In late 2015, tuberculosis (TB) edged past HIV/AIDS to become the leading infectious disease worldwide. While impressive strides have been made over the past decade or so to control this debilitating and life-threatening disease, there are still gaps to close before TB can be eradicated.
How did we get to this point? How is it possible that this age-old disease continues to prevail and even thrive globally?
The picture is complex – the TB bacteria (Mycobacterium tuberculosis) is a very tough organism to kill; it’s difficult to access patients in remote areas and transport samples for testing; the complexities of diagnosing TB accurately; the numerous barriers to treatment (especially drug resistance); the list goes on.
One of the critical lines of attack on TB is globally coordinated laboratory practice and quality. Efforts are being made to ensure labs follow best practices and standardized methods. But how do these systems work? Who trains, implements, and safeguards these practices and methods? Enter experts such as consultant Khye Seng Goh, a laboratory technician and TB laboratory consultant with more than three decades of experience in TB laboratory science and diagnostics.
Mr. Goh has been a TB lab and implementation consultant for organizations worldwide such as the Foundation for Innovative New Diagnostics (FIND), the Global Laboratory Initiative (GLI, the scientific/technical arm of the WHO), and the Pacific American Health Association (PAHO). On each assignment, he typically works alongside a small technical team within a national TB program. His tasks vary, but can include:
- assessing laboratories for safety, quality and readiness;
- providing critique, training, troubleshooting and recommendations related to GLI accreditation and technical methods;
- setting up reference laboratories; and
- providing implementation support for new TB diagnostics.
Mr. Goh has a wealth of technical knowledge and experience assisting far-flung labs with managing logistical and infrastructure constraints, handling funding complexities, accommodating environmental factors, and aligning with national or global governance related to TB diagnostics and lab practice.
DNA Genotek had an opportunity to sit down with Mr. Goh and discuss his views on TB laboratory work, needs and progress for these labs globally, and advancements he envisions for the next five years in the fight against TB. Following are excerpts from that interview.
What are the greatest challenges that labs face every day in countries with the highest TB burdens?
A common issue is that a high-quality sputum specimen must be collected in order for a lab to produce a good result in the end. Obtaining a good specimen and transporting it to the lab, especially when a sample is to be cultured, are challenging for many countries, especially low-income countries where transportation is not very well organized and takes a long time. It is a significant challenge for people to get the specimen to the lab to be cultured and obtain a good result in the end. And if a specimen is not transported in the correct way, then there is risk that contaminants in the sputum [i.e., organisms other than those that cause TB] will prevent the growth of Mycobacterium tuberculosis.
How can TB labs best build capacity?
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“… in-country training is very important.”
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The best approach is to train people so that they are adept at doing the procedures in the lab and so they follow procedures correctly, which requires writing out good Standard Operating Procedures (SOPs). Training is a very important thing. Sometimes workers are trained overseas but training within countries is also very important. When laboratory workers travel outside their country to be trained, the problem is that when they return they are in a different setting from the training environment. They are not working under the same conditions. This is why in-country training is very important.
And of course you need a laboratory with good management. Good supervision is always needed to monitor/support the technicians and make sure they follow the SOPs, the procedures, and to ensure that technicians start to question and attempt to troubleshoot any unexpected or suspicious results. They must begin to question why certain results might not be correct.
How difficult is it for a TB lab to implement new technologies and build capacity for these?
Technologies are much more simplified now; they tend not to be very complicated. Many companies are developing new diagnostic tools that make it simple for any person to use. As such, it should not be very difficult to adopt a new technology when that method is simpler than a conventional form of technology that involves tedious and very long steps, extensive laboratory work, and results that are not very reliable due to the potential for human error. Also, now most new technology for TB diagnostics is automated, which means the machines will analyze for you and human analysts are not needed. This reduces errors in the interpretation of results.
What hinders a TB lab from using new technologies? Is it mainly funding?
The problem is always funding because most low-income countries depend on external funding, such as the Global Fund, and from partners. Currently, the WHO is gradually pressing at ministry of health level that government ministries should begin to cover the expenses of running all the different activities from the government’s budget [i.e. domestic funding sources should be used] because the current funding structure is not sustainable long term. So we are actually making ministries of health aware that this is something we must work towards over time so that their countries will be able to maintain the same diagnostic tools they currently use.
What areas need the most improvement for lab staff to be able to do more with less (e.g., diagnostics, culture, consumables, training)?
Currently, I think the most important thing is to simplify the work of the technologists in the lab so that they have more sufficient time to work on other activities. For example, currently most labs are trying to become accredited [by the WHO Global Laboratory Initiative], which requires a lot of work and demands that every step done in the lab is quality assured. By simplifying and eliminating routine work, they can spend more time developing these accreditation activities. As an example, for culture, if we can make something simpler for them, less time consuming, then the staff can spend more time on other activities.
How challenging is it for lab personnel to deal with failed results; for example, contaminated cultures or GeneXpert tests that don’t work?
If a lab has such problems then they must go back and troubleshoot, review what happened from the beginning of the test to the end. At the same time, they usually request a repeat specimen, but it is also important that the lab staff be able to troubleshoot and determine the cause/s of errors or incorrect results, or persistent culture contamination or high culture contamination rate. With Xpert, the problem could be human error or it could be due to the machine or certain features of the products. So this work is all part of accreditation: in the case of a poor-quality sputum collection, for example, if the lab is working towards accreditation, when there is such a problem they must be able to retrace the steps have they taken and these steps must be documented, everything must be documented. This way, they should be able to identify the cause and then determine the solution - what they need to do to rectify or avoid the issue in future.
Is there something you hope to see in the TB world in the next 5 years? Do you think it is possible that TB will be eliminated as a global epidemic?
With the current development of new techniques, new technology, there is much more rapid detection of TB patients, so hopefully with new diagnostics out in the field and detecting more TB patients, hopefully yes. I mean, the goal of the WHO is to try to eliminate TB or at least minimize the propagation of TB in certain populations. This is important now, as many people are trying to develop new techniques, rapid techniques, much simpler techniques, and these are generating good, reliable results. It is very important that the results at the end be correct, reliable.
You see, all this depends on researchers and manufacturers developing new technologies, products for labs to use. For the clinicians there is nothing more you can do; [their focus] is clinical diagnosis. But for the laboratory there are still many improvements to be made, such as new products or new methods for more rapid detection, accurate detection, which will simplify the work of the technical people. Everybody’s working towards that, and to eliminate TB this is what we need: to be able to detect the disease as rapidly as possible.