Challenges and Opportunities of Centrifugal Microfluidics for Extreme Point-of-Care Testing

Abstract

The advantages offered by centrifugal microfluidic systems have encouraged its rapid adaptation in the fields of in vitro diagnostics, clinical chemistry, immunoassays, and nucleic acid tests. Centrifugal microfluidic devices are currently used in both clinical and point-of-care settings. Recent studies have shown that this new diagnostic platform could be potentially used in extreme point-of-care settings like remote villages in the Indian subcontinent and in Africa. Several technological inventions have decentralized diagnostics in developing countries; however, very few microfluidic technologies have been successful in meeting the demand. By identifying the finest difference between the point-of-care testing and extreme point-of-care infrastructure, this review captures the evolving diagnostic needs of developing countries paired with infrastructural challenges with technological hurdles to healthcare delivery in extreme point-of-care settings. In particular, the requirements for making centrifugal diagnostic devices viable in developing countries are discussed based on a detailed analysis of the demands in different clinical settings including the distinctive needs of extreme point-of-care settings.

Keywords: centrifugal microfluidics; clinical chemistry; developing countries; diagnostics; immunoassays; nucleic acid tests; point-of-care.

Figure 1

Life expectancies at birth in 1990 and 2013 for both sexes and different causes of life expectancy variation in different regions [26].

Figure 2

Examples of IVD technology in different treatment settings. Clinical settings: (A) Aquios CL flow cytometer (Beckman Coulter, Inc., Brea, CA, USA) for CD-4 testing; (B) COBAS^® AmpliPrep/COBAS^® TaqMan^® HIV-1 Test, v2.0, (Roche Diagnostics, Indianapolis, IN, USA); (C) BD FACS Count Instrument with Kit (Absolute CD4+, CD8+, and CD3+ Counts), (BD Biosciences, San Jose, CA, USA). POC settings: (D) BD FACSPresto^TM (BD Biosciences, San Jose, CA, USA); (E) Pima CD4 Test (Alere^TM, Waltham, MA, USA); (F) Samba II (DRW (US) Ltd., Sunnyvale, CA, USA), approved in a few African countries, yet to be certified by the World Health Organization (WHO). EPOCT settings: (G) CareStart™ Malaria RDT (Access Bio Korea, Inc., Seoul, Korea); (H) Alere Determine HIV-1/2 Ag/Ab Combo (Alere^TM, Waltham MA, USA); (I) HIV 1/2 STAT-PAK® dipstick Assay (ChemBio Diagnostics sytems, Inc., Medford, NY, USA) [38,39].

Figure 3

Examples of centrifugal microfluidic-based diagnostic devices for POCT settings: (A) Piccolo^® by Abaxis (Union City, CA, USA); (B) COBAS B101 by Roche Diagnostics (Indianapolis, IN, USA); (C) Gyro Lab Explore by Gyros (Uppsala, Sweden); (D) Spinit^® by Biosurfit (Lisboa, Portugal); (E) LAB GEO ib10 from Samsung healthcare (South Korea); (F) Focus Dx (Quest) by 3M (Cypress, CA, USA).