NAPLEX Question of the Week: Interpreting OTC Diagnostics

This week's question involves interpretation of an important OTC self-test.
NAPLEX Question of the Week: Interpreting OTC Diagnostics
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You receive a phone call from a 29 year old female who recently bought the Oraquick test from your pharmacy. Her past medical history is significant for allergic rhinitis and hypothyroidism. She takes levothyroxine 100mcg by mouth daily along with Flonase nasal spray 1 instillation in each nostril daily. She followed the directions per the manufacturer's instructions and the test showed a positive result. 

Which of the following is detected by Oraquick?

A. SARS-CoV-2

B. HIV

C. Influenza

D. HCG

Answer with rationale:

The correct answer is B.

Rapid diagnostic testing is becoming more and more available, with many pharmacists actively participating to improve patient access and ultimately care for a number of infectious diseases. A number of these tests for influenza, SARS-CoV-2, and even Group A streptococcus (S. pyogenes) i.e. "Strep throat" are available and allow for rapid prescribing of therapy. Answers A, C, and D are incorrect as the Oraquick test is not for any of these potential pathogens or conditions (HCG is elevated in pregnancy). There are a number of branded products available for testing of these. 

Oraquick is an in vitro home diagnostic test used to detect HIV antibodies (HIV-1 and HIV-2) qualitatively. As indicated by the name, the test is completed via oral fluid from the gumline (not saliva) with results available in approximately 20-40 minutes. Some important tips for use are the following:

1. The test should ideally be used 3 months or after the index event that may have led to HIV acquisition as it takes at least this period of time for antibodies to develop.

2. Do not eat, drink, or use any oral care products within a half hour prior to administering the test. 

3. The test is indicated for anyone 17 years of age or older.

4. All positive results are only considered preliminary and should be confirmed by testing with a healthcare professional. This would be critical counseling for the pharmacist taking this phone call as triage/medical referral is an important NAPLEX competency statement (3.1). 

A very important part of pharmacy practice going forward will be administration and interpretation of rapid diagnostic tests with subsequent treatment if indicated. Knowledge of these are critical for pharmacists as this allows for quicker treatment of pathogens which will improve time to effective therapy.

More information about Oraquick from the FDA can be found here: https://www.fda.gov/consumers/consumer-updates/facts-about-home-hiv-testing

Until next week!

Dr. B

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