Drink deep, or taste not the Pierian spring: Inadequate use of GeneXpert-Xpert MTB/RIF- and impact on the NTP tuberculosis case notifications in Africa

Over the past five years, the diagnosis of tuberculosis (TB) has changed from simple to 'complicated': from a simple (age-old) sputum smear microscopy (with or without a chest X-ray) to a modern molecular test (Xpert MTB/RIF) which is more sensitive to detect TB than sputum microscopy. However, the molecular test is 'expensive' to implement in the public health settings, and cannot be adequately implemented without the support of international donor agencies, in the resource limited country settings. Thus, several countries  are implementing the technology in a piecemeal approach- called roll-out strategy- starting from the target groups such as multi-drug resistant TB, TB among HIV clients, cross-border populations, refugees and other vulnerable populations to general population if adequate capacity is 'acquired'. 'Saturation' of GeneXpert technology has never been more than 25%-35% in several TB high burden countries, and further the 'optimal' theoretical capacity of GeneXpert systems to run about 2000 tests in a year was never realized in clinical settings due to various reasons. Out of this operational reality, countries have endorsed use of Xpert MTB/Rif test along with sputum smear microscopy, simultaneously, based on the on-site availability. World Health Organization, too, endorsed such a step (with ever multiplying diagnostic tests and the 'algorithms'- latest was additional Urinary LAM test among certain HIV positive patients) For example, at the health facilities where GeneXpert systems were installed (generally at the level of hospitals, and district level health centers) Xpert MTB/RIF test is the initial test for diagnosis of tuberculosis. And in the absence of GeneXpert systems, sputum smear microscopy remained the initial test for diagnosis of TB. Further, referral to GeneXpert testing from microscopy sites became a catch word, although specimen transport systems were never invested upon and were not well developed. This lead to diagnostic delays, and the clinicians could not adjust. This reality made the NTPs endorse two types of diagnostics technologies for initial TB diagnosis at two levels of health care- based on availability-within a country set-up (either Xpert MTB/RIF test or Smear microscopy). Smear negative 'clinical' TB (TB that could not diagnosed by sputum microscopy due to low sensitivity of microscopy, but clinically evident) became unpopular with introduction of Gene"Xpert". Clinicians were discouraged to make judgement in the absence of Gene'Xpert' results or microscopy results. This limitation is further amplified in the high HIV burden countries, due to differential clinical picture TB patients present with. The National TB programmes (NTPs) failed reorient their clinical staff (at the same pace as technologies are changing). In practice, the clinicians (being aware of HIV/AIDS and un-symptomatic TB among HIV clients) diagnosed 'clinical TB' (TB without bacteriological confirmation) among HIV positive clients, but disregard the clinical symptoms of TB among HIV negative clients. How this type of anomaly could be identified: (1) shift in proportion of smear negative TB to smear positive TB, in the historical case notifications (2) discussion with clinicians at the smear microscopy sites (3) 'missed-to-diagnose' TB cases being high among HIV negative TB clients (4) virtually no impact of GeneXpert based diagnosis on the NTP case notifications.

What are the consequences of this piecemeal implementation of modern TB diagnostics: Continued transmission of TB among communities, and long term wastage of resources. The global END-TB goals, indicators and targets will not be met any time, sooner. Solution: Either invest more on modern diagnostics, or revamp the public health systems with break-neck speed of changing diagnostic realities.

The above observations emphasize that roll-out should be aimed at replacing the existing technology- not a piece meal approach. It justifies common adage: Drink deep, or taste not the Pierian spring.
-Ajay (notes from Uganda)
              

Last mile connectivity (2)

Urge to share new knowledge with professionals in science, generally, results in the scientific publications, which are written by scientific people intended to be read by the scientific people. Common man (public) have no time to understand or learn from it, as it is filled with scientific evidence (call 'statistics'). Neither these scientific papers provide any clear-cut answers to problems (knowledge gets bogged down in technical jargon). Thus, it takes a lot many publications to derive a scientific truth or, alternately, a way-forward to a pressing problem. However, it is critical to share the knowledge we gained, however limited it may be, to advance a solution to a problem. Last mile connectivity in providing access to tuberculosis diagnostics remained a pressing problem- too small for the scientific community but, too large for public health programs.

Cogs in the ‘last mile connectivity’ in providing diagnostic access are: (1) a diagnostic technology simple enough to reach point-of-testing (private house-holds) (2) access to laboratory health services till communities (3) improvement in commutations of people from smaller communities/settlements to nearby by towns/villages at higher level, without wastage of time and devastating costs (4) a good efficient “amazon” service for specimen transport. Several of above solutions are applicable at different levels. And some of them are not cost-effective, or impractical given the lack of appropriate diagnostic technologies.

