Diagnostic blood testing is the most prevalent medical procedure performed and forms the cornerstone of modern healthcare delivery. It is a critical procedure, as diagnostic test results inform upwards of 70–80 percent of clinical decisions. Although the technology for blood draws has previously remained relatively unchanged for tens, if not hundreds of years, a number of companies have been making inroads into easier, safer, and more efficient ways to collect blood samples.
There is a growing trend toward innovations in blood collection. Two firms won US Food and Drug Administration 510(k) clearances for blood collection devices recently, 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.
Blood drawn by venipuncture is one of the most commonly performed hospital procedures, affecting nearly every hospitalized patient daily. Many modern diagnostic tests, such as some PCR-based assays, do not require large volumes of blood to run. An HIV viral load test, for example, uses a fingerstick blood sample and has shown good results in clinical trials. A firm is purportedly using fingerstick samples for next-generation sequencing-based liquid biopsy testing. Fingerstick, or even capillary blood draws from other parts of the body, is an ideal technique for pharmacy clinics. The method eliminates the need for a trained phlebotomist and is more appealing to patients than venipuncture.
One problem with fingerstick, however, is the potential for variation between droplets of blood. Seventh Sense’s TAP device, overcomes this obstacle by collecting up to 100 microliters capillary blood into a vacuum chamber by firing an array of 30 microneedles into the upper arm. The firm is also planning to launch a larger volume device in the near future, which will collect up to 250 microliters. The device is about 2 inches long and 1.5 inches wide, approximately the size of the head of a stethoscope and is considered to be virtually painless. The 250 microliters drawn by the forthcoming larger-volume collection device is likely to provide enough samples for many types of tests.
Even though many patients in hospitals tend to have short, peripheral IV catheters placed, phlebotomists still must typically draw blood from another vein, sometimes multiple times per day for different tests because of presence of platelet debris and dilution with whatever had been infused in that vein previously. The catheter tubing is also designed to soften with body heat, but this means that it tends to collapse or kink with the vacuum pressure of attempting to draw blood.
The Pivo device overcomes this by injecting a narrower and sturdier length of tubing inside of the IV, essentially uncollapsing it, and extending this further into the vein to bypass any debris. It can be used to draw as many tubes as are needed, and then removed and disposed of so that the IV line can be used for its primary purpose. This avoids sticking patients repeatedly with needles and also accessing central lines, which can increase infection risk. This is also particularly useful for patients considered to have difficult venous access (DVA), who tend to be chronically ill, obese, or diabetic.
The recent FDA clearance was for a second generation of Pivo, that was enhanced for manufacturability and usability based on customer feedback. The firm is also developing new, as-yet undisclosed products to improve efficiency and provide more humane care for hospitalized patients.
Another firm developing products for microsampling is Neoteryx, with a CE-marked product called the Mitra. The device is, in fact, not just limited to blood, but can be used for any biological fluid. For blood collection, the device collects between 10 and 20 microliters from a fingerstick and automatically places these into a dried blood spot sample. The device essentially combines two alternative methods – wet sampling and dried blood spotting. The Mitra also seems to reduce issues of hematocrit bias, in which levels of hematocrit influence viscosity and spread of the sample on the card, which in turn determines the actual volume of blood samples in a punch from the dried blood spot. The device is also fully compatible with standard high-throughput lab instrumentation.
Moreover, GE Ventures has announced the launch of Drawbridge Health, a personal diagnostic testing startup developing proprietary technology designed to integrate blood draw, collection, and sample stabilization into a single device. Healthcare providers using the new blood collection technology will be able to deliver a superior patient experience. This integrated technology is also being developed to support room temperature shipping and streamlined downstream processing, ensuring reliable, accurate results.
The easy-to-use blood collection device could be used anywhere – at a clinic in a city, in a remote village or potentially even at home. Users will be able to apply the device to the upper arm and activate it. It will then store and stabilize the sample in a special cartridge. The blood stabilization technology inside the device is a high-tech paper-like material known as the matrix. The collection device will draw a small amount of blood and channel it onto the matrix, which stores the sample for later extraction and testing. The matrix also stabilizes the collected blood sample and eliminates the need to refrigerate it, which will simplify transporting it to the lab.
The blood collection business is certainly ripe for change. Although capillary draws and fingersticks for diagnostic work is a complementary space, there are clearly trends and growth in this area. Today, blood sampling is dominated by a few large companies. They have been doing the same thing for decades. Although new innovations are not expected to change the world overnight, the new devices’ applications could include wellness testing, chronic disease management, and reproductive health, among others.
The global blood collection market size was valued at USD 8.6 billion in 2017 and is projected to grow at 6.1 percent during 2017–2025, predicts Grand View Research. Increasing prevalence of infectious and noncommunicable diseases, mounting number of accident and trauma cases are the major factors contributing toward the growth. Therefore, the demand for blood collection products for diagnostics application is expected to grow at a high rate in the near future.
