Jala News – July 5, 2022
FDA Approves First At-Home Test for Chlamydia and Gonorrhea
In a significant development for public health, the US Food and Drug Administration (FDA) has authorized the first at-home test for chlamydia and gonorrhea. The Simple 2 Test, developed by LetsGetChecked, has received FDA market authorization, making it the first FDA-authorized test for a sexually transmitted infection that allows home collection.
Traditionally, individuals concerned about chlamydia or gonorrhea had to visit a doctor’s office to get tested. However, this new at-home test eliminates the need for such visits and allows users to collect their samples in the comforting privacy of their own homes.
To activate the test, users simply complete a health questionnaire and collect a vaginal swab or urine sample using the provided Simple 2 collection kit. The collected sample is then sent in for evaluation, and the results are later delivered online to the user. In case the test shows a positive result or the results are deemed invalid, a healthcare provider will follow up with the individual to provide appropriate guidance and support.
Dr. Jeff Shuren, the FDA’s Center for Devices and Radiological Health Director, highlighted the significance of this authorization, stating that it represents an important milestone in public health. Dr. Shuren emphasized the added advantage of allowing patients to gather more information about their health while staying in the comfort of their own homes.
The COVID-19 pandemic has significantly increased the popularity and demand for home diagnostic tests, prompting the FDA to support increased access to at-home diagnostic tools. By authorizing this at-home test for chlamydia and gonorrhea, the FDA aims to provide individuals with easier and more convenient access to crucial testing.
Chlamydia and gonorrhea are common sexually transmitted infections that can be transmitted through unprotected sex. Both infections can be effectively treated with antibiotics. Unfortunately, the pandemic has led to increased sexual activity and a decrease in routine screenings, contributing to the global spread of these diseases.
According to the Centers for Disease Control and Prevention (CDC), the US reported over 700,000 cases of gonorrhea in 2021, marking a staggering 118% increase since the record low in 2009. It is important to note that many individuals infected with these infections may not experience any symptoms, underlining the significance of routine screenings.
Gonorrhea symptoms include stomach or pelvic pain, increased vaginal discharge, painful urination, and bleeding between periods. If left untreated, the infection can lead to serious health problems, such as disseminated gonococcal infection, which can cause arthritis, skin problems, and tenosynovitis. In severe cases, it can even be life-threatening.
On the other hand, the CDC also reported over 1.6 million cases of chlamydia in the US in 2021, making it the most common sexually transmitted infection that year. Symptoms of chlamydia include pain or burning during urination, pain during sex, abdominal pain, abnormal vaginal discharge, swollen or tender testicles, and bleeding around the anus. Untreated chlamydia can cause permanent damage to the reproductive system in women and make it difficult to conceive. It can also lead to ectopic pregnancies, which occur outside of the womb.
With the FDA’s recent authorization of the at-home test, individuals now have increased access to a convenient and confidential method to get tested for chlamydia and gonorrhea. By promoting routine screenings and early detection, this development offers hope in curbing the spread of these common sexually transmitted infections and protecting public health.
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