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New At-Home STI Test Could Help Stop The Spread Of Infection
Checking for sexually transmitted infections (STIs), which are notoriously underreported and stigmatized, may soon get easier now that U.S. Authorities have recently approved the first commercial at-home test kit for STIs other than human immunodeficiency virus (HIV). The kit tests for gonorrhea and chlamydia from a vaginal swab or urine sample that can be collected in the privacy of one's home. The samples are mailed to a lab for analysis, and people with positive results are put in contact with a physician. Experts say that the Food and Drug Administration approval this past November could lead to far more STI testing in the U.S., but questions remain about how officials will handle the approval of other, similar tests in the future.
The FDA's approval of the kit, called Simple 2 and made by a company called LetsGetChecked, comes as STI cases in the U.S. Are rising at a rate unprecedented in the modern era. Gonorrhea cases rose by 28 percent between 2017 and 2021, and chlamydia cases rose by 4 percent between 2020 and 2021—a trend some epidemiologists attribute to decreased funding for public health services during this period.
Although the nation's STI epidemic is getting worse based on the STI test results that do get reported, the overall testing rates themselves remain low. This is largely because many people fear buying a test at a drugstore or going into a primary care facility—where experts say clinicians can sometimes appear judgmental about unprotected sex, says epidemiologist Barbara Van Der Pol at the University of Alabama at Birmingham. Being able to order a reliable kit online without a face-to-face interaction or doctor's prescription could help normalize STI testing, she says. "Instead of avoiding it, it will help people catch things earlier," she says, adding that the approval is "a great thing."
LetsGetChecked is not the first to offer mail-order or over-the-counter self-collection tests. Numerous companies offer similar services that can cost hundreds of dollars and are not always covered by insurance. But Van Der Pol says FDA approval for Simple 2 makes it more likely that government and private insurers will eventually cover the test, which currently costs $99. Approval could also make it possible for local public health agencies to offer the kits at health fairs or free clinics, rather than expecting people to seek STI exams or kits out on their own.
"It's a game changer," says Charlotte Gaydos, an infectious disease expert at Johns Hopkins University. For nearly 20 years her team has offered a free testing program, called I Want the Kit, for STIs including HIV. The team sends people vaginal, penile or anal swabs with instructions to collect samples and mail the swab back to Johns Hopkins for analysis. Research from Gaydos's lab and others has shown that people can safely perform self-collection at home and obtain accurate results. In a statement to Scientific American, the FDA said it evaluates the stability of mailed samples and whether users can correctly collect them, as well as whether kits contain hazardous chemicals that could potentially harm users.
Gaydos' team analyzes I Want the Kit samples using FDA-approved assays similar to those used in Simple 2, and she says her group plans to seek direct approval for its collection kits as well. Test kits such as those used for COVID, along with genetic tests such as AncestryDNA, have already normalized at-home testing, she says. This could increase the number of people regularly testing themselves for STIs, Gaydos adds. "Things are very much changing for the better."
The FDA's recent approval comes with a shift in how the agency regulates tests for STIs and other conditions. Many clinics use assays that are categorized as so-called lab-developed tests (LDTs), which do not currently require FDA approval. Some LDTs allow people to collect their own sample, although the collection and testing must both be done in a clinic, not at home.
But the FDA still considers at-home collection kits to be devices that are subject to regulation and don't fall within the LDT category—meaning some commercial STI-testing companies may have been operating in an unclear legal space. The FDA has generally not enforced this regulation. But in September the agency announced a proposed rule that would require the makers of both LDTs and over-the-counter at-home tests (including STI tests already on the market) to seek FDA approval.
Those plans have drawn pushback from some public health groups, particularly those working with high-risk LGBTQ populations, who worry it will cause companies to roll back or stop investing in STI tests already available on the market. In a public comment, the National Alliance of State & Territorial AIDS Directors (NASTAD) wrote that requiring companies and health departments to go through the lengthy and expensive FDA approval process would undermine public health efforts by "delaying identification of infection, engagement in treatment, undercutting public health surveillance, and, most crucially, exacerbating health inequities."
The FDA says it exercises enforcement discretion on such tests. When deciding whether to crack down, an agency spokesperson explained to Scientific American, it "considers a number of factors, and may consider whether the laboratory is actively working with the FDA to achieve authorization."
