Due to the recent surge in COVID-19 cases, resulting from variants such as Omicron and associated supply chain issues, the FDA announced an update to their device shortage list to include all blood specimen collection tubes. Their recommendations are to employ conservation strategies, including only performing blood draws considered medically necessary and to use forms of testing that do not require blood specimen collection tubes.

Non-invasive sample types, including saliva and urine have shown to offer potential in oncology as well as infectious disease testing. These sample types have also proven to offer solutions for COVID-19 testing as well as ways to continue healthcare practices especially at times when systems are under pressure. (1)

Non-invasive sample types for cancer research and screening

The collection and analysis of DNA from tissue and blood have long been considered the gold standards in oncology studies. However, there are challenges with these methods. Obtaining tissue samples is not always feasible and the process can be invasive, painful, expensive, time-intensive, as well as clinician dependent. Additionally, blood sampling also has drawbacks as the invasive and inconvenient nature requires a trained medical professional and can pose risks to the patient and caregiver.

“Think outside (the blood tube) box”

The use of minimally invasive procedures such as liquid biopsies and detection of circulating tumor markers in body fluids is gaining interest. Many of these methods are attractive as they are easy to perform, less painful, and often associated with less morbidity.

Saliva

Saliva provides a non-invasive alternative source of genomic DNA for use in genetic analysis and is equivalent to blood in many downstream applications, such as:

• Single-nucleotide polymorphisms (SNP)/copy number variation (CNV) microarrays
• Next generation sequencing (NGS)
• HLA (Human Leukocyte Antigen) typing
• Microsatellite analysis
• Whole genome amplification
  
  

Read our blogpost “Why collect blood if saliva does the job?” to see some examples that demonstrate the compatibility and proven performance of saliva with several downstream applications. Saliva collected using DNA Genotek saliva collection kits, Oragene®•DNA and ORAcollect®•RNA offer an all-in-one system for reliable self-collection, stabilization, and transportation of high-quality DNA and RNA samples. The devices are compatible with manual, column and magnetic bead-based extraction methods, high-throughput processing, and validated with a wide range of molecular assays. Saliva samples are painless for the patient and relatively easy to collect. Studies have found salivary diagnostics for the detection of specific cancer biomarkers to be simple and pain-free for the patient.(2)

Urine

Several studies have shown the potential of urine as a liquid biopsy due to the ease of sampling and high acceptability compared to blood and tissue.(3) Several biomarkers, including DNA, RNA, metabolites, and proteins for various cancers have been found in urine, including for bladder, kidney and prostate cancer, but also for breast, colon and lung cancer. Additionally, urine is an attractive biofluid as it allows for easy, non-invasive and hygienic self-sampling and enables cost-efficient rapid and serial sampling. (3)

• Easily accessible and available in larger quantities
• Non-invasive
• Applicable for home collection
• Cost efficient
• Not limited by the health status of a patient
• Does not entail any risk of transmission of blood-borne pathogens

The COVID-19 pandemic has brought several challenges to healthcare. One area that has been significantly hit is cancer screening and care; it has delayed the diagnosis of cancers such as breast, cervix, prostate, and colorectal cancers. Alternative methods of sample collection, which are easy, non-invasive and can be performed independently, can help continue healthcare practices; urine as a sample type has shown potential for detecting and monitoring urogenital and systemic cancers.

Benefits of home-based urine sampling

However, like other sample types, to use urine for clinical applications, it is important to limit preanalytical errors caused by collection, transport, and storage. Novosanis' urine collection device, Colli-Pee® allows for standardized and volumetric collection of urine and ensures immediate mixing with preservative, improving sample collection for downstream analysis.

Non-invasive sample types for infectious disease testing

Routine screening is critical for prevention and control of several infectious diseases, including sexually transmitted infections (STIs). Testing for COVID-19 is also important to prevent outbreaks and asymptomatic spread.

Saliva

When the pandemic hit, the demand for COVID-19 testing drastically increased, resulting in shortages of COVID-19 sampling and laboratory supplies, and impacting the number of tests that could be performed.

