| Test | Indication | Population | Cost* |
|---|---|---|---|
| Simple 2 Test for at-home gonorrhea and chlamydia testing | NAAT via urine (for people with a penis) or vaginal swab (for people with a vagina) to detect asymptomatic or symptomatic infections | Adults 18 years and older | $99 for a single test or $69.30 every 3 months for a subscription |
*—Cost according to LetsGetChecked.com. Price does not include clinician consultations or treatment.
NAAT = nucleic acid amplification test.
The Simple 2 Test is an at-home self-collection test used to detect symptomatic or asymptomatic Neisseria gonorrhoeae and Chlamydia trachomatis infections. The test is indicated for use in nonclinical settings without direct medical supervision in adults 18 years and older.1
Vaginal swabs are recommended over urine samples for people with a vagina due to increased sensitivity, whereas urine samples are used for people with a penis. Oral, anal, or penile swabs cannot be used for testing. Per the manufacturer, the Simple 2 Test is not intended for use in individuals with known exposure to gonorrhea or chlamydia.
The Simple 2 Test was approved by the US Food and Drug Administration in 2023, helping to meet the 2019 World Health Organization recommendation to make self-collection samples for gonorrhea and chlamydia available to remove barriers that prevent patients from seeking care from clinics (strong recommendation based on moderate-certainty evidence).2,3 Results are available online 2 to 5 days after samples are received in the mail by the Simple 2 Test laboratory.1
ACCURACY
The Simple 2 Test uses the Aptima Combo 2 assay, a nucleic acid amplification test (NAAT), to detect N gonorrhoeae and C trachomatis ribosomal RNA. Table 1 summarizes data from three large multicenter clinical studies conducted in North America that compared clinician-collected samples with self-collected samples.4 These studies included symptomatic and asymptomatic patients. The Aptima Combo 2 assay was highly accurate overall but lacked sensitivity for detecting gonorrhea in urine from females. Studies did not include nonbinary or transgender patients; therefore, the term female here reflects the language in the study.
TABLE 1. Accuracy Data for Aptima Combo 2 Assay
| Sample type | Sensitivity | Specificity | Prevalence | PPV | NPV | LR+ | LR− |
|---|---|---|---|---|---|---|---|
| Chlamydia | |||||||
| Male swab (n = 1,065) | 95.9 | 97.5 | 25.4% | 92.9% | 98.6% | 38.4 | 0.04 |
| Male urine (n = 1,095) | 97.9 | 98.5 | 25.8% | 95.8% | 99.3% | 65.3 | 0.02 |
| Female swab (n = 1,389) | 94.2 | 97.6 | 14.9% | 87.4% | 99.0% | 39.3 | 0.06 |
| Female urine (n = 1,391) | 94.7 | 98.9 | 15.0% | 93.8% | 99.1% | 86.1 | 0.05 |
| Gonorrhea | |||||||
| Male swab (n = 1,103) | 99.1 | 97.8 | 29.2% | 94.0% | 99.6% | 45.0 | 0.01 |
| Male urine (n = 1,134) | 98.5 | 99.6 | 29.0% | 99.1% | 99.4% | 246.0 | 0.02 |
| Female swab (n = 1,479) | 99.2 | 98.7 | 8.6% | 88.1% | 99.9% | 76.3 | 0.01 |
| Female urine (n = 1,484) | 91.3 | 99.3 | 8.6% | 92.1% | 99.2% | 130.0 | 0.09 |
Note: The prevalence of chlamydia or gonorrhea in patient populations depends on risk factors such as age, gender, the presence of symptoms, the type of clinic, and the test method. For the vaginal swab, endocervical swab, male urethral swab, and urine specimen clinical studies, performance for detecting chlamydia and gonorrhea is derived from high-prevalence populations. Positive results in low-prevalence populations should be interpreted carefully with the understanding that the likelihood of a false-positive may be higher than a true-positive.
LR+ = positive likelihood ratio; LR− = negative likelihood ratio; NPV = negative predictive value; PPV = positive predictive value.
Information from reference 4
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