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News From SystemOne
Join Us May 6th to Discuss How Connectivity Solutions Support RealTime Diagnosis for TB, HIV, and COVID-19
SystemOne's Christopher Macek and Patricia Moscibrodzki will be presenting at the Stop TB Partnership's Virtual Innovation Spotlight on May 6, 2020 at 5:30 CEST. Register here
COVID-19 Test Capacity
Can Be Met Without
Reducing TB Testing
A Major Opportunity to Utilize Current Diagnostic Investment in Cepheid's GeneXpert and SystemOne's GxAlert and Aspect Software to Rapidly Detect, Track, and Control COVID-19 Without Reducing TB Efforts

By Natasha Gous, PhD


No one really knows the true extent of spread of the novel coronavirus that has killed over 229,220 people worldwide and decimated healthcare systems since it was first reported in China December 2019. Available reports indicate that there are 3,245,791 confirmed cases (as of 30 April 2020), 62% of which still have active COVID-19 disease (1). These numbers are likely the tip of the iceberg. It is uncertain how many people with mild or asymptomatic disease have not been tested, making accurate tracking of COVID-19 impossible.


As the world grapples with how to interrupt transmission and contain the virus, the WHO Director General had one simple message for all countries during his media briefing on the 16th March 2020, ‘You cannot fight a fire blindfolded. Test, test, test’ (2). Countries such as South Korea, have been widely praised for implementing an aggressive and expansive testing approach facilitating early identification of positive cases for quarantine. Based on this strategy, they have essentially managed to slow down transmission rates and are seeing a sharp drop in reported cases (3). Whilst this approach clearly works, adequate testing capacity is severely lacking worldwide.


As countries with already fragile health systems brace for the impact of COVID-19, many are ramping up their available testing capacity. The WHO African region has launched a massive upscaling of their testing capacity; there are currently 47 countries with laboratory facilities available to test for coronavirus, at the start of the outbreak, there were only two. However, there are many challenges ahead. Not only will laboratories face critical shortages in test kits, but many fear they will not have enough capacity to perform the testing on available diagnostic instruments. Laboratories are already being inundated with samples and this will only increase in the coming weeks. But, amidst all the uncertainty, a glimmer of hope emerges.


SystemOne Advisory:


Many but Not All GeneXperts Ready 

for Immediate COVID-19 Testing 

The GeneXpert, a technology that revolutionized TB molecular diagnostic testing, can now be utilized for COVID-19 testing through the recent release of the new Xpert® Xpress SARS-CoV-2 cartridge (1). In a time when testing is an integral component to COVID-19 preparedness and response, the new assay comes as a welcome addition to the market, especially by countries who already utilize the GeneXpert platform. GeneXpert has a massive footprint worldwide, which allows countries to leverage this existing technology to rapidly increase their testing capacity for COVID-19.

GeneXperts are capable of running tests for multiple diseases. In many low- and middle-income countries, where the GeneXpert is primarily used for TB response, plans are underway to repurpose or maximize some of these instruments for COVID-19 testing. However, an important factor to bear in mind when transitioning a testing fleet to accommodate COVID-19 testing, is that the new cartridge only operates on GeneXpert software version 4.7b or later. For countries operating on lower versions of the software, upgrades will be required before testing can commence. This process will need careful planning as it may take time and have cost implications due to the need for additional human resource capacity. Coordination may also be required with the manufacturer (Cepheid) or Authorised Service Providers (ASP) to ensure the process runs smoothly (2). 


To gain a better understanding of what software versions countries are currently using, an analysis of 18 countries connected to the GxAlert software platform (SystemOne, LLC) was performed. The analysis included 594 GeneXpert TB testing sites, which we categorized into two groups, 1) those that require a software upgrade (i.e operating on version 4.7a or lower) or 2) those that are COVID-19 ready (i.e those operating on version 4.7b or higher).

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LMICs Can Now Leverage COVID-19
Diagnostic Data in Near Real-Time with the New Abbott m2000 Assay and Aspect®
Our Aspect connectivity solution and software for rapid diagnostic data delivery and management is optimized for immediate use with a range of diagnostic machines already in place that are essential to the COVID-19 response in LMICs, including the Abbott m2000. 

The Abbott m2000 device and its new COVID-19 assay, like many other diagnostic tests authorized for emergency use, will prove critical to a successful worldwide Coronavirus response. This high throughput PCR device and its RealTime SARS-CoV-2 EUA test  “allows scalable, automated processing for flexible testing volume (24-96 samples) and up to 470 patient samples in 24 hours.” But without a connectivity solution in place, the majority of LMIC’s will have to move their COVID-19 data the usual way: manually, slowly, often transporting samples and test results via motorbike or mail courier from central lab to patient care site. Given that the only effective weapon we currently have against the COVID-19 pandemic is the isolation of positive cases to control further transmission of this highly infectious disease, systems that can connect and move diagnostic data in near real-time are as important as the diagnostic tests themselves.  

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