A Review of the Scope of Direct-to-Consumer Sexually Transmitted Infection Testing Services Offered on the Internet : Sexually Transmitted Diseases

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The Real World of STD Prevention

A Review of the Scope of Direct-to-Consumer Sexually Transmitted Infection Testing Services Offered on the Internet

Manca, Ellie MPH; Van der Pol, Barbara PhD, MPH; Exten, Cara PhD, MPH; Pinto, Casey N. PhD, MPH, NP-C

Author Information
Sexually Transmitted Diseases 50(6):p 323-328, June 2023. | DOI: 10.1097/OLQ.0000000000001783

Sexually transmitted infections (STIs) continue to increase as of 2020 surveillance data—despite the decrease in testing seen during the SARS-CoV-2 pandemic—with the exception of chlamydia, which is likely due to this lack of screening.1,2 The high incidence of STIs leads to undue health complications such as pelvic inflammatory disease, infertility, ectopic pregnancy, and congenital diseases.1,2 In addition, the lifetime medical costs of the top 8 most prevalent STIs were approximately $15.9 billion in 2021.3 Despite the adverse health outcomes and costs, STIs continue to be a public health burden likely exacerbated by the SARS-CoV-2 pandemic due to lack of access to or deferral of testing.2,4,5

The use of direct-to-consumer testing services has increased in past years for a variety of health concerns, such as genetic screenings, predictive cancer tests, general wellness tests, COVID-19 screenings, and STI tests.6 The term “direct-to-consumer” in this context refers to a product sold online directly to a consumer, without necessarily requiring the involvement of a health care provider or a physical examination.7 These direct-to-consumer services are available in a variety of different formats. Some services may include telemedicine with their service. Some require self-collection of samples in a nonclinical setting, with subsequent return to a testing laboratory,8 hereafter referred to as “STI self-collection kits.” Others provide a laboratory order for a consumer to attend a local laboratory for specimen collection by a health care professional (HCP), hereafter referred to as “HCP specimen collection.”

Using a direct-to-consumer modality can lower perceived barriers to seeking testing services. Specifically, for STIs, using direct-to-consumer modalities can decrease embarrassment or possible stigma,9 discrimination,10 self-consciousness, and perception of negative clinician attitudes.11 In addition, the SARS-CoV-2 pandemic restrictions decreased access to many direct patient care opportunities, such as primary care offices or urgent cares, by either decreasing patient volume or switching to telemedicine, and many government-funded STI clinics decreased their services due to COVID-19–related duties.12,13 These closures and shifts of clinical care further increased the use of direct-to-consumer modalities.14 However, challenges like quality of testing, result delivery, high cost, misleading information, and diagnostic reliability persist as issues with this testing format.8

With the emerging market of direct-to-consumer products rapidly increasing in popularity, a gap exists in both consumer and HCP understanding of the available modalities. Previously, the “secret shopper” method (where services are purchased using false identities and mock specimens) was used to investigate the accuracy of chlamydia and gonorrhea tests purchased on the Internet.15 Overwhelmingly, vendors were difficult to contact and unwilling to answer specific questions. From their limited sample, only 71% of vendors provided results, of which only 20% were accurate. Despite the increase in direct-to-consumer testing, this work has not been replicated due to protections making secret shopper evaluations unlawful in many states.16 A recent position statement from the American Sexually Transmitted Diseases Association (ASTDA) highlighted the importance of understanding and evaluating the quality of direct-to-consumer STI test collection services.8 Specifically, the statement highlighted College of American Pathology (CAP) accreditation, Clinical Laboratory Improvement Amendments (CLIA) certification, provider roles, collection processes, tests and bundles offered, cost, marketing of tests, and accuracy of information as areas of interest when investigating direct-to-consumer STI testing services.8

For the purposes of this study, we extracted publicly available, consumer-facing information from commercial websites that offer direct-to-consumer STI testing services. Using the ASTDA position statement as a guide, the objective of this review was to understand the scope of direct-to-consumer STI testing services being offered and provide recommendations for consumers and industry.


