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.

Article written by Joanne M. Lozar Glenn, MS

Source Used for Current Review

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 through http://www.aacc.org. Accessed April 2008.

Sources Used in Original Article

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

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

Reports
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 through http://www.fda.gov

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 through http://www.ama-assn.org

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 through http://www.fda.gov.

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.

Internet
Center for Devices and Radiological Health

Dr. Koop's Conditions and Concerns Medical Encyclopedia

Medline Medical Encyclopedia

National Library of Medicine, National Institutes of Health

U.S. Food and Drug Administration