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Blood testing

Blood testing has played an important role in controlling the COVID-19 pandemic. As the number of COVID-19 cases increased worldwide, governments across the globe explored the possibilities of allowing private laboratories to ramp up blood testing. The immediate detection of COVID-19 cases required a wide availability of diagnostics to control the rapid spread of the virus. A public health emergency was determined, justifying the authorization of emergency use of in vitro diagnostics (IVDs) for the diagnosis of COVID-19, which ultimately drove the blood testing market growth across the world.

CBC scoring crucial in predicting COVID-19 severity
COVID-19 induces haemocytometric changes. Complete blood count changes, including new cell activation parameters, analysed for distinctive patterns observed haemocytometric patterns formed the basis to develop a multi-haemocytometric-parameter prognostic score to predict, during the first three days after presentation, which patients will recover without ventilation or deteriorate within a two-week timeframe, needing intensive care or with fatal outcome.

Andre van der Ven and his colleagues at Sysmex, Europe GMBH created an algorithm based on 1587 CBC assays from 923 adults. They also validated the scoring system in a second cohort of 217 CBC measurements in 202 people. The findings were concordant — the score accurately predicted the need for critical care within 14 days in 70.5 percent of the development cohort and 72 percent of the validation group.

The scoring system was superior to any of the 10 parameters alone. Over 14 days, the majority of those classified as noncritical (NC) within the first 3 days remained clinically stable, whereas the clinical illness group progressed. Clinical severity peaked on day 6. Most previous COVID-19 prognosis research was geographically limited, carried a high risk for bias and/or did not validate the findings.

The aim of the score is to assist with objective risk stratification to support patient management decision-making early on, and thus facilitate timely interventions, such as need for ICU or not, before symptoms of severe illness become clinically overt, with the intention to improve patient outcomes, and not to predict mortality.

Hematology testing in donor assessment and blood banking applications

Jeanette Nikus
PhD, Global Product Manager,
Boule Diagnostics
Hematology testing constitutes an important part of donor assessment and quality control of blood products. In a donor screening, only individuals of good health are selected. Donor-induced iron deficiency is of particular concern and it is recommended that individuals with low pre-donation hemoglobin are excluded from erythrocyte donation. The increasing need for apheresis platelets additionally raises concerns of donor platelet and leukocyte depletion. Donors are therefore closely monitored for adverse effects such as anemia, thrombocytopenia, and lymphocytopenia.

Challenges of blood collection centers and blood banks include achieving short turnaround time for donor screening, events related to repeated venipuncture of the donor, and efficient quality assurance of the blood products derived from the donated blood.

Rapid tests for on-site donor screening are available for many analyses, including hemoglobin, blood type, and common bloodborne infections. Blood cell counts, however, sometimes require that samples are sent to the central laboratory for testing, a procedure often associated with venipuncture and prolonged time from sampling to results.

Many hematology system manufacturers are therefore actively working on small systems for rapid on-site testing that would significantly reduce turnaround time for donor screening. Capability of reporting a complete blood count from a finger-stick sample is also within scope. Blood collection from a fingerstick is easier on the donor and, at the same time, saves the vein for the donation.

Hematology testing is also an important part of quality assurance of the blood products. With early-generation hematology testing devices, analysis of platelet concentrates with high platelet counts demanded a dilution step, with the associated risk of erroneous results. The broad linearity range of modern hematology systems allows measurements of platelet counts of up to 5000 × 109/L, omitting the need for dilution of platelet concentrates.

Van der Ven and colleagues developed the score based on adults presenting from February 21 to April 6, with outcomes followed until June 9. Median age of the 982 patients was 71 years and approximately two thirds were men.

Only 7 percent of this cohort was not admitted to a hospital. Another 74 percent were admitted to a general ward and the remaining 19 percent were transferred directly to the ICU. The scoring system includes parameters for neutrophils, monocytes, red blood cells, and immature granulocytes, and when available, reticulocyte and iron bioavailability measures.

The researchers report significant differences over time in the neutrophil-to-lymphocyte ratio between the critical illness and non-critical groups (P < .001), for example. They also found significant differences in hemoglobin levels between cohorts after day 5. The system generates a score from 0 to 28. Sensitivity for correctly predicting the need for critical care increased from 62 percent on day 1 to 93 percent on day 6.