An online search of STI testing options was conducted from February 1, 2021 until March 31, 2021. Using Google, the search string “STD tests” was used to locate online vendors. The principal investigator and co-author recruited peers via text message to participate. To ensure geographically diverse and inclusive results, 9 college-educated volunteers (44.4% male, 55.6% female; average age 22.8 years; 22.2% LGBTQ) across the United States assisted with these searches. None of the volunteers purchased online STI tests in the past. Locations of the volunteers included Rochester, NY (urban); Seattle, WA (urban); Orlando, FL (suburban); Boston, MA (urban); Nashville, TN (urban); Providence, RI (urban); Philadelphia, PA (urban); Yonkers, NY (suburban); and Detroit, MI (suburban). Geographically diverse locations were chosen to account for differences in individuals' Google results based on location and previous search history. The top 3 Google hits, inclusive of Google advertisements, were selected for each participant. Then, the principal investigator (female; 23 years; Philadelphia, PA [suburban]) extracted remaining vendors up to and including the third page of Google results according to her own individual search. Google hits beyond page 3 were not searched due to the high number of repeat vendors (indicating saturation) and the low likelihood of a consumer searching beyond page 3. Finally, we compared our list to previously published research.17

Inclusion/Exclusion Criteria

This analysis includes any vendor that provided either (a) STI self-collection kits, or (b) a laboratory order for HCP specimen collection. Vendors that required insurance information or a virtual, face-to-face visit with a provider before accessing STI testing details were excluded due to the aforementioned “secret shopper” rules.16


For each vendor, 16 variables were extracted (Table 1), including Google advertisement status, CAP accreditation, CLIA certification, and more. The principal investigator conducted the data extraction process from the vendor's publicly available website. Any information not reported on websites was gathered through phone calls or email inquiries. Any questions during data extraction were reviewed by 2 subject matter experts who also performed random data checks to ensure reliability. All variables except 1 required no specialized knowledge of the topic. The information accuracy variable required knowledge of STI screening guidelines18,19 and Food and Drug Administration (FDA) regulations20 specific to screening recommendations and testing practices on the part of the data extractors. One subject matter expert reviewed 3 vendors alongside the principal investigator. Then, the subject matter expert reviewed 50% of the principal investigator's extracted information accuracy data to ensure consistency.

TABLE 1 - Variables of Interest
Variables Description
Google advertisement status Y or N
CAP accreditation Y or N
CLIA certification Y or N
Provider name listed Y or N
Curriculum vitae of provider(s) availability, if applicable Y or N
Provider role Description pulled from website
Presence of risk assessment Y or N
Who/what is used for testing? Self-collection kit or HCP specimen collection
Which laboratories are involved? Description pulled from website
Where are specimens sent?, if applicable Location
Which STIs are available for testing? STI and type of test, if available
How many specimens are needed? Number and type
What are the different bundles available for purchase? Description pulled from website
How did the website market the test(s)? Any additional descriptor of the tests
Price Price per bundle and individually
Misinformation, if applicable Direct quotes from websites that counter current screening recommendations
N, no; Y, yes.

Statistical Analysis

Descriptive analyses were performed on all variables. Thematic qualitative analyses were conducted on the extracted data by the primary investigator and 3 subject matter experts.

Ethical Considerations

The Pennsylvania State University IRB deemed this study nonhuman subjects research.


Study Sample

Twenty-four vendors were screened for this analysis. Two were excluded, as they required virtual, face-to-face visits with a provider prior to test purchase. An additional 2 redirected to an already included vendor, and thus were also excluded from the analysis. None of the 24 required insurance information to proceed. Twenty vendors were included in this analysis. Of the 20 vendors, 55% (11/20) appeared as Google advertisements. Only 5% (1/20) required the completion of a risk assessment prior to viewing testing options.

Laboratory Information

Overall, 95% (19/20) reported using CAP accredited laboratories. One vendor did not disclose this information. Similarly, 95% (19/20) reported using CLIA-certified laboratories. The same vendor did not disclose this information.

Clinician Role

Only 20% of vendors (4/20) provided names and biographies of clinicians involved in the STI testing process on their websites. One vendor also provided LinkedIn profiles. The remaining vendors did not list any specific provider names or biographies. Roles of the providers included consultations, review/approval of orders, and providing treatment(s) (Table 2). Four vendors of 20 (20%) provided no clinician information whatsoever.

