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POCT in Developing Countries

Point of Care Technology (POCT) means acquiring clinical parameters from the place where the patient is, thus generating faster test results leading to a faster turnaround time. However, improvements in patient outcomes depend on how healthcare delivery professionals and system utilize faster turnaround times. Thus, POCT, by itself, does not lead to better clinical outcomes. Throughout the last two decades, advances in POCT have been impressive, but its impact on developing countries depends on the present healthcare infrastructure. Presently, in most developing countries, POCT is delivered in remote locations or Physicians chamber or Hospital setup of Emergency rooms, Operation Theaters, ICU. It is applied for therapeutic aid (for treatment of certain diseases like diabetes or myocardial infarction), preventive measures (for targeted screening in high-risk groups) or surveillance measures (monitoring of routine blood parameters). There are several challenges in implementing POCT like poor patient demographics, lack of workforce, training, lacking healthcare infrastructure, reluctance in physicians to accept new technology and certain technological limits. Although it may take time, solutions to these challenges will lead to a proper implementation of POCT in the developing nations. Further, integrating it with mobile phone technology will lead to higher acceptance and application. The boom of POCT will depend on the overall improvement and capacity building in the healthcare infrastructure of developing nations.

Point-of-care testing (POCT) is a rapidly growing diagnostic tool that has improved delayed testing challenges in resource-limited settings worldwide, especially in areas with the unavailability of modern laboratory equipment and trained human resources. The objective of POCT is to provide a rapid test result for prompt clinical decisions to improve the patient’s health outcomes. It can be used in primary health care (PHC) clinics, outpatient clinics, patient wards, operating theatres, clinical departments, mobile clinics, and even small peripheral laboratories . POC diagnostics are easy to use devices managed by laboratory staff and other health care professionals with basic training . The World Health Organization (WHO) has provided the ASSURED (Affordable, Sensitive, Specific, User-friendly, Rapid and robust, Equipment-free and Deliverable to end-users) guideline, which forms the basis of the development of POC devices globally .

Development of a rapid test kit for SARS-CoV-2: an example of product design

We present an example of applying ‘need-driven’ product design principle to the development of a rapid test kit to detect SARS-COV-2 (COVID-19). The tests are intended for use in the field and, longer term, for home use. They detect whether a subject is currently infected with the virus and is infectious. The urgent need for large numbers of tests in field setting imposes constraints such as short test time and lack of access to specialist equipment, laboratories and skilled technicians to perform the test and interpret results. To meet these needs, an antigen test based on RT-LAMP with colorimetric readout was chosen. Direct use of swab sample with no RNA extraction was explored. After extensive experimental study (reported elsewhere), a rapid test kit has been fabricated to satisfy all design criteria.

The COVID-19 pandemic caught almost every country in the world off guard and has made huge impact on every aspect of our society. With over 2 million confirmed cases and 130,000 deaths to date (April 2020), scientific researchers in all disciplines have united to fight this invisible enemy on several fronts. Examples of them include detection and diagnostics, recovery, development of drugs, therapies and a vaccine, rapid production of protective equipment, epidemiology and origin of the disease and its spread and societal impact. We have developed a rapid test kit for detecting SARS-CoV-2 that can be performed on field without the need for a laboratory or specialist equipment. The technical details have been reported elsewhere . Here, we present the methodology behind the design and development of this test kit as an example of a product design exercise. Chemical product design methodology has been well developed in recent years , which is particularly useful to customer product development. The need-driven product design methodology can be summarised as follows:

Step 1. Identify the needs.

Step 2. Gather ideas.

Step 3. Select "the most likely successful idea" based on the information available.

Step 4. Test the selected idea. If successful, go to Step 5. If not, go back to Step 3.

Step 5. Evaluate scalability and manufacturability. If feasible, go to Step 6; if not, go back to Step 3.

Step 6. Commence manufacture; obtain regulatory approval and access market.

We applied this methodology to guide our development of COVID-19 rapid test kits.

