2014年10月21日发布

罗氏（Roche）2月18日宣布，双靶标HIV-1定性检测试剂盒COBASAmpliPrep/COBAS TaqMan HIV-1 Qualitative Test v2.0已获CE标志认证，使得该试剂盒可在欧盟及接受CE标志的其他国家上市，用于HIV-1感染的检测。该试剂盒可同时扩增和检测HIV-1基因组中不受药物选择压力限制的2个不同区域。这种独特、双靶标设计，能够提供更可靠的检测结果，以自信并有效地诊断HIV-1感染。

该款试剂盒，适用于血浆（plasma）和干血斑（Dried blood spots，DBS）采集卡，可方便PCR检测，更重要的是，使样品的采集和运输更简单方便，甚至是最边远农村的婴幼儿样本。

该款HIV-1双靶标定性试剂盒和DBS采集卡消除了冷藏的必要性，极大地减少了贮存或运输的血量，同时大大地改善了母亲和孩子的压力，有助于推动许多非洲国家早期婴幼儿HIV诊断。

关于早期HIV婴幼儿诊断：

婴幼儿HIV早期诊断是一个重大的挑战。抗体检测在婴幼儿中无效，因为随着出生，母亲的抗体存在于婴儿的体内。事实上，对于大至15个月的婴儿，抗体检测仍可能产生假阳性结果。目前有一些替代方法可用于感染HIV的婴幼儿的早期诊断。许多方法使用分子生物学技术，特异性检测病毒DNA或RNA，可用于6周大婴儿的HIV诊断。

对于感染HIV的儿童，早期诊断至关重要。如果发现HIV阳性，患儿可在病情加重前，得到恰当的医疗护理。若发现HIV阴性，则母亲可得到恰当的辅导，以确保婴儿保持无HIV状态。

英文原文：Roche announces launchof the Dual Target HIV-1 Qualitative Test in markets accepting the CE mark

-- New test will help increase access for earlyinfant HIV diagnosis

PLEASANTON, California, Feb. 18, 2014 /PRNewswire/-- Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that its dual-targetHIV-1 qualitative test, v2.0[1] has received CE Mark certifications, allowingit to be sold for clinical use in the European Union and those countriesaccepting CE Marked products. The test simultaneously amplifies anddetects two separate regions of the HIV-1 genome, which are not subject toselective drug pressure. This unique, dual target design allows for morereliable results to confidently and effectively diagnose HIV-1 infection.

The new dual-target HIV-1 qualitative test, v2.0works with both plasma and dried blood spot (DBS) collection cards tofacilitate PCR testing, and more importantly make sample collection andtransportation easy, even from the smallest infant in the most rural area.

The DBS collection card and the need for moresensitive and accurate information to diagnose babies early in their life andpatients across many African countries is instrumental to facilitate the stateof the art healthcare required for the region. The HIV-1 dual targetqualitative test and DBS cards eliminates need for refrigeration, drasticallyreduces the volume of blood to be stored or transported, and the stress for themother and the child is dramatically improved.

"The ability to determine the HIV status of aninfant as early as six weeks is crucial to determining the appropriate care andsupport for HIV-positive babies," stated Paul Brown, President of RocheMolecular Diagnostics. "With this new solution from Roche, we arereiterating our commitment to healthcare solutions that make a real differencefor patients."

About Early HIV Infant Diagnosis

Diagnosing HIV in infants and young children is amajor challenge. Antibody tests are ineffective in children because themother's antibodies remain in the child's system following birth. Infact, antibody tests in infants may yield false positive results for up to 15months. There are a number of alternate methods available for early diagnosisof HIV infected infants. Many approaches use molecular techniques, specificallydetecting the viral DNA and/or RNA, which enables HIV diagnosis as early as sixweeks.

Early diagnosis is critical for children infectedwith HIV. If found HIV positive, they can receive appropriate medical carebefore they develop significant illness, and can remain healthy despite theirinfection. If found HIV negative, the mother can get appropriate counseling toensure their child maintains a HIV-free status.

About the test

The COBAS? AmpliPrep/COBAS? TaqMan? HIV-1Qualitative Test, version 2.0 is an in vitro diagnostic, total nucleic acidamplification test for the qualitative detection of Human ImmunodeficiencyVirus Type 1 (HIV-1) DNA and RNA (or total nucleic acid, TNA) in human plasmaor dried blood spots using the COBAS? AmpliPrep Instrument for automatedspecimen processing and the COBAS? TaqMan? Analyzer or COBAS? TaqMan? 48Analyzer for automated amplification and detection.

The test is a diagnostic test, indicated forindividuals who are suspected to be actively infected with HIV-1. Detection ofHIV-1 TNA is indicative of active HIV infection. Infants born to mothersinfected with HIV-1 may have maternal antibodies to HIV-1, and the presence ofHIV-1 nucleic acid in the infant indicates active HIV-1 infection. In adults,the test may be used as an aid in the diagnosis of HIV-1 infection.

About HIV-1

Accordingly to the World Health Organization (WHO),there were 35 million people living with HIV around the world in 2012. Thatsame year 2.5 million people became newly infected with HIV worldwide.[2] For the most impacted region of Sub-Saharan Africa nearly 1 in every 20 adultsor 69% of all people living in this region are with HIV positive.

The transmission of HIV from an HIV-positive motherto her child during pregnancy, labor, delivery or breastfeeding is called verticalor mother-to-child transmission (MTCT). In the absence of any interventions HIVtransmission rates are between 15-45%.

Diagnosis, highly active antiretroviral treatment(HAART) and viral load tests, a test to determine the amount of circulatingHIV, have contributed to a steady increase in life expectancy for HIV infectedpeople of 13 years.[3]