TABLE 2 - Clinician Roles
Roles Vendors (N = 20)
 Not reported 10 (50)
 Physician consultation/advice provided [+ result only] 5 (25)
 Optional consultation available [+ or − result] 3 (15)
 Nursing team member provides results [+ or − result] 2 (10)
 Review/approve order 7 (35)
 Not reported 13 (65)
 Provide treatment [if possible]* 13 (65)
 Not reported 6 (30)
 Can purchase treatment online 1 (5)
No specific provider role listed 4 (20)
+, positive test result; −, negative test result.
Data shown as n (%).
*Only offered treatment for chlamydia, gonorrhea, trichomoniasis, syphilis, HSV-1/HSV-2.

What Is Used for Testing?

Nine vendors provided STI self-collection kits. Ten vendors provided a laboratory order for HCP specimen collection. One vendor offered both options. For this reason, the future results will consider 10 vendors that offered STI self-collection kits and 11 vendors that offered HCP specimen collection orders.

Laboratories Involved

Of the STI self-collection vendors (N = 10), 6 used a single laboratory while 2 send specimens to the nearest affiliated laboratory depending on consumer zip code. One STI self-collection vendor would not disclose which laboratories they use. The final vendor identified a laboratory, but the samples were collected, tested, and resulted at home.

All sites that offered HCP specimen collection (N = 11) used Quest Diagnostics as one of their in-person HCP specimen collection options. Two vendors used LabCorp in addition to Quest Diagnostics, and 2 vendors used other laboratories in addition to Quest Diagnostics.

STI Tests

The most common tests offered for STI self-collection kits (N = 10) were chlamydia, genital (n = 10); gonorrhea, genital (n = 10); human immunodeficiency virus (HIV) (n = 10); hepatitis C (n = 10); syphilis (n = 9); trichomoniasis (n = 9); hepatitis B (n = 8); HSV-2 (n = 7); HPV, genital (n = 6); and mycoplasma (n = 5). The most common tests offered for HCP specimen collection (N = 11) were chlamydia, genital (n = 11); gonorrhea, genital (n = 11); hepatitis C (n = 10); syphilis (n = 10); hepatitis B (n = 10); HSV-2 (n = 10); HIV (n = 9); HSV-1 (n = 9); HIV RNA early detection (n = 7); and trichomoniasis (n = 7). See Supplementary Table 1 (https://links.lww.com/OLQ/A920) for a comprehensive list.

The most commonly bundled tests for STI self-collection (N = 10) were chlamydia and gonorrhea (n = 9); chlamydia, gonorrhea, trichomoniasis, and HIV (n = 6); chlamydia, gonorrhea, and trichomoniasis (n = 4); and hepatitis B/C (n = 4). The most commonly bundled tests for HCP specimen collection (N = 11) were chlamydia and gonorrhea (n = 11); HSV-1/2 (n = 10); chlamydia, gonorrhea, HIV, syphilis, hepatitis B/C, HSV-1/2 (n = 4); chlamydia, gonorrhea, HIV, and syphilis (n = 3); and chlamydia, gonorrhea, HIV, syphilis, hepatitis B/C, HSV-1/2, and HIV RNA early detection (n = 3). See Supplementary Table 2 (https://links.lww.com/OLQ/A921) for a comprehensive list.

Specimen Source

The STI self-collection kit vendors offered urogenital chlamydia and gonorrhea (100%) more often than oropharyngeal and rectal chlamydia (30%) or oropharyngeal and rectal gonorrhea (20%).

The HCP specimen collection kit options often did not specify genital, rectal, or oropharyngeal specimens for chlamydia or gonorrhea. The majority, when disclosed, specified 1 urine sample.


For the cost analysis, we focused on chlamydia/gonorrhea, trichomoniasis, HIV, and syphilis based on CDC testing recommendations (Table 3). For the bundle of all 5 tests, the median (range) cost was $223 ($149–$326) and $313 ($161–$385) for the STI self-collection kits and HCP specimen collection, respectively.

