/PRNewswire/ -- Hardy Diagnostics is pleased to announce the FDA clearance of the NG-TEST® CTX-M Multi, an

/PRNewswire/ -- Hardy Diagnostics 很高兴地宣布 NG-TEST® CTX-M Multi 获得 FDA 批准，

in vitro,

体外，

rapid, and visual immunoassay for the qualitative detection of most prevalent CTX-M enzymes (groups 1, 2, 8, 9, and 25) from pure colonies of Enterobacterales suspected of ESBL production. This breakthrough assay rapidly confirms the presence of CTX-M enzymes in minutes, not hours.

快速、可视化的免疫测定法，用于定性检测来自疑似产ESBL的肠杆菌目纯菌落中最普遍的CTX-M酶（第1、2、8、9和25组）。这项突破性测定法可在数分钟内快速确认CTX-M酶的存在，而非数小时。

NG-Test® CTX-M Multi: Rapid Immunoassay detect CTX-M enzymes from Enterobacterales suspected of ESBL

NG-Test® CTX-M Multi：快速免疫检测法检测疑似产ESBL的肠杆菌科细菌中的CTX-M酶

CTX-M Multi Product Photo

CTX-M 多产品照片

The rapid and widespread emergence of extended-spectrum beta-lactamases (ESBLs) is a growing global health concern. These enzymes confer resistance to many beta-lactam antibiotics, making infections more difficult to treat.

产超广谱β-内酰胺酶（ESBLs）的快速广泛出现是一个日益严重的全球健康问题。这些酶赋予许多β-内酰胺类抗生素耐药性，使感染更难以治疗。

First reported in 1989 in

最早于1989年报道

Germany

德国

, CTX-M β-lactamases were considered rare in

，CTX-M β-内酰胺酶被认为很罕见

North America

北美

until 2003, when the Centers for Disease Control and Prevention identified them in nine

直到2003年，疾病控制和预防中心在九个中识别出它们。

Escherichia coli

大肠杆菌

isolates from five U.S. states. Since then, CTX-M ESBLs have become the most prevalent type in the U.S. and globally.

分离自美国五个州。从那时起，CTX-M ESBLs已成为美国乃至全球最主要的类型。

Over 100 variants within the five major CTX-M groups are known, with CTX-M variants belonging to groups 1 and 9 being the most widespread. CTX-M enzymes are found in various bacterial species, including

目前已知五大类CTX-M组内有超过100种变异体，其中属于第1组和第9组的CTX-M变异体最为广泛传播。CTX-M酶存在于多种细菌物种中，包括

E. coli, Klebsiella pneumoniae

大肠杆菌，肺炎克雷伯菌

and

和

Proteus mirabilis

奇异变形杆菌

Antibiotic resistance continues to pose significant challenges worldwide. ESBL-related infections lead to increased healthcare costs due to the use of broad-spectrum antibiotics, extended hospital stays, increased risk of side effects, and more complex treatment regimens. Early detection concurrent with the traditional antimicrobial susceptibility testing in critical cases or in instances of suspicion of resistant Enterobacterales, leading to timely treatment, and appropriate antibiotic selection are key to improving patient outcomes..

抗生素耐药性持续在全球范围内构成重大挑战。ESBL相关感染由于使用广谱抗生素、住院时间延长、副作用风险增加以及治疗方案更加复杂，导致医疗成本上升。在重症病例或疑似耐药肠杆菌科细菌感染的情况下，与传统的抗菌药物敏感性测试同步进行早期检测，从而实现及时治疗和合理选择抗生素，是改善患者预后的关键。

As prevalence continues to rise, so does the need for increased CTX-M ESBL testing. Detection has primarily relied on MIC and disk diffusion susceptibility testing, molecular techniques like PCR, or screening culture media. These methods can be time-consuming or expensive.

随着流行率的持续上升，对增加CTX-M ESBL检测的需求也在增加。检测主要依赖于MIC和纸片扩散敏感性测试、PCR等分子技术或筛选培养基。这些方法可能耗时或昂贵。

NG-TEST® CTX-M Multi offers a cost-effective and rapid solution, delivering results in just 15 minutes.

NG-TEST® CTX-M Multi 提供了一种经济高效且快速的解决方案，仅需15分钟即可提供结果。

Hardy Diagnostics is the exclusive distributor of the NG-TEST® CTX-M Multi in

哈迪诊断公司是NG-TEST® CTX-M Multi的独家经销商。

the United States

美国

and its territories. This test joins our growing portfolio of diagnostic innovations to support better patient care through faster, targeted treatment decisions.

及其领土。该测试加入了我们不断增长的诊断创新产品组合，通过更快、更有针对性的治疗决策来支持更好的患者护理。