The hemocytometric changes, reflected together in the prognostic score, could aid in the early identification of patients whose clinical course is more likely to deteriorate over time. The findings also support other work that shows men are more likely to present to the hospital with COVID-19, and that older age and presence of comorbidities add to overall risk. However, not all young patients had a mild course, and not all old patients with comorbidities were critical. Therefore, the prognostic score can help identify patients at risk for severe progression outside other risk factors and support individualized treatment decisions with objective data. It is likely a CBC-based score will be combined with other measures.

The specific alterations in circulating blood cells that come along in COVID-19 patients can be detected by a routine hematology analyzer, especially when that hematology analyzer is also capable to recognize activated immune cells and early circulating blood cells, such as erythroblast and immature granulocytes. The algorithm should be installed on the hematology analyzers so the prognostic score will be automatically generated if a full blood count is asked for in a COVID-19 patient. So, implementation of score is the main focus now.

COVID-19 creates huge market demand for related products
The COVID-19 pandemic has encouraged major market players to focus on the development of other new innovative products.

Blood glucose meters. In May 2020, DarioHealth Corp. announced that the FDA has approved the use of self-test blood glucose meters by hospitalized patients with diabetes. This was intended to limit the exposure to the COVID-19 virus by self-checking of blood glucose levels by hospitalized patients and providing information to healthcare personnel.

Immune biomarker test. Tests such as immune biomarker test are being used in the treatment of COVID-19 to quantify and identify the human immune system’s response to the virus.

Blood viscometers. Blood thickness has emerged as an important indicator of dangerous complications in COVID-19 patients, causing demand for blood viscometers. Recognizing that a second wave is likely, medical providers are now eager to equip themselves with testing equipment that is emerging as having a key role in directing the treatment of COVID-19 patients.

The link between blood viscosity and COVID-19 began to emerge in June when doctors at Emory University noticed that many COVID-19 patients had unusual blood clotting that did not respond to the usual anti-clotting medication.

The team considered other causes of clot formation, like hyperviscosity, which can be detected by plasma viscosity (PV) testing. Hyperviscosity syndrome, where the high viscosity leads to dangerous sludging of the blood in the brain and other organs, produces viscosity levels similar to those seen in the sickest COVID-19 patients. They found that the sickest patients with COVID-19 had the highest PV levels, more than twice normal levels. It was also found that patients with the highest viscosity levels were more likely to have a blood clot. The inflammation caused by COVID infection causes the hyperviscosity, which may contribute to blood clots in some patients.

In a further development, it has been observed that doctors can examine the blood of COVID-19 patients to identify those at greatest risk of severe illness and to pinpoint those most likely to need a ventilator. The scientists from the University of Virginia (UVA) School of Medicine in the US, found that the levels of a particular cytokine in the blood upon diagnosis could be used to predict later outcomes. The discovery could become part of a scoring system to let doctors flag at-risk COVID-19 patients for closer monitoring and personalized interventions.

The finding also identifies cytokines doctors could target as a new treatment approach, according to the findings shared on the pre-print server medRxiv.org. The team identified 57 COVID-19 patients treated at UVA who ultimately required a ventilator. The researchers then tested blood samples taken from the patients within 48 hours of diagnosis or hospital admission. They compared the results with those from patients who did not wind up needing a ventilator.

Blood gas and electrolyte analyzers. For COVID-19 patients that display signs of respiratory distress, or who are admitted in ICU units and are on ventilation support, blood gas testing is considered crucial. The overall development rate of blood gas and electrolyte analyzers is high. Although it comes at the cost of shorter product life cycles, it allows for a higher rate of product improvements. Demand increased by 10.1 percent in 2020 and is expected to continue to grow to reach USD 1 billion by the year 2027, trailing a post COVID-19 CAGR of 5.1 percent.

Arterial blood gas is a common test used for measuring blood acid and oxygenation levels along with diagnosing respiratory or renal conditions. Respiratory systems of patients are critically damaged by COVID-19 infection and hence they are unable to move oxygen inside the body and remove carbon dioxide. Also, acid-base imbalance is common in patients suffering from COVID-19.

Hence, accurate measurement of blood gas results is important to manage the progression of the disease in patients to assess their critical condition. Blood gas and electrolyte analyzers measure various parameters from blood samples, such as pH, PCO2 and PO2, electrolytes, and metabolites. The pH value of blood and serum indicates the balance between the blood, renal, and lung systems, while the PCO2 value is used to assess the amount of carbon dioxide eliminated from the body, and the PO2 value of arterial blood indicates oxygen absorbance in the lungs.

