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.