Increasing number of surgical procedures is another major factor considerably promoting toward the growth of the market. The increase in the number of surgical procedures such as organ transplant and cancer surgeries that require blood transfusion is expected to propel the application of these products of the market. Thus, the demand for needles, syringes, tubes, and blood bags is growing for the diagnostics and treatment application, which is expected to drive the growth.
On the basis of product, needles and syringes have generated the largest revenue in this segment and is also projected to uphold its dominance till 2025. The high demand of syringes and needles in diseases diagnosis and surgical procedures is the major factor contributing to the growth of this segment. In addition, these products are easy-to-handle and economical. These factors drive its application for diagnostics and therapeutic purposes.
The blood collection tube segment is expected to showcase lucrative growth over the years. The increase in the prevalence of diseases drives the demand for blood testing and subsequently for blood collection tubes. In addition, product advancement is another major factor that propels the adoption of blood collection tubes.
By method, the automated blood collection segment is expected to register the highest CAGR. Growth in this segment is attributed to the increasing demand for safer procedures to withdraw and separate blood components for transfusion; availability of advanced blood collecting products; and the rising demand for plasma by biopharmaceutical companies.
Geographically, North America held the largest share of the global blood collection market in 2016, while Asia-Pacific (APAC) is expected to witness the highest growth. A large population base, improving healthcare infrastructure, growing medical tourism, increasing number of hospitals, and rising disposable incomes in the region are expected to offer significant growth opportunities for key players operating in the market.
Some of the key players comprise Abbott Laboratories, Terumo, Becton, Dickinson and Company, Nipro Medical, Medtronic, Qiagen, Greiner Holding, Haemonetics, Sarstedt, and F.L. Medical. The major companies are undertaking several organic as well as inorganic strategies such as collaborations, new product development, acquisitions, and regional expansion to gain maximum share in the industry. For instance, a partnership between Safeway and Quest Laboratories.
For a participant, a blood draw can be an unsettling experience. But the makers of new blood collection devices are rethinking needles and venipuncture and opening an exciting frontier of product design. Since 1947, scientists have successfully tried to improve the experience from the creation of Vacutainer vacuum tubes and standardization of blood collection tubes to dried blood spot sampling. Other industry innovations speak to the efficacy of using capillary blood for routine purposes. New devices use capillary action to draw blood through tiny channels. These disposable devices can replace traditional venipunctures at medical laboratories. They can collect 150 microliters of blood, enough to test for cholesterol, blood sugar, cancer cells, infections, and other ailments.
Microsampling technology. It has enabled collection of very tiny amounts of blood that are enough to evaluate the drug levels and the biochemistry parameters of blood. Microsampling devices enable accurate and precise collection of a fixed volume of blood while eliminating bias posed by dried blood spotting hematocrit analysis (volumetric blood hematocrit). They require only minimal training and are easier to use. This enables collection of blood from remote locations.
Moreover, the blood collected does not require cold storage or biohazard transportation, consequently eliminating associated costs. The microsamplers are available in several formats, including the clamshell and the cartridge. The cartridge format is a suitable device for remote blood collection. It uses native barcoding and its associated accessories include a resealable bag.
Plasma separation during blood collection. The new card-shaped device collects drops of blood and separates out the plasma without the need for any laboratory equipment. It is faster and more convenient to collect and process blood samples and prevents RBCs from changing the chemical composition of the sample right at the time of blood collection. It combines blood collection, plasma fractionation, sample preservation, transportation, and sample preparation into a single step.
As plasma travels through a three-membrane stack, the technology separates and filters plasma from blood cells. It does not require any power source and can be used anywhere. The card works with either fresh or chilled blood. Depending on the device’s configuration, it can collect 3 to 6 microliters of plasma.
Vacuum blood collection device. Before the modern vacuum tube, collecting blood was difficult and imprecise. Sanitation was also an issue because tubes and syringes were washed between patients. Vacuum blood collection device, using the vacuum technology, is a part of a closed system which is used to collect the blood sample directly from the patient’s vein into the appropriate test tube. The vacuum tube blood-collection system made blood draws safer and easier, and their results more accurate. Regulatory agencies such as the FDA, ISO, and CLSI now enforce guidelines that ensure that blood collection systems are consistent in both design and manufacture.
The devices prevent needle stick injury by eliminating needles from human contact and avoid the chances of the spray of fluid getting into the air when the needle is retracted and also avoids the potential aerosoling. The blood collection tubes are accessible in various sizes used for adult and pediatric phlebotomies. Some tubes have additives such as anticoagulants.