Could we see “AMAZON” extending its services to the public health specimen transport without risking lower profit margins? Will the volumes of specimens that are transported could break-even the costs incurred in such a business (higher scale-of bossiness)? What are elements interest an “amazon” for specimen transport. Business model of “Amazon” relies heavily on vendors who transport their products to the ‘Amazon designated warehouses’. The reach could even extend up to a neighborhood individual retail shops. Amazon provides what is called a ‘market-places’: services that support the vendor to photograph all the products and make them ready for online consumption. Through the whole life of the relationship with vendor, the market- places provide inventory reports, order reports and trends. The vendors need to focus on their products and find easy ways to ship their products to the Warehouses of the Marketplace. For the buyers, the product just reaches their homes, in a predicted time, at an affordable price. This is enabled by multiple courier services- who also find market place with 'Amazon'.

Could we dream of extending this type of service in public health? Obtaining biological clinical specimens could pose multiple challenges? Why does it pose problem?- because of limitations of the knowledge or practice? How much training does it need to learn how to obtain a valid urine, stool, throat swab, or a sputum sample? How should the specimens be packaged for safe transport to labs nearby or far? I see a solution here already. We need to take back Public health to Public for extended participation to solve the problems. 
Corporate hospitals, send their laboratory staff to homes to collect specimens, in larger cities- but it has obvious limitation of access.  

Bridging the gaps in Universal access to TB diagnostics and Drug susceptibility testing strengthens laboratory networks in Africa

Bridging the gaps in Universal access to TB diagnostics and Drug susceptibility testing strengthens laboratory networks in Africa

Our recent publication in African Journal of Laboratory Medicine (Afr J Lab Med. 2017;6(2)) highlights the imperative for stronger tuberculosis laboratory networks and services in Africa to move towards ending tuberculosis. It is a mistake to reduce the focus on laboratory networks, as the TB diagnostics leave the typical bio-safe laboratories to point-of-care sites. We would do away with laboratory systems, and laboratory personnel only at the pearl of going back to dark ages of empirical diagnosis and wastage of resources. Especially, the gaps in Universal access to TB diagnostics and Drug susceptibility testings highlighted at the figure 2 of the publication need refocused attention and serve as new rallying point to improve the TB diagnosis and care. Clinical diagnosis of TB and empirical treatment, without confirmed bacteriological evidence, stands at 62% in Africa in 2015 (also highlighted in earlier blogs at this website). Sputum transport systems and accountability of laboratory network- plays a key role in bridging these gaps, while the new and accurate diagnostic technologies are becoming more and more accessible to the rural populations in Africa. It is never ending financial and technical support that is needed to be recognized. Laboratories serve as horses to pull the TB treatment services on a bidirectional Road (one way for TB medicines, and other way for the TB specimen transport to sites of diagnosis) - and need unflinching support for funding. The horses are becoming more and more stronger, and of superior breeds- but the time has NOT arrived to remove the horses, and replace with automatic engines, however interested we are in moving with artificial intelligence smart machines. We appreciate that it will take more time will for machines to rule the world, but never it is afar and a few generations apart. Several weaknesses and at the same time opportunities in TB laboratory networks are provided at table 1 of the opinion piece. 

Link to the article is given below:
Stronger tuberculosis laboratory networks and services in Africa essential to ending tuberculosis 


  

Integrated public health disease systems in Africa

Integrated public health surveillance, 'smart' laboratories and networks, and systematic prompt response along with capacity enhancement to the work-force are critical for combating threats to health and emerging diseases. We published a paper in this regard in African journal of Laboratory medicine, hyperlinked below: (African Journal of Laboratory Medicine; Vol 5, No 3 (2016), 4 pages. doi: 10.4102/ajlm.v5i3.431)

Integrating laboratory networks, surveillance systems and public health institutes in Africa

Abstract -

The Ebola outbreak in West Africa underlined the urgent need for integration of public health systems, including the establishment of national laboratory networks, surveillance systems, and health research institutions at all levels of service delivery. The integration schema presented here would assist in driving the immediate steps needed for integration of public health systems, particularly laboratory networks, in support of the implementation of International Health Regulations and the Global Health Security Agenda in the African region. Increased funding, political willingness from countries, and coordination through enhanced technical assistance from international partners, are critical in achieving this objective.