TABLE 3 - Costs Per Test and Per Bundle, USD
STI Test(s) Self-Collection Kits HCP Specimen Collection*
Chlamydia and gonorrhea, genital 79 (49–99)/9 106.5 (60–159)/12
Trichomoniasis 79 (49–79)/5 109 (68–115)/4
HIV 78.5 (29–79)/6 79 (49–97)/10
Syphilis 78 (29–89)/5 55 (28–129)/11
All 5 223 (149–326)/8 313 (161–385)/4
HCP (ie, Phlebotomist in outpatient laboratory).
Data shown as median (minimum, maximum) / n.
n = total number of vendors who sold each test individually or the 5 test bundle. The median (minimum, maximum) calculation was done with this amount of values.
*Prices have been adjusted for laboratory fees, when disclosed.

FDA Information

Of the STI self-collection kit vendors, 30% (3/10) did not list any information regarding the FDA approval status of their tests. Two of 10 vendors (20%) had FDA statements that referred to specific tests. For example, 1 vendor's website had the following statement: “The only instant kit approved by the FDA is for HIV. All other instant kits are not approved by the FDA and sold illegally in the US.” Five vendors framed FDA statements in an overarching way, applying to all tests. For example, 1 vendor's search result indicates “FDA-Approved Lab Tests.”

Bundle Descriptors

Sexually transmitted infection test bundles often came with descriptors used for marketing purposes. For example, an STI self-collection kit vendor highlighted their “Standard 5” bundle [chlamydia; gonorrhea; trichomoniasis; HIV; syphilis] as their “Most popular choice, covering the same STDs as testing done by physicians and hospitals.” Another STI self-collection kit vendor distinguished select bundles as “Popular,” including HIV; chlamydia and gonorrhea 3-site; chlamydia and gonorrhea; HSV-2; the “V-Box” [chlamydia, gonorrhea, trichomoniasis, bacterial vaginosis, yeast]; the “Safe Box” [chlamydia, gonorrhea, trichomoniasis, HIV]; the “Total Box” [chlamydia, gonorrhea, trichomoniasis, HIV, hepatitis C, HSV-2, syphilis, mycoplasma genitalium, HPV]; and the “Uber Box” [chlamydia, gonorrhea, trichomoniasis, HIV, hepatitis C, syphilis, HSV-2]. Lastly, another STI self-collection kit vendor described their “Standard Test” [chlamydia, gonorrhea, trichomoniasis, HIV, hepatitis C, syphilis, HSV-2] as the “Doctor recommended bundle.”

Vendors using HCP specimen collection also used marketing descriptors. One vendor described their main panel [chlamydia, gonorrhea, HIV, syphilis, hepatitis A/B/C, HSV-1/2] as “doctor recommended.” Similarly, another vendor marketed their main panel [chlamydia, gonorrhea, HIV, syphilis, hepatitis B/C, HSV-1/2] as “most popular.” A third vendor's “Full STD Panel” [chlamydia, gonorrhea, HIV, syphilis] was marketed with “Doctors recommend this panel after unprotected sex.” A fourth vendor distinguished many bundles as “popular tests,” including the “Comprehensive STD Panel” [chlamydia, gonorrhea, HIV, syphilis, hepatitis A/B/C, HSV-1/2]; hepatitis A/B/C; the “MMA Fighter Blood Test” [HIV, hepatitis B/C]. Another vendor described their “Complete STD Panel” [chlamydia, gonorrhea, HIV, syphilis, hepatitis B/C, HSV-1/2] as the “most popular option.” Lastly, another vendor described almost all of their tests as “Most Popular,” including the comprehensive panel [chlamydia, gonorrhea, syphilis, hepatitis A/B/C, HSV-1/2].

Information Accuracy

Information found within vendor websites was misleading and often inaccurate. Two researchers examined consumer-facing information on multiple pages of each website for alignment with STI screening guidelines18,19 and FDA regulations.20 The information reviewed may not be comprehensive as it was impossible to read every webpage on each website.

Of the 10 vendors that utilized STI self-collection kits, 6 vendors (60%) were noted to have inaccurate information. Two vendors incorrectly cited HPV screening guidelines when they marketed HPV tests to people with a cervix over 30 years of age, instead of those aged 25 through 65.18 Additionally, another website published the following: “Human papillomavirus (HPV) is transmitted through sexual contact and causes almost 100% of cervical cancer in women. It is estimated that 1 in 2 will contract the virus in their lifetime.” They fail to mention that although the incidence is high, not all strains can/do progress into cervical cancer. Another example is the statement “We recommend you do this annually” in reference to a bundled kit [chlamydia, gonorrhea, trichomoniasis, HIV, syphilis, gardnerella, mycoplasma, ureaplasma], when this may not always be indicated depending on the consumer and their sexual risk behavior; further, testing for ureaplasma is currently never indicated.

