Figure: Gastrointestinal panel QIASTAT-DX 2 MINI B works in Qiastat-DX (photographs with kind permission of Qiagen)
Acute infectious gastroenteritis occurs every year in the United States in approximately 179 million cases, creating a large number of outpatient visits and hospitalization. To solve this problem, the new gastrointestinal panel offers a quick detection of five common bacterial pathogens for outpatient use, allowing faster and better informed decisions on treatment.
The Qiastat-DX 2 mini B Qiagen (Venlo, Netherlands) has been approved by the United States Food and Drug Administration (FDA) for clinical use, improving the company’s syndrome test supply on the US market. This recently approved panel focuses specifically on bacterial infections and detects Campylobacter, Salmonella, They showed chill Similarly producer toxin in (Stec), Shigella y Yersinia EnterocoliticaPathogens identified by the United States Society Infectious Diseases Society (IDSA) as the main causes of gastrointestinal diseases. The panel complements the gastrointestinal panel QIASTAT-DX 2 mini B&V (bacterial and viral) (which includes the same bacterial pathogens and also adds Norovirus.
The Qiastat-DX 2 mini B gastrointestinal panel works with QIAST-DX and uses PCR technology in real time to reinforce multiple genetic goals in one response. The results are supplied in approximately an hour, with less than a minute of manual working time required. The values of the cycle values (CT) and the amplification curves offer more information about coinfects, all of which are immediately visible to the touch screen tools without any additional software. The QIAST-DX is available in more than 100 countries, while at the end of 2024 there are more than 4,600 tools worldwide worldwide.
This is the second FDA permit for Qiastat-DX panel in 2025, after approval of five panels for use in Qiastat-DX in the last 10 months. Qiagen has now received a regulatory permit for three mini -panels intended for outpatient use to help provide quick and accurate decisions on the treatment of respiratory and gastrointestinal conditions. The Qiastat-DX 2 mini B gastrointestinal panel is specifically optimized for the environment in which bacterial pathogens are the main problem, and offers a complement to the Qiast-DX 2 mini B&V gastrointestinal panel, which covers bacterial and viral goals.
QIAGEN is the first company to offer gastrointestinal panels complete and specific, which allows the laboratories to customize the tests to meet their specific needs. In addition to recently approved panels, for hospitalized patients with higher risk factors for serious illnesses, it is ideal for hospitalized patients with higher risk factor with higher risk disease. These panels deal with the unique diagnostic needs of the hospital and outpatient care and respond to the growing demand for flexible test options to manage challenges in reimbursement of medical care. Qiagen also plans to expand its Qiastat-DX portfolio and recently introduced Qiastat-DX Rise for regulatory approval, a highly capacity tool suitable for processing up to 160 tests per day.
“Qiagen undertakes to expand its portfolio of syndomic tests in the US to provide laboratory and doctors specific and effective diagnostic solutions,” said Nadia Aelbrecht, vice president and director of infectious Qiagen diseases. “With the approval of the FDA of our second gastrointestinal panel Qiastat-DX Mini, we further strengthen our ability to solve the diverse needs of patients, while helping medical care providers to optimize diagnostic workflows and offer them the flexibility they need.”
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