At-Home Diagnostic Kits: A Growing Trend

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Pharmacy Times
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When used correctly, at-home diagnostic tests can prompt patients to seek early medical intervention, which is why proper counseling is important.

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Ms. Terrie is a clinical pharmacy writerbased in Haymarket, Virginia.

RecommendingAt-Home Tests: Key Tips

  • Check the expiration date of testing kitsbefore use.
  • Read the instructions before testing andadhere to the step-by-step directions.
  • Understand the testing procedure andfactors that may interfere with theaccuracy of the selected test.
  • If unsure about the testing procedure orresults, contact the primary care provideror the manufacturer.
  • Use an accurate timing device whenperforming the tests.
  • If using collection testing kits thatrequire mailing, proper collection, storage,and shipment are critical to obtainingaccurate results.
  • Report positive test results immediatelyto the primary care provider to confirmresults and obtain further medicalevaluation.
  • Question negative test results andconfer with the primary care provider,especially if experiencing any symptomsor have any concerns.
  • Patients with visual impairments orproblems with dexterity-ask forassistance when performing tests or bereferred to their primary care providerfor testing.
  • Patients with bleeding disorders ortaking anticoagulants-because excessivebleeding may occur with tests thatrequire a finger stick blood sample-confer with the primary care providerbefore using.

Adapted from reference 2.

Pharmacists can be a patient'sbest resource with regard to theproper selection of the variousat-home diagnostic and monitoring testscurrently on the market. These productsfall into the personal diagnostics category.At-home diagnostic tests may assistpatients in detecting or monitoring certainmedical conditions, according tothe FDA's Office of In Vitro DiagnosticDevice Evaluation and Safety.1 At-hometesting provides various advantages,such as privacy, convenience, ease ofuse, and low cost. The FDA classifies athometest kits into 2 categories1:

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

Self-diagnostic kits provide patientswith information about their currenthealth condition, which enables themto make informed decisions. Althoughthe use of diagnostic kits may be convenient,the kits should never replace afollow-up visit with a physician. Properuse of these tests and adhering to themanufacturer's directions regardingtesting protocol are crucial to obtainingaccurate results.2 At-home diagnostictests may provide a patient with valuableinformation and enable patients toseek medical intervention earlier, preventingfurther medical complications.The Table lists some of the varioustypes of at-home tests available.

Selecting an At-HomeDiagnostic Kit

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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 testsperform as well as those used by healthcare professionals; however, thesetests must be used properly to ensureaccurate results.2 Pharmacists can bea fundamental source of informationfor patients seeking the use of at-homediagnostic test kits, as well as makingcertain that patients are adequatelycounseled on their proper use. Oftenthe selection of appropriate at-hometests may be based on ease of use, easeof interpreting results, presence of acontrol, and cost.2

During counseling, pharmacists alsomay assess the patient's symptoms andascertain if immediate medical evaluationis warranted. It is important forpatients to consult with a health careprofessional, if needed, as well as thepatient information hotlines found inmost kits, if patients are unsure abouttest results or testing procedure. Patientsalso should be reminded thatalthough these testing kits may be beneficial,patients should always maintainroutine visits to their primary healthcare provider.

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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 TechnologySystems 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 InnovationInc)
  • 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 CoInc)

Prostate-Specific Antigen (PSA)

  • BIOSAFE PSA Screen (BIOSAFE Medical Technologies Inc)

Thyroid

  • BIOSAFE Thyroid Stimulating Hormone (BIOSAFE MedicalTechnologies 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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