Of the 11 vendors that offered HCP specimen collection, 7 (64%) were found to have inaccuracies on their websites. Four vendors offered bundles including HIV-1/HIV-2 fourth generation in conjunction with HIV RNA early detection, which is likely superfluous in most contexts. Another vendor marketed many tests underneath the heading of “Sexual Health,” yet many are not necessary nor indicated. This same vendor allows purchase of chlamydia, gonorrhea, and trichomoniasis treatments regardless of test results. Lastly, almost all vendors that offered a hepatitis B test fail to mention the low risk of infection among vaccinated persons.


Direct-to-consumer STI services offer a convenient method of screening, which can minimize stigma and improve access for patients who would not otherwise attend clinics.8 Despite these positives, there are concerns about the lack of regulation, questionable marketing claims, and adherence to guidelines. We examined 20 different entities that offered STI testing services using the ASTDA's position statement, with recommendations for consumers and industry provided.

The legality of direct-to-consumer testing without provider involvement varies from state to state, with 34 states and the District of Columbia allowing some form of direct-to-consumer testing, and the rest either having no associated laws or explicitly not allowing it.21 For example, Pennsylvania does not allow laboratory testing without a health care provider licensed to practice in the commonwealth.22 Many of the states that do allow direct-to-consumer testing require provider approval of tests to determine appropriateness and subsequent review of results to determine if further treatment is necessary. Since the vendors included in this study are available nationally, we expected to see more information about providers on the websites. Despite the necessity for provider involvement at the early testing phase, only about half of the entities in this study mentioned the possibility of a consultation with a provider, which was contingent upon a positive test result; further, 20% did not mention any provider involvement at all. On a positive note, most reported the possibility of providers prescribing treatment depending on the infection acquired (Table 2). Due to the nature of our study, it was not possible to confirm whether the vendors would follow through with the level of provider involvement reported on their websites.15 Previous literature has documented a lack of follow-through, despite these claims.15 Conversely, it is possible that all vendors adhered to specific state laws but did not indicate as such on their website, or did not describe provider roles. The importance of provider involvement from a legal perspective—to ensure clients receive appropriate tests and to discuss abnormal results and treatment options—cannot be overstated.

FDA approval provides consumers with the knowledge that tests are safe and effective based on their intended use.20 The vendors evaluated often provided blanket statements such as: “FDA Approved Lab Tests” and “Confidential FDA approved testing” which were only true in instances where consumers went for HCP specimen collection20; all STI self-collection kits are not FDA approved at the time of this study. Additional phrasing such as “FDA cleared” or “FDA registered” were often used, although they have no regulatory meaning. Only 1 vendor documented the lack of approval of STI self-collection and warned consumers. Similarly, many websites documented that they used CAP accredited or CLIA-certified laboratories, which is difficult to refute with the lack of transparency regarding which laboratories they use, specifically among the STI self-collection kit vendors. However, even if a vendor is using a qualified laboratory, if the method of collection for the test is not FDA approved, the validity of the test is questionable and may leave consumers with false positives or false negatives.

Marketing for testing kits/bundles on vendor websites was often misleading for consumers. Phrases like the “Standard 5,” “Most popular choice,” “Popular,” “Total Box,” and “doctor recommended” directed the consumer to certain bundles that were rarely indicated, based on CDC screening guidelines.19 The HCP specimen collection vendors were more likely to include individual tests that would not be recommended for the majority of sexually active consumers, such as ureaplasma, HSV-1/2, gardnerella, and mycoplasma.19 This bundling likely guides consumers to purchase unneeded and unwarranted tests, which increases price unnecessarily. Although the STI self-collection kits are not approved by the FDA,20 the bundles more often aligned with clinical recommendations.19 Ultimately, it is up to the consumer to choose a bundle based on descriptions, which will likely include unnecessary tests, or to conduct research to determine their own exposure and select exposure-based testing.

