From the NIH: Proceedings of a Workshop on the Importance of Self-Obtained Vaginal Specimens for Detection of Sexually Transmitted Infections

Abstract

On June 27, 2006, the NIH conducted a workshop to review published data and current field practices supporting the use of self-obtained vaginal swabs (SOVs) as specimens for diagnosis of sexually transmitted infections (STIs). The workshop also explored the design of studies that could support FDA clearance of SOVs for STI testing, particularly for specimens collected in nonclinical settings including patients' homes. This report summarizes the workshop findings and recommendations. Participants concluded that self-obtained vaginal swabs are well accepted by women of all ages and that SOVs perform as well as or better than other specimen types for Chlamydia trachomatis and Neisseria gonorrhoeae detection using transcription-mediated amplification. In addition, workshop participants recommended the validation of SOV testing by public health practitioners and manufacturers of STI diagnostic tests to expedite incorporation of SOVs as a diagnostic option in clinical and nonclinical settings for Chlamydia trachomatis and Neisseria gonorrhoeae testing. Similarly, SOVs should be explored for use in the diagnosis of other sexually transmitted pathogens.

Performance of Three Nucleic Acid Amplification Tests for Detection of Chlamydia trachomatis and Neisseria gonorrhoeae by Use of Self-Collected Vaginal Swabs Obtained via an Internet-Based Screening Program

“…For women, vaginal swabs may be preferred over FCU specimens for this type of screening (26). This and many other studies have demonstrated that self-collected vaginal swabs are suitable specimens for chlamydia and gonorrhea testing by NAATs, and their use has been recommended by the NIH and the CDC (17).…”

“…While such samples collected at home are not yet FDA cleared, self-obtained vaginal swabs collected in a clinic are FDA cleared for one type of NAAT (26). We therefore decided to compare the performances of the three commercially available NAATs for C. trachomatis and N. gonorrhoeae testing with vaginal samples obtained at home through an Internet screening program and mailed in a dry state (10,17,29) to the laboratory for testing.…”

“…Utilization of self-obtained specimens for C. trachomatis and N. gonorrhoeae testing, which employ the highly sensitive and specific NAATs, has enhanced the use of noninvasive urogenital samples (9,17). Studies have reported that self-collected vaginal specimens are acceptable and can be successfully used to diagnose STIs, especially chlamydia and gonorrhea, when they are used with NAATs (3,14,17,18,26). This can eliminate the necessity for a clinician-performed pelvic examination for women for sample collection and may represent cost savings when a woman does not require a Pap test or have symptoms (1).…”

Poor uptake of self‐sample collection kits for Chlamydia testing outside primary care

“…15 Self-taken vaginal swabs are an acceptable and accurate specimen type for chlamydia testing using NAAT techniques. 16 Instructions for males described how to collect a urine sample. Both sets of instructions were pre-tested with young people and modified according to feedback received.…”

Stability Studies on Dry Swabs and Wet Mailed Swabs for Detection of Chlamydia trachomatis and Neisseria gonorrhoeae in Aptima Assays

“…However, SOVS specimens are FDA cleared for use only when collected in a clinic setting. The ability to self-collect at home and mail in specimens could have a significant impact on sexually transmitted disease (STD) control efforts (13)(14)(15). To assess such use in screening programs, we initially performed a pilot study to determine specimen stability and monitor the shipping temperatures during transit.…”