Depending on patient care scenario, physicians are relying on sophisticated critical care testing devices such as cartridge combinations of electrolytes and gases. The increasing use of these systems for PoC testing in laboratories and acute care venues such as COVID-19 emergency rooms, intensive care units, and ambulances is boosting demand for blood gas and electrolyte analyzers. To leverage the opportunities for growth, several companies are launching advanced devices.

By the end of 2023, North America is estimated to generate a demand worth of USD 1134.6 million. The developed country of the US has been a key promoter for the use of combination analyzers over the recent past, as opposed to other devices that have a smaller analysis spectrum.

The conventionally used standalone blood gas and electrolyte analyzers are rapidly nearing maturity in multiple regions. The conventional tabletop analyzers are now being replaced by the improved portable and combination analyzers. The segment of combination blood gas and electrolyte analyzers is expanding at the second-highest CAGR of 10.4 percent by 2023.

North America hospitals and healthcare organizations are also showing a high interest for PoC devices and the integration of wireless connectivity. The large-scale adoption of electronic health records will benefit from the implementation of blood gas and electrolyte analyzers that can communicate faster.

Meanwhile, Asia Pacific is expected to open up its doors to new blood gas and electrolyte analyzer devices soon, due to a greater awareness of modern analyzers, increasing expenditure on the healthcare industry, and a rapidly developing healthcare infrastructure. Currently, a large part of the blood gas and electrolyte analyzers consumption in the region is through used or refurbished devices. Most healthcare institutes are finding it difficult to meet the high costs of blood gas and electrolyte analyzers, therefore staying with reusing older devices.

Way forward
The assessment of damage caused due to COVID-19 in patients requires several diagnostic tests and medical interventions. While RT-PCR tests remain gold standard to diagnose the infection, blood tests are found useful among the medical fraternity for effective treatment decisions.

Several governments have invested in procuring and sourcing new technologies that can be used to improve blood testing and diagnosis. In addition to this, the collective efforts of all regional governments to tackle the spread of the coronavirus has generated new opportunities for market growth.

The presence of a seamless industry for medical testing and diagnosis will be a sound gamechanger for the vendors.

COVID ailment and utility of blood gas and electrolyte analyzers

Santosh Aghamkar
Director – South Asia,
Medica Corporation
Over the past one year, Indian medical fraternity has realized the need of better diagnostic tools for managing the COVID patients especially in critical care. Moving forward, industry is aligned in designing innovative products that meet and exceed the expanding needs of critical care, within various hospital classes and private labs in India and globally.

The technology interface used in many blood gas analyzers facilitates measurement of PO2, PCO2, and pH, as well as electrolytes utilizing disposable, maintenance-free electrodes. The development of simplified user interfaces using complex, internal algorithms have allowed for the expansion of result reporting to include calculation of parameters important for accurate and timely patient care, such as temperature correction, oxygen saturation, base excess, and bicarbonate concentrations. The use of minimal sample volumes allows for testing in environments where the collection of syringe samples is not achievable, such as neonates with cardiopulmonary problems where capillary samples are the preferred choice. Blood gas analyzers commonly include universal samplers, which aid in accommodating varying sample collection devices such as syringes or capillaries used in diverse patient populations.

Acid-base disturbances are common in hospitalized patients, especially in patients with severe viral infections such as COVID-19. The accurate interpretation of blood gas results is key to managing the progression of disease of patients in critical condition. The prevalent patient conditions and the need for timely results are key factors when deciding on a blood gas analyzer. Most hospitals, laboratories, and COVID-19 centers are in search of a system that will deliver total automation at affordable pricing without making any civil changes in set up, since space is also a major constraint.

In all, those in search of a blood bas analyzer should consider the following features during the selection process:

  • Simplicity in operation;
  • Accuracy and precision of results;
  • Software that supports a quality control program acceptable worldwide such as Levey-Jennings charts and plots;
  • Consumption of reagent should be as minimal as possible resulting in lower cost-per-sample; and
  • Capabilities such as barcode reading and LIS/HIS connecti­vity are important for accurate result reporting and improvement in the turn-around-time of reporting patient results.

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