Evaluation of a Modified Sanitary Napkin as a Sample Self-Collection Device for the Detection of Genital Chlamydial Infection in Women

Abstract

A modified sanitary napkin was compared with endocervical swab and urine specimens for the detection of urogenital Chlamydia trachomatis infection. Endocervical swabs and/or first-catch urine were collected from 510 women at medical or community settings in Quebec City. Participants were also asked to wear a modified sanitary napkin (Ezy-Detek) during 4 consecutive hours and to bring it back to the clinic or mail it to the laboratory. Endocervical and urine specimens were tested using the Cobas Amplicor CT/NG assay (Roche Diagnostic Systems) according to the manufacturer's instructions, as were specimens collected with the napkin after adequate preparation. If the PCR test result was positive on the endocervical sample or on any two samples, a woman was considered to be infected. PCR testing results on paired samples were identical for 493 Chlamydia trachomatis infection is the most frequently reported sexually transmitted disease in the industrialized countries. The association of this infection with transmission of human immunodeficiency virus infection, pelvic inflammatory disease, infertility, ectopic pregnancy, and chronic pelvic pain (10, 20, 30) constitutes a major public health concern. Because most infected women have no specific symptoms or are asymptomatic, screening programs represent one of the main approaches to control this infection (20,21).The current literature provides very good information on the value of gene amplification techniques, such as PCR or ligase chain reaction, for the detection of C. trachomatis in the lower genital tracts of women. Both technologies have been evaluated in depth using endocervical swab or urine samples. With a specificity higher than 98%, the sensitivity of PCR on either cervical specimens or urine samples varies from 80.0 to 100% (4,12,18,19,27,28).More recently, detection of chlamydial infection by these techniques has also been assessed on secretions recovered from vaginal introitus collected by clinicians or patients themselves (2,5,9,15,16,22,26,31,33) or from vaginal tampons (13,(23)(24)(25). Urine and self-collected samples represent easy and noninvasive techniques compared to the usual cervical swabbing, which necessitates vaginal speculum insertion and a gynecologic examination. In a study, as many as 60% of chlamydia-infected adolescents would have been missed if the urine screening program had not been in place, because they refused the gynecologic examination (14). In addition, specimens may be collected in nontraditional medical settings, such as community centers and schools, and eventually at home (6,11,15,17). Although these methods have been shown to be relatively easy to use and sensitive for the detection of C. trachomatis, some women failed to collect adequate specimens or did not feel at ease with the technique (2,16,31). The objective of the present study was to evaluate a modified sanitary napkin (Ezy-Detek [EDI] Inc., Sillery, Canada) as a specimen self-collection device for detection of chlamydial infection in women. Results of PCR tests ...

Acceptability of Self-Taken Vaginal Swabs and First-Catch Urine Samples for the Diagnosis of Urogenital Chlamydia trachomatis and Neisseria gonorrhoeae With an Amplified DNA Assay in Young Women Attending a Public Health Sexually Transmitted Disease Clinic

“…Another study compared a modified sanitary napkin with traditional gynecologic swab and FCU from 510 women at medical or community settings with Roche PCR. 11 In that study, testing results on paired samples were identical for slightly fewer participants as in our study (96.6%), with a comparable CT prevalence (11.3%), with best results for the FCU (sensitivity 100%, ppv 100%; npv 98%). Prior studies showed that SVSs have equivalent sensitivity and reliability as traditional endocervical swab specimens.…”

“…7,[12][13][14][15][16][17] One study determining the feasibility and acceptability of SVS among 228 female high school students (15-19 years) with CT prevalence of 8% and GC prevalence of 2% gave similar results as our study. 11 Nearly 13% of women in that study who had never previously had a gynecologic examination tested positive for an STD. This is a similar finding compared to 11% in our study.…”

Home STI testing: The adolescent female’s opinion

“…Recent work by our group has shown that a systems-based intervention significantly increased CT screening among adolescents attending health supervision visits in pediatric clinics within a large health maintenance organization (HMO) [24]. Progress is also being made toward application of noninvasive sampling (urine and vaginal) to home-based sampling for STI screening [25][26][27], and home-testing kits may become an option in the future using the home pregnancy test as a model.…”

Molecular investigation of menstrual tissue for the presence of Chlamydia trachomatis, Ureaplasma urealyticum and Mycoplasma hominis collected by women with a history of infertility

“…In order to overcome collected specimens inadequacy, several studies suggest the use of modified sanitary napkins and tampons as alternatives for cervicovaginal secretions collection, which can in fact enhance the quality of the collected specimen; however, these still are indirect approaches and rather invasive. 36,37 Overall, the main advantage of using the menstrual tissue as the starting material in such cases is its direct relation with the exact location of the microbial activity, whereas approaching endometritis from cervical or vaginal materials is rather indirect. By this non-invasive technique, patients can easily collect their own sample at home and repeat this procedure as many times as required throughout their treatment.…”