雅培推出世界上最敏感的快速诊断测试，确定HBsAg 2，加速乙

StephenW

Abbott Introduces the World's Most Sensitive Rapid Diagnostic Test, Determine™ HBsAg 2, to Accelerate Hepatitis B Care
Wed February 20, 2019 8:00 AM|PR Newswire|About: ABT
- Life-changing test has obtained CE Mark and is now available in Europe, Africa, Asia, Latin America, and other countries that recognize CE Mark
PR Newswire

ABBOTT PARK, Ill., Feb. 20, 2019 /PRNewswire/ -- Abbott (ABT) announced today it has received CE Mark for the world's most sensitive rapid diagnostic test for the detection of hepatitis B surface antigen, the Determine™ HBsAg 2 test for use with serum, plasma or whole blood.1,2,3 This highly sensitive, easy-to-use, rapid lateral flow test enables identification of those with the virus and facilitates linkage to care in every healthcare setting.

Hepatitis B is a serious liver infection caused by the hepatitis B virus (HBV). For some people, hepatitis B infection becomes chronic and can lead to liver failure, liver cancer or cirrhosis of the liver, a condition that permanently scars the liver.4

An estimated 257 million people worldwide were living with chronic HBV infection. While the global burden of this disease is significant, the rate of diagnosis is extremely low, at approximately 9 percent of all HBV-infected persons. Furthermore, among those diagnosed with HBV, only 8 percent actually received treatment.5

In a global effort to reduce the current burden of disease, the World Health Organization (WHO) has set baseline targets to diagnose 30 percent of HBV-infected individuals by 2020 and 90 percent by 2030.5 In order to reach these targets, rapid testing is imperative. Testing and diagnosis of HBV is the gateway for access to both prevention and treatment services and is a critical component of an effective response to the hepatitis epidemic.

"Because HBV is severely underdiagnosed, it is crucial to regularly screen people and efficiently link those who test positive to specialist care and where indicated, antiviral medication," said Patrick Kennedy, M.D., Reader and Consultant Hepatologist at Barts and The London School of Medicine and Dentistry. "Early diagnosis may support timely viral suppression, which reduces the risk for HBV-related complications."

Early identification of people with chronic HBV allows them to receive the necessary care and treatment to prevent or delay progression of liver disease. Testing also provides an opportunity for interventions that reduce transmission, through counselling on risk behaviors and provision of prevention products, such as sterile needles, and on vaccination.

"To achieve the WHO targets, 107 million HBV-infected people need to be urgently diagnosed, especially in highly endemic regions in Africa and Asia," said Damian Halloran, vice president, Infectious Disease-Emerging Markets, Abbott. "The unparalleled sensitivity, portability and ease-of-use of the Determine HBsAg 2 provides life-changing technology that can dramatically scale up testing services so more infected people can know their status and get treatment earlier."

High sensitivity tests are important for certain populations, such as pregnant women, to reduce mother-to-child transmission, and for HIV-positive individuals, in which it may be difficult to detect HBV.1 Highly sensitivity tests such as the Determine HBsAg 2 allow people in these populations to be diagnosed quickly and accurately and linked to appropriate care.

ABOUT DETERMINE HBsAg 2
The Determine HBsAg 2 provides rapid and accurate results of one's HBV status with an analytical sensitivity of 0.1 IU/mL. The test is an in-vitro, visually read, qualitative immunoassay for the detection of HBsAg in serum, plasma or whole blood. The test is easy-to-use, deployable at the point of care and detects HBV in just 15 minutes, while the patient is still present. This allows for prompt treatment decisions and ultimately contributes to the reduction of the global epidemic.

The Determine HBsAg 2 is part of Abbott's broader portfolio of life-changing technologies for hepatitis, which extends testing from the core laboratory to the point of care for people living in remote and underserved communities.

The test is now commercially available in Europe, Africa, Asia Pacific and Latin America. It has received CE Mark and data has been submitted for WHO prequalification.

StephenW

雅培推出世界上最敏感的快速诊断测试，确定HBsAg 2，加速乙型肝炎护理
2019年2月20日星期三上午8:00 |美通社|关于：ABT
- 改变生活的测试已获得CE标志，现已在欧洲，非洲，亚洲，拉丁美洲和其他认可CE标志的国家推出
美通社

伊利诺伊州雅培公园，2019年2月20日/美通社-PR Newswire /  - 雅培（ABT）今天宣布，它已获得CE Mark，用于检测乙型肝炎表面抗原的世界上最灵敏的快速诊断测试，Determine™HBsAg 2测试用于血清，血浆或全血.1,2,3这种高度灵敏，易于使用，快速的侧向流动测试可以识别患有病毒的人，并在每个医疗环境中促进与护理的联系。

乙型肝炎是由乙型肝炎病毒（HBV）引起的严重肝脏感染。对于一些人来说，乙型肝炎感染变成慢性，可导致肝功能衰竭，肝癌或肝硬化，这种情况会永久性地伤害肝脏.4

全世界估计有2.57亿人患有慢性HBV感染。虽然这种疾病的全球负担很重，但诊断率极低，约占所有HBV感染者的9％。此外，在被诊断患有HBV的患者中，只有8％实际接受了治疗

在减少目前疾病负担的全球努力中，世界卫生组织（WHO）制定了基线目标，到2020年诊断30％的HBV感染者，到2030年诊断为90％。为了达到这些目标，快速检测势在必行。 HBV的检测和诊断是获得预防和治疗服务的门户，是有效应对肝炎流行病的重要组成部分。

“由于HBV严重未被严重诊断，因此定期筛查人员并有效地将那些检测阳性的人与专科医生以及指示的抗病毒药物联系起来至关重要”，Barts和伦敦医学院的读者和顾问，肝脏病学家，医学博士Patrick Kennedy说。和牙科。 “早期诊断可能支持及时的病毒抑制，从而降低HBV相关并发症的风险。”

早期识别慢性HBV患者可以接受必要的护理和治疗，以预防或延缓肝脏疾病的进展。通过对风险行为的咨询和提供预防产品（如无菌针头）和疫苗接种，测试还为减少传播的干预措施提供了机会。

“为实现世界卫生组织的目标，需要紧急诊断出1.07亿HBV感染者，特别是在非洲和亚洲的高度流行地区，”雅培传染病新兴市场副总裁Damian Halloran说。 “Determine HBsAg 2无与伦比的灵敏度，便携性和易用性提供了改变生活的技术，可以大大扩展测试服务，使更多受感染的人能够更早地了解他们的状态并获得治疗。”

高灵敏度检测对于某些人群（例如孕妇）减少母婴传播以及HIV阳性个体很重要，其中可能难以检测HBV.1高敏感性检测如确定HBsAg 2允许这些人群中的人们快速准确地诊断并与适当的护理相关联。

关于确定HBsAg 2
确定HBsAg 2可提供一种HBV状态的快速准确结果，分析灵敏度为0.1 IU / mL。该试验是用于检测血清，血浆或全血中HBsAg的体外，视觉读取，定性免疫测定。该测试易于使用，可在护理点进行部署，并在患者仍然存在的情况下在15分钟内检测到HBV。这样可以做出及时的治疗决定，并最终有助于减少全球流行病。

确定HBsAg 2是雅培更广泛的肝脏生命变化技术组合的一部分，该组合将测试从核心实验室扩展到生活在偏远和服务欠缺社区的人们的护理点。

该测试现已在欧洲，非洲，亚太地区和拉丁美洲商业化。它已获得CE标志，并已提交数据进行世卫组织资格预审。