Over the last few weeks, the world has changed in many ways - healthcare systems are under pressure and hospitals are reaching capacity in many areas. In this scenario, finding alternative and simple methods, that can ideally be performed independently, to detect and monitor non-COVID diseases is as critical. Home-based sampling methods, such as urine testing, offers a great solution to reach a wider population.
Urine as a sample type has shown benefits in many areas, in particular, in the detection of several sexually transmitted infections (STIs) such as Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), Trichomonas vaginalis (TV), and Mycoplasma genitalium (MG) (1,2). Additionally, urine has been proposed as an alternative biofluid for detecting and monitoring cancers, as samples can contain Human Papillomavirus (HPV) (3), a major cause of cervical cancer as well as biomarkers for prostate cancer (4).
Despite the COVID-19 pandemic, the World Health Organization (WHO) recommends that patients continue to receive care and essential medical services like routine vaccination, reproductive health services as well as management of noncommunicable diseases and infectious diseases continue (5). In this regard, urine sampling offers a great solution to reduce the global burden. Over the years, Novosanis has researched the benefits of urine collection, in particular first-void urine through its unique urine collection device, Colli-Pee®:
- Accurate and improved self-collection
Collecting first-void urine in a regular urine cup is not standardized and can be inconvenient for the user. Colli-Pee® allows consistent and volumetric first-void urine collection.
Recent research conducted by the Tropical Institute of Medicine in Antwerp, Belgium, shows that home-based collection through a first-void capturing device like Colli-Pee® positively influences the quality of STI testing. The study compares routine clinic-based urine collection using a regular urine cup with home-collected urine samples using Colli-Pee® among Men who have Sex with Men (MSM) Pre-exposure prophylaxis (PrEP) users (2). A total of 11 additional STIs (three CT, two NG and six MG infections) were detected in home-collected samples and not in the equivalent clinic-collected urine samples.
Additionally, given the drawbacks of blood-based Prostate Cancer Antigen (PSA) testing for prostate cancer screening, finding a more precise detection method has been important. Urine contains biomarkers for prostate cancer and one study concluded that first-void urine identified patients with the disease with 91% sensitivity and 69% specificity, while midstream urine was uninformative (6).
- Potential of postal delivery without the need to visit a laboratory
The results of the study performed by the Tropical Institute of Medicine further highlight that postal delivery of urine samples did not influence STI detection. This opens several avenues – for example, results can be made available to a physician at the time of consultation, allowing immediate treatment if positive, as well as limiting the risk of further transmission (2).
Novosanis Colli-Pee® device can also be prefilled with its proprietary Urine Conservation Medium (UCM) preservative, offering stabilization of different urinary analytes as well as improving transport and storage of urine at ambient temperatures.
Further, urine self-collection and postal delivery can significantly increasing participation in cervical cancer screening programs (6). Several large trials, including the EVAH and VALHUDES are currently being performed using Colli-Pee® to detect HPV (7,8).
- Easy and non-invasive collection for the patient, as well as limiting the risk for healthcare workers
Research has shown that individuals prefer urine testing over other sampling methods. A recent online survey conducted at University of California, Los Angeles (UCLA) looked at the knowledge and STI testing preferences in a subset of female undergraduate students. Participants preferred urine over vaginal swabs, as well as favored home-sampling over clinic-based testing (9).
Additionally, studies highlight that users rated Colli-Pee® as easy-to-use and would use the device again for collection of first-void urine (2). This type of method also benefits healthcare workers, and can avoid any risk of transmission through sampling from patient to healthcare professional.
Urine sampling could be the way to continue many healthcare practices in times like today and for the future.
(1) Paudyal P, Llewellyn C, Lau J, Mahmud M, Smith H. Obtaining self-samples to diagnose 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.
(2) 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.
(3) Pattyn J, Van Keer S, Biesmans S, Ieven M, Vanderborght C, Beyers K, Vankerckhoven V, Bruyndonckx R, Van Damme P, Vorsters A. Human papillomavirus detection in urine: Effect of a first-void urine collection device and timing of collection. J Virol Methods. 2019 Feb;264:23-30. doi: 10.1016/j.jviromet.2018.11.008. Epub 2018 Nov 16. PubMed PMID: 30452931.
(4) Theodorescu D, Schiffer E, Bauer HW, et al. Discovery and validation of urinary biomarkers for prostate cancer. Proteomics Clin Appl. 2008;2(4):556-570.
(5) World Health Organization - WHO releases guidelines to help countries maintain essential health services during the COVID-19 pandemic - https://www.who.int/news-room/detail/30-03-2020-who-releases-guidelines-...
(6)Ducancelle A, Reiser J, Pivert A, Le Guillou-Guillemette H, Le Duc-Banaszuk AS, Lunel-Fabiani F. Home-based urinary HPV DNA testing in women who do not attend cervical cancer screening clinics. J Infect. 2015 Sep;71(3):377-84. doi: 10.1016/j.jinf.2015.05.001. Epub 2015 May 9. PubMed PMID: 25964233.
(7) Leeman A, Del Pino M, Molijn A, et al. HPV testing in first-void urine provides sensitivity for CIN2+ detection comparable with a smear taken by a clinician or a brushbased self-sample: cross-sectional data from a triage population. BJOG.2017;124(9):1356-1363.
(8) Arbyn M, Peeters E, Benoy I, et al. VALHUDES: A protocol for validation of human papillomavirus assays and collection devices for HPV testing on self-samples and urine samples. J Clin Virol. 2018;107:52-56.
(9) 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.