DNA Genotek saliva collection kits, OMNIgene®•ORAL and ORAcollect®•RNA, were not only used to combat test kit shortages, but these devices also offered sample collection methods that were less painful for patients and protect healthcare professionals by enabling at-home self-collection.

These devices are authorized for use under Emergency Use Authorization (EUA) and are intended for the collection, stabilization and transportation of saliva specimens for COVID-19 testing. The stabilization solutions in the devices allows inactivation of the SARS-CoV-2 virus, allowing safe transport and handling of the specimens, and maximizing the safety of those coming in contact with the specimen. The devices are compatibility with many extraction kits and automated laboratory equipment. Read more in our blog, "Saliva samples for COVID-19 testing: scalable collection for anyone, anywhere".

Urine

Most cases of cervical cancer have been linked to 14 types of high-risk Human Papillomavirus (hrHPV), a common sexually transmitted infection. Self-sampling for HPV, through brush-based techniques, or urine sampling, offers the opportunity to reach more women, especially those who do not participate in traditional screening programs.

Women have reported a significantly higher preference for urine as a sample type for hrHPV testing compared to brush-based or clinician collected sampling.(4) Additionally, urine showed similar performance to clinician-taken smears as well as brush-based self-sampling, with very good detection of HPV in women with CIN2+ (cervical intraepithelial neoplasia grade 2+), emphasizing the potential of urine as a sample type.

While urine allows for HPV detection, the concentration of HPV is not the same in all urine fractions. Studies have shown that first-void urine (initial urine flow) contains higher concentrations of HPV DNA than midstream urine, highlighting the importance of collecting this fraction for improved sensitivity.(5)

Colli-Pee®, allows for standardized and volumetric collection of first-void urine, which can be challenging with a traditional urine cup. Colli-Pee® can also be prefilled with non-toxic Novosanis proprietary preservation medium UCM, which has been developed to preserve HPV DNA.

Are non-invasive sample types the future?

Non-invasive sample types, including saliva and urine enable more personalized medicine. These sample types offer easy, at-home collection, and can be used for various applications including cancer and infectious disease screening. These methods are especially attractive at times where blood sampling may be inconvenient, or when healthcare systems are under pressure.

Novosanis and DNA Genotek are both subsidiaries of OraSure Technologies, a leader in the development, manufacture, and distribution of rapid diagnostic tests, sample collection and stabilization devices, and molecular services solutions designed to discover and detect critical medical conditions.

If you would like to learn more about urine as a sample type, you can email Novosanis at info@novosanis.com. Request a free trial kit for evaluation purposes here - https://novosanis.com/request-trial-kit

If you are interested in learning more about saliva collection kits, you can email DNA Genotek at info@dnagenotek.com. Request a free trial kit for evaluation purposes here - https://www.dnagenotek.com/US/products/request-trial-kit.html

References:
(1) Poehls UG, Hack CC, Ekici AB, Beckmann MW, Fasching PA, Ruebner M, Huebner H. Saliva samples as a source of DNA for high throughput genotyping: an acceptable and sufficient means in improvement of risk estimation throughout mammographic diagnostics. Eur J Med Res. 2018 Apr 27;23(1):20. doi: 10.1186/s40001-018-0318-9. PMID: 29703267; PMCID: PMC5921411.

(2) Xiaoqian Wang et al. (2016). Salivary biomarkers in cancer detection. Med Oncol. 34(1):7

(3) Urine as a liquid biopsy - is it the holy grail? https://novosanis.com/sites/default/files/poster/pdf/White%20Paper%20Urine%20as%20a%20liquid%20biopsy%202019-9A_0.pdf?1645106801

(4) De Pauw H, Donders G, Weyers S, De Sutter P, Doyen J, Tjalma WAA, Vanden Broeck D, Peeters E, Van Keer S, Vorsters A, Arbyn M. Cervical cancer screening using HPV tests on self-samples: attitudes and preferences of women participating in the VALHUDES study. Arch Public Health. 2021 Aug 30;79(1):155. doi: 10.1186/s13690-021-00667-4. PMID: 34462004; PMCID: PMC8403820.

(5) 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. PMID: 30452931.