42 Technology (42T), Global Diagnostics Alliance FIND and Rutgers University (Rutgers) have collaborated to develop an innovative stool sample processing toolkit that has played a role in notifying the World Health Organization (WHO) of recent policy updates The core role is to improve the diagnosis of childhood tuberculosis (TB).

In 2020, there will be approximately 10 million people in the world, of which 1.1 million children have tuberculosis. Although tuberculosis is treatable and preventable, it can be difficult to diagnose and treat in children.

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, several 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. . age.

Sarah Knight, Head of Healthcare Technology at 42 Technology, said: “42T, Rutgers University and FIND have successfully developed a simple, low-cost sample The first proposed design and process method. Rutgers University Institute of Public Health. Large-scale trials have shown that the kit is effective and easy to use in a variety of environments. We are very pleased that it helped inform the WHO in the diagnosis of childhood tuberculosis Breakthrough policy update."

Morten Ruhwald, Head of Tuberculosis at FIND, added: “Diagnosing tuberculosis in children is a major challenge that requires new thinking, because traditional tuberculosis testing samples cannot be obtained from young children. The stool of almost anyone is easy to collect-so it can be used. Coming to test for 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." 

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 requires a lot of pretreatment to 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 method.

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 the developing world.

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