Ultimately, Gaydos says, public health experts would like to see FDA approval for truly at-home STI tests that provide an immediate result without the need to mail samples to a lab—much like how COVID test results appear minutes after sampling. Two companies already have FDA approval for immediate tests for chlamydia and gonorrhea, but the analysis systems are so complex and expensive that the tests can only be performed in a clinic. Gaydos says STI test kits that can be used in a similar way to at-home COVID tests are already undergoing clinical trials, and the results so far show them to be highly accurate. "We're very close," she says.
A main concern with at-home tests is that public health agencies such as the U.S. Centers for Disease Control and Prevention would lose the ability to easily track STI rates. As seen with COVID home testing, people rarely voluntarily report at-home test results. Some states require companies and clinics that analyze samples to report positive results to public health authorities, but it would be difficult to enforce this with individuals. LetsGetChecked did not immediately respond to questions about whether it plans to report positive results obtained from its self-collection kits.
But Van Der Pol says these are minor concerns, given the urgent need for increased STI testing. Because care cannot be fully monitored, many STI statistics are already based on voluntary self-reports. It is impossible to confirm, for example, whether people with such infections take antibiotics they may have been prescribed or whether they inform their partners. Furthermore, epidemiologists estimate that only a small percent of STI cases are detected in the first place because the majority of cases of some STIs, such as chlamydia, are asymptomatic and so few people seek testing in clinics.
"We can't be paralyzed by the need for perfection, and [LetsGetChecked's service] is still one more option in our tool kit," Van Der Pol says. If even half a million people tested themselves with Simple 2 and 20 percent of those sought care in the clinic, she says, "we still treated 100,000 more cases than we knew about."
The 5 Best Herpes Test Kits For 2024
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Testing for herpes used to mean a trip to the doctor's office. But thanks to at-home herpes test kits, you can receive your results privately in just a few days.
Genital herpes is caused by two viruses called herpes simplex virus type 1 (HSV-1) and herpes simplex virus type 2 (HSV-2). Globally, approximately 67% of people younger than 50 years oldhave HSV-1, while 13% of people ages 15 to 49 years have HSV-2.
An in-person appointment with a doctor could require a few different tests, including a virus antigen detection test, and/or an antibody test. This could require multiple pricks or trips to the doctor to accomplish.
An at-home test kit, on the other hand, can be done by yourself in private.
You can order a herpes test kit online — which may include a swab test or finger-prick blood test — and send the sample back in the mail. Most companies will send your results within 5 business days.
When researching at-home herpes tests, we looked for options with fast and accurate results and excellent customer feedback to compile our list of best buys.
Here are the criteria we considered:
FYI: We did include a couple of options that may call for you to leave home to pick up your test kit, so they may not fall 100% into the at-home category. But they are solid options, nonetheless.
Best herpes test subscriptionWhen you join the LetsGetChecked subscription service, testing is easy and convenient as you receive everything you need to take your sample in a discrete kit through the mail. Plus, you'll save 25% on the full price of the kits.
There are also helpful videos on the website that explain the instructions in clear, straightforward language so you can be confident you're taking your sample correctly.
Like all other testing services on our list, LetsGetChecked is privacy and HIPAA compliant. Your results will be available online in 2 to 5 business days. Should your results be positive, you can contact one of the nursing team members who can help you determine a treatment plan.
What our tester saysOne of our freelance writers, Breanna Mona, was given the opportunity to test the LetsGetChecked Herpes Test to see firsthand what the testing kit process was, whether the test was difficult to perform, and how long it would take to get the results. Here's what she found.
Breanna appreciated how straightforward the ordering process was and shared that "the process was simple and took very little time to complete." After placing the order, it took about a week to for her to receive the kit, and the actual test results came back in 1 to 2 business days.
But she thought the blood collection process could be an issue for some users. Since Breanna had some experience testing out similar kits, she had already learned the best way to collect enough blood for the test. But she thought users who were new to finger-prick tests might find it difficult to collect enough blood.
Overall, Breanna said this test might be a good match for someone who wants to skip a visit to the doctor, someone who may not have insurance to cover a doctor's visit, or anyone who would prefer to keep the test and results private.
One of our freelance writers, Breanna Mona, was given the opportunity to test the LetsGetChecked Herpes Test to see firsthand what the testing kit process was, whether the test was difficult to perform, and how long it would take to get the results. Here's what she found.
