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Genexpert Test TB When did the Genexpert test first

become available?
diagnosis and resistance
The Genexpert system was launched in 2004, and
Testing the development of the Genexpert test, based on
The Genexpert test is a new molecular test for TB the Genexpert platform, was completed in 2008.4 5
which diagnoses TB by detecting the presence of The first clinical validation studies were carried out
TB bacteria, as well as testing for resistance to the in 2009.6 A large scale demonstration project was
drug Rifampicin. then carried out in a number of different countries
Some organisations have claimed that the including South Africa and India to assess the
Genexpert test is going to revolutionize the implementation of the Genexpert.7
diagnosis and care of people with TB.1So what are Data from these studies were then submitted to the
the advantages and disadvantages of the World Health Organisation (WHO) for evaluation in
Genexpert, how is the Genexpert test used, and is September 2010. In December 2010 WHO
it really going to result in the breakthroughs that endorsed the Genexpert technology and released
are claimed? a recommendation and guidance for countries to
incorporate the new test into their programs.

What is the cost of the Genexpert

TB test?
FIND originally negotiated discounts for the
Genexpert Test
Genexpert test in 120 high burden and in all low
and middle income countries and the initial cost
was approximately US$17 per cartridge.
How does the Genexpert test
work? In June 2012 the organisation UNITAID approved
funding of $30 million with the aim of scaling up
The test is a molecular test which detects the DNA access to the Genexpert test. It was hoped that the
in TB bacteria. It uses a sputum sample and can roll out of the test would bring the price down from
give a result in less than 2 hours. it can also detect US$17 to US$10. However the roll out proceeded
the genetic mutations associated with resistance to slower than expected and it is believed that many
the drug Rifampicin.2 customers delayed ordering as they expected the
price to be reduced following the UNITAID
Who developed the Genexpert
The Genexpert has been developed by the
Foundation for Innovative New Diagnostics (FIND),
who have partnered with the Cepheid corporation
and the University of Medicine and Dentistry of
New Jersey. Some of the funding for the
development of the Genexpert was provided by
the NIH.3
GeneXpert 4 module machine GHE
Advantages and disadvantages of
It was subsequently announced in August 2012 the test
that Cepheid had entered into an agreement with
the Bill and Melinda Gates Foundation, PEPFAR, WHO have been particularly keen on the use of the
and USAID to further bring down the cost of the test and in 2010 said that:
test. It was agreed that the test would immediately This new test represents a major milestone for
be available for US$9.98 with the difference global TB diagnosis and care. It also represents
between this and the earlier US$16.86 being paid new hope for the millions of people who are at the
by the collaborators with an initial US$3.5 million highest risk of TB and drug resistant disease.
being provided by the Bill and Melinda Gates
Foundation.8 Dr Mario Ravihlione, Director of WHO Stop TB
In addition to the cost of each test there is the cost
of the Genexpert device. The device comes in The test does however have disadvantages as well
different sizes providing for a different number of as advantages.
samples to be tested simultaneously. The
commonly used GX4 which has 4 modules, has a
cost of approximately US$17,000. There are in Disadvantages
addition costs for delivery and installation, and
There are a number of disadvantages which
there is an annual servicing cost.9
The shelf life of the cartridges is only 18
The use of the Genexpert test months;
A very stable electricity supply is required;
WHO recommended that the test should be used
as the initial diagnosis test in individuals suspected The instrument needs to be recalibrated
of having MDR TB, or HIV associated TB. They annually;
also suggested that it could be used as a follow on
The cost of the test;
test to microscopy in settings where MDR TB
and/or HIV is of lesser concern, especially in The temperature ceiling is critical.14
smear negative specimens, because of the lack of
accuracy of smear microscopy. They did however
say that they recognised the major resource Advantages
implications of using it in this second way.10
The main advantages of the test are, for diagnosis,
WHO did also emphasize that the test does not reliability when compared to sputum microscopy
eliminate the need for conventional microscopy and the speed of getting the result when compared
culture and drug sensitivity testing, as these are with culture. For diagnosis of TB, although sputum
still required to monitor treatment progress and to microscopy is both quick and cheap, it is often
detect other types of drug resistance. The unreliable. It is particularly unreliable when people
Genexpert MTB/RIF cannot be used for treatment are HIV positive. Although culture gives a definitive
monitoring, as it detects both live and dead diagnosis, to get the result usually takes weeks
bacteria. rather than the hours of the Genexpert test.
Further guidance was subsequently provided by The main advantage in respect of identifying
WHO on the rapid implementation of the new rifampicin resistance, is again the matter of speed.
test.11 12 Normally to get any drug resistance result takes
weeks rather than hours.