FDA Approves LetsGetChecked Simple 2 Test for Chlamydia and Gonorrhea: November 15, 2023

Jul 22, 2024

What is LetsGetChecked Simple 2 Test prescribed for?  

The Simple 2 Home Sample Collection Kit is for anyone who is over the age of 18 who is sexually active and wants to test for chlamydia and gonorrhea.

What is the name of the drug and what does it do? 

The LetsGetChecked Simple 2 Test is an over-the-counter test that detects chlamydia and gonorrhea using vaginal swabs or urine samples. 

It offers a convenient way for adults aged 18 and older to test for these common STIs from the comfort of their homes.

How does it work? 

Users activate the test kit online, collect the sample at home, and send it to a lab for analysis. 

Results are delivered online, with follow-up from a healthcare provider if needed. The test helps in early detection of chlamydia and gonorrhea, enabling prompt treatment and reducing the spread of these infections.

What did the research discover? 

The LetsGetChecked Simple 2 Test, authorized by the FDA, is the first at-home diagnostic test for chlamydia and gonorrhea. 

In 2021 alone, there were an estimated 1.6 million cases of chlamydia and over 700,000 cases of gonorrhea in the United States. 

The test uses vaginal swabs or urine samples to detect Chlamydia trachomatis and Neisseria gonorrhoeae, the bacteria causing these infections. 

Early detection is crucial as untreated chlamydia and gonorrhea can lead to serious health complications, including infertility. 

Expanding access to STI testing can help curb the rising rates of these infections.

What are some of the side effects? 

The test itself has no side effects, but here are some symptoms of gonorrhea and chlamydia: 

Chlamydia:
  • Painful urination
  • Abnormal vaginal discharge in women
  • Discharge from the penis in men
  • Painful intercourse in women
  • Abdominal pain
  • Rectal pain, discharge, or bleeding if the infection is in the rectum
  • Eye redness, pain, and discharge if the infection spreads to the eyes
Gonorrhea:
  • Pain or burning sensation when urinating
  • Increased vaginal discharge in women
  • Discharge from the penis in men
  • Painful or swollen testicles in men
  • Rectal pain, discharge, or bleeding
  • Sore throat if the infection is in the throat
  • Eye redness, pain, and discharge if the infection spreads to the eyes

What are the dosage recommendations and how is it prescribed? 

The Simple 2 Test for chlamydia and gonorrhea is a direct-to-consumer test that can be bought without a prescription. 

To take the test, you activate the kit online and complete a health questionnaire for a healthcare provider to review. 

You then collect a vaginal swab or urine sample at home using the provided kit. After collecting the specimen, you send it back to the lab for testing. 

Results are provided online, and if the test shows positive or invalid results, you will receive follow-up from a healthcare provider.

Source:

FDA Grants Marketing Authorization of First Test for Chlamydia and Gonorrhea with at-home Sample Collection [Internet]. U.S Food and Drug Administration. 2023 [cited 2024 Jun 27]. Available from: https://www.fda.gov/news-events/press-announcements/fda-grants-marketing-authorization-first-test-chlamydia-and-gonorrhea-home-sample-collection

Reported by

Tags:

You May Also Like