Breanna appreciated how straightforward the ordering process was and shared that "the process was simple and took very little time to complete." After placing the order, it took about a week to for her to receive the kit, and the actual test results came back in 1 to 2 business days.
But she thought the blood collection process could be an issue for some users. Since Breanna had some experience testing out similar kits, she had already learned the best way to collect enough blood for the test. But she thought users who were new to finger-prick tests might find it difficult to collect enough blood.
Overall, Breanna said this test might be a good match for someone who wants to skip a visit to the doctor, someone who may not have insurance to cover a doctor's visit, or anyone who would prefer to keep the test and results private.
Pros & consSTD Check has more than 4,500 testing sites nationwide. You can choose an individual test like HSV-1 or HSV-2 for $45 each. You can also order a 10-test panel, which includes the most common STIs, such as chlamydia and gonorrhea.
The company is known for quick test results, which are sent to your online account in 1–2 days.
Once you complete your order online, you can select a local testing center based on your ZIP code. According to the company, in-person tests only take 5 minutes.
Your test and results will be completely confidential. If your test results are positive, a physician can answer questions about your diagnosis.
Pros & consFor $169, people with a vagina can test for six common STIs at once, including HSV-2. Tests require both a finger prick and a vaginal swab.
For the same price, people with a penis can also test for herpes by purchasing the company's STD Test for Men. It looks for the same six STIs as the other test, but sample types include a finger prick and a urine sample instead of a vaginal swab.
The kit includes prepaid shipping both ways, digital results, and detailed instructions. Once your kit arrives, you'll need to register it on Everlywell's website using the unique ID number included in your box.
In your kit, you'll receive all you need to collect a finger-prick sample and either a vaginal swab packet or a urine cup and urine sample tube.
After shipping your sample, you'll receive digital results on your account within a few days. If your results are positive, a board certified physician in your state will contact you at no additional cost to discuss your case and prescribe medication if necessary. Everlywell will also send you a personalized report detailing your results.
The site is HIPAA compliant and physician reviewed. This means your information is kept private, and medical information is approved by independent, board certified healthcare professionals.
Pros & consWith a finger prick, myLAB Box's at-home genital herpes test is pretty straightforward. Online lab results are provided within 2 to 5 days.
When you order a kit, you'll receive materials to take your finger-prick sample in discreet packaging. It also comes with simple instructions and a prepaid envelope to send the sample off for testing.
If your results are positive, you can schedule a free consultation with one of myLAB Box's doctors. The company works with labs that are certified by the Clinical Laboratory Improvement Amendments Act of 1988 (CLIA) and the College of American Pathologists (CAP). Plus, the website itself is HIPAA compliant.
Testing is not yet available in New York. The company is waiting for its state application to be approved.
Pros & consPriority STD has a 4.8 rating on Trustpilot with more than 2,600 reviews.
You can order the Priority STD individual herpes test online or by phone, which normally requires a waiting period of at least 12 days after exposure.
After scheduling an order, you'll be directed to find a lab near you. There are more than 4,000 labs to choose from, and you can use the site's online scheduling system to make an appointment.
STI test results are available online through a secure patient login, typically within 1–3 days of collection.
Pros & consGenital herpes is a common sexually transmitted infection (STI). You can contract it by having vaginal, anal, or oral sex with someone who has the STI.
HSV-1 can also cause oral herpes, which may lead to sores or blisters around the mouth. You can contract oral herpes by kissing or engaging in oral sex with someone who already has it.
Some cases of oral herpes (HSV-1) can lead to genital herpes (HSV-1 and HSV-2) since the virus can spread from the saliva of someone with the infection into your body through oral sex.
It generally takes 4–7 days for herpes symptoms to appear. In addition to sores or blisters — which are called herpes lesions — around your mouth or genitals, other possible symptoms may include:
Some people don't experience any symptoms at all, but they can still transmit the infection to others.
The popularity of at-home testing has increased over the past several years, and there are many reasons for this.
At-home herpes testing offers convenience and privacy and can be less expensive than in-person testing. Instead of making an appointment with your doctor for an in-person visit, you order the test kit online, collect your sample at your convenience, and mail it to the lab.
Collection methods are typically the same with both kinds of testing — you'll either do a genital swab, urine collection, or blood sample.
