ADDIS ABABA, Ethiopia (24 March 2021)

On World Tuberculosis Day 2021, ASLM is excited to release the Diagnostic Integration Knowledge Library recognising that lessons learned from integrating tuberculosis and HIV testing could contribute to the integration of coronavirus disease 2019 (COVID-19) testing into diagnostics.  

Over the last year, most countries have rapidly expanded molecular testing capacity for severe acute respiratory coronavirus 2 (SARS-CoV-2) to several sites at the sub-national level. Among the critical success factors, the network of GeneXpert instruments within the tuberculosis programme has provided a unique opportunity to integrate testing for COVID-19 into existing diagnostic platforms. This remarkable achievement would not have been possible without significant investments made over the past decade to increase the availability of nucleic acid amplification test (NAAT) diagnostic systems for tuberculosis and HIV programmes. Most of these molecular testing instruments are (or have the potential) to run diagnostics for multiple infectious diseases (e.g., HIV, hepatitis C virus (HCV), hepatitis B virus, human papillomavirus (HPV), tuberculosis). As the third wave of COVID-19 is on the way and the threat of a long-term epidemic becomes increasingly real, sustainable strategies to ensure routine SARS-CoV-2 testing are warranted. While rapid diagnostics tests play a role in screening strategies and diagnosis in settings where PCR is not feasible, SARS-CoV-2 PCR remains the gold standard method to confirm COVID-19 cases and the first step for further investigation of pathogen genomics.

While molecular platforms offer a good opportunity to integrate testing, finding ways to consolidate COVID-19 testing in settings where other diagnostics tests are also conducted supports a patient-centred approach to healthcare delivery. The recent report from the STOP TB partnership highlights how crucial it is for the health system to detect respiratory infections that carry similar symptoms in an integrated way. Integrating and sharing technologies and supportive systems can create a more responsive, supportive and efficient overall patient-centric diagnostic network. At the same time, it provides a chance to maintain the case-finding and testing services for essential diseases such as HIV, malaria and tuberculosis. Sharing technologies across diseases and programmes could represent a paradigm shift towards a comprehensive people-centred healthcare service delivery towards universal health coverage.

With this perspective, ASLM and Clinton Health Access Initiative (CHAI), through funding from Unitaid, have partnered to develop a Diagnostic Integration Knowledge Library. The library is a compilation of advocacy materials used to sensitise stakeholders about the need for diagnostic service integration, resources from various countries that have piloted or implemented integrated testing, and technical product materials from the industry. Here are some of the select items in the upcoming library. Stay tuned for additional resources coming soon.

Integration Overview. Presentation outlining the need for point-of-care (POC) testing, how integrated testing improves access to POC testing, benefits of integration, considerations and implementation framework for integrated testing.

Integration on GeneXpert – Considerations and Lessons. Presentation outlining steps of an integration implementation framework, top tips and caveats (e.g., what could go wrong, lessons learned from pilot countries on each step or area of implementation).

GeneXpert Capacity Utilisation Analysis Tool. An Excel-based tool to assess the capacity utilisation of GeneXpert platforms for integrating tuberculosis, HIV, HCV and human papillomavirus testing.  It has been used to identify platforms running at full-capacity and with un-used capacity to inform integration decisions in Cameroon, Ethiopia, Indonesia, Malawi, Nigeria, Tanzania, Uganda, Zambia and Zimbabwe.

Integration Readiness Assessment Tool. Checklist to evaluate and help select sites in a country where tuberculosis/HIV/HCV/HPV integration on the GeneXpert platform would be most feasible.

GeneXpert integration cross-programme cost savings calculator. Excel-based tool to assess financial benefits across programmes from integrating tuberculosis, HIV and HCV testing on GeneXpert platforms and combining cross-cutting costs.

Lessons learned from Zimbabwe. Visualises the impact of integration in a real situation, and helps understand best practices for implementation.

Despite its devastating effect globally, COVID-19 teaches us that diagnostic integration is possible and that integration generally allows a better and quicker response to health threats. Diagnostic integration also offers more efficient device utilisation, lowers per-test costs, promotes cost-sharing between programmes, and increases overall affordability of diagnostics compared to vertical systems.