Cholesterol testing on a smartphone

Home self-diagnostic tools for blood Cholesterol Test System have been around for over a decade but their widespread adoption has been limited by the relatively high cost of acquiring a quantitative test-strip reader, complicated procedure for operating the device, and inability to easily store and process results. To address this we have developed a smartphone accessory and software application that allows for the quantification of cholesterol levels in blood. Through a series of human trials we demonstrate that the system can accurately quantify total cholesterol levels in blood within 60 s by imaging standard test strips. In addition, we demonstrate how our accessory is optimized to improve measurement sensitivity and reproducibility across different individual smartphones. With the widespread adoption of smartphones and increasingly sophisticated image processing technology, accessories such as the one presented here will allow cholesterol monitoring to become more accurate and widespread, greatly improving preventive care for cardiovascular disease.

Medical ultrasound systems

Medical ultrasound imaging has advanced dramatically since its introduction only a few decades ago. This paper provides a short historical background, and then briefly describes many of the system features and concepts required in a modern commercial ultrasound system. The topics addressed include array beam formation, steering and focusing; array and matrix transducers; echo image formation; tissue harmonic imaging; speckle reduction through frequency and spatial compounding, and image processing; tissue aberration; Doppler flow detection; and system architectures. It then describes some of the more practical aspects of ultrasound system design necessary to be taken into account for today's marketplace. It finally discusses the recent explosion of portable and handheld devices and their potential to expand the clinical footprint of ultrasound into regions of the world where medical care is practically non-existent. Throughout the article reference is made to ways in which ultrasound imaging has benefited from advances in the commercial electronics industry. It is meant to be an overview of the field as an introduction to other more detailed papers in this special issue.

Medical ultrasound systems have experienced a revolution in recent years owing to increasing compute power of modern electronics. Capabilities considered to be a fantasy only a few years ago are now taken for granted. In many ways, these advances mirror those in the consumer electronics industry and make use of them. Computing power has dramatically increased ultrasound system capability, but it has also significantly widened the application space in which ultrasound can be found. Ultrasound is now being used in doctors' offices, emergency departments, ambulances, surgical intervention suites and in developing countries with little access to medical imaging technology. Miniaturization of other components enables the body to be visualized from within the oesophagus and even inside blood vessels and the heart. This paper will describe the state of the art in ultrasound systems and some of the technologies that are now commonplace, though many are only a few years old. Other papers in this special edition will describe some of the more novel technologies that are less fully developed.

The Working Principle Of Urine Analyzer

Urine analyzer is an automated instrument for determining certain chemical components in urine. It is an important tool for automated urine inspection in medical laboratories. It has the advantages of simple and fast operation. Under the control of the computer, the instrument collects and analyzes the color information of various reagent blocks on the test strip, and undergoes a series of signal conversion, and finally outputs the measured chemical composition content in the urine.

The essence of the test principle of the urine analyzer is the absorption and reflection of light. The liquid sample is directly added to the multi-linked reagent strip with different solidified reagents. The corresponding chemical composition in the urine causes the color of the module containing various special reagents on the multi-linked reagent strip to change. The color depth is consistent with the specific chemistry in the urine sample. The component concentration is proportional; the multi-link test strip is placed in the colorimetric injection tank of the urine analyzer, and each module is irradiated by the light source of the instrument and produces different reflected light. The instrument receives the light signal of different intensity and converts it into the corresponding The electrical signal is calculated by the microprocessor (CPU) to calculate the reflectance of each test item, and then compared with the standard curve and corrected to the measured value, and finally the result is automatically printed out in a qualitative or semi-quantitative manner. This type of instrument is generally controlled by a computer, and the color change on the test strip is measured semi-quantitatively by using a spherical area spectrometer to receive dual-wavelength reflected light. There are several reagent pads containing various reagents on the reagent strip, each of which reacts independently with the corresponding components in the urine, and displays different colors. The depth of the color is proportional to a certain component in the urine. There is another one in the reagent strip. "Compensation pad", as the background color of urine, compensates for errors caused by colored urine and instrument changes.

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