Hybrid blood collection tube. The tube combines engineered plastic – cyclic olefin polymers – with a silicon dioxide-coated barrier layer. The layers are fused together, providing an end product with the best properties of glass and the safety and convenience of plastic. The properties of the tube provide excellent oxygen barrier properties preventing vacuum loss and moisture content loss of the stabilizing reagents over time. The tubes are extremely robust and durable, making them resistant to breakage. However, the tube is yet manufactured for research use only.
The tubes also contain a preservative that stabilizes nucleated blood cells. This unique stabilization prevents the release of genomic DNA (gDNA), allowing isolation of high-quality cell-free DNA (cfDNA) samples. These can then be used for a wide range of downstream applications in clinical research studies, drug discovery, and diagnostic assay development. The tubes have also been demonstrated to minimize the degradation of circulating tumor cells (CTCs).
The blood collection market in the country is prophesied to ride on the growing awareness about blood donation through various government and nongovernment initiatives. This could eventually up the demand for blood collection products, and thereby produce quality business opportunities in the market. Besides manual blood collection, other methods such as automatic collection of blood are expected to be widely available. Players looking to penetrate in the market could take advantage of such advancements in the industry.
In general, improving the patient experience and making the blood draws more efficient seem to be increasingly important to practitioners. It is a really big trend – everybody is so focused on diagnostics, and that is super important, but blood collection is the interface between the patient and all of the testing and results!
Tips to Longevity of Equipment
The versatility and transformation of these electro mechanical equipment have come a long way ever since the professional blood transfusion services, which have undergone a revolution in the new millennium post 2000.
Lots of engineering gets involved in producing the device meant for use in a blood transfusion speciality.
Self-maintenance and upkeep is the key to a long-term usage, which should of course be understood at the time of installation by the manufacturing company.
Refrigeration equipment used for storage of whole blood, low temperature freezers for plasma and platelet agitators with incubators for platelets are a few of the major equipment functioning day and night must be dealt on frequent intervals while observing simple steps.
Appropriate power input should be ensured and checked on frequent intervals.
Blood transfusion services should be supported by a servo back up system to ensure a disruption free power to the equipment in use.
Simple and regular cleaning of fins of the heat exchangers of respective equipment will ensue a free flow of fresh air to facilitate an effective cooling to the compressors for an improved performance.
All the refrigeration equipment should not be frequently shifted or tipped to new locations.
Power points and plugs should be monitored and checked regularly.
Calibration of all equipment should be undertaken against the manufacturer’s guide lines. The calibrated equipment should have calibration traceability to national or international traceabilities.
Rooms where these equipment are placed should always have adequate lighting and ventilation even during nights so that these heat emitting equipment dissipate the heat of the stored material in a scientific manner.
Refrigeration equipment should never be opened like domestic almirahs thus preventing the loss of temperature of the stored inventory.
On numerous occasions the stabilizers connected to the equipment are non-performing and dysfunctional to feed an appropriate power.
On such occasions such faulty attachments, be disconnected immediately to prevent further damage to the equipment and stored material.
All above simple tips will help the users to draw optimum mileage from their vital equipment being used for storing blood and its components.
Patient monitoring – Fast track growth
Dr Anju Verma
Rotary Blood Bank
Blood safety for patients begins with healthy blood donors. A regular voluntary blood donor is the safest source of blood for transfusion to patients. Blood component quality depends on the methodology used for whole blood collection. For drawing blood, a phlebotomist has to be skillful. Random donor platelets cannot be prepared if blood collection is not done within 7 minutes. An automated electronic blood collection monitor (BCM) helps in good quality blood collection suitable for blood component preparation.
A BCM is a device which is used to monitor collection of blood in a blood bag during blood donation. They are so designed that they protect against over or under collection of blood. Apart from displaying weight and volume of blood these monitors have an automated clamping system which clamps the tube once the required blood is collected from the donor. Thus, there is no risk of excess blood collection. There are audio-visual alarms to monitor the collection process. The device provides smooth, gentle, and uniform mixing of whole blood with anticoagulant without damaging blood cells and platelets during collection of blood which helps in increasing red cells, platelets, and plasma yield. They also come with battery backup.
With all these features the BCMs are most ideal for use in blood banks and outdoor camps. By using them a phlebotomist can handle more than one donor at a time. Automated cell separators target collection of specific blood components required for the patient. These machines enable us to collect the needed component from the donor, for instance platelets and the rest is returned to the donor’s body. The cell separators are used for therapeutic purpose also. Donor’s and patient’s safety is ensured throughout the procedure. In these machines, disposable sets are used which are unique to the cell separator.
The advantages of these machines are:
The product yield is more hence effective dose of component is given at a time
Multiple donor exposure is not there thus reducing risk of all immunization
The quality of the product is better
To maintain highest level of quality in blood banks continuous scientific progress coupled with automation and computerization is needed.