Author: Yvette C. Terrie, BSPharm, RPh
Pharmacists are in a pivotal position to help patients select and properly use at-home test and monitor kits.
According to the FDA’s Office of In Vitro Diagnostic Device Evaluation and Safety, in vitro diagnostic tests are often utilized to detect certain medical conditions or infections.1,2
At-home test/monitor kits provide patients with the convenience of detecting the presence or absence of a medical condition and monitoring certain medical conditions.1,2
While test/monitor kits are frequently utilized in physicians’ offices, health care laboratories, and other health care settings, a variety of diagnostic test kits are also designed and marketed for patients to use in the privacy of their own homes. According to the FDA, at-home testing/monitoring kits can be beneficial because they provide privacy, convenience, and expedient results and are sometimes cost-effective.3
While test/monitor kits have advantages (Table 1), they also have limitations that can cause serious health consequences for individuals who rely solely on the tests instead of following up with their physicians for confirmation, further evaluation, and treatment, if warranted.2,4
Patients must be reminded that these tests are designed to help identify medical conditions, but not to replace routine medical exams with a health care provider.4
The FDA requires that at-home test kits perform as well as those used by health care professionals and states that following proper testing procedure is critical to obtaining accurate and reliable results.2,3
Advances in technology, such as monoclonal antibodies, have led to simpler test/monitor kits that can be safely used at home.2
Some tests provide rapid results right at home, while other tests require patients to provide a small test sample that has to be mailed to the manufacturer to process; then the patient is informed of the results via phone. Proper collection, storage, and shipment of test samples are critical steps to ensuring test accuracy.2,4
In addition, patients should be aware that test results may be affected by severe temperature changes, taking urine samples too early or too late in the day, or ingesting certain foods.4
Selection of test/monitor kits may be based on the cost of the test, complexity of a testing procedure, or the ease of interpreting results.2,4
With most testing/monitoring kits, an indicator changes color, and the results can be interpreted according to the manufacturer’s instructions.2
FDA Classification of At-Home Test Kits
Collection kit: The patient collects the sample, mails it to the designated laboratory, and obtains results from the lab.
Test kit: The patient collects the sample, performs the recommended testing procedure, and obtains results at home.
A host of at-home test/monitor devices are on the market. Although pregnancy test kits, ovulation detection kits, and blood glucose monitoring systems are popular, there are many other types of test/monitor kits. Table 2 lists categories for which test/monitor kits are available.1-3
In July 2012, the FDA approved OraQuick In-Home HIV Test (OraSure Technologies, Inc)—the first and only oral HIV at-home test kit—for patients 17 years and older. The kit allows patients to use an oral swab instead of a blood sample, and the results are provided in about 20 minutes.5-7
The FDA stresses that patients must be aware that positive test results using OraQuick must be confirmed by laboratory-based testing.6
Furthermore, it is also important for patients to know that the test can provide false-negative results for various reasons, such as infection with HIV within 3 months before testing.5-7
The manufacturer’s website states that this test detects HIV infection if it is used 3 months after a risk event because the body takes up to 3 months to produce detectable antibody levels.5-7
Patients with concerns or questions should always be encouraged to seek counsel from their physician, including confirming the results and obtaining further evaluation and treatment. The manufacturer provides a 24-hour confidential support center for patients. More information on this test can be found at www.oraquick.com/What-is-OraQuick
While at-home test/monitor kits may be useful, they should never replace a follow-up visit with a physician, especially if the patient has symptoms. The use of at-home test/monitor kits can be beneficial in detecting various health conditions so that patients can obtain treatment early and possibly prevent further complications. For example, women who utilize home pregnancy tests can use the results to obtain prenatal care earlier and possibly prevent potential problems in the pregnancy. Patients with diabetes mellitus can monitor their blood glucose level routinely, which helps prevent and reduce the development of associated complications. Test/monitor kits can also detect asymptomatic conditions, such as hypercholesterolemia, enabling patients to seek medical treatment if warranted.
Adhering to directions, such as timing and proper sample collection, is crucial to obtaining reliable results (Table 3). It is important for patients to consult a health care professional, if needed, or refer to the consumer help information in test/monitor kits to answer questions about procedures and results. It is important to note that all tests are not FDA approved. Patients can obtain more information on certain tests on the FDA website: www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfIVD/Search.cfm
. When helping to select at-home test/monitor kits, pharmacists should advise patients to adhere to the tips (Table 3) to ensure that the kits are used properly and safely to obtain accurate results.2,7
Ms. Terrie is a clinical pharmacy writer based in Haymarket, Virginia.
In vitro diagnostics. FDA website. www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/InVitroDiagnostics/default.htm. Accessed August 26, 2013.
Briggs G, Hurley H. Home testing and monitoring device. In: Krinsky D, Berardi R, Ferreri S, et al, eds. Handbook of Nonprescription Drugs 17th ed. Washington, DC: American Pharmacists Association; 2012.
Home use tests. FDA website. www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/InVitroDiagnostics/HomeUseTests/default.htm. Accessed August 26, 2013.
Home diagnostic kits: the ultimate house call. US Department of Agriculture Food and Nutrition Service. www.agis.com/Document/413/home-diagnostic-kits-the-ultimate-house-call-by-usfda.aspx. Accessed August 26, 2013.
HIV home test kit approved by FDA. Medical News Today website. www.medicalnewstoday.com/articles/247407.php. Accessed August 26, 2013.
Information regarding OraQuick In-Home HIV Test. FDA website. www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/PremarketApprovalsPMAs/ucm311895.htm. Accessed August 26, 2013.
OraQuick product information. OraSure Technologies website. www.oraquick.com/What-is-OraQuick. Accessed August 26, 2013.
How you can get the best results with home use tests. FDA website. www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/InVitroDiagnostics/HomeUseTests/ucm125664.htm. Accessed August 26, 2013.