At-Home Diagnostic Kits: A Growing Trend

Yvette Terrie, BSPharm, RPh
Published Online: Sunday, March 1, 2009

Ms. Terrie is a clinical pharmacy writer based in Haymarket, Virginia.


Recommending At-Home Tests: Key Tips

  • Check the expiration date of testing kits before use.
  • Read the instructions before testing and adhere to the step-by-step directions.
  • Understand the testing procedure and factors that may interfere with the accuracy of the selected test.
  • If unsure about the testing procedure or results, contact the primary care provider or the manufacturer.
  • Use an accurate timing device when performing the tests.
  • If using collection testing kits that require mailing, proper collection, storage, and shipment are critical to obtaining accurate results.
  • Report positive test results immediately to the primary care provider to confirm results and obtain further medical evaluation.
  • Question negative test results and confer with the primary care provider, especially if experiencing any symptoms or have any concerns.
  • Patients with visual impairments or problems with dexterity-ask for assistance when performing tests or be referred to their primary care provider for testing.
  • Patients with bleeding disorders or taking anticoagulants-because excessive bleeding may occur with tests that require a finger stick blood sample- confer with the primary care provider before using.

Adapted from reference 2.

Pharmacists can be a patient's best resource with regard to the proper selection of the various at-home diagnostic and monitoring tests currently on the market. These products fall into the personal diagnostics category. At-home diagnostic tests may assist patients in detecting or monitoring certain medical conditions, according to the FDA's Office of In Vitro Diagnostic Device Evaluation and Safety.1 At-home testing provides various advantages, such as privacy, convenience, ease of use, and low cost. The FDA classifies athome test kits into 2 categories1:

  • Test Kit—the patient collects the sample, performs the test, and reads the results.
  • Collection Kit—the patient collects the sample, mails it to a laboratory, and obtains the results via phone.

Self-diagnostic kits provide patients with information about their current health condition, which enables them to make informed decisions. Although the use of diagnostic kits may be convenient, the kits should never replace a follow-up visit with a physician. Proper use of these tests and adhering to the manufacturer's directions regarding testing protocol are crucial to obtaining accurate results.2 At-home diagnostic tests may provide a patient with valuable information and enable patients to seek medical intervention earlier, preventing further medical complications. The Table lists some of the various types of at-home tests available.

Selecting an At-Home Diagnostic Kit

Types of Diagnostic Kits

  • Allergy
  • Anemia
  • Cholesterol
  • Drug abuse
  • Fecal occult blood
  • Hepatitis C
  • HIV
  • Male infertility
  • Menopause
  • Ovulation predictor
  • Pregnancy
  • Prothrombin time
  • Urinary tract infections
  • Yeast infections

Adapted from references 1 and 2

The FDA requires that at-home tests perform as well as those used by health care professionals; however, these tests must be used properly to ensure accurate results.2 Pharmacists can be a fundamental source of information for patients seeking the use of at-home diagnostic test kits, as well as making certain that patients are adequately counseled on their proper use. Often the selection of appropriate at-home tests may be based on ease of use, ease of interpreting results, presence of a control, and cost.2

During counseling, pharmacists also may assess the patient's symptoms and ascertain if immediate medical evaluation is warranted. It is important for patients to consult with a health care professional, if needed, as well as the patient information hotlines found in most kits, if patients are unsure about test results or testing procedure. Patients also should be reminded that although these testing kits may be beneficial, patients should always maintain routine visits to their primary health care provider.

Examples of Available At-Home Diagnostic Tests

Allergy

  • MyAllergyTest Tests for Airborne and Food Allergens (ImmuneTech)

Anemia

  • BIOSAFE Anemia Meter (BIOSAFE Medical Technologies Inc)

Cholesterol

  • BIOSAFE Cholesterol Panel (BIOSAFE Medical Technologies Inc)
  • CardioChek HDL Cholesterol Test Strips (Polymer Technology Systems Inc)
  • CARE Cholesterol (CARE Products Inc)
  • CholesTrak (AccuTech LLC)
  • EarlyDETECT Cholesterol Test (EarlyDETECT)
  • First Check Home Cholesterol Test (First Check Diagnostics LLC)
  • Home Access Full Cholesterol Panel (Home Access Health Corp)

Colorectal Screening

  • EarlyDETECT Colorectal Home Screening Test Kit (EarlyDETECT)
  • EZ DETECT (Biomerica Inc)

Diabetes

  • BIOSAFE Hemoglobin A1C Test (BIOSAFE Medical Technologies Inc)
  • EarlyDETECT Glucose Home Screening Test Kit (EarlyDETECT)

Drug Abuse

  • First Check Home 12 Drug Test (First Check Diagnostics LLC)

Hepatitis C

  • Home Access Hepatitis C Test (Home Access Health Corp)

HIV

  • Home Access Express HIV-1 Test (Home Access Health Corp)
  • Home Access HIV-1 Standard Test (Home Access Health Corp)

Menopause

  • Early DETECT Menopause Home Test Kit (EarlyDETECT)

Ovulation

  • Clearblue Easy Digital Ovulation Test (Inverness Medical Innovation Inc)
  • First Response Daily Ovulation Test (Church & Dwight Co Inc)

Pregnancy

  • Clear Blue Easy Pregnancy Test (Inverness Medical Innovation Inc)
  • e.p.t. (Pfizer)
  • Fact Plus (Inverness Medical Innovation Inc)
  • First Response Early Result Pregnancy Test (Church & Dwight Co Inc)

Prostate-Specific Antigen (PSA)

  • BIOSAFE PSA Screen (BIOSAFE Medical Technologies Inc)

Thyroid

  • BIOSAFE Thyroid Stimulating Hormone (BIOSAFE Medical Technologies Inc)

    Urinary Tract Infection

    • AZO Test Strips (Amerifit Brands Inc)
    • EarlyDETECT Urinary Tract Infection Home Test Kit (EarlyDETECT)
    • Women's Wellbeing UTI (Consumer Choice Systems)

    Yeast Infection

    • Vagisil Screening Kit (Combe Inc)


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