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羅氏（Roche）2月18日宣布，雙靶標HIV-1定性檢測試劑盒COBASAmpliPrep/COBAS TaqMan HIV-1 Qualitative Test v2.0已獲CE標志認證，使得該試劑盒可在歐盟及接受CE標志的其他國家上市，用于HIV-1感染的檢測。該試劑盒可同時擴增和檢測HIV-1基因組中不受藥物選擇壓力限制的2個不同區域。這種獨特、雙靶標設計，能夠提供更可靠的檢測結果，以自信并有效地診斷HIV-1感染。

    該款試劑盒，適用于血漿（plasma）和干血斑（Dried blood spots，DBS）采集卡，可方便PCR檢測，更重要的是，使樣品的采集和運輸更簡單方便，甚至是最邊遠農村的嬰幼兒樣本。

該款HIV-1雙靶標定性試劑盒和DBS采集卡消除了冷藏的必要性，極大地減少了貯存或運輸的血量，同時大大地改善了母親和孩子的壓力，有助于推動許多非洲國家早期嬰幼兒HIV診斷。

    關于早期HIV嬰幼兒診斷：

    嬰幼兒HIV早期診斷是一個重大的挑戰。抗體檢測在嬰幼兒中無效，因為隨著出生，母親的抗體存在于嬰兒的體內。事實上，對于大至15個月的嬰兒，抗體檢測仍可能產生假陽性結果。目前有一些替代方法可用于感染HIV的嬰幼兒的早期診斷。許多方法使用分子生物學技術，特異性檢測病毒DNA或RNA，可用于6周大嬰兒的HIV診斷。

對于感染HIV的兒童，早期診斷至關重要。如果發現HIV陽性，患兒可在病情加重前，得到恰當的醫療護理。若發現HIV陰性，則母親可得到恰當的輔導，以確保嬰兒保持無HIV狀態。

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]

羅氏推出雙靶標HIV-1定性檢測試劑盒

2014年10月21日發布