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Infectious
Gonorrhea: Page 2
Binx point-of-care STI testing clears FDA
By
LabPulse.com staff writers
The polymerase chain reaction (PCR) product includes a benchtop instrument with a single-use, assay-specific cartridge. Vaginal swabs may be collected by patients in a clinical setting or by laboratorians, and results are available within half an hour, according to the company.
August 11, 2019
SpeeDx gonorrhea test gets breakthrough status in U.S.
By
LabPulse.com staff writers
ResistancePlus GC uses real-time quantitative polymerase chain reaction (qPCR) technology to test for gonorrhea and is already cleared for use in Europe, Australia, and Canada. The test detects the presence of N. gonorrhoeae bacteria, as well as sequences in the gyrA gene of the bacteria that could be a sign of an individual's susceptibility or resistance to treatment with the oral antibiotic ciprofloxacin.
June 10, 2019
FDA clears 2 Hologic tests for yeast infections
By
LabPulse.com staff writers
Hololgic's Aptima BV test is for bacterial vaginosis (BV), and the Aptima CV/TV assay is designed for detecting Candida vaginitis (CV) and Trichomomas vaginalis (TV). These three are the most common types of vaginitis, accounting for 90% of cases, and coinfection is common, the company noted.
May 28, 2019
New world order for STD tests | Red flags on CLIA-waived products | FDA's burst of preholiday actions
By
Emily Hayes
Dear LabPulse Member,
May 27, 2019
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
FDA clears 1st extragenital STD tests
By
LabPulse.com staff writers
The tests are designed to detect the presence of the bacteria Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) with extragenital specimens acquired via the throat and rectum. Previously, the tests were cleared only for use with urine, vaginal, and endocervical samples.
May 22, 2019
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