The Point of Care Testing Market


Welcome to Kalorama Information's Point of Care Testing page! You'll find all the information you need concerning the Point of Care Testing industry through our market research reports, blog posts, press releases, videos, and multimedia, consolidated for your convenience. 

Point of care (POC) tests are performed outside central laboratories and produce quick results. POC has been an important goal in IVD (in vitro diagnostics), and new developments have made achieving it possible. Point of care testing is transforming, thanks to innovations in smartphones, biosensors, lab-on-a-chip, and wearable devices. For healthcare professionals, having an expedited diagnosis is of paramount concern. Point of care diagnostics will be part of a paradigm shift from curative medicine to predictive, personalize, and preemptive medicine. 

POC testing has migrated from the hospital to different medical environments over the years. Thanks to the introduction of transportable, portable, and handheld instruments, point of care testing exists in the workplace, at home, within disaster care and, most recently, convenience clinics.


Point of care testing’s twin hallmarks are speed and efficiency. POC is done within the clinical management setting; testing is done in proximity to the patient, samples are analyzed, and results are determined and interpreted on-site, within the time span of an office visit. Reduced turnaround time streamlines the workflow, eliminating the need to re-familiarize physicians with the case.

Advantages of Point of Care

POC testing allows physicians to quickly make decisions and begin treatment. Point of care improvies clinical care and increases throughput, benefiting both patients and clinical facilities.

Point of care simplifies procedures fewer (often automated) steps. There is little need to aliquot specimens or store and transport samples, reducing the potential for contamination or deterioration. There is little need to aliquot specimens or store and transport samples, reducing the potential for contamination or deterioration. 

Testing devices have been designed for point of care with reduced footprints and ability to analyze a larger range of biomarkers, making them more flexible than machinery in the central laboratory. Portability and versatility have expanded POC testing’s capability; diagnoses are conducted in less traditional places, such as lower income areas and under-served populations, rural region, and areas with limited infrastructure.

Examples of Point-of-Care in the Professional Setting:

  • Dov Frankel, MD, of Sinai Hospital in Baltimore, interviewed in Tech Target, asked executives there to purchase Abbott Laboratori’es i-STAT system because of point of care’s workflow efficiency; he uses the handheld machine to perform chemistry screens, measuring blood electrolytes. The i-STAT provides vital information in less than two minutes, particularly important for stroke patients, says Frankel, who must quickly know patients’ blood coagulates before administering medication.
  • A UK emergency department conducted a trial testing point of care's efficacy, which found clinicians made health management decisions 74 minutes sooner on average, compared to diagnoses made following traditional evaluation. 
  • Cardiologist Judy Mangion said in a Tech Target interview that the Vscan portable ultrasound device by GE Healthcare makes it possible to see what is happening within patients’ cardiovascular systems quicker than traditional ultrasound machines. “These devices do allow you to get [diagnostic equipment] to people and places that might not have easy acess,” said Mangion. “It does improve access substantially.”

Potential Flaws of Point of Care

Examples: 

John Petersen of the University of Texas reports that handheld glucose meters are incomparable to full lab sugar tests, despite portability and user-friendliness. These potentially minor variations can severely impact patients who are on strict glucose control plans. 

The Mayo Clinic's Paula J Santrach reports that there are multiple methods of performing the same tests, and lack of standardization can lead to incosistent results. She warned that, despite a test's simplicity, data management and oversight is complex, requiring training and proper competency assessments for potentially hundreds of people in a single system. 

Common Criticisms Against Point of Care Include:

  • Limited battery life
  • Images are lower quality compare to those of echocardiograms
  • Tests may potentially be inaccurate or unreliable 
  • Tests may lead to false negatives
  • Inability to upload device images to hospital archives and communications systems

Clinical Laboratory Improvement Amendments (CLIA)-waived tests, by definition, have limited ranges of values relative to full laboratory tests, a troublesome fact considering accuracy is more important than speed. Mangion expressed concern that clinicians may use point of care testing as a screening tool, rather than for on-site diagnosis, leading to more comprehensive tests ordered.

Are There Differing Opinions on POCT?

On one hand:

Point-of-care carries a question of efficacy, and opinions vary contingent upon the application for which they are used. A 2015 British study published in the Emergency Medicine Journal reports that blood gas analyzer tests used for measuring calcium and electrolytes can reliably replace centralized lab tests so that clinicians receive results in less time.

On the other:

The Centers for Disease Control (CDC) recommend caution when using CLIA-waived rapid diagnostic tests for influenza, as presentations of false positives or negatives depends upon the test’s sensitivity, specificity and level of patient influenza activity. To maximize test efficacy, clinicians must collect specimens as close to the onset of symptom presentation as possible.


Industry News

In-depth Industry Coverage with links to Kalorama's press releases, and industry sources.

