Genital Herpes and Other STIs During Pregnancy

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."

FDA Authorizes At-home Chlamydia And Gonorrhea Test For The First Time

Earlier this month, the United States Food and Drug Administration authorized the first at-home tests for chlamydia and gonorrhea. The Simple 2 Test is available over-the-counter and costs between $58 and $99 per kit. Results are returned within a week and officials with the FDA hope that it helps curb the country's STI epidemic.

[Related: A guide to preventing, spotting, and managing STIs.]

Bacteria causes both gonorrhea and chlamydia. While HPV is a more prevalent STI, chlamydia and gonorrhea are the most commonly reported STIs in both the US and other countries. According to the FDA, roughly 1.6 million cases of chlamydia and over 700,000 cases of gonorrhea were reported in 2021. The STIs cause painful urination and bleeding between menstrual periods. They are generally easily treated with antibiotics, but if left unattended, both gonorrhea and chlamydia can cause serious health complications, including infertility.

Rates of gonorrhea, chlamydia, and syphilis have skyrocketed over the past 20 years. The increase is at least partially driven by a lack of funding of the Centers for Disease Control and Prevention's budget to fight the spread of STIs. Public health officials believe that easy and more accessible testing for STIs is one of the necessary tools needed to combat the country's STI crisis.

"This authorization marks an important public health milestone, giving patients more information about their health from the privacy of their own home," Doctor Jeff Shuren, director of the FDA's Center for Devices and Radiological Health, said in a press release on November 15. "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."

The Simple 2 Test kit can be purchased online at LetsGetChecked's website. It comes with tools to collect urine specimens or vaginal swabs. The patient then uses a prepaid shipping label to send the specimens to a lab. Users also must complete an online questionnaire. After two to five days, the patient can view the results online. If the test is positive or the results are invalid, users can arrange a telehealth consultation with a healthcare provider.

Doctor Matthew Golden, Director of the  Seattle King County public health departmen's HIV and STI control program, told NBC News that FDA is catching up on regulating an industry that has grown since the COVID-19 pandemic began.

[Related: This 'morning after' pill could prevent STIs from unprotected sex.]

"At some level, the horse has left the barn," said Golden. He noted that self-testing kits have been widely used for years, but "some of those tests, how well they perform is not well known. So cleaning this up makes sense."

University of Hawaii STI expert and medical consultant at the Hawaii State Department of Health's Diamond Head STI/HIV Clinic Alan Katz told Stat News that the Simple 2 Test uses the same investigative procedure that clinicians use to diagnose chlamydia and gonorrhea.

"This option is exceptionally useful for individuals who live in rural areas or are geographically distanced from a clinic where STI testing can be done and there is no telehealth option available," Katz said. "If a person screens positive, they can then contact a healthcare provider for further evaluation and treatment."

While unapproved home tests for chlamydia and gonorrhea have already been on the market, The Simple 2 Test is the first to go through the FDA's approval process. The approval could potentially make it easier for future such tests to clear the FDA's regulatory pathway.

Why, When And How Should You Check For Sexually Transmitted Infection?

VERIFIED The Importance Of Regular STI Testing: A Health Check-Up Guide

Written by Tavishi DograUpdated : December 29, 2023 7:19 PM IST

Sexually transmitted infections (STIs) represent a significant health concern globally. More than 1 million new STIs are acquired daily, according to WHO data. The prevalence of STIs continues to be a public health challenge, emphasizing the critical need for awareness, education, and regular testing. STIs spread between sexual partners via either oral and or vaginal sex. Most commonly, STIs include chlamydia, Gomorrah syphilis, Herpes and HIV. Dr Duru Shah, Director of Gynaecworld,explains understanding why, when, and how to check for STIs is pivotal in safeguarding personal health and preventing the spread of these infections.

Why Check for Sexually Transmitted Infections?

STIs pose severe risks to individual health and well-being. The reasons to get tested are multifaceted:

1. Early Detection and Treatment: Many STIs may not exhibit symptoms immediately, leading to delayed diagnosis.Have an open dialogue with your doctor about your sexual history, risk factors and follow-up.

2. Preventing Transmission: People can unknowingly transmit STIs to their partners. Testing helps in identifying infections, enabling informed decisions about sexual health and preventing transmission.

3. Protecting Long-Term Health: Untreated STIs can result in severe health consequences, such as infertility, pelvic inflammatory disease, certain cancers, and increased susceptibility to HIV.

4. Peace of Mind: Regular testing provides peace of mind, ensuring individuals can maintain their sexual health and well-being.

When to Get Tested?

Determining the right time for STI testing depends on various factors:

1. New Sexual Partners: It's advisable to get tested when entering a new sexual relationship or if you suspect your partner may have an STI.

2. Regular Testing: Individuals with multiple sexual partners consider regular testing, typically every 3-6 months.

3. Symptoms or Concerns: If you experience symptoms like unusual discharge, pain during sex, vaginal itching, or burning sensations while urinating, prompt testing is essential.

4. Before and During Pregnancy: STI testing for the couple is crucial before conceiving.

How to Check for Sexually Transmitted Infections?

Several methods are available for STI testing:

1. STI Clinics or Healthcare Providers: Visit a doctor or a specialized clinic for testing. They can perform physical exams, collect samples (urine, blood, swabs), perform molecular tests, and offer appropriate advice. This is the best method to confirm STIs rather than self-testing hits

2. Regular Screenings: Engage in routine screenings as healthcare providers advise. These screenings may include tests for HIV, syphilis, gonorrhoea, chlamydia, and others based on individual risk factors.

3. Opt for pre-exposure vaccination: Discuss available vaccines for HPV and hepatitis B, which can be sexually transmitted

Conclusion

Prioritizing sexual health through regular STI testing is crucial for personal well-being and public health. It's essential to normalize conversations around STIs. Education, regular testing, and seeking prompt medical attention in case of concerns are pivotal steps towards preventing and managing sexually transmitted infections. Remember, taking charge of your sexual health contributes significantly to a healthy and fulfilling life.

Prevention is the best cure

1. Practising Monogamy can help you stay away from STIs. Also, practising abstinence while you are being treated for an STI can prevent reinfection

2. Condoms:- Using condoms constantly and in a proper, correct manner is proven to be effective in preventing STIs. Both Male and female condoms are available

3. Take your vaccines! Consult your doctor today and get more information on how vaccines for both HIV and HPV can help you prevent STIs.

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