Keep in mind that some at-home test kits allow a finger-prick blood sample that you can collect at home. But for others, you may have to visit an in-person lab to have your blood drawn by a professional.
The downside of some at-home testing is that you may not have a doctor to help you interpret your results. In some cases, sample results are sent right to you, and it's up to you to interpret the information.
With herpes testing, you'll generally get a positive or negative, so the results aren't as complicated as some other types of tests. But having a doctor's guidance can be helpful if you don't know the proper next steps to take.
That being said, we recommend that with all the at-home herpes tests you have a physician follow-up or phone consultation with the clinical team when you get your results.
If you receive a positive result, you should schedule an appointment with a doctor to talk through treatment and next steps, regardless of whether you received follow-up care.
It's important to note that while testing for STIs is essential for your health, the Centers for Disease Control and Prevention (CDC) suggests that only people with herpes symptoms test for it.
Otherwise, people without symptoms or exposure may have inaccurate test results. The CDC states that those with a low risk for infection have a higher chance of getting the wrong test results.
It's also a good idea to test for herpes if you have been exposed to it or have been sexually active with a partner who has a history of herpes.
After receiving a positive test result, following up with your healthcare professional for fast treatment is the best next step.
If you're considering getting tested for herpes, you may wonder how to choose between the various options. Here are some things to consider:
Your HSV test results will likely be reported as negative (sometimes called "normal") or positive (sometimes called "abnormal"):
If your test results are positive for HSV, talk with a healthcare professional about your next steps.
Talk with a healthcare professional if you notice any sores on or around your genitals. Other STIs, like syphilis, can look like herpes but need different treatments. Treatment is needed to prevent complications and transmission.
Your doctor will let you know whether you should test for herpes or another STI, and they can help you get treatment if needed.
Are at-home herpes test kits accurate?These tests use the same type of samples used in a doctor's office. The accuracy of a herpes test primarily depends on when you get tested.
These tests use the same type of samples used in a doctor's office. The accuracy of a herpes test primarily depends on when you get tested.
When should I get tested for herpes?If you haven't had an initial outbreak, the best time to get tested for herpes is 12 days after exposure. This is because your body will have had time to produce antibodies that can be detected on a test.
A blood test can determine whether you have these antibodies.
Swabs, on the other hand, can detect the virus directly from an active herpes lesion.
If you haven't had an initial outbreak, the best time to get tested for herpes is 12 days after exposure. This is because your body will have had time to produce antibodies that can be detected on a test.
A blood test can determine whether you have these antibodies.
Swabs, on the other hand, can detect the virus directly from an active herpes lesion.
How can I prevent transmitting herpes?Although latex condoms can reduce the risk of transmitting STIs, condoms don't prevent herpes transmission. This is because not all herpes sores occur in areas that are covered by a condom.
If you're experiencing an active outbreak, you can prevent herpes transmission by:
Taking a daily antiviral herpes medication can also help prevent transmission, shorten outbreaks, and manage symptoms.
Although latex condoms can reduce the risk of transmitting STIs, condoms don't prevent herpes transmission. This is because not all herpes sores occur in areas that are covered by a condom.
If you're experiencing an active outbreak, you can prevent herpes transmission by:
Taking a daily antiviral herpes medication can also help prevent transmission, shorten outbreaks, and manage symptoms.
Are at-home herpes test kits private?Yes. All the tests listed here are completely confidential and private.
Your results won't be reported to your insurance company and, therefore, won't be placed on your permanent medical records.
The package you receive will only have the shipping label — no test name or visuals that indicate what it's for. These online platforms are also HIPAA compliant.
Yes. All the tests listed here are completely confidential and private.
Your results won't be reported to your insurance company and, therefore, won't be placed on your permanent medical records.
The package you receive will only have the shipping label — no test name or visuals that indicate what it's for. These online platforms are also HIPAA compliant.
What should I do if my herpes test results are positive?Many at-home services have independent physicians or nurses reach out to people with positive test results. They'll discuss your results with you and suggest a plan of action, possibly including medication.
If your results are positive, it's important to let any recent sexual partners know so they can also get tested.
Many at-home services have independent physicians or nurses reach out to people with positive test results. They'll discuss your results with you and suggest a plan of action, possibly including medication.
If your results are positive, it's important to let any recent sexual partners know so they can also get tested.
