In this article:
Editor’s Note: This is an interview with Dr. Yun F. Wang, Associate Professor of Pathology and Lab Medicine at Emory University School of Medicine, and Director of Microbiology, Immunology, and Molecular Diagnostics at Grady Memorial Hospital in Atlanta. As one of the largest public hospitals in the Southeast, Grady is an internationally recognized teaching hospital committed to the health of the most vulnerable patients.
What are the key issues for molecular diagnostics in an emerging market?
“The viability of a lab in an emerging market depends on whether it can have sustainable testing mechanisms, such as facility support, reagent availability, personnel, and reimbursement or financial support. We need to make labs in emerging markets sustainable; not just rely on outside funding. Even here in the U.S., public health depends on continuous funding. There is a need to offer lower-cost, but feasible, testing such as for malaria testing. The issues are how we can maintain the lab without solely depending upon grant supports, and how we can still utilize tests for diagnosis of diseases and monitoring the treatment. Labs in emerging markets need rapid and simple ways to detect infections such as HIV, tuberculosis (TB), syphilis and malaria. Resource-constrained markets, because of the nature of the setting in developing places, may not have comprehensive testing like in the U.S. Because of the culture in many emerging markets, it is not customary to have to wait a few days or weeks for results. It is best to get results quickly. With advanced molecular technologies, which can support multiple analytes, we will be able to offer the cost-effective tests that can provide rapid turnaround times on test results. With consolidated platforms for molecular testing, we will be able to cut down the cost of testing for better sustainability in emerging markets.”
What experience do you have in emerging markets?
“Here at Emory and Grady, we collaborate with colleagues who come to visit our lab from Africa, Asia, and Eastern Europe (Republic of Georgia, for example). They spend a few days or even months here to observe and understand our lab operation and we learn their situations, too. It is part collaboration, part education, and part global health. Our visitors from the Republic of Georgia look into the feasibility of the microbiology setting including mycobacterial testing and laboratory capacity requirements. They see what we do here and decide what they can do there. We educate them on testing including, but not limited to, TB, HIV and others. I also have experience with the Centers for Disease Control and Prevention (CDC) and have collaborated on the CDC Global AIDS program. I travel to Asia, specifically China, Taiwan and Hong Kong. In addition, I have collaboration in China through a pilot grant from the Emory Institute of Global Health. I have seen how emerging markets function, the challenges they face, and try to help them find different ways to do things.”
What things can they do differently?
“Lab capacities in resource-limited settings, such as some places in Africa or Asia, may not be able to handle conventional methods or technologies such as the Western blot for HIV confirmation or RIBA test for Hepatitis C virus (HCV) testing. Efforts to replace or bypass those conventional methods used in the U.S. or developed countries include, but are not limited to rapid testing, Dried Blood Spot Testing (DBS), or molecular testing, including HIV or HCV viral load testing, which are better in these areas. DBS is a good way to help laboratory technicians or technologists get used to performing molecular testing. The most important thing for colleagues from emerging markets to learn and take back to their markets is how we utilize tests including molecular techniques and learn our test algorithms and practice. It is not all about our facility or instrumentations. Purchasing instruments can be made through funding or capital money, however, knowing how to use those instruments and integrate into routine clinical testing can be achieved through education, communication, and collaborative efforts for ultimate sustainability in emerging markets. This is more important than going to an exhibition and just seeing new technology. It’s also important for the clinician to see how to use the technologies and see the benefit of laboratory tests including molecular diagnostics. If a doctor is not going to order the test, it doesn’t help anyone.”
What can emerging markets learn from resource-constrained molecular lab start-ups in the public health sector?
“Education and continuing education (CE) will help — conferences, symposiums, seminars, and webinars. This is what people need. In Asia-Pacific for example, clinical laboratory technicians, technologists, supervisors, laboratory administrators, and clinicians who want to learn may not have an opportunity to travel and attend these conferences. We need to offer those people more education, including CE, so they will understand molecular technologies and won’t worry about technology-related concerns, such as contamination. We need to help them not be afraid of molecular technologies. There is a stigma with some tests. From my experience, I see change happen gradually. Once they know more and have better experience, they are more likely to bring an assay in-house.”
What do you mean by stigma?
“In some areas, technologists don’t want to handle the HIV or TB samples. We can teach them not to be afraid. We can teach them how to reduce exposure and prevent contamination. If they follow good procedure, quality control, and practices, it will help them feel more comfortable using the technologies. In emerging markets, there is a need to have a good facility. If you don’t have a good ventilation system or a negative pressure room, you worry about handling TB samples. With adequate facilities, advanced molecular techniques, and good practice, I am sure people can take the knowledge home and utilize it accordingly.”
What other challenges do lab directors face in emerging markets?
“Some of the biggest challenges are funding and reimbursement. In places like Taiwan, the government has strict and standardized reimbursement. One may not be able to offer new tests if there is no government reimbursement available. Thus, the government policy is critical. Different countries have different policies. In some areas they may want to offer a test, but they can’t because of policies. There are many levels to deal with. Their approach is sometimes limited. Directors also want to recruit and retain quality personnel and prevent laboratory contamination. Laboratory directors need to be familiar with new technologies, and make decisions to utilize those technologies accordingly. I see associations in the U.S., such as the Association of Public Health Laboratories (APHL), the Association for Molecular Pathology (AMP), doing more to approach this and offer education and seminars.”
What best practices do you recommend for emerging markets?
“The CDC is coming out with quality control and quality assurance guidelines that target molecular genetics. I was trained by APHL in public health for lab management in emerging markets, so I understand quality control. With my experience in the College of American Pathologists (CAP) accredited clinical laboratories, I understand why there is a need for checklists, proficiency testing, quality assurance, and quality improvement as part of good laboratory practice and education. If a clinician makes a complaint, you need to find the problem, try to pinpoint what is happening, and improve on it. If a technologist is not following protocol, you need to identify the issue and take corrective action accordingly. TB, for example, can be an aerosol transmission. It can jump from one tube to another and cause laboratory contamination. In one case many years ago in another facility, we identified a problem through advanced molecular technology called genotyping. We had one technologist that had to be retrained not to open all the tubes at the same time. You must monitor the data to see if the positive rate is out of range. If so, you may want to act on it. It may not be the assay or the technologist. It could be the pre-analytic sample collection or transport. Emerging markets need to understand that if you do not have good collection, storage, or transport, it will impact test performance, as well as clinicians’ opinions about molecular testing, the test vendor, or the technology. Do some troubleshooting and look for what really happened. What are the conditions? Sometimes there is too much emphasis on the technology. Sometimes you need to look at pre- and post-analytics to determine the problem.”
What are the technology and instrument considerations for an emerging market facility?
“Space and location has a big impact on instruments. You need to consider whether the instrument can fit in the lab itself. In China, you can see different instruments in different settings, i.e., in clinical microbiology, molecular diagnostics, or the so-called core laboratory. In one case many years ago, I saw a semi-automated molecular instrument in the hallway and one automated culture system in an air-conditioned space. It all depends on people’s understanding and the facility. In some countries they like to buy high-tech instruments, but do they know how to use them? They spend the money, but they don’t use it routinely. To me, that is kind of a waste. You need sustainability in the long run. They should have one system or consolidated systems that can handle multiple tests and thus save the space and resources.”
How can molecular tests improve patient care in emerging markets?
“Molecular tests can save on turnaround time (TAT). This is a benefit for patient care and clinician satisfaction. In a developing country setting, it could take one or two days for a patient to travel from a rural area to a clinic — and then they have to go back. It would be perfect if the patient doesn’t have to wait, and clinicians can get results right there. Patients can’t wait around too long. Clinicians are constantly looking for results so they know what to do next. With the molecular test for diagnosis of TB here at Grady, instead of waiting a week or a month for results, we know the results in two or three days on smear positive respiratory samples. There is good sensitivity and specificity with minimal false positives. With Human Papillomavirus (HPV), we could have the results in days instead of two weeks or so for a Pap smear result. HIV viral load testing has changed a lot — now we have results in two days. Clinicians are very happy about this because they can see the major impact of less time for detection and reporting. They see it’s worth the money. It makes sense to centralize certain testing to cut down on cost and offer comprehensive service in one area. In China, there is a public health setting, where centralized testing is preferred for HIV, TB, and STD. However, there is a need for emerging market government guidelines to recognize the possibility of utilizing new and advanced molecular diagnostics for better and cost-effective patient care.”