Delivering rapid test results when and where they are needed most

Point-of-care (POC) testing provides immediate, actionable information, contributing to better clinical, operational, and economic outcomes.

Faster Decisions are Better Decisions

Faster results at the POC mean faster treatment decisions to patients around the world.¹

Diagnostic laboratories are centralized, specialized facilities, with expensive equipment that needs regular maintenance and highly trained staff.²

The World Health Organization has called for new diagnostic tests that can function in areas with little access to a central laboratory.³

Outpatient Clinic

Emergency Ambulance

Mobile Clinic

Home Testing

Emergency Department

Affordable by those at risk of infection

Sensitive (few false negatives)

Specific (few false positives)

User-friendly (simple to perform and needs minimum training)

Rapid (to enable treatment at first visit) and robust (does not need refrigerated storage)

Equipment not needed

Delivered to those who need it

Decentralized Extension of Lab Medicine

Before a POC device can be marketed or sold, it must be cleared by the U.S. Food and Drug Administration or the appropriate country.⁴

POC devices are often a miniaturization of laboratory instruments and procedures.⁵

Many POC devices are CLIA (Clinical Laboratory Improvement Amendments) waived and may be run in laboratories as well as any setting with a CLIA certificate of waiver.⁶

POC test results are available immediately for medical decisions vs. laboratory test results, which could take hours or days.⁷

POC devices may offer:

Diagnosis

Aid in diagnosis of disease

Screen

Screen populations to identify diseases

Prognosis

Aid in predicting risk of an adverse event or anticipate course of disease

Management

Monitor progression of disease and alter clinical management

Advantages of POC Testing

Effective use of limited resources

Less complex infrastructure and training.⁸ After implementation of lipid and HbA1c testing in one practice, there was an 89% decrease in follow-up phone calls, an 85% decrease in follow-up letters and a 61% decrease in patient revisits for abnormal lab test results. The estimated cost savings from improved efficiency was $24.64 per patient.⁹

Rapid results

Provides result during a clinic visit or within a reasonable waiting time, often within minutes. Addresses patient’s needs quickly (especially important with life-threatening diseases).

Fewer operational steps

Traditional methods of laboratory testing involve multiple preparatory steps:

Take sample
Run test
Read result
Healthcare provider consults with patient

Small sample volume

Many POC tests use small samples that are easily obtained and directly applied to the test.

Easy test procedures

Simple test procedures reduce the number of steps needed to obtain results, accelerating turnaround times and treatment decisions.

Patients get results

They get results on the spot rather than having to go to a lab, or experiencing the anxiety of waiting at home for results to arrive.

The Impact of POC Testing

Patients who received rapid HIV testing were almost twice as likely to receive their follow-up results than participants who received standard testing.¹⁰

Post-POC days

HIV patients tested with POC device received antiretroviral therapy (ART) treatment at 14 days compared to 144 days for the traditional lab.¹¹

68%

95%

only 68% of the patients with diabetes had HbA1c measured. 6 months after the introduction of POC HbA1c testing, this metric increased to 95%.¹²

POC testing can reduce Emergency Department wait time for test results by 30 to 50 minutes in cases of stroke and 102 minutes in cases of pulmonary embolism.¹³

Use of POC urine drugs of abuse tests in the Emergency Department decreased length of stay 27% compared with central laboratory testing.¹³

Heart failure patients who received a POC test at the hospital had their length of stay decrease from 11 to 8 days.⁷

View references

1. Drain, Paul K et al. Diagnostic point-of-care tests in resource-limited settings. Lancet Infectious Diseases (2014)14: 239-249.

2. Peeling, RW and Mabey, D. Point-of-care tests for diagnosing infections in the developing world. Clin Microbiol Infect. (2010)16:1062–1069.

3. Kettler H, White K, Hawkes S. WHO/TDR, Mapping the landscape of diagnostics for sexually transmitted infections. 2004.

4. DuBois JA. The role of POCT and rapid testing. Here is an overview of an evolving approach to direct patient care. MLO Med Lab Obs. (2013) Sep;45(9):18, 20, 22.

5. Ralf Junker, Harald Schlebusch, Peter B. Luppa. Point-of-Care Testing in Hospitals and Primary Care. Dtsch Arztebl Int. (2010) 107:561–567. Published online 2010 Aug 20. doi: 10.3238/arztebl.2010.0561

6. Wagar, E.A., et al. Point-of-Care Testing: Twenty Years’ Experience. Lab Medicine. (2008) 39:560-563. . DOI: 10.1309/9R9Y0V68Y3BA0KDN

7. Mueller C, Scholer A, Laule-Lilian K, et al. Use of B-type natriuretic peptide in the evaluation and management of acute dyspnea. N Engl J Med. 2004

8. Urdea M, Penny LA, Olmsted SS, Giovanni MY, Kaspar P, Shepherd A, Wilson P, Dahl CA, Buchsbaum S, Moeller G, Hay Burgess DC. Nature. (2006) Nov 23; 444 Suppl 1:73-79.

9. Crocker, J. Benjamin, et al. Implementation of Point-of-Care Testing in an Ambulatory Practice of an Academic Medical Center. Am J Clin Pathol (2014), 142:640-646.

10. Pottie K, Medu O, Welch V, et al. Effect of rapid HIV testing on HIV incidence and services in populations at high risk for HIV exposure: an equity-focused systematic review. BMJ Open. (2014) 15:e006859.

11. Wynberg E et al. Impact of point-of-care CD4 testing on linkage to HIV care: a systematic review. Journal of the International AIDS Society (2014)17:18809-18815.

12. Veronica Egbunike and Sally Gerard. The Impact of Point-of-Care A1C Testing on Provider Compliance and A1C Levels in a Primary Setting. (2013) The Diabetes Educator 39:66-73.

13. Rooney, Kevin D and Schilling, Ulf Martin. Point-of-care testing in the overcrowded emergency department – can it make a difference? (2014) Critical Care 18:692-699

14. Lewandrowski, Kent, et al. Implementation of Point-of-Care Rapid Urine Testing for Drugs of Abuse in the Emergency Department of an Academic Medical Center. Impact on Test Utilization and ED Length of Stay. (2008) Am J Clin Pathol 129:796-801.

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Delivering rapid test results when and where they are needed most

Faster Decisions are Better Decisions

POC testing
increases access to healthcare¹

Ideal characteristics
for a POC test in
resource-limited
settings¹:

Decentralized Extension of Lab Medicine

POC technologies
include⁴: