Point-of-Care Testing (POCT) Tools : Transformation in Veterinary Practice

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Point-of-Care Testing (POCT) Tools -Transformation in Veterinary Practice
Point-of-Care Testing (POCT) Tools -Transformation in Veterinary Practice

Point-of-Care Testing (POCT) Tools : Transformation in Veterinary Practice

A point-of-care testing (POCT) device is a medical diagnostic tool used to test patients at the point of care, generally defined as at or near the patient’s site of care.POCT devices are often portable and easy to use, and they offer many benefits over traditional laboratory tests. Perhaps the most significant advantage of POCT is that it provides rapid results, which can be critical in emergency situations. Another benefit is that POCT can be performed without the need for trained laboratory personnel, which can make it more convenient and cost-effective. In addition, POCT devices typically require less blood or other specimens than traditional laboratory tests, making them less invasive to the patient. Although point-of-care testing has some limitations, such as lower accuracy compared to laboratory tests, its benefits make it an important tool in a variety of settings.

Abstract

Point of Care Testing (POCT) is a revolutionary approach that has transformed the field of clinical veterinary biochemistry. This method enables rapid, accurate, and on-site diagnostic testing, offering veterinarians invaluable insights into an animal’s health. With the growing importance of pets and livestock in our lives, the integration of POCT in clinical veterinary biochemistry is reshaping the way animals are diagnosed and treated. In this article, we will delve into the world of POCT, exploring its applications, benefits, challenges, and the future it holds in the realm of animal healthcare.

In Veterinary, clinical biochemistry labs play important role in diagnosis of different infectious diseases but sometimes these laboratory methods of diagnosis delay the treatment of animal and so increase the risk of life of animal. Therefore, alternative to lab diagnosis is point of care (POC) testing, which involves bedside testing of different laboratory parameters like pH, Blood gas analyzer, pCo2, electrolytes etc. and decrease the therapeutic turn around time. PoCT technologies can be split into many categoriesout of which the two major categories, the first is small handheld devices, providing qualitative or quantitative determination of an increasing range of analytes (glucose, electrolytes, antibody). The second category of devices are larger, often benchtop devices that are essentially laboratory instruments thathave been reduced in both size and complexity. These include critical care analyzers and, more recently, small haematology and immunology analyzers. Recent advances in emerging technologies [i.e., cellphone (CP)-based technologies, paper-based assays (PBAs), and lab-on-a-chip (LOC) platforms] are paving the way for next-generation point-of-care testing (POCT). In veterinary with the advancement of artificial intelligence, this area is likely to grow with many devices being developed and is likely to reach the commercial market in the next few years.

Keywords: POCT, Veterinary, Cell phone.

INTRODUCTION

The most important driver responsible for the increased growth in the veterinary diagnostic market is the imminent demand for the animal-derived food products and a higher rate of occurrence of zoonotic diseases. Diagnosis of diseases in companion animals like cats, dogs and horses are expected to boost the demand for veterinary diagnostics for maintaining the animal health and safety over the forecast period. Zoonosis can cause a wide range of ailments in individuals and animals resulting in mild to severe illness and can even cause death.With the development of artificial intelligence, (AI) and technological innovations in healthcare sector provide a closer connection with the patient. With the use of smartphone apps, biosensors, lab-on-a chip, and wearable devices—all of which offer an on spot or near patient bedside diagnostics(Vashist et al. 2015). Therefore, on spot testing technologies are quickly becoming part of the healthcare landscape. The driving concept in support of point of care testing (POCT) is to bring testing closer to the patient and results conveniently and quickly to the provider to expedite diagnosis and subsequent treatment. POCT helps in decreasing turn around time (TAT), time from test request to patient treatment.Pointof-care testing (POCT) is the testing of patient samples outside the hospital laboratory, in clinical areas near to the patient, usually by staff who are not trained and registered healthcare scientists. Other terms used to describe POCT includes bedside testing, near patient testing. POCT’s devices popularity has risen in recent years, As POCT devices are very handy so they are very helpful in improving likelihood of patient, physician, and care team will receive the results faster, allowing for immediate clinical management decisions. Furthermore, development, implementation, and connectivity of portable diagnostic and monitoring devices for POCT will be part of a successful shift from curative medicine to predictive, personalized, and pre-emptive medicine.

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BACKGROUND

In 1500 B.C.,Egypt pharaoh’s doctor noticed accumulation of ants around the urine of some people rather thanothers that gives the indication of some disease in humans. Inthe pre -1900s, chemical analysis have been carried out close to the patient, i.e., at the bedside, or more commonly, in specially designated ward side- rooms since they were first introduced for diagnostic purposes during the early 19th century at differenthospitals. So with the advancement in science push the diagnostic lab methods to point of care testing to decrease turn around time and for faster result so that treatment will start. In 1950s, first urine test stripswere made on industrial scalecommercially. Company Boehringer Mannheim, today Roche, launched its first Combur test strips (urine) in 1964. The first glucose meter were used in 1970 under name of Dextrostix®. In 1990 MediSense, now owned by Abbott Laboratories, introduced electro-chemical readings or biosensors, which were supposed to make glucometers more accurate. This is done by turning biochemical reactions into electrical signals.

FACTORS STIMULATING POCT DEMAND

The increasing prevalence of infectious zoonotic diseases in developing countries, the rising incidences of lifestyle diseases such as cardiac diseases and diabetes, the rising usage of home based POC devices, and technological advancements with regard to development of advanced, faster, and easy to use devices are stimulating the demand for POCT (Bill 2012). • Technological advancements (faster, easier-to-use devices)

• Laboratory staff shortages

• Increasing older population and more chronic disease

• Rising incidence of lifestyle diseases (e.g., cardiac, diabetes)

• Increase in home-based POC usage

• Long-term savings

• Rural locations with limited lab services

• Prevalence of diseases in developing countries

TYPES OF POCT TECHNOLOGY

A typical classification of PoCT technology splits devices into small handheld ones including quantitative and qualitative strips, and those which are larger bench-top devices with more complex built-in fluidics, often variants of ones used in conventional laboratories (Umesh G. 2018). Now-a-days, biosensor as the basis of analysis in many point-of-care testing (POCT) instruments. Biosensors are used for toxicology and drug screens, measurement of blood cells, coagulation, detection of cardiac markers and glucose self-testing.Different others POCT devices works on different analytical principle like

(a) Reflectance : e.g. Urine and blood dipsticks for glucose and various other analytes,

(b) Electrochemistry in strip device, cassette and bench-top device

(c) Lateral Flow Immunoassays: The recognition agent is an antibody that binds to the analyte in a biological sensor.E.g. measurement of troponin T, myoglobin, and D-dimer.

REQUIRED FEATURES OF POCT DEVICES

Designers of PoCT devices start with the needs of their users and some extent depend on the clinical setting(Price Cet al. 2010). However some key features include are common to virtually all users in all settings: (Table 1)

1. It must be simple to use.

2. The reagents and consumables are robust in storage and usage.

3. The results should be concordant with an established laboratory method.

4. The device together with associated reagents and consumables are safe to use.

Table 1. The ASSURED guidelines that indicate the features that should be designed into all PoCT devices.

1 Affordable- For those at risk of infection (Improve economic outcomes)

2 Sensitive- minimal false negatives

3 Specific -minimal false positives

4 User-friendly -minimal steps to carry out test

5 Rapid &Robust -short turn around time (TAT) and no need for refrigerated storage

6 Equipment-free- no complex equipment

7 Delivered-to end users

(TAT = time from test request to patient treatment)

Novel Technological Developments: With the advancements in artificial intelligence and technology new generation POCT devices includes the usages of cell Phone (CP) Based Technologies e.g. iHealth Align glucometer, paper base assay (PBA) e.g. cardiac markers estimation and lab on chip (LOC) devices which is very helpful in on spot determination of results near bed side patients. Following things to keep in mind while developing new generation devices (Vashist et al. 2015).

(a) Miniaturization: With the trend of increasing miniaturization of devices and the application of technologies developed in relation to consumer electronics, it is becoming increasingly possible to make smaller and smaller devices that incorporate all of the previous mentioned design features. Microfluidics, chip technology and DNA may be directly analyzedin a few microliters of sample. The advantages of miniaturization fluid volumes in the nL and pL range, Requires less time (Vashist et al. 2015).

(b)Parallelization: Chip technology opens up the possibility of measuring multiple channels or multiple time points in the smallest space; photolithographic techniques allow reaction reservoirs and liquid channels to be etched on a wafer to enable 100 or more measurements to be taken simultaneously(Vashist et al.

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(c) Networking: Next-generation laboratory systems will generally be networked via IT, and an international communication standard (POCT1-A) already exists for this purpose The available market for both professional and patient self-monitoring POCT tests and includes testing kits for blood gases/electrolytes, cardiac markers, cholesterol/lipids, coagulation monitoring, drugs of abuse testing (DAT), fecal occult blood, food pathogens, glucose monitoring, hematology, infectious diseases, pregnancy and fertility, tumor/cancer markers, urinalysis testing.

Some examples where POCT devices can be used includes:

• Outbreaks of disease veterinary medicine;

• Critical Care Unit Emergency Department

• Respiratory Medicine Outpatient Department

• Community Respiratory Service in managing COPD

• Air Ambulance Retrieval Unit

• Remote Rural Hospitals

• Intra–operatively in cardiac bypass surgery

• General Practice

• Home Use

• Military medicine

• Mobile emergency paramedical care (blood mobiles, mobiles for public events); transport vehicles (e.g., ambulances and helicopters);

• Fitness studios.

Point Of Care Diagnostics In Veterinary Medicine

Many pet owners desire to have all the information possible to make important decisions about their pet’s healthcare, while they are also very busy with life’s fast pace and are actually stressed about the veterinary visit and health of their pet. Since many veterinarians send blood to a commercial lab and the results are not returned for interpretation or discussion until after the client leaves the building, the assumption is made that the client is not concerned with the wait. The veterinarian must assume that not only is the wait ok for the client, but that running the tests at the point-of-care does not provide a medical or financial advantage to the practice, client and patient. Veterinarians account for multiple factors when determining whether to run blood work in house or send to a commercial laboratory. Various common reasons for the choice of POC testing includes:

1. Cost

2. The time (or perceived time) to prepare and run the sample

3. The perception of the need for immediate results

4. The work flow of the practice

5. The tests available on the panel vs. those on the point-of-care analyser.

 Benefits of POC testing (Umesh G. 2018)

  • Faster test results lead to more timely triage or treatment

• Less sample volume (neonatal, pediatric, ICU benefit)

• Tests at a variety of remote locations meet a diversity of medical needs

• Decrease pre-analytical concerns related to processing of specimen. (e.g., clotting, centrifugation, etc.)

• A Lean process

• Improved patient morbidity & mortality Reduction in hospital admission

• Increase provider and patient satisfaction

• Reduce length of hospital stay

• Reduce hospital admissions

• Optimize drug treatments

• Decrease inappropriate use of drugs

• Reduce postoperative care time

• Rapid analysis times

• Optimize clinical efficiency and use of staff time

• Reduction in clinical visits .

Disadvantages (Vashist et al. 2015):

  • Increase in administrative work associated with training and Certification of operators

• Caregivers required to perform test so chances of increased risk of errors

• Interference due to endogenous substances in the sample can affect result.

• Result is dependent on operators.

• Narrower measurement range for some analytes or variability in results.

• Higher cost of POCT compared with laboratory testing. Cost can, however, be partially offset by processing small sample volumes on-site with resulting short TTAT (therapeutic turn around times) to minimize the overall hospital cost.

• An extra step is required to integrate test results with laboratory information systems.

Quality Control (QC) Requirement:

This is very important step in POC testing, if any test performed incorrectly presents a significant patient risk and potential for increased healthcare costs. So quality control tests must run time to time like in areas of low use, QC should be conducted weekly even when patient samples are not processed to identify faults. Testing should be conducted at each analyzer site to monitor differences in storage conditions and operator performance.

  1. Understanding Point of Care Testing (POCT)
  2. Defining POCT
    • Point of Care Testing (POCT) refers to diagnostic testing performed near or at the location where medical care is delivered. In veterinary medicine, this can be the clinic, farm, or even in the field.
  3. Key Features of POCT
    • Rapid Results: POCT provides quick results, enabling veterinarians to make timely decisions.
    • Portability: POCT devices are typically portable, making them suitable for use in various settings.
    • On-site Testing: POCT eliminates the need to send samples to external laboratories, saving time and resources.
  1. Applications of POCT in Clinical Veterinary Biochemistry
  1. Blood Chemistry Analysis
    • POCT devices can measure various blood parameters, including glucose, urea, creatinine, electrolytes, and liver enzymes. This aids in the diagnosis of conditions like diabetes, renal disease, and hepatic disorders.
  2. Hematology
    • Veterinary hematological POCT devices provide insights into an animal’s blood count, including red and white blood cell counts, hemoglobin, and platelet levels.
  3. Infectious Disease Testing
    • Rapid diagnostic tests for infectious diseases such as parvovirus, feline leukemia, and heartworm are essential for early diagnosis and intervention.
  4. Electrolyte Analysis
    • Monitoring electrolyte levels is crucial for the management of conditions like dehydration and acid-base imbalances.
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III. Benefits of POCT in Veterinary Medicine

