Awareness and acceptability are fuelling the growth of the Rapid Diagnostic Tests market

 

The need for timely diagnosis as a first step in the treatment pathway is creating commendable growth opportunities for rapid tests.   

For most people in India, the utility of rapid tests is limited to a pregnancy home test. However, these tests are also deployed as a screening tool for malaria, dengue and critical infections and most recently, COVID-19. In fact, the pandemic has generated widespread awareness for these tests making them a house-hold name.

Growth drivers for the Rapid Diagnostic Tests (RDT) market

The global RDT market stood at USD 23 bn in 2020 and is expected to grow at a steady CAGR of 8.14% up to 2026*. In India too, RDTs are gaining ground. Several factors are contributing to the growth of the market:

Prevalence of infectious diseases including vector-borne diseases: Along with NCDs, India faces challenge from a range of infectious diseases including vector-borne diseases. The good news is that as a country we have made progress to achieve the elimination goals of these infections. Efforts for the early and accurate detection of these diseases need to be sustained especially in low-resource settings.

Despite advanced screening technologies, prevention of Transfusion Transmitted Infections (TTIs) such as HIV, Hepatitis B and C, HIV and Syphilis among others is a growing concern. Therefore, the WHO recommends that all blood donations should be mandatorily screened for HIV, hepatitis B, hepatitis C and syphilis, prior to use. In addition to ELISA, CLIA and NAAT, RDTs with validated high sensitivity and specificity are usually chosen for immediate and emergency testing or in labs with limited resources.

According to WHO’s World Malaria Report 2021**, India was the only high burden country to have sustained a reduction in the disease prevalence. However, it still shares over 80% of the burden of South-east Asia. Needless to say, screening and early diagnosis can help India reach its elimination goal by 2030 and rapid tests are proving to be an important tool in this fight against malaria.

Speaking of dengue, over the last few years, the Indian government has taken concerted efforts to control its spread. Among the various initiatives, sufficient diagnostic kits including RDTs have been made available with the states and union territories.

Besides, the government has also chalked out a national guideline*** for management of co-infection of COVID-19 with dengue and malaria among other seasonal diseases. According to the guideline, RDTs should be made available in COVID-19 treatment facilities.

COVID-19 has fuelled the growth of RDTs:  As the number of cases in India surged, the Indian Council of Medical Research (ICMR) approved the COVID-19 rapid antigen tests for home and professional use for primary screening. These tests has gained widespread acceptance as an alternative method for the diagnosis of COVID-19 outside of health care settings. In fact, the centre has notified the state governments to promote the use of rapid diagnostic home tests, in a bid to avoid straining the local health systems.

Growing awareness for diagnosis: The pandemic has brought diagnosis into focus and patients are realizing the importance of early screening. As a result, an increased number of people are likely to opt for rapid tests in the future owing to its various advantages.

Resource-limited settings: 70% of Indians lack access to sophisticated healthcare infrastructure. In such a scenario, rapid tests are proving a boon as they require only limited resource allotment.

Advantages of Rapid Diagnostic Tests

While RT-PCR and immunoassays such as ELISA and CLIA are considered as high sensitive methods for testing, the future seems bright for RDTs as they are slowly picking pace and gaining wider acceptability. Easy accessibility of these tests coupled with ease-of-use and short span of execution, can aid in minimizing the diagnostic time gap and foster timely treatment. The affordability factor is another big advantage in favour of these tests.  

Principle of testing

RDTs are devised on immunochromatography technique (ICT) or immune-filteration techniques. ICT is based on the principle of affinity chromatography. The sample containing the analyte of interest along with the buffer flows through a nitrocellulose membrane coated with the corresponding antigen/antibody. The use of colloidal gold conjugate makes the reaction visible to the naked eye in the form of a band. A control band is also coated which acts as a procedural control.

ICT based rapid tests are most commonly preferred due to their advantages such as simultaneous detection of multiple analytes and use of samples i.e. serum/plasma, whole blood and urine. For example, differential diagnosis of HIV 1 and HIV 2 is possible on a single device.

In the case of COVID-19, a nasopharyngeal swab is used for the detection wherein the SARS-CoV-2 virus is lysed using an extraction buffer to allow detection of nucleocapsid proteins. These tests have proven high specificity and significant sensitivity in SARS-CoV-2 diagnosis in the early phase of infection. They have been approved by ICMR for home testing in addition to professional use.

Use of black gold particles: Gold nanoparticles are used as conjugate in the test membrane strip. As the sample passes through the strip, the gold particle conjugate creates a coloured test and control band.

As a general rule, the colour of the gold nanoparticle solution changes with the change in the size of the particle, ranging from red to purple black with the increasing particle size.

Transasia’s ErbaQik range of rapids for dengue and malaria use two different sizes of gold particles to generate two visually distinct coloured bands for test (purple black) and control (red). Using a different size of the gold nanoparticle called as ‘Black Gold’ particle gives ErbaQik rapid a unique dual colour advantage making it the only bi-colour detection immunochromatographic device.

Moreover, the larger size of the Black Gold particle provides a larger surface area for the reaction, thereby enhancing the sensitivity and the specificity of the test and reducing the incidence of false results.

Application

The health ministry has in the recent past, encouraged the use of RDTs as a first line of diagnosis for COVID-19. Experts believe that rapid tests can be put to good use as a screening tool at public places and implementing back to work strategies.

Besides COVID-19, rapid test have found acceptance as a part of the ANC profile for screening of critical infections during pregnancy.

In endemic region, these tests are being successfully deployed for screening dengue and malaria.

What the future has in store

Decentralized diagnostics has the potential to improve patient outcomes and reduce healthcare spending. From a viewpoint of clinical management, timely infection control, and the ability to act upon results faster, the future seems promising for rapid diagnostic tests.

While rapid testing is already a full-fledged market for certain ailments, it is the right time for manufacturers to take the plunge and expand the portfolio for other infections too. Also, diagnostic manufacturers are developing systems that rely on other body fluids such as saliva for testing, making sample collection simpler yet robust.

Accuracy of testing depends a lot on the virus load and sample quality. Diagnostic manufacturers will need to devise tests with greater sensitivity and specificity. It will become even more imperative for labs to choose kits that have been assessed and approved by reference reputed labs for their sensitivity and specificity.

Transasia’s portfolio for rapid diagnostic tests

Transasia Bio-Medicals Ltd. offers a wide portfolio of ErbaQik range of rapids based on immuno-chromatography for malaria, dengue and critical infections such as HIV, HCV, Hepatitis B and C, and Syphilis with a high sensitivity and specificity. The recently introduced ErbaQik COVID-19 Ag test detects all COVID-19 variants including Omicron, Delta+ and Deltacron.  

Sources:
*https://www.researchandmarkets.com/reports/5238566/rapid-test-kit-market-global-industry-size

**https://economictimes.indiatimes.com/news/india