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With Home Testing, Consumers Take Charge of Their Health

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NOTE: This article is based on research that utilizes the sources cited here as well as the collective experience of the Lab Tests Online Editorial Review Board. This article is periodically reviewed by the Editorial Board and may be updated as a result of the review. Any new sources cited will be added to the list and distinguished from the original sources used. To access online sources, copy and paste the URL into your browser.

Source Used in Current Review

Gnoth, C. and Johnson, S. (2014 July). Strips of Hope: Accuracy of Home Pregnancy Tests and New Developments. Geburtshilfe Frauenheilkd. Available online at http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4119102/. Accessed on 12/15/2015.

Hynes, V. (2013 Feb 19). The Trend Toward Self Diagnosis. Canadian Medical Association Journal. Available online at http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3576458/. Accessed on 12/15/2015.

(2014 December 10, Updated). How You Can Get the Best Results With Home Use Tests. U.S. Food and Drug Administration. Available online at http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/InVitroDiagnostics/HomeUseTests/ucm125664.htm. Accessed on 12/15/2015.

(2014 June 05, Updated). U.S. Food and Drug Administration. Hepatitis C. Available online at http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/InVitroDiagnostics/HomeUseTests/ucm125785.htm. Accessed on 12/15/2015.

(2015 October 16, Reviewed). HIV/AIDS Home Tests. Centers for Disease Control and Prevention. Available online at http://www.cdc.gov/hiv/testing/hometests.html. Accessed on 12/15/2015.

Byrne, S. (2015 August 11). Do-it-yourself Health Screening Tests That Are Worth the Money. Consumer Reports. Available online at http://www.consumerreports.org/cro/news/2015/08/do-it-yourself-health-screening-tests/index.htm. Accessed on 12/15/2015.

Topol, E. J. (2015 January 09). The Future of Medicine is in Your Smartphone. Wall Street Journal. Available online at http://www.wsj.com/articles/the-future-of-medicine-is-in-your-smartphone-1420828632. Accessed on 12/15/2015.

(2014 March 19). Pocket diagnosis: App turns any smartphone into a portable medical diagnostic device. Science Daily. Available online at http://www.sciencedaily.com/releases/2014/03/140319103612.htm. Accessed on 12/15/2015.

(2014 January). Direct to Consumer Genetic Tests. Federal Trade Commission. Available online at http://www.consumer.ftc.gov/articles/0166-direct-consumer-genetic-tests. Accessed 12/18/2015.

Sources Used in Previous Reviews

Mark Hughes and Joseph Keane, Enterprise Analysis Corporation, Stamford, CT. Interviews: 7/3/01 and 7/2/01.

James Nichols, PhD, Baystate Medical Center, Springfield, MA. Interview: 6/21/01.

Farley, Dixie. In-Home Tests Make Health Care Easier. FDA Consumer. December 1994. Available online at http://www.fda.gov/bbs/topics/CONSUMER/CON0292f.html.

Frost and Sullivan; cited in "Home Tests" by Deborah Shelton for amednews.com. Available online at http://www.ama-assn.org/sci-pubs/amnews/pick_99/feat0405.htm.

International Workshop on the Standardization of Whole Blood Coagulation Devices (transcript). August 13, 1999. Sponsored by the Department of Health and Human Services, the FDA, the Center for Devices and Radiological Health (CDRH), and the College of American Pathologists (CAP). Report available on the FDA website as a PDF at http://www.fda.gov/cdrh/ode/wbcw-transcript.pdf or from Miller Reporting Company, Inc., 507 C St. NE, Washington, DC 20002.

Kurtzweil, P. Internet Sales of Bogus HIV Test Kits Result in First-of-Kind Wire Fraud Conviction. FDA Consumer 1999. Available online at http://www.fda.gov/fdac/departs/1999/499_irs.html.

Weissman DW. Over-the-Counter Test Sales Are a Growing Market. Laboratory Industry Report 2001;X(2):9. Additional information available at: Diagnostic Testing and Technology Report, Feb 2001. Enterprise Analysis Corporation.

Kibak P. The Outlook on Home, Direct Access Testing: Are Consumers Ready to Manage Their Health? Clinical Laboratory News. March 2008: Volume 34, Number 3. Available online at http://www.aacc.org/publications/cln/2008/mar/Pages/cover2_0308.aspx. Accessed April 2008

Morago, Greg. Over-the-counter DNA home-test kits have hit the market. Lifebeat.com. The Providence Journal. Available online at http://www.projo.com/lifebeat/content/home_dna_test_12-26-07_DO8CMJB_v4.10ab70e.html. Accessed June 2011.

Emery J. Stephans, MS, Gerard Conti, MS, Michelle Keane, MBA, and Susan Farber, MBA. Does the Economic Downturn Impact Point of Care? Point of Care. Volume 8, Number 4, December 2009.

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