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Article on Diagnostic Test Design in Lancet Infectious Diseases Quotes CHS Senior Researcher

Reliable and user friendly diagnostic tests for HIV, tuberculosis (TB), malaria, and sexually transmitted infections (STIs) are key to stemming the spread of these diseases. At present, however, the diagnostic tools used in developing countries have many limitations and are largely inadequate for addressing health needs.

An article entitled “The complex art of making diagnostics simple” in the August edition of Lancet Infectious Diseases quotes Dr. Steven Harvey, a senior researcher with University Research Co., LLC (URC) and the Center for Human Resources (CHS), URC’s non-profit affiliate.

Harvey summarized key criteria that make diagnostic tests feasible in developing country settings. The World Health Organization (WHO) states that new tests should be developed which are affordable, sensitive, specific, user-friendly, robust, rapid, equipment free, and deliverable to those who need them. Recognizing the realities of conducting these tests in developing country settings, Harvey added some practical points to the list: “a shelf-life long enough to remain viable through months of transport and storage, reagent-free or that use low-cost reagents, readily available, and heat and humidity stable.”

CHS Evaluating Market for Diagnostic Tests in Developing Countries

Harvey is the principle investigator for Diagnostic Cost Analysis for the Developing World, a CHS project funded by the Bill and Melinda Gates Foundation. The project team is evaluating the potential market for new rapid diagnostic tests for the infectious diseases—HIV/AIDS, tuberculosis (TB), malaria, sexually transmitted infections (STIs), and acute lower respiratory infections—that disproportionately affect developing countries.

Early Diagnosis Can Yield Successful Results

Early and correct diagnosis of infectious diseases can produce a wide range of benefits, including preventing or delaying the spread of drug-resistant microbes. In addition to potentially halting the spread of infectious diseases, early diagnosis can allow health care providers to administer treatments that save lives. For example, congenital syphilis is preventable with only a single dose of penicillin administered in the first two trimesters of pregnancy to a woman with the infection, as the article points out. But because 99 percent of women are asymptomatic, 62 percent never receive treatment.

Development of Effective Tests Presents Complex Challenges

Tests are urgently needed to distinguish diseases that are initially asymptomatic or present with non-specific symptoms such as fever and cough but require radically different treatments without which they can lead to severe illness or death. But developing tools that are quick, simple-to-use, accessible, sensitive, and specific is a tall order.  At present, the diagnostic tools used in developing countries have many limitations and are largely inadequate for addressing health needs. While there are promising technologies being developed, few have emerged as “game changers,” as the article notes. 

CHS Research Confirms that Diagnostic Tools Must Meet an Array of Standards

Harvey draws from his experience in training health care workers to effectively use malaria diagnostic tools.  In collaboration with the WHO Special Programme for Research and Training in Tropical Diseases, the Foundation for Innovative New Diagnostics (FIND), and the Zambia National Malaria Control Center, Harvey developed a job aid and a ½ day training program that improved community health worker performance of malaria rapid diagnostic tests (RDTs) from 60 percent to over 90 percent. The work is becoming the standard for RDT training through much of Africa.

For more information on the development and application of rapid diagnostic tests in developing countries, please contact Dr. Steven Harvey at sharvey@urc-chs.com.