November 16, 2023: The USFDA has approved a first test for chlamydia and gonorrhea that will allow people to collect samples from home and not need to visit a doctor.
The drug regulator gave the marketing authorisation for the Simple 2 Test, a diagnostic kit made by the New York and Dublin-based LetsGetChecked company.
The Simple 2 Test is available over-the-counter and is intended for use in adult patients ages 18 years and older.
The Simple 2 Test uses vaginal swabs or urine specimens to detect the presence of the bacteria Chlamydia trachomatis and Neisseria gonorrhoeae.
Before the marketing authorisation was cleared by the FDA, patients in the US with the two conditions needed to test samples collected at a doctor’s office.
First after HIV
It is the first FDA-authorized test with at-home sample collection for any sexually transmitted disease other than HIV, according to a statement.
“This authorization marks an important public health milestone, giving patients more information about their health from the privacy of their own home,” said Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health.
“We are eager to continue supporting greater consumer access to diagnostic tests, which helps further our goal of bringing more health care into the home.”
According to the Centers for Disease Control and Prevention’s Sexually Transmitted Infections Surveillance Report, chlamydia and gonorrhea are the first and second most common bacterial sexually transmitted infections in the US.
The rate of these infections was rising steadily in the US, with an estimated 1.6 million cases of chlamydia and more than 700,000 cases of gonorrhea, in 2021 alone.
“Typically, both infections can be easily treated, but if left untreated, both infections can cause serious health complications for patients, including infertility,” according to the FDA statement.
The test results are delivered online, with follow-up from a healthcare provider in cases of positive or invalid test results.
Gonorrhea is transmitted through sexual contact with the penis, vagina, mouth, or anus of an infected partner. Ejaculation does not have to occur for gonorrhea to be transmitted or acquired. Gonorrhea can also be spread perinatally from mother to baby during childbirth.
People who have had gonorrhea and received treatment may be reinfected if they have sexual contact with a person infected with gonorrhea.
Symptoms of rectal infection in both men and women may include discharge, anal itching, soreness, bleeding, or painful bowel movements.
Rectal infection also may be asymptomatic. Pharyngeal infection may cause a sore throat but usually is asymptomatic.
Chlamydia is a common STD that can cause infection among both men and women. It can cause permanent damage to a woman’s reproductive system. This can make it difficult or impossible to get pregnant later.
Chlamydia can also cause a potentially fatal ectopic pregnancy (pregnancy that occurs outside the womb). One can get chlamydia by having vaginal, anal, or oral sex with someone who has chlamydia.
A pregnant person with chlamydia can give the infection to their baby during childbirth.