The Food and Drug Administration has authorized the first-ever at-home diagnostic tests for chlamydia and gonorrhea in hopes of controlling the STD epidemic in America.
Rather than requiring people to travel, the newly-authorized test kit is administered following a health questionnaire filled out by the patient and reviewed by a doctor.
Then, it is mailed directly to that patient for at-home use before being sent back through the mail to a laboratory for analysis.
The Simple 2 Test will be marketed by LetsGetChecked, a New York-based company specializing in lab testing that sees people take samples in the comfort of their own homes and send them out to a lab, which returns results securely online.
The new test will not require a prescription and will save people a trip to a doctor’s office for invasive testing and will help people seek treatment before their infection worsens.
Federal regulators celebrated this as a win for public health that will help combat steadily rising rates of STDs in the US, a concerning trend that worsened during the pandemic when access to regular preventative care was stunted.
Gonorrhea has been on the rise since 2012, with rates in men per 100,000 rising considerably higher than in women
Chlamydia has had a more steady increase since 2012. But since 2001, cases have more than doubled
Dr Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health said Thursday: ‘This authorization marks an important public health milestone, giving patients more information about their health from the privacy of their own home.
‘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.’
After HIV, which can be screened for at home with an antibody test, this is the first FDA-approved self test.
For $99, the Simple 2 test will be sent to a person’s house in discreet packaging. After receiving the kit, patients will have to fill out a health questionnaire for a doctor to review. They will then collect and submit vaginal swabs or urine samples, which can detect the bacteria that cause gonorrhea and chlamydia.
Users then send their kits through the mail for free to the same accredited labs used by doctor’s offices and hospitals, which the company says ensures accuracy.
People will receive their results in two to five days via a secure online portal. If the test is positive, they can consult with a healthcare provider to discuss treatment options.
The main risk of using the at-home test is receiving a false negative result, which can ‘result in delays to effective treatment, progression to disseminated disease, and spread of infection to other persons throughout your community,’ according to the FDA.
The company can also help administer necessary medication to the patient if they do consult with a physician after receiving a positive result.
Less than half of men are using condoms, compared to between 75 and 55 percent since 2011 and an increasing number are relying on women to use contraception
The company said its services will also benefit the partners of those who test positive: ‘If your results are positive and you’re suitable for treatment, we can also offer treatment for your partner(s) at an additional cost. All they need to do is start their own virtual consultation and we can get them on the same path towards peace of mind.’
Low levels of access to preventative care and disease screening during the pandemic, on top of lax attitudes toward contraception, were major drivers of the increase in the number of STD cases.
There were 2.53 million cases of chlamydia, gonorrhea, and syphilis in 2021, according to the Centers for Disease Control and Prevention (CDC), up almost 6 percent from the figure in 2020 and a 7 percent increase from 2017.
Additionally, the surge could also be attributed to the fact that less than half of men are using condoms, compared to between 75 and 55 percent since 2011. An increasing number are now relying on women to use contraception to prevent pregnancy.
However, birth control does not protect against STIs, an Office of population affairs annual family planning report said.
Between 2020 and 2021, the gonorrhea rate among men increased by more than six percent (from 234.8 to 249.7 per 100,000 men) and the rate among women increased by more than two percent (from 173.8 to 177.9 per 100,000 women).
Chlamydia cases, which were more common with 1.58millon cases in 2020, shot up to 1.64million in 2021.
The above map shows gonorrhea cases across the US in 2021
Alaska, a largely rural state where healthcare access might be limited, had the highest rate of Chlamydia. It has a relatively young population which is, in general, more likely to have STDs
Dr Leandro Mena, director of the CDC’s division of STD prevention issued a grim warning last spring the STI epidemic in the US ‘shows no signs of slowing.’
New data published in the New England Journal of Medicine regarding doxycycline, one of the most common drugs used to treat STDs which is cheap and has been sold for half a century, is giving doctors some measure of hope that the epidemic of STIs could be curtailed.
The study, published in April, looked at 501 gay men, bisexual men and transgender women in Seattle and San Francisco with a history of sexually-transmitted infections who had taken one doxycycline pill within 72 hours of having unprotected sex.
Participants who took the pill were about 90 percent less likely to get chlamydia, 80 percent less likely to get syphilis, and more than 50 percent less likely to get gonorrhea compared with people who did not take the pills after sex.
Whether the CDC will formally recommend doxycycline as a different type of morning-after pill is still in question as officials will have many factors to consider, such as the drug’s adverse health risks.
For instance, when combined with the blood thinner warfarin to treat or prevent blood clots, doxycycline can thin out blood further, raising a person’s risk of severe bleeding and bruising.
Other medications including over-the-counter antacids and some barbiturates render the medication less effective.
A recent analysis conducted by the health research firm InnerBody used federal data to rank the cities with the highest rates of STDs, including HIV, chlamydia, gonorrhea, and syphilis.
Southern cities were disproportionately represented in the roundup, which looked at metropolitan areas in the US.
They accounted for 14 of the top 25 of states with the highest concentrations of STD cases.
And most of the top-scoring cities were located in states that spend less than the national average on healthcare for their citizens.