Clinical laboratory tests play a crucial role in making sure patients get appropriate care, yet many small labs and clinics in low resource settings cannot afford the instruments needed to provide these tests.
Research on a novel fingerprick test that can perform all common clinical diagnostics could help to expand access to basic medical testing in the developing world, and will be featured at the 2015 AACC Annual Meeting & Clinical Lab Expo.
Public health experts estimate that approximately one third of the world's population does not have adequate access to quality healthcare due to a range of barriers, from limited geographic accessibility to a lack of affordable services. Clinical laboratories in particular are poorly outfitted and sparsely distributed in low-income countries, and few primary healthcare centers in these regions are located within reach of a well-equipped and staffed lab. So-called point-of-care testing devices that are portable and do not require lab support could improve access to testing in underserved areas. However, multiple point-of-care instruments would be required to run the full spectrum of common clinical tests, and this equipment is often expensive.
At AACC's 2015 Annual Meeting, researchers from DiaSys Diagnostics India in Mumbai will present the first point-of-care device, named QDx InstaLab, that can perform all of the clinical tests that labs routinely order as part of yearly physicals to evaluate organ function and check for conditions such as diabetes, liver disease, and kidney disease. Additionally, the QDx InstaLab can test cholesterol levels to screen for risk of heart disease or to monitor treatment for it, and can screen for bleeding problems or monitor treatment for inappropriate blood clotting as well. To run these numerous tests, the device analyzes a few drops of blood from a fingerprick using inexpensive microfluidic cartridge technology together with novel nanomaterial-based plastic electrochemical biosensors. It provides results in 3 to 10 minutes or less.
To evaluate QDx InstaLab's accuracy, the researchers performed each of its tests on 40 to 70 patient blood samples and compared the results with those of standard laboratory instruments. Through this, they found that the tests run on QDx InstaLab have a coefficient of variation < 3%, an R² value > 0.95, and an interference bias < 10%, which signifies that the QDX InstaLab is reliable and meets all the performance specifications of a lab.
"In areas where cost and efficiency are of paramount importance, labs will be able to consolidate all instrumentation into a single QDx InstaLab," said Dr. Vijaywanth Mathur, head of research and development at DiaSys Diagnostics India. "This breakthrough technology will revolutionize and enable quality healthcare for all in both low-to-middle-income and high-income countries, and particularly in rural, semi-rural, second tier, and third tier cities where there is no access to healthcare diagnostics or the cost per test is so high."