罗氏推出新一代乙肝（HBV）病毒载量试剂盒cobas HBV

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瑞士制药巨头罗氏（Roche）近日宣布，在所有承认CE标识的市场商业化推出应用于cobas 6800/8800系统的cobas HBV定量核酸检测试剂盒。该款cobas HBV试剂盒将在所有关键医疗决策点提供针对所有已知乙肝（HBV）基因型（A-H）的高灵敏度和广覆盖面。cobas HBV试剂盒及cobas 6800/8800系统在所有承认CE标志的国家和地区上市，但目前尚未在美国上市。

cobas 6800/8800系统代表了新一代分子诊断设备，由罗氏于2014年下半年推出，该系统能够提供无与伦比的性能、无可比拟的灵活性、绝对的自动化。该系统结合病毒载量检测试剂盒，旨在提高实验室效率，同时提供所需的快速结果以做出明智的治疗决策。基于该平台开发的病毒载量试剂盒包括：cobas HIV-1（人类免疫缺陷病毒-1）、cobas HCV（丙肝病毒）、cobas CMV（巨细胞病毒）、cobas HBV（乙肝病毒）；开发的献血者筛查试剂盒包括：cobas MPX（HIV-1 M组、HIV-1 O组、HIV-2、HCV、HBV）cobas WNV（西尼罗病毒）、cobas HEV（戊型肝炎病毒）。

cobas 6800/8800系统是一套完全自动化的解决方案，旨在为献血者筛查、病毒载量监测、女性健康、微生物学检测开发设计。目前商业化销售的有中、高通量2种型号。基于PCR技术，该系统旨在更短的时间内实现更高的自动化和数据吞吐量，为用户提高更高的检测灵活性以提高整体工作流程的效率。

据世界卫生组织（WHO）估计，全球约有20亿人已感染乙肝病毒（HBV），有超过3.5亿为慢性感染者，每年有100万患者死于乙肝。由于许多HBV感染要么是无症状要么从未报道，因此实际新感染人数估计要高10倍。乙肝病毒通过无防护性行为、共用针头或孩子出生时由母亲感染婴儿传播。约70%患者出现黄疸、乏力、腹痛、食欲不振、恶心、呕吐等症状。

英文原文：Roche launches next-generation viral load assay for HBV in markets accepting the CE mark

cobas HBV assay offers unparalleled performance on the cobas 6800/8800 Systems

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today the commercial availability of the cobas? HBV quantitative nucleic acid test for use on the cobas? 6800/8800 Systems—adding to the viral load monitoring portfolio on the newest molecular diagnostic platforms from Roche. The new assay offers broad coverage of all known Hepatitis B (HBV) genotypes (A-H) with high sensitivity, across all critical medical decision points.

“With the cobas? HBV assay, laboratories now have a highly robust and sensitive assay for quantifying HBV DNA, with a lower sample requirement that provides a new standard of flexibility," said Roland Diggelmann, COO, Roche Diagnostics.

This assay builds on the viral load monitoring portfolio (cobas? HIV-1, HCV and CMV) for the cobas? 6800/8800 Systems that was launched in late 2014. The cobas? 6800/8800 Systems, combined with the viral load assay portfolio, are designed to improve laboratory efficiencies while providing the rapid results needed to make informed treatment decisions. The cobas? HBV assay and the cobas? 6800/8800 Systems are commercially available in markets that recognize CE-Mark. Both products are not currently available in the United States.

About the cobas? 6800/8800 Systems

The cobas? 6800 and 8800 Systems are fully automated solutions designed for blood donor screening, viral load monitoring, women's health and microbiology testing. They are available in medium and high throughput models, respectively. Based on the Nobel-prize winning PCR technology, the systems are designed to deliver increased automation and throughput with shorter time to results, providing users with greater testing flexibility to increase overall workflow efficiencies.

The systems provide up to 96 results in less than 3.5 hours, and a total of 384 results for the cobas? 6800 System and 960 results for the cobas? 8800 System in an 8 hours shift3. Both systems allow for mixed batching, making it possible for labs to perform up to three tests in the same run with no pre-sorting required. The systems also enable up to eight hours (cobas? 6800) and four hours (cobas? 8800) of "work-away" time2 with minimal user interaction.

For more information about the systems, please visit www.cobas68008800.com.

The cobas? 6800/8800 Systems are not available in all markets, including the U.S.

About the Assays for the cobas? 6800/8800 Systems

Assays for viral load monitoring

cobas? HIV-1 is a real-time PCR test built upon the dual-target assay design from Roche. The test simultaneously amplifies and detects two separate regions of the HIV-1 genome, which are not subject to selective drug pressure, allowing for more reliable results to confidently and effectively quantify the amount of HIV-1 RNA in a patient's blood.

cobas? HCV is a real-time PCR test that employs Roche's unique dual-probe approach to provide an extra layer of protection against mutations that can occur in the viral genome and is designed to accurately detect and quantify hepatitis C virus ribonucleic acid (RNA) with state-of-the-art sensitivity in order to assess a patient's response to antiviral therapy.

cobas? HBV is a real-time PCR test designed to offer an expanded linear range with two input volumes coupled with broad coverage of all known HBV genotypes (A-H), including pre-core mutations with high sensitivity.

cobas? CMV is a real-time PCR test traceable to the first WHO International Standard for Human Cytomegalovirus for Nucleic Acid Amplification Techniques (NIBSC 09/162), therefore provides consistent, reliable results across the dynamic range of the assay and across institutions.

Assays for blood donor screening

cobas? MPX is a real-time PCR multiplex test covering five critical viral targets: HIV-1 Group M, HIV-1 Group O, HIV-2, HCV and HBV, from a single sample. It offers real-time detection and identification of HIV, HCV and HBV, eliminating both the need for discriminatory testing and the potential for discrepant results. Plus, the dual-target approach with amplification of separate regions of HIV-1, and dual probes for HCV, improve coverage of new virus variants.

cobas? WNV is a real-time PCR test for West Nile virus (WNV) that is highly sensitive for both WNV lineages 1 and 2. It also provides broad coverage of other flaviviruses that cause transfusion-transmitted infectious diseases.

cobas? HEV is a real-time PCR test for hepatitis E virus (HEV), providing broad coverage of all 4 major HEV genotypes.

About Hepatitis B Virus (HBV)

According to the World Health Organization (WHO), an estimated 2 billion people worldwide have been infected with the hepatitis B virus, and more than 350 million are chronically infected. Over 1,000,000 people die every year due to the consequences of hepatitis B1. Because many HBV infections are either asymptomatic or never reported, the actual number of new infections is estimated to be tenfold higher.

The hepatitis B virus is spread through having unprotected sex, by sharing needles or from an infected mother to her baby during child birth. Symptoms occur in about 70 percent of patients and include jaundice, fatigue, abdominal pain, loss of appetite, nausea and vomiting.