Sexually transmitted infections (STIs) continue to remain a global health challenge. Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), Trichomonas vaginalis (TV) are all common infections that can have serious, long-term consequences in both men and women (1).
Despite the recommendations and benefits of regular STI testing for prevention and control, screening is low in many areas. As a result, a lot of work is being performed to better understand the reasons for poor uptake, as well as find new methods to improve screening.
A recent study conducted at University of California, Los Angeles (UCLA) looked at the knowledge and STI testing preferences in a subset of female undergraduate students. Through an online survey, the team asked participants a range of questions focussing on sexual activity, awareness of STIs and factors considered when selecting a screening method based on hypothetical situations (2).
Of the 5,000 students the survey was shared with, 793 women responded. The results showed that in general there were gaps in knowledge about the symptoms, detection, and methods of transmission of CT, NG and TV, with TV being the least known STI (2).
Additionally, cost was the most important factor considered when participants selected between STI testing methods. Other aspects included specimen type, with urine being preferred over vaginal swabs and location, with home-sampling being favored over clinic-based testing (2).
Although the study is limited to a specific group, in a specific location, similar findings have been observed in other work focusing on STI screening methods. Conclusions from a review showed that home-based STI screening is feasible and is often preferred by individuals. In most cases, higher testing rates were accomplished with home-sampling, including urine as a sample type, compared to traditional clinic-based STI screening (3). Some reasons for poor participation in clinic-based testing include lack of privacy, discomfort, lack of time and/or financial resources (4).
For detection of some STIs, including CT and NG, urine has become the recommended sample type in men in many areas (6). Alternatively, for women, while testing methods are not as standardized, urine has also shown to be a good indicator, and offer similar sensitivities to cervical and vaginal specimens (5). A recent review used patient infected status as a reference to evaluate and compare the performance of urine, vaginal and cervical specimen for the detection of CT and NG. While similar sensitivities were reported for all sample types, the performance of urine was higher than 70% in all but one study for CT and one study for NG (5).
While urine offers an easy and simple collection process, as well as has the potential for home-collection, there are some challenges. Urine components are not the same in all fractions and timing of specimen collection is critical for results. First-void urine, generally termed the first 20 mL of urine flow, contains the highest concentrations of components needed for detection of several STIs (7,8).
However, efficiently capturing first-void urine with a regular urine cup is not standardized and can be messy for the user (9). It also has the risk of overfill and can capture significantly more than the first 20 mL. A recent study emphasized some of the risks of overfill (>30 mL), including dilution of the sample and potentially yielding false-negative results (6).
Colli-Pee®, Novosanis' first-void urine collection device offers a solution. The device allows guaranteed collection of first-void urine. Recent data by the Tropical Institute of Medicine in Antwerp, Belgium compared routine clinic-based urine collection through a regular urine cup with home-collected urine sampling using Colli-Pee®, among Men who have Sex with Men (MSM) Pre-exposure prophylaxis (PrEP) users (9).
A high correlation was found between clinic-based and home-collected urine samples. Only 3 infections were not detected in the home-collected urine samples, while a total of 11 additional STIs (three CT, two NG and six Mycoplasma genitalium (MG) infections) were detected in home-collected samples using Colli-Pee®, and not in the equivalent clinic-collected urine samples. This highlights the importance of first-void urine, rather than a random sample for better accuracy (9). Another study also showed the first 4 to 5 mL of first-void urine collected through a urine collection device improved detection of CT by six-fold in comparison to a regular urine cup (7).
Alongside the original 20 mL Colli-Pee®, Novosanis has recently launched a small volume variant, which captures up to the first 10 mL of urine. The new version is now compatible with many high-throughput instruments, thereby improving lab work flow. It also allows for collection of a more concentrated urine sample, possibly offering additional applications in the fields of infectious disease and STI detection.
Urine sampling, in particular, first-void urine has the potential to improve the way STIs are screened and detected for and can move us one step closer to ‘a world without STIs’.
1. WHO Website. Sexually transmitted infections (STIs) - https://www.who.int/news-room/fact-sheets/detail/sexually-transmitted-infections-(stis) – June 2019
2. Keizur EM, Bristow CC, Baik Y, Klausner JD. Knowledge and testing preferences for Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis infections among female undergraduate students. J Am Coll Health. 2019 May 29:1-8. doi:10.1080/07448481.2019.1616742. PubMed PMID: 31140943.
3. Shih SL, Graseck AS, Secura GM, Peipert JF. Screening for sexually transmitted infections at home or in the clinic?. Curr Opin Infect Dis. 2011 Feb;24(1):78-84. doi: 10.1097/QCO.0b013e32834204a8. Review. PubMed PMID: 21124216; PubMed Central PMCID: PMC3125396.
4. Paudyal P, Llewellyn C, Lau J, Mahmud M, Smith H. Obtaining self-samples todiagnose curable sexually transmitted infections: a systematic review of patients'experiences. PLoS One. 2015;10(4):e0124310. doi: 10.1371/journal.pone.0124310. eCollection 2015. Review. PubMed PMID: 25909508; PubMed Central PMCID:PMC4409059.
5. Rönn MM, Mc Grath-Lone L, Davies B, Wilson JD, Ward H. Evaluation of the performance of nucleic acid amplification tests (NAATs) in detection of chlamydia and gonorrhoea infection in vaginal specimens relative to patient infection status: a systematic review. BMJ Open. 2019 Jan 17;9(1):e022510. doi: 10.1136/bmjopen-2018-022510. PubMed PMID: 30659036 PubMed Central PMCID: PMC6340625.
6. O'Byrne P, Orser L. Overfilled urine specimens for gonorrhea and chlamydia testing: Implications for practice. Appl Nurs Res. 2018 Feb;39:121-124. doi: 10.1016/j.apnr.2017.11.014. Epub 2017 Nov 6. PubMed PMID: 29422146
7. Wisniewski CA, White JA, Michel CE, Mahilum-Tapay L, Magbanua JP, Nadala EC Jr, Barber PJ, Goh BT, Lee HH. Optimal method of collection of first-void urine for diagnosis of Chlamydia trachomatis infection in men. J Clin Microbiol. 2008 Apr;46(4):1466-9. doi: 10.1128/JCM.02241-07. Epub 2008 Jan 30. PubMed PMID: 18234860. PubMed Central PMCID: PMC2292916.
8. Vorsters A, Van den Bergh J, Micalessi I, Biesmans S, Bogers J, Hens A, De Coster I,Ieven M, Van Damme P. Optimization of HPV DNA detection in urine by improving collection, storage, and extraction. Eur J Clin Microbiol Infect Dis. 2014 Nov;33(11):2005-14. doi: 10.1007/s10096-014-2147-2. Epub 2014 Jun 12. PubMed PMID: 24916950.
9. De Baetselier I, Smet H, Abdellati S, De Deken B, Cuylaerts V, Reyniers T, Vuylsteke B, Crucitti T. Evaluation of the 'Colli-Pee', a first-void urine collection device for selfsampling at home for the detection of sexually transmitted infections, versus a routine clinic-based urine collection in a one-to-one comparison study design: efficacy and acceptability among MSM in Belgium. BMJ Open. 2019 Apr 3;9(4):e028145. doi:10.1136/bmjopen-2018-028145. PubMed PMID: 30948618; PubMed Central PMCID:PMC6500257.