
July 22, 2020
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Thermo Fisher debuts infectious disease quality controls
By LabPulse.com staff writers
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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STD test market grows with incidence, new tech
By Bruce Carlson
Not that long ago, rates of gonorrhea infection were at historically low levels, and elimination of syphilis was a reasonable goal. The diagnostics industry was able to highlight how advances in STD detection and prevention brought increased rates of detection and treatment.
May 27, 2019
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