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Re-thinking the blood collection process

Diagnostics plays a critical role in the determination of treatment protocol as well as clinical outcomes. COVID-19 has raised concerns about blood sample collection, becoming a catalyst for remote and automated blood collection measures.

Diagnostic blood sampling and testing is the most basic laboratory practice in the world and forms the cornerstone of modern health care delivery. Yet blood tests are still being predominantly carried out in centralized labs using large-volume samples acquired by manual venipuncture and a lack end-to-end solution from blood draw to sample analysis has been felt. Venipuncture, the most common blood collection method that uses vacuum tubes to collect blood from the vein, is getting outdated.

New advancements in blood specimen collection methods and instruments provide faster, efficient, safer as well as easier alternatives. Modern vacuum tube revolutionized the blood collecting systems and devices, overcoming the challenges and imprecision of earlier methods. Innovative solutions that facilitate more convenient, accurate, and remote or at-home sampling are coming up, for example volumetric absorptive microsampling systems. These easy-to-use devices collect a high-quality blood sample for accurate, validated lab testing for clinical diagnostics.

Present scenario with COVID-19 further puts emphasis on secure and no-touch collection of samples from the patients. Remotely collected blood samples for serology tests are playing a critical role in the effort to track SARS-CoV-2 antibodies to understand COVID-19 immunity and/or develop COVID-19 vaccines and treatments.

Recent developments
Earlier this year, a team from Rutgers University, New Jersey created a robot device capable of venipuncture. The device, an ultrasound image-guided robot, combines miniaturized robotics with 2D ultrasound imaging to identify and cannulate vessels in a patient. Ultrasound imaging provides the position of a vessel, which the device uses to determine where to insert the needle. Force sensors along the needle axis record the insertion force and detect when the needle has successfully punctured the vessel. A fully integrated device, which includes a module that handles samples and a centrifuge-based blood analyzer, it could be used at bedsides and in ambulances, emergency rooms, clinics, doctors’ offices and hospitals.

Two firms recently won US FDA 510(k) clearances for blood collection devices—a push-button device from Seventh Sense called TAP, and a needle-free device from Velano Vascular called Pivo.

Meanwhile, other firms, such as Neoteryx, are pursuing microsampling of blood but focusing on dried blood spots. Neoteryx ramped up production and shipment of its Mitra microsamplers and Mitra blood collection kits to healthcare systems and research organizations since the COVID-19 crisis gathered momentum in March 2020. Scientists value the reliable precision of Mitra, which utilizes patented, VAMS technology to collect small, volumetrically accurate specimens of blood and other bio-fluids. The absorbent tips on the Mitra device collect and deliver the precise volume needed for analysis. This technique is an advancement over dried blood spot (DBS) card-based devices, which do not consistently deliver a reliable blood sample for dependable analysis nor easily integrate in typical lab automation workflows. Mitra VAMS technology has been cited in over 100 publications with its successful usage in a variety of areas, including clinical trials that monitor remote participants, medical studies that examine drug efficacy in transplant patients, lab studies that examine pathogens, pediatric care and monitoring, and more.

In 2020, FL Medical SRL launched Vacumed tech blood collection sets that are ready to use collection sets because of a pre-attached holder. BD made an agreement with Babson Diagnostics, USA in 2020, to develop small-volume blood collection set for diagnostic testing in retail settings.

Tasso, a Seattle-based company, has developed devices that help patients painlessly collect their blood at home. It constitutes two devices, Tasso-M20 for dry blood samples and Tasso-SST for liquid blood samples. Testing kits are dispatched directly to the patient and blood collection is as simple as pressing a button. In the times when it is encouraged to avoid physical contact with others as much as possible, being able to collect blood without having to visit a health setting is clearly advantageous. In July 2020, Tasso raised USD 17 million in Series A financing round, which will be used to scale manufacturing and operations for its devices. Tasso’s devices are being validated for routine diagnostics, chronic disease monitoring, athletic testing and clinical trials.

Blood collection device manufacturers are now more focused on developing innovative products with automated and precision enhancing techniques, to overcome the challenges of previous methods including reducing pain, finding a good vein easily and a no-touch method of collecting a volumetrically accurate, high-quality blood sample.

Market dynamics
The global blood collection devices market is expected to grow at a CAGR of 6 percent from USD 4.8 billion in 2020 to USD 6.4 billion in 2025. according to MarketsAndMarkets.

The list of key players include Becton, Dickinson and Company, USA; Haematinics, USA; Terumo BCT, Japan; Fresenius Kabi AG, Germany; Grifols, Spain; Nipro Medical Corporation, Japan; Greiner Holding, Austria; Quest Diagnostics, USA; Sarstedt AG & Co., Germany; Macopharma, France; Smiths Medical, USA; Kawasumi Laboratories, Japan; Retractable Technologies, USA; LiuyangSanli Medical Technology Development, China; FL Medical SRL, Italy; AB Medical, South Korea; APTCA SPA, Italy; MicsafeMedical Group Limited, China; Ajosha Bio Teknik Pvt. Ltd., India; Preq Systems, India; CML Biotech, India, LmbTechnologie GmbH, Germany; and Neomedic Limited, UK.

The automated blood collection segment is expected to grow at the highest rate during the forthcoming years. Among the product segments, blood collection tubes, blood collection needles/holders, blood collection sets, and others, the largest share was held by the blood collection needles/holders in 2019.

COVID-19 impact
The COVID-19 global pandemic has been an unprecedented global public health challenge and is expected to have a significant impact on the blood collection devices market. Hospitals and laboratories had to review each test to decide whether to recommend consultations with laboratory hematologists for tests with a higher risk profile or refrain from offering tests that could not be performed safely. Also, results now take an average of four to six days for the general public, much longer than earlier period of two to three days. This is primarily because the tests for hospital patients and symptomatic healthcare workers are prioritized and take one day on average, leading to a delayed cycle.

These factors caused reduction in the use of blood collection devices. However, increasing caution and the rising testing volumes, along with the need for regular health and body check-ups will ensure market growth in a later phase.

Need to transition to the modern method of collection
The driving force behind the new developments in blood collection devices is the desire to design products that not only improve efficacy but also minimize pain and discomfort. Having said this, the healthcare facility seems to be stuck using the same thing for decades. They are ultimately responsible for adopting the upcoming devices and promote better ways for validating products.

Although, the new innovations are not expected to change the world within a night, the devices’ far-reaching applications can expedite the progress. The growing awareness toward safe health practices, strong foothold in the medical devices manufacturing sector and increasing government and nongovernment organization initiatives for blood donation, are producing quality business opportunities for the blood collection devices. Of course, financial budgets will always be a constraint, particularly in emerging countries as India, ultimately determining widespread adoption.

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