At-home diagnostic testing kits provide patients with convenience and privacy, but it is critical that they understand how to properly perform such tests to obtain accurate results. 

Pharmacists are in a pivotal position to aid patients in the selection of and proper use of at-home HIV diagnostic testing kits. They can also be instrumental in educating patients about modes of transmission, preventive measures, risk factors, and the virus itself.

An estimated 1.1 million individuals age 13 and older live with HIV, including an estimated 162,5000 representing an estimated 15% who have yet to be diagnosed, according to the CDC

The FDA regulates the tests for detecting HIV, and the FDA-approved options that can be employed to test for HIV include:2
  • A patient collects the sample at home, mails it to a medical laboratory, and trained health professionals run the test.
  • A patient collects a sample, performs the test and obtains the results at home.2
  • Trained health professionals collect a sample and perform the test in a professional medical setting to obtain results.
At-home testing kits can be beneficial, because they provide convenience, expedient results, privacy, and are sometimes cost-effective, according to the FDA.

At-home HIV diagnostic kits detect antibodies to HIV.Because 3 weeks to 6 months may be warranted for an exposed individual to develop sufficient antibodies, the time of possible exposure to HIV must be taken into consideration to ascertain the proper time to take the tests. 

There are 2 at-home HIV diagnostic tests kits on the market: the Home Access HIV-1 Test System and the OraQuick In-home HIV test.The Home Access HIV test, available as express mailing and standard testing kits, requires a blood sample, and the sample is then mailed to a testing center to obtain the results. OraQuick is a saliva-based testing kit that provides immediate results in the home.4-7 Since the approval of at-home HIV test kits, the FDA predicted that the availability of these testing kits may be beneficial to public health by assisting more infected patients in becoming aware of their HIV status, thus possibly diminishing transmission of the virus.

The FDA also said that these at-home tests are targeted toward individuals who would otherwise not be tested, because of fear or concerns about a lack of confidentiality or privacy.8

The Role of the Pharmacist 
Pharmacists are in a pivotal position to remind patients that while at-home kits have advantages, they can also have limitations, especially if used incorrectly. Proper sample collection, storage of testing kit before testing, following the testing protocol, and shipment of testing kits that require mailing are critical to obtaining accurate results. Patients electing to use these kits should be reminded to only use those that are FDA-approved and when in doubt to always seek counsel from their pharmacists or primary health care providers. During counseling, patients should always be prompted to follow up with their primary health care providers if they have any concerns and to confirm results, as early detection and treatment are critical. The manufacturers of both testing kits encourage patients to contact their 24-hour help lines to answer questions or concerns and to contact their primary health care providers to confirm their results, whether they are negative or positive. Pharmacists should also encourage patients to explore the HIV patient educational resources, modes of transmission, preventive measures, and risk factors. Through patient education, pharmacists can empower patients with knowledge to reduce the transmission of HIV.

Pharmacists should direct patients to the manufacturer websites for more information about these testing kits: Home Access Test (testkitsathome.com/home-access-express-hiv-1-test-kit-results-in-1-day/) and OraQuick HIV Test  (oraquick.com/What-is-OraQuick).        

Additional resources include the CDC (cdc.gov/hiv/default.html), and the US Department of Health and Human Services (cdc.gov/hiv/default.html).     
 
Yvette C. Terrie, BSPharm, RPh, is a consulting pharmacist and a medical writer in Haymarket, Virginia. 

References
  1. CDC. Statistics overview. cdc.gov/hiv/statistics/overview/index.html. Published November 16, 2018. Accessed December 11, 2018. 
  2. FDA. HIV testing. fda.gov/forpatients/illness/hivaids/prevention/ucm117922.htm. Updated August 14, 2018. Accessed December 11, 2018. 
  3. FDA. Home Use Tests. fda.gov/medicaldevices/productsandmedicalprocedures/invitrodiagnostics/homeusetests/default.htm. Updated September 27, 2018. Accessed December 11, 2018. 
  4. CDC. Home tests. cdc.gov/hiv/testing/hometests.html. Updated October 16, 2015. Accessed December 11, 2018. 
  5. Briggs G. Home testing and monitoring devices. In: Krinsky D, Berardi R, Ferreri S, et al, eds. Handbook of Nonprescription Drugs 19th ed. Washington, DC: American Pharmacists Association; 2018.
  6. In-Home HIV Test. OraQuick website. oraquick.com/What-is-OraQuick/OraQuick-In-Home-HIV-Test. Accessed December 11, 2018. 
  7. FDA. Information regarding the OraQuick In-Home HIV Test. fda.gov/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/PremarketApprovalsPMAs/ucm311895.htm. Updated December 5, 2018. Accessed December 11, 2018. 
  8. At-home HIV testing: Educating patients. American Pharmacists Association website. Published March 1, 2013. https://www.pharmacist.com/home-hiv-testing-educating-patients  Accessed December 11, 2018.