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Review
. 2021 Jan 15:8:602659.
doi: 10.3389/fbioe.2020.602659. eCollection 2020.

Microfluidic Point-of-Care Testing: Commercial Landscape and Future Directions

Shivangi Sachdeva  1 , Ronald W Davis  1 , Amit K Saha  1
Affiliations
Review

Microfluidic Point-of-Care Testing: Commercial Landscape and Future Directions

Shivangi Sachdeva et al. Front Bioeng Biotechnol. .

Abstract

Point-of-care testing (POCT) allows physicians to detect and diagnose diseases at or near the patient site, faster than conventional lab-based testing. The importance of POCT is considerably amplified in the trying times of the COVID-19 pandemic. Numerous point-of-care tests and diagnostic devices are available in the market including, but not limited to, glucose monitoring, pregnancy and infertility testing, infectious disease testing, cholesterol testing and cardiac markers. Integrating microfluidics in POCT allows fluid manipulation and detection in a singular device with minimal sample requirements. This review presents an overview of two technologies - (a.) Lateral Flow Assay (LFA) and (b.) Nucleic Acid Amplification - upon which a large chunk of microfluidic POCT diagnostics is based, some of their applications, and commercially available products. Apart from this, we also delve into other microfluidic-based diagnostics that currently dominate the in-vitro diagnostic (IVD) market, current testing landscape for COVID-19 and prospects of microfluidics in next generation diagnostics.

Keywords: COVID-19 diagnostics; LFA; NAATs; microfluidics; point-of-care diagnostics.

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Conflict of interest statement

The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Figures

Figure 1
Figure 1
POCT Market Segments. Three segments of the global POCT market include: (a.) Regional - North America, Europe, Asia Pacific & Rest of World; (b.) Product Type - Glucose monitoring, Cardiac markers, Infectious disease testing, Cholesterol testing, Coagulation monitoring, Pregnancy & Infertility testing, Hematology testing, Blood-gas testing, Others; (c.) End User - TPP1 - Homes, TPP2 - Communities, TPP3 - Clinics, TPP4 - External Laboratories, TPP5 – Hospitals (Pai et al., ; DUBLIN, ; Kaur et al., 2019).
Figure 2
Figure 2
Global Anticipated Revenue Generation by Product Type in 2022. Glucose Monitoring is expected to have the largest market share (39%), followed by, Blood gas testing (15%), Cardiac markers (13%), Infectious Diseases (8%), Pregnancy & Fertility testing (5%), Alcohol & Drug Abuse (5%), Hemoglobin testing (4%), Cholesterol testing (3%), Urine chemistry (3%), Tumor markers (3%), Others (2%) (DUBLIN, 2018).
Figure 3
Figure 3
Overview of POCT Technologies. POCT platforms are mostly based on two technologies (a.) Lateral Flow Assay (LFA) and (b.) Nucleic Acid Amplification (NAAT). LFAs are subclassified into Immuno based (Competitive and Sandwich) and Nucleic acid based [Nucleic Acid LFA (NALF) and Nucleic Acid Lateral Flow Immunoassays (NALFIA)] whereas NAATs are subclassified as PCR (Time Domain and Space Domain) and Isothermal amplification (NASBA and LAMP) based.
Figure 4
Figure 4
LFA Strip Components. A simple LFA test strip consists of a sample pad, a conjugate pad, test line, control line, and an absorption pad.
Figure 5
Figure 5
POCT Global Market Share by Company. Roche Diagnostics accounts for the largest market share of 20%, followed by Siemens 10%, Abbott 8%, Danaher 6%, Alere 5%, remaining companies contribute 2–4%. Other small and mid-sized companies hold 29% of the total market share (DUBLIN, 2018).
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