The importance of logistics and shipping for remote testing and diagnostics

Effective and reliable methods for clinical researchers to conduct patient testing have always been important to the successful execution of studies supporting vaccine development and disease diagnostics ^[1]. This has become even more evident during the COVID-19 pandemic, which has led to an increased adoption of virtual models that rely on home-based activities such as telehealth and digital monitoring tools^[2].

While COVID-19 has been a catalyst for many of these changes, there is growing consensus across the medical industry that the clinical landscape will continue to move towards remote models for testing, diagnostics, and clinical research. A recent whitepaper surveying 180 clinical trial professionals across the globe found that 76% agree that the COVID-19 pandemic is leading to increased use of decentralized clinical trial (DCT) components, with 85% expecting the adoption of remote models to increase in the next two years^[3].

As a result of these significant shifts towards remote healthcare and clinical research, the logistical challenges facing the diagnostic and investigatory stages of research have evolved. In this article, we look at one of the most significant changes occurring in diagnostics – the increased need for remote testing – and the challenges this presents to clinical researchers.

From on-site to remote testing

In light of the COVID-19 pandemic, many healthcare practitioners (HCPs) who have previously been slow to embrace practices such as telehealth and virtual appointments^[4] have moved to adopting remote processes to preserve their ability to provide clinical services. Such remote interventions enable practitioners to isolate potentially infectious individuals and reduce strain on urgent care facilities. In fact, by April 2020 85% of physicians surveyed were seeing patients by video and/or phone ^[5].

Clinical services that are now being delivered remotely include drive-through medicine and at-home diagnostics. Drive-through sites offering testing, such as for COVID-19, or vaccinations for diseases like the flu, allow patients to access diagnostic and treatment services for communicable diseases without fear of contracting or spreading illnesses in a clinical environment^[6]. Meanwhile, home diagnostics has experienced high public demand^[7], with COVID-19 seeing home testing kits raced to market – with mixed results^[8].

In a healthcare landscape that is becoming increasingly virtual, the need for efficient and effective diagnostic processes is expanding from COVID-19 through to treatment for other diseases and conditions. As the medical industry innovates to meet the growing demand for accurate remote testing^[9], repercussions can be seen throughout the field of clinical research.

The major challenges of remote testing

Moving testing to the participant’s home or a remote location raises a number of new considerations for clinical research, including shipping logistics, sample preservation throughout the shipping process, and tracking and tracing all samples.

Proper shipping and logistics are required to maintain valid remote testing, including regulatory-compliant shipping containers such as refrigerated shippers and molecular pathology collection and transport kits. As diagnostic errors can quickly result from not adhering to recommended testing procedures or improper transport, using the right materials is essential.

For COVID-19, tests typically include either the collection of a quality nasopharyngeal specimen by swabbing inside the nostril, or the collection of an oropharyngeal specimen through swabbing the posterior pharynx; the swabs must be taken by trained healthcare personnel^[10] then placed immediately into a sterile tube containing viral transport solution^[11]. Home tests typically involve a saliva specimen attained through supervised self-collection^[12]. Samples must then be stored in closed, airtight containers to minimize contamination and shipped as UN 3373 Biological Substances, Category B^[13] – when shipped immediately, samples must be stored at 2-8°C and shipped with an ice pack^[14]. If shipping is to occur after 72 hours, specimens must be stored at -10°C and shipped on dry ice^[15]. Use of the wrong materials or the introduction of any contamination could obviate the outcome, resulting in incorrect diagnosis and potentially leading to further spread of the disease.

Tests for other conditions may require blood, urine, or fecal samples. For example, home testing kits for HIV can include either an oral swab or supplies for collecting a blood sample from a finger prick (16). Mail-in HIV test kits include the tools and guidance necessary for patients to safely prick their fingers and collect a small sample of blood on a card, along with the materials to package the sample and return it to a laboratory for testing^[17].

Major challenges facing such remote diagnostics include:

• Adherence to proper collection protocols – clinical personnel must be trained to properly and safely collect specimens, while the correct storage and shipping procedures must be followed, including the use of regulated shipping systems^[18].
• Availability of materials – testing for diseases necessitates materials such as swabs, specimen tubes, and viral transport mediums, along with the specific packaging materials needed for shipping specimens at the correct temperature and to meet regulatory standards. As the demand for home testing and monitoring materials has resulted in supply shortages through traditional consumer sources^[19], it is vital that HCPs and clinical researchers partner with providers able to adjust to these needs.
• Logistical capabilities – clinicians who are used to collecting samples on-site may not have the time or expertise to manage the logistics of remote testing. These considerations include sourcing and assembling test supplies, enacting proper measures to prevent cross-contamination, monitoring and shipping test kits, and implementing robust tracking systems. This underscores the need for providers who can bring external resources and logistical expertise, including implementing regulation-compliant packaging, shipping, and tracking^[20].
• Maintaining sample viability – sample collection kits should be well-constructed and designed, with all the necessary components for participants to easily return samples, including the capacity for refrigeration to the correct temperature^[21], pre-printed labeling, and instructions for easy return shipping.
• Lab processing capabilities – most tests need to be processed at a central lab, which requires both proper kitting and relationships with labs able to accommodate surging demand^[22].
• Problems of scale – testing demands may change at short notice and clinicians may struggle to scale up as needed. HCPs and clinical trial managers must be flexible and prepared to respond to changing requirements.
• Difficulty in getting an accurate sample outside of a clinical setting – well-considered kit construction is essential, with clear patient guidance and the right materials included to facilitate the sample collection process, ensure sample isolation, and simplify storage and shipping of samples according to proper protocols^[23] whether done at home or at a mobile testing center.

The burden for these considerations need not fall entirely on clinicians, with experienced providers of kitting and cold chain logistics support such as Avantor stepping in to provide much-needed assistance and expertise in regulated shipping systems^[24] – thereby freeing clinicians to concentrate on the medical situation at hand.

How the healthcare industry is responding to testing needs

The urgency with which effective COVID-19 testing has had to develop demonstrates how healthcare needs can change drastically at very short notice, and clinicians must be supported by partners in responding to a common goal, such as increases in demand.

Important approaches to pursuing successful clinical outcomes include:

Some additional ways in which the industry is responding to an increased need for remote testing include:

• Clinicians and suppliers are working together to understand the requirements for resourcing tests and developing a strategic approach to manage testing^[25].
• Diagnostic providers are developing more accurate testing and monitoring for quality and po-tential improvements^[26] despite initial setbacks^[27].
• Testing is being fast-tracked across clinical investigations^[28], necessitating a deep understanding of the kitting and trial study landscapes with the ability to innovate and adapt at a moment’s notice.
• Efficient logistics and regulated shipping systems^[29] are proving vital to effectively managing testing and ensuring sample validity, particularly when testing outside a sterile clinical environment^[30]. Providers can meet clinical needs through proactive inventory management to ensure adequate supplies through periods of higher demand.

It is essential that partners provide clinicians with the capacity to navigate these and other unforeseen requirements to avoid further backlogs and delays^[31]. At Avantor Clinical Services, we remain committed to providing our top-line expertise to clinical researchers and working together to develop ever-more efficient protocols to support your research needs, even away from the lab.

Summary

When remote testing is vital, the ability to meet unpredictable needs is key. The capacity of clinical researchers and healthcare providers to fast-track testing depends on kitting supply, logistical management, and regulated shipping systems – and working with a partner who can respond to all of these clinical requirements.

This article has been produced by Avantor Clinical Services as part of our ongoing commitment to set-ting science in motion to create a better world through the delivery of mission-critical products and services. To learn more, contact us today.

