Sonia Allibardi, PhD, market access manager at Copan Group, which conducted the study, said patients preferred the home-based test to point-of-care (POC) self-testing for personal reasons.
“The main reason was related to better privacy and the possibility to save time,” she told Infectious Disease News. “Women are really busy.”
FLOQSwabs (Copan) are composed of a solid plastic applicator shaft topped by highly absorbent nylon fibers that are flocked, or sprayed, onto the tip of the swab, according to Copan. The study compared a novel flocked swab developed by Copan for home collection with a flocked swab that has already been validated for POC testing, Allibardi said.
According to Allibardi, there are several differences between the swabs. The shaft of the home-based swab has no breaking point, making it safer for home collection, she said. And it is bigger than the POC swab, which has a breaking point.
For their study, Allibardi and colleagues recruited 80 asymptomatic donors aged 18 to 45 years to perform a double self-vaginal sampling to test for chlamydia and gonorrhea: one using the novel home-based swab and another using the POC swab under the supervision of a gynecologist. They asked patients to fill out a questionnaire to assess the usability of the home-based test and processed the swabs using the Xpert CT/NG (Cepheid) assay.
Both methods produced the same results: All 77 donors who were negative for Chlamydia trachomatis and all three who were positive were correctly identified by both the home collection method and self-collection under the supervision of a gynecologist. The tests did not reveal any patients who were positive for Neisseria gonorrhea, Allibardi said.
According to Allibardi and colleagues, the home-based testing method also recovered vaginal cells as efficiently as POC self-testing and preserved chlamydia and gonorrhea DNA on spiked samples after 4 weeks.
Allibardi said home-based self-sampling vaginal swabs are a cost-effective way to increase participation in STD screening programs. She said the swabs can encourage patients who would not ordinarily attend an STD screening for various reasons, including lack of time, fear, shyness or religious motives, to test themselves.
“This self-vaginal collection supports STI prevention,” she said. – by Gerard Gallagher
Allibardi S, et al. Performance of a new home-based self-vaginal device for diagnosis of chlamydia trachomatis and Neisseria gonorrhea. Presented at: ASM Microbe; June 1-5, 2017; New Orleans.
Disclosure: Allibardi and the other researchers are employed by Copan.