When should I talk with a doctor about herpes?If you have a primary care doctor who you regularly visit, you can share your results with them to provide better insight into your next steps.
If you don't have a primary care doctor, you can consult with a physician or nurse from the testing site about treatment options.
If you've been treating your symptoms with medication and are still in pain or discomfort, reach out to a healthcare professional.
If you have a primary care doctor who you regularly visit, you can share your results with them to provide better insight into your next steps.
If you don't have a primary care doctor, you can consult with a physician or nurse from the testing site about treatment options.
If you've been treating your symptoms with medication and are still in pain or discomfort, reach out to a healthcare professional.
Will I have to pay for a herpes test out of pocket?You'll have to check with your insurance network to see whether at-home STI tests are covered.
Insurance does typically cover them, but sites like Everlywell recommend verifying the purchase with your insurance.
Additionally, some networks may reimburse you for your purchase.
However, most at-home testing sites aren't currently partnered with any insurance companies, which means you'll have to reach out yourself.
If you don't have insurance, you'll likely have to pay for the test out of pocket. Some sites like Priority STD don't accept insurance, so it's a flat rate of $99 regardless of your coverage.
You'll have to check with your insurance network to see whether at-home STI tests are covered.
Insurance does typically cover them, but sites like Everlywell recommend verifying the purchase with your insurance.
Additionally, some networks may reimburse you for your purchase.
However, most at-home testing sites aren't currently partnered with any insurance companies, which means you'll have to reach out yourself.
If you don't have insurance, you'll likely have to pay for the test out of pocket. Some sites like Priority STD don't accept insurance, so it's a flat rate of $99 regardless of your coverage.
Can you be exposed to herpes and not get it?Yes. Research suggests that in couples where only one partner had genital herpes, the other partner contracted genital herpes within 1 year in only 5% to 10% of couples.
You can prevent transmission by:
Yes. Research suggests that in couples where only one partner had genital herpes, the other partner contracted genital herpes within 1 year in only 5% to 10% of couples.
You can prevent transmission by:
There's no current cure for herpes, but treatment can prevent or shorten outbreaks and manage symptoms.
Getting tested can prevent oral herpes from spreading to the genital area. It can also protect your sexual partners from contracting the virus.
Bonnie Azoulay Elmann is a freelance writer with 6 years of experience. She's written for Glamour, Marie Claire, Health, and more publications. You can find her work here.
2014 To 2021 Saw Increase In HIV Testing, PrEP In Transgender Persons
From 2014 to 2021, there was an increase in the number of transgender persons with an HIV test and who received preexposure prophylaxis (PrEP), according to a study published online Dec. 19 in the Annals of Internal Medicine.
Ya-Lin A. Huang, Ph.D., from the U.S. Centers for Disease Control and Prevention in Atlanta, and colleagues estimated the number of commercially insured transgender women (TGW) and transgender men (TGM) in the United States and their use of HIV prevention services in a retrospective analysis of secondary data from commercial databases from 2014 to 2021.
The researchers found that from 2014 to 2021, there was an increasing trend in the prevalence of transgender-related diagnosis codes and in the proportion of persons who used gender-affirming hormone therapy (GAHT). Persons aged 18 to 34 years drove the increases.
In 2021, 61.1 percent of the 10,613 TGW and 48.3 percent of 4,184 TGM with a test for or a diagnosis of a sexually transmitted infection (STI) in the previous 12 months had an HIV test; of these, 20.2 and 10.2 percent, respectively, were prescribed PrEP.
From 2014 to 2021, there was a substantial increase seen in the prevalence of TGW and TGM with a test for or a diagnosis of an STI, who had an HIV test, and who were prescribed PrEP.
"The health and well-being of transgender persons can be increased with holistic service models that include HIV prevention and other prevention services in addition to GAHT," the authors write.
More information: Ya-Lin A. Huang et al, HIV Testing and Preexposure Prophylaxis Prescriptions Among U.S. Commercially Insured Transgender Men and Women, 2014 to 2021, Annals of Internal Medicine (2023). DOI: 10.7326/M23-2073
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Citation: 2014 to 2021 saw increase in HIV testing, PrEP in transgender persons (2023, December 19) retrieved 28 December 2023 from https://medicalxpress.Com/news/2023-12-hiv-prep-transgender-persons.Html
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