MSF responds to updated WHO pediatric tuberculosis guidelines

Cepheid must lower the price of TB diagnostic test so treatment can be initiated sooner.

An MSF doctor in India looks at an X-ray of a lung.

India 2021 © Atul Loke/MSF

NEW YORK/GENEVA, MARCH 21, 2022—New World Health Organization guidelines for the management of tuberculosis (TB) in children and adolescents recommend diagnosis and rapid treatment initiation closer to where they live. With more than 60 percent of children with TB remaining undiagnosed, all countries, especially high TB-burden countries, must adopt these recommendations in order to prevent unnecessary deaths among children, said the international medical humanitarian organization Doctors Without Borders/Médecins Sans Frontières (MSF).

While these updated guidelines stress the importance of diagnosing children and starting treatment sooner, many countries can’t test children. The test they need—produced by US corporation Cepheid—is too expensive. Additionally, the machine needed to run the test is not adapted for use in remote, low-resource settings where most children with TB live.

Since it’s difficult for children to produce sputum—the standard specimen to test TB—and because of the low levels of bacteria in children’s specimens, WHO now recommends the testing of stool, in addition to other samples, with the GeneXpert Ultra test that is exclusively produced by Cepheid. However, Cepheid charges $9.98 per test in low- and middle-income countries. This is far too expensive for people in most high burden countries. It is also more than double the price it costs Cepheid to produce the test, based on MSF’s analysis.

Dr. Lazro Fidelle, TB operational research manager for MSF in Malakal, South Sudan:

“We are encouraged by the improved WHO guidelines that could facilitate the timely diagnosis and treatment of TB in children in many resource-limited and conflict-ridden countries. They could substantially reduce the number of deaths among children due to this deadly but treatable disease.

“Amid years of war and a fragile health system, MSF and other health care providers in South Sudan face extreme challenges to diagnose and treat TB in children. In our project, despite an experienced team and access to all available tests, in most cases we are not able to confirm TB diagnosis in children. Therefore, we have to balance the need for timely and lifesaving TB treatment with the need to avoid unnecessary TB treatments amongst those who might have other possible diagnoses. When using tests, our biggest challenge lies in sample collection. Generally, sputum samples are of poor quality and alternatives such as gastric lavage are not well accepted. We are still in desperate need of a TB test for children that can be used in even the most remote settings and can test samples that are easy to collect, such as with mouth swabs or blood from a finger prick.”

Stijn Deborggraeve, diagnostics advisor for MSF’s Access Campaign:

“TB programs in many countries struggle to access the WHO-recommended GeneXpert Ultra test from Cepheid because it’s too expensive and requires fragile equipment that is hard to operate in the remote settings where we need to diagnose children. As treatment providers struggling to save lives of children with TB, we call on Cepheid to urgently reduce the price of the GeneXpert tests and urge other companies to develop tests that are suited for use in remote settings.

“It’s painful to see how despite decades-long calls for more efforts to improve tools for TB, children continue to die of the disease without ever being put on treatment due to delayed diagnosis and a lack of access to effective tests.”