Roche HIV-1 dual genetic test given EU approval
24 February 2014
Roche has announced that its dual-target HIV-1 qualitative test,
v2.0 has received the CE Mark certifications, allowing it to be sold
for clinical use in the EU.
The test simultaneously amplifies and detects two separate
regions of the HIV-1 genome, which are not subject to selective drug
pressure, giving a more reliable diagnosis.
The new test works with both plasma and dried blood spot (DBS)
collection cards to facilitate PCR testing, and more importantly
make sample collection and transportation easy, even from the
smallest infant in the most rural area.
The DBS collection card and the need for more sensitive and
accurate information to diagnose babies early in their life and
patients across many African countries is instrumental to facilitate
healthcare for the region. The HIV-1 dual target qualitative test
and DBS cards eliminate need for refrigeration, drastically reduces
the volume of blood to be stored or transported, and the stress for
the mother and the child is dramatically improved.
"The ability to determine the HIV status of an infant as early as
six weeks is crucial to determining the appropriate care and support
for HIV-positive babies," stated Paul Brown, President of Roche
Molecular Diagnostics. "With this new solution from Roche, we are
reiterating our commitment to healthcare solutions that make a real
difference for patients."
About early HIV infant diagnosis
Diagnosing HIV in infants and young children is a major
challenge. Antibody tests are ineffective in children because the
mother's antibodies remain in the child's system following birth. In
fact, antibody tests in infants may yield false positive results for
up to 15 months. There are a number of alternate methods available
for early diagnosis of HIV infected infants. Many approaches use
molecular techniques, specifically detecting the viral DNA and/or
RNA, which enables HIV diagnosis as early as six weeks.
Early diagnosis is critical for children infected with HIV. If
found HIV positive, they can receive appropriate medical care before
they develop significant illness, and can remain healthy despite
their infection. If found HIV negative, the mother can get
appropriate counselling to ensure their child maintains a HIV-free
About the test
The COBAS AmpliPrep/COBAS TaqMan HIV-1 Qualitative Test, version
2.0 is an in vitro diagnostic, total nucleic acid amplification test
for the qualitative detection of Human Immunodeficiency Virus Type 1
(HIV-1) DNA and RNA (or total nucleic acid, TNA) in human plasma or
dried blood spots using the COBAS AmpliPrep Instrument for automated
specimen processing and the COBAS TaqMan Analyzer or COBAS TaqMan 48
Analyzer for automated amplification and detection.
The test is a diagnostic test, indicated for individuals who are
suspected to be actively infected with HIV-1. Detection of HIV-1 TNA
is indicative of active HIV infection. Infants born to mothers
infected with HIV-1 may have maternal antibodies to HIV-1, and the
presence of HIV-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.
Accordingly to the World Health Organization (WHO), there were 35
million people living with HIV around the world in 2012. In the same
year 2.5 million people became newly infected with HIV worldwide.
For the most impacted region of Sub-Saharan Africa nearly one in
every 20 adults or 69% of all people living in this region are with
The transmission of HIV from an HIV-positive mother to her child
during pregnancy, labor, delivery or breastfeeding is called
vertical or mother-to-child transmission (MTCT). In the absence of
any interventions HIV transmission rates are between 15-45%.
Diagnosis, highly active antiretroviral treatment (HAART) and
viral load tests, a test to determine the amount of circulating HIV,
have contributed to a steady increase in life expectancy for HIV
infected people of 13 years.