  1. Immediate Results
    • One of the primary advantages of POCT is the immediate availability of test results. Veterinarians can make timely treatment decisions, especially in critical cases.
  2. Reduced Turnaround Time
    • POCT eliminates the need to send samples to external laboratories, reducing the time it takes to receive results.
  3. Enhanced Patient Care
    • Rapid diagnostics improve patient care by enabling swift interventions and tailored treatments.
  4. Remote and Field Applications
    • POCT devices are designed for use in various settings, including farms and remote locations, where access to traditional laboratory facilities is limited.
  5. Client Satisfaction
    • Clients appreciate receiving results during their visit, increasing their confidence in the veterinary practice.
  1. Common POCT Devices in Veterinary Biochemistry
  1. Blood Glucose Monitors
    • These devices are commonly used in managing diabetes in pets. Regular monitoring of blood glucose levels helps in adjusting insulin doses.
  2. Electrolyte Analyzers
    • These devices provide quick measurements of electrolyte levels in animals, aiding in the diagnosis and management of electrolyte imbalances.
  3. Hematology Analyzers
    • Portable hematological analyzers offer complete blood count (CBC) results, including red and white blood cell counts and platelet levels.
  4. Blood Gas Analyzers
    • These devices measure blood gases and provide insights into a patient’s acid-base balance and respiratory status.
  1. Challenges and Considerations
  1. Cost of Equipment
    • POCT devices can be expensive, and the initial investment may be a barrier for some veterinary practices.
  2. Training and Expertise
    • Proper training is essential to ensure accurate results and the correct use of POCT devices.
  3. Quality Control
    • Maintaining quality control and calibrating devices regularly is crucial for reliable results.
  4. Sample Collection and Handling
    • Ensuring proper sample collection and handling is essential to obtain accurate results.
  1. The Future of POCT in Veterinary Medicine
  1. Technological Advancements
    • Ongoing advancements in POCT technology will lead to more compact, accurate, and affordable devices.
  2. Integration of AI
    • Artificial intelligence will play a significant role in the interpretation of POCT results, offering veterinarians valuable insights.
  3. Telemedicine and Remote Monitoring
    • The integration of POCT with telemedicine will enable remote consultations and monitoring, extending veterinary care to remote areas.
  4. Customized POCT Panels
    • Tailored panels for specific conditions or species will become more readily available, enhancing the diagnostic capabilities of POCT devices.

Conclusion

Point of Care Testing (POCT) has become an indispensable tool in clinical veterinary biochemistry. Its rapid results, portability, and on-site testing capabilities offer veterinarians the means to provide timely and effective healthcare to animals. While challenges such as equipment costs and training persist, the future of POCT in veterinary medicine is bright. As technology continues to advance and AI integration becomes more prevalent, the diagnostic and monitoring capabilities of POCT devices will only expand. The ongoing evolution of POCT will undoubtedly improve the quality of care for our beloved animal companions and further our understanding of their health.

Decreasing costs, rapidly increasing processing power, inbuilt sensor and camera capabilities, connectivity, and widespread uptake even in the developing world, CPshave emerged as highly promising interfaces for POCT, thereby constituting the next generation of futuristic smart devices for affordable personalized health care, mobile veterinary care, and telemedicine.

Recent developments in paper- and LOC-based microfluidic assays together with novel assay formats have unprecedentedly expanded the number and complexity of tests that can be conducted using low-cost and disposable POCT kits, particularly in the developing world.

Compiled  & Shared by- This paper is a compilation of groupwork provided by the

Team, LITD (Livestock Institute of Training & Development)

 Image-Courtesy-Google

 Reference-On Request.

MEDICAL & VETERINARY DIAGNOSTIC KITS IN INDIA :A Brief Overview of Regulatory framework for Medical & Veterinary  Devices in India

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