Home Tests

Home testing is a growing area of health care that places new responsibilities on the health care consumer.

If you need additional information or would like to learn about recently approved tests, visit the FDA web page Over-the-Counter In Vitro Diagnostic Devices. Another FDA page, Currently Waived Analytes, includes links to a broad range of tests kits and devices that are identified by brand. Not all are for home use -- those that are will be clearly marked. The following home testing kits are available.

  • KEY: This key applies to all of the tests listed below

  • SA=stand-alone test, results available to consumer in the home

  • OTC=over-the-counter, no prescription needed.

  • N/A= not applicable

Glucose

  • Condition: Diabetes

  • Purpose: To monitor blood sugar levels

  • Format: SA

  • Availability: OTC, physician recommendation

Comments: Home testing for diabetes has advanced from urine testing to whole blood testing. Less invasive or painful procedures, such as alternate site testing meters and those that use infrared technology to "read" blood sugar through the skin, are becoming more common. In 2001, the FDA approved a watch-like device for testing blood sugar.

Cholesterol

  • Condition: Heart disease

  • Purpose: Screening for total cholesterol in blood

  • Format: SA

  • Availability: OTC

Comments: Does not separate out cholesterol. Natural variations in cholesterol may make test results hard to interpret. If results indicate potential heart disease, see your doctor.

Luteinizing Hormone

  • Condition: Ovulation

  • Purpose: Predicting time when woman is most likely to be fertile

  • Format: SA

  • Availability: OTC

Comments: Certain monitoring devices can store information and accessed by the couple and their health provider for retrospective review.

Human Chorionic Gonadotropin (hCG)

  • Condition: Pregnancy

  • Purpose: Screening for possibility of pregnancy

  • Format: SA

  • Availability: OTC

Comments: Results should be confirmed by doctor or laboratory testing

Fecal Occult Blood

  • Condition: Colo-rectal cancer

  • Purpose: Screening for blood in the stool

  • Format: SA

  • Availability: OTC

Comments: Subject to false positives; substances in the body or in your system can affect results.

Prothrombin Time (Coagulation Testing)

  • Condition: Heart disease, stroke, atherosclerosis

  • Purpose: Measuring the concentration of blood thinner in the body

  • Format: SA; portable, battery-operated device.

  • Availability: By prescription

Comments: Relatively new; safety and efficacy are still being evaluated. Requires considerable patient training and compliance to be useful. Cost covered by some insurers.

Drugs of Abuse

  • Condition: Possible current or past illicit drug use that results in organ systems damage

  • Purpose: Screens for the possibility that the consumer takes illegal or restricted drugs of abuse

  • Format: SA; In commercial employer situations, positive results are then referred to laboratories for confirmation.

  • Availability: OTC

Comments: Results could be affected by medications or foods, such as poppy seeds.

HIV Antibody

  • Condition: Forerunner of AIDS; susceptibility to other sexually transmitted diseases (STD)

  • Purpose: Screens for infection by HIV, the virus that causes AIDS

  • Format: Kit; sample sent to lab for analysis.

  • Availability: OTC

Comments: Results available by phone, which protects anonymity. Counseling is required if test is positive and recommended if test is negative.

Hepatitis C

  • Condition: Liver dysfunction

  • Purpose: Screens for past or current infection by Hepatitis C.

  • Format: Kit; sample sent to lab for analysis. Lab runs same tests used by doctors and hospitals to determine whether antibodies to Hepatitis C are present.

  • Availability: OTC

Comments: Like HIV, combines telephone registration/pretest counseling, collection of blood sample, shipping, laboratory testing, telephone results retrieval, and post-test counseling.

Other Home Tests

  • Condition: Various, such as osteoporosis, hormone levels, STD's

  • Purpose: Screening

  • Format: N/A. Varies.

  • Availability: N/A. Some tests may be available internationally but are not yet approved in the U.S.

Comments: The FDA continuously updates its list of tests approved and cleared for marketing. For example, recent approvals include a monitoring test for patients who have been diagnosed for bladder cancer, a screening test for blood in urine, etc.