Vendor websites rarely discerned the site of specimen collection; none of the HCP specimen collection vendors reported this, and less than 30% of STI self-collection kit vendors offered oropharyngeal/rectal chlamydia and gonorrhea testing. Of those that did offer 3-site testing options, they did not provide any education or indication for testing. For certain populations, specifically men who have sex with men, rectal specimens can detect gonorrhea that would be missed by urogenital screening. For example, the STD Surveillance Network found that more than 70% of extra-genital gonorrhea infections and 85% of extra-genital chlamydia infections would not have been detected with only a urethral specimen.23 Direct-to-consumer testing is providing a needed service, but the importance of the availability of 3-site testing and education on who should be screened using extragenital modalities cannot be overstated.

Direct-to-consumer testing may increase access to care, especially among stigmatized groups and the uninsured. However, they may be cost-prohibitive. None of the vendors required insurance information to proceed, which increases access to testing for some, as only 32.6% of people are covered by their parents' insurance and 38.1% of people covered by private insurance were willing to use their insurance to pay for STI screening visits (among those roughly 14 through 26 years of age).24 However, this increases the disparity among individuals with low income who may be unable to afford direct-to-consumer testing, yet have higher rates of STIs.11,25 Further, those willing to pay may be forced to pay for the least expensive tests (ie, STI self-collection kits; see Table 3), which are not FDA approved and may be unreliable, or forced to select just 1 test instead of a bundle that matches their sexual risk.



There is a lack of regulation among direct-to-consumer STI testing services, yet they provide an accessible and destigmatized avenue for STI screening. Consumers will benefit from doing their own research prior to purchasing any product; however, we recommend consumers select vendors offering prescriptions for HCP specimen collection at local CAP accredited and CLIA-certified laboratories. Ideally, a vendor that offers an interaction with a provider is beneficial to a consumer. In this way, a consumer can thoroughly explain his or her own behaviors to obtain individualized tests that align with STI screening guidelines.18,19 In addition, if treatment is needed after a positive result, provider interaction can serve to alleviate concerns and provide patient education. Furthermore, a consumer should consult screening guidelines to discern his or her own indications for screening until vendors widely implement a behavior assessment or screening tool to assist with testing selection. From here, individual tests or bundles should be reviewed by price, taking note of any laboratory fees (ie, HCP specimen collection). Vendor selected bundles are rarely cost-effective, as many of the tests included within are not typically indicated.


Vendors should provide a screening tool to assess consumer behaviors prior to test purchase. This screening tool should provide guideline-based recommendations for screening based on consumer reported behaviors, allowing consumers to avoid excessive unneeded tests, while ensuring appropriate screening is completed. In addition, vendors should be transparent about their affiliated laboratories, sharing both CAP accreditation and CLIA certification statuses and laboratory locations. The site of specimen collection should be clearly specified, and options should be available for oropharyngeal and rectal swabbing for certain infections. Bundled tests should be aligned with clinical recommendations, and not saturated with tests that are not indicated. Website content should be vetted by a subject matter expert routinely for potential misinformation and alignment with clinical guidelines. Lastly, providers should be listed and involved in the result delivery process.


Our somewhat restrictive search string of “STD tests” may not have revealed all relevant vendors from the Internet. We excluded vendors that required insurance information or a face-to-face visit to include those that presented few barriers to a patient seeking care. However, this may have biased our sample, in that these excluded vendors may have been more aligned with guidelines or more likely to have a provider role. In addition, although our volunteers spanned 8 US states, Google results may differ across other states or territories; so, this analysis may not be generalizable to all readers. To this point, although we used multiple geographic locations, all vendor websites were searched for variables in 1 state (Pennsylvania); it is possible that website content may change based on location. Lastly, the prevalence of misinformation may have been underestimated since we did not search all webpages of each vendor website.


Overall, direct-to-consumer testing will continue to expand in popularity and be an informative public health service. Direct-to-consumer vendors should be more transparent, provide information that aligns with STI screening guidelines,18,19 include FDA regulations,20 have a strong HCP role, and reassess content annually to ensure alignment with guidelines to provide the best possible patient care.


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