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References

1. The Importance of Diagnostic Tests in Fighting Infectious Diseases. https://www.lifechanginginnovation.org/medtech-facts/importance-diagnostic-tests-fighting-infectious-diseases. Accessed October 2020.
2. Life after COVID-19: What Will Change?. April 2020. https://medicalfuturist.com/life-after-covid-19-what-will-change/. Accessed October 2020.; Wearable Technology. https://www.mesm.com/blog/the-potential-of-wearable-technology-for-the-future-of-clinical-trial-research/. Accessed October 2020.
3. Pharma Intelligence Whitepaper. Decentralized Clinical Trials in 2020: A Global Survey. July 2020. Available at https://pharmaintelligence.informa.com/resources/product-content/2020/07/20/10/43/sitecore/shell/~/media/informa-shop-window/pharma/2020/covid-24-campaign/slides/decentralized-clinical-trials-in-2020.pdf. Accessed November 2020.
4. Using Telehealth to Expand Access to Essential Health Services during the COVID-19 Pandemic. June 2020. https://www.cdc.gov/coronavirus/2019-ncov/hcp/telehealth.html. Accessed October 2020.
5. Jen A. Miller. COVID-19 Is a Catalyst for Remote Sampling and Telemedicine. July 2020. https://www.aacc.org/publications/cln/articles/2020/july/covid-19-is-a-catalyst-for-remote-sampling-and-telemedicine. Accessed October 2020.
6. Lisa Spear. Drive-thru Coronavirus Testing Catches on in Unites States. March 2020. https://www.rtmagazine.com/disorders-diseases/infectious-diseases/other-infections/drive-thru-coronavirus-testing-united-states/. Accessed October 2020.; Doug Kanis. Healthcare organizations implement remote testing in light of COVID-19. April 2020. https://blog.meditech.com/healthcare-organizations-implement-remote-testing-in-light-of-covid-19-0. Accessed October 2020.
7. National Institutes of Health. NIH delivering new COVID-19 testing technologies to meet U.S. demand. July 2020. https://www.nih.gov/news-events/news-releases/nih-delivering-new-covid-19-testing-technologies-meet-us-demand. Accessed November 2020.
8. Why it's so hard to test for the new coronavirus at home. June 2020. https://www.advisory.com/daily-briefing/2020/06/10/rapid-tests. Accessed October 2020.
9. MESM. The Rise of Home Diagnostics in Clinical Trials. https://www.mesm.com/blog/the-rise-of-home-diagnostics-in-clinical-trials/. Accessed November 2020.
10. CDC. Interim Guidelines for Collecting, Handling, and Testing Clinical Specimens for COVID-19. October 2020. https://www.cdc.gov/coronavirus/2019-ncov/lab/guidelines-clinical-specimens.html. Accessed October 2020.
11. Ibid.
12. Ibid.
13. CDC. Interim Laboratory Biosafety Guidelines for Handling and Processing Specimens Associated with Coronavirus Disease 2019 (COVID-19). September 2020. https://www.cdc.gov/coronavirus/2019-ncov/lab/lab-biosafety-guidelines.html. Accessed October 2020.
14. Avantor Services. Refrigerated Shipping Supplies. https://www.therapak.com/docs/Therapak_Shippers-CatB.pdf. Accessed October 2020.
15. CDC. Interim Guidelines for Handling and Processing Specimens Associated with Coronavirus Disease 2019 (COVID-19).
16. CDC. HIV Self Testing (Home Testing). https://www.cdc.gov/hiv/basics/hiv-testing/hiv-self-tests.html. Accessed November 2020.
17. Ibid.
18. CDC. Interim Guidelines for Handling and Processing Specimens Associated with Coronavirus Disease 2019 (COVID-19).
19. Remote Patient Monitoring: COVID-19 Applications and Policy Challenges. March 2020. https://www.himss.org/news/remote-patient-monitoring-covid-19. Accessed October 2020.
20. CDC Shipping and Packing Guidelines. https://www.cdc.gov/laboratory/specimen-submission/shipping-packing.html. Accessed October 2020.
21. Avantor. Refrigerated Shipping Supplies.
22. VWR. Supporting Research on COVID 19. https://us.vwr.com/cms/covid_19. Accessed October 2020.
23. CDC. Interim Guidelines for Handling and Processing Specimens Associated with Coronavirus Disease 2019 (COVID-19).
24. Avantor Clinical Services supports the need to fast-track clinical trials related to COVID-19 disease progression. https://www.avantorsciences.com/pages/en/success-story-coronavirus-detection. Accessed October 2020.
25. VWR. Supporting Research on COVID 19.
26. Responding to the COVID-19 Pandemic: the Diagnostic Industry Angle. May 2020. https://www.medtecheurope.org/wp-content/uploads/2020/05/Responding-to-the-COVID-19-Pandemic-the-Diagnostic-Industry-Angle.pdf. Accessed October 2020.
27. Coronavirus (COVID-19) Update: FDA Revokes Emergency Use Authorization for Chembio Antibody Test. June 2020. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-revokes-emergency-use-authorization-chembio-antibody-test. Accessed October 2020.
28. Lydia DePillis and Caroline Chen. Coronavirus Tests Are Being Fast-Tracked by the FDA, but It’s Unclear How Accurate They Are. April 2020. https://www.propublica.org/article/coronavirus-tests-are-being-fast-tracked-by-the-fda-but-its-unclear-how-accurate-they-are. Accessed October 2020.
29. VWR. Supporting Research on COVID-19.
30. Miller Report. July 2020. COVID-19 Is a Catalyst. https://www.aacc.org/cln/articles/2020/july/covid-19-is-a-catalyst-for-remote-sampling-and-telemedicine
31. Alexis C. Madrigal and Robinson Meyera. Dire Warning From COVID-19 Test Providers: U.S. coronavirus testing could fail again, as surging demand creates new backlogs and delays. June 2020. https://www.theatlantic.com/science/archive/2020/06/us-coronavirus-testing-could-fail-again/613675/. Accessed October 2020.