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42 Technology (42T), FIND, Global Diagnostics Alliance, and Rutgers University (Rutgers) have collaborated to develop an innovative stool sample processing toolkit that has played a role in informing the World Health Organization (WHO) of recent policy updates. The core role is to improve the diagnosis of childhood tuberculosis (TB) [Reference 1].
In 2020, there will be approximately 10 million people in the world, of which 1.1 million children have tuberculosis. Although tuberculosis can be treated and prevented, it can be difficult to diagnose and treat in children [Reference 2].
The Specimen Handling Kit (SPK) was developed to determine whether stool samples and automated PCR testing can be used as a viable alternative to smear microscopy and culture techniques when diagnosing children. In the past three years, multiple research institutions have tried three different sample processing methods, which led to the analysis of aggregated data and the World Health Organization’s recommendation that stool should now be used as the main sample for the diagnosis of tuberculosis in children under 10 years of age. Years old [reference 3].
"42T, Rutgers University and FIND have successfully developed a simple, low-cost sample preparation kit based on the design and Process method. Large-scale trials have shown that the kit is effective and easy to use in a variety of environments. 42 Technology’s head of healthcare technology, Sarah Knight, said: “We are very pleased that it has helped inform WHO’s efforts in diagnosing childhood tuberculosis. Breakthrough policy update. "
Diagnosing tuberculosis in children is a major challenge that requires new thinking, because traditional tuberculosis test samples cannot be obtained from young children. The stool of almost anyone is easy to collect-so being able to use it to detect tuberculosis is an important step forward. FIND is pleased to work with 42T and other partners to help generate key data for the WHO review. We warmly welcome updates to the guidelines. "
Morten Ruhwald, head of tuberculosis at FIND
Respiratory tract samples (such as samples of sputum, nasal wash, or stomach contents) are usually used to diagnose tuberculosis. But these are unpleasant and invasive procedures, and it is often difficult to obtain samples from children. Stool is an ideal non-invasive sample, but it requires a lot of pretreatment before it can be analyzed using a highly sensitive PCR test.
The easy-to-use SPK is designed to efficiently process stool samples without any professional laboratory equipment or technical skills. It is used in conjunction with the Cepheid Xpert MTB/RIF Ultra test jointly developed by David Alland's team at Rutgers University, FIND and other institutions, and has been recognized by the World Health Organization many times to provide improved diagnosis for the detection of tuberculosis in adults and children . Reference 4].
42T's investment in the design and development of the SPK project includes: working closely with Rutgers University to help test key equipment functions, design prototype molding equipment, and convert the final design into mass production to produce initial quantities for clinical trials. This work was also funded by the National Institute of Allergy and Infectious Diseases.
In the past 10 years, 42T and FIND have cooperated on a number of long-term joint development projects. 42T was specifically introduced for its creative approach to help solve the complex and interrelated design issues that often arise when preparing new diagnoses for private and public sector startups. This work covers the development of diagnostic methods for tuberculosis, malaria and other diseases in developing countries.
1 A quick exchange on updated guidelines for the management of tuberculosis in children and adolescents https://www.who.int/news/item/26-08-2021-who-issues-rapid-communication-on-updated-guidance-for-children and Youth tuberculosis management
2 WHO tuberculosis fact sheet (updated on October 14, 2021) https://www.who.int/news-room/fact-sheets/detail/tuberculosis
3 On World Children’s Day, FIND welcomes improved access to childhood tuberculosis diagnosis https://www.finddx.org/newsroom/pr-20nov21/
4 Xpert MTB/RIF-rapid tuberculosis testing-WHO issues policies and guidelines for implementers https://www.who.int/news/item/18-05-2011-xpert-mtb-rif-rapid- tb-test—who-publish policy and implementer's guide
Published in: Children's Health News
Labels: adolescents, allergy, testing, children, diagnosis, healthcare, infectious diseases, laboratory, malaria, microscopy, public health, research, breathing, sample preparation, stomach, tuberculosis
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