A Plethora of New Products

Product Company Description
Accu-Check Inform II Roche User-friendly hand-held system for POC glucose testing and monitoring in hospitals
Accu-Chek Safe-T-Pro Plus lancet Roche designed to reduce the spread of infection and meets safety requirements, while minimizing pain for patients
Alere Afinion AS100 Analyzer Alere multi-assay analyzer system able to provide A1C results that are CLIA Waived in 3 minutes and ACR (Albumin/Creatinine Ratio) results in 5 minutes
Alere i Influenza A & B, Strep A, and RSV Alere a rapid diagnostic test, delivers molecular flu results in less than 15 minutes on the Alere i platform; the Alere i Influenza assay was the first ever molecular assay to be granted CLIA waiver
CoaguChek XS Plus System Roche monitor coagulation (blood-clotting), delivers CLIA-waived testing with enhanced connectivity for professional use
Cobas Liat PCR System Roche the only real-time PCR testing platform that’s CLIA-waived for Influenza A/B, Influenza A/B & RSV and Strep A, delivering results in 20 minutes or less
CueSee CO-OX Eurotrol unassayed real hemoglobin quality control material; COOX controls with real Hb derivatives in 1 sample
EasyRA Clinical Chemistry Analyzer Medica test menu expanded to include a moderately complex drugs of abuse panel
Epoc Blood Analysis System Alere delivers blood gas and electrolyte results in about 30 seconds, and is the only wireless bedside testing solution to use “SmartCard” technology
Fast Flow HP Nitrocellulose Membrane GE Healthcare a highly consistent membrane for use with most sample types in a lateral flow assay
S-Monovette POC Collect Kit SARSTEDT innovative, easy-to-use POC solution for venous sampling
TEG Manager Software System Haemonetics delivers secure and convenient TEG analyzer results viewing and system administration; accessed within the hospital network via web browser and provides robust TEG analyzer data warehousing, real-time remote patient results viewing/reporting, LIS connectivity, and user and device management and reporting
TEG 6s Hemostasis Analyzer System Haemonetics new thrombelastography technology that significantly improves ease of operation while measuring the same viscoelastic properties of blood coagulation; for lab or near patient settings
Thermo Scientific Samco Clicktainer vials Thermo Fisher Scientific Samco Clicktainer vials are leakproof specimen containers used in a wide variety of applications: urine, feces, sputum, etc. to capture and contain samples for clinical, diagnostics, and research use
ZeptoMetrix Respiratory Verification Panel (KZMC037) ZeptoMetrix a 6 member RUO panel (Influenza A, Influenza B, RSV, Adenovirus, Rotavirus & Negative) intended for use with in vitro rapid tests for the determination of viral presence or absence

Roche, Alere, Abbott Among Leaders

Kalorama Information’s research, Point of Care Market and Market Share Analysis, reports that Roche leads point of care, holding nearly one-fifth of the testing market. Roche offers many POC testing products, and leads POC testing segments including:

  • Blood Glucose Monitoring
  • Rapid Coagulation
  • Drugs
  • Cholesterol

The merger between Abbott and Alere has the potential to create a point-of-care juggernaut that could replace Roche’s market share. Alere secured the second market position with 12.5% of the market. Alere participates in nearly all POC test segments but has a dominating position in rapid cardiac markers, blood glucose including HbA1c, coagulation, drugs of abuse, infectious disease, lipid and pregnancy and fertility testing. Abbott Laboratories held the third position with 12.3%. Abbott offers a good selection of POC tests, with its strongest sales in blood glucose monitoring. The introduction of the i-STAT Total β-hCG, a handheld blood test for pregnancy, has helped Abbott’s point of care sales.


The Market for Point of Care Testing (POCT)

Kalorama Information’s report,Point of Care Diagnostics Market and Market Share Analysis finds that Globally, millions of dollars are spent annually on POC diagnostic testing, both professional testing and self-testing. In 2016, sales of POC testing reached $18.4 billion, increasing 3.8% from $17 billion in 2014. A major contributing factor to slower growth was pricing strategies that continued to discount the cost of POC diagnostic testing in some segments and higher cost in other segments of testing. In 2021, the total global POC diagnostic testing market is expected to reach $23 billion, displaying growth of 4.6% over the forecast period 2016-2021.

Point of Care/Rapid Test Immunoassays

Immunoassays – testing antibody responses in specific patient samples – are useful in POC testing in two main areas. Fertility tests and infectious disease tests comprise 45% of the total POC/rapid test immunoassay market, covered in Kalorama Information’s Immunoassay Markets report.

Diseases comprising sifniciant parts of the market include:

  • HIV
  • Tuberculosis
  • Hospital-acquired infections
  • Clostridium difficile
  • Vancomycin-resistant enterococcus