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The Role of Molecular Testing in Emerging Markets

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In this article:

  • How the HIV epidemic has fueled molecular growth
  • Adapting molecular methods for developing markets
  • Choosing the right automation to fit market needs
 
 

 

The benefits of molecular testing — faster results, improved sensitivity and increased accuracy — are just as valuable in emerging markets as they are in the mature markets. In conjunction with the economy growth, the utilization of more advanced technologies as molecular based testing is growing in BRIC (Brazil, Russia, India and China) as well as in Africa, SEA (South-East Asia) or Latin America. While challenges still exist, there have been incredible achievements in underserved and resource-limited settings thanks to molecular diagnostics.

The improvements gained from molecular testing in emerging countries can be dramatic. For instance, with current mycobacterial testing it can take weeks for a tuberculosis (TB) culture to grow. Technicians cannot definitively declare that a culture is negative for 42 days. Depending on the country and the situation, a physician may choose to wait that long before treating a patient. If a PCR test is used, a diagnosis can be made in seven hours. This makes a huge difference in quality of treatment.

HIV Fuels Molecular Growth

The HIV/AIDS epidemic across parts of Africa is devastating, but this tragedy has a lot of do with the growth of molecular diagnostics in these areas. Because of the urgent need for molecular testing for HIV infection, more funding has come from international donors (bilateral and/or multilateral) that have the influence and the funds to increase access to healthcare.

With more available money to deal with this growing HIV problem, there is a lot of progress being made in molecular testing in general. New assays are addressing specific needs, and activity is picking up. For instance, there has been the introduction of integrated and faster technology for tuberculosis testing in HIV patients. There is still a long way to go, but experts agree there is a lot of potential for further growth and improved patient care in developing markets.

Experts in the field are also seeing a change in people’s opinions of healthcare. In many developing countries, people are used to going to the hospital as a last resort. Due to economic reasons or socio-cultural factors, they will often try home remedies before going to a hospital.

The treatment of HIV has made health care and medicine more accepted because people see firsthand that HIV can be controlled. Success with HIV treatment has helped to bolster confidence in health care.

Adapting to the Environment

New developments and methods in emerging markets often come from problem solving. When faced with transportation challenges for molecular HIV testing, emerging markets often use dried blood spot (DBS) cards. This method involves placing a drop of blood onto blotter paper. When dried, it can be sent to a lab for tests. The benefits of this method in a developing market include:
•    Easy collection — little equipment required
•    Easy transportation — the specimen weighs next to nothing
•    Easy storage — no need for refrigeration
•    Dependable — the specimen remains stable for a long period of time and there is little   
     chance of contamination.

This process revolutionized the access to testing in many emerging markets. Many countries have limited transportation options. It can take days for a patient to get to a clinic. DBS makes it easy to gather samples in the village and bring the cards to a clinic or hospital by motorbike.
With this method, a lot more patients can be tested easily.

Automation Considerations

In a developing market, it makes sense to choose automation that can run a series of assays on one machine. This is valuable because:
•    You can do more with a single machine
•    You optimize your investment by not purchasing multiple machines
•    You don’t have to train personnel on various machines.

To see success and progress, it is wise to address the specific needs and find the right product to fit the market. If you are in an area with a high prevalence of a certain disease, the platform should have high output. In Africa for instance, HIV testing needs a high throughput device with good sensitivity and accuracy.

For developing markets, efficiency, ease of use, standardization of training, dependability, and a good cost benefit are important. The trend toward simple, integrated systems, as well as multiplex tests, will be advantageous to the emerging market setting.

Overcoming the Challenges

Two main factors that limit molecular growth are funding and human resources. Without funding, you can’t buy the necessary supplies and equipment. Without trained personnel, you can’t run the tests.

Another challenge in emerging market molecular laboratories is inconsistency in personnel. In many cases, the laboratory cannot offer competitive wages or a stable job situation. Laboratories in emerging markets need to strive toward a stable work environment with good pay in order to keep qualified personnel on staff. Good laboratory practices in the field come with repetition and experience. The longer someone is in the same job, running the same tests, the better they become.

In developing markets, laboratory directors and technicians may have a concept of what needs to be done and how to do it, but pulling all the pieces together can be difficult. It is wise to seek the advice of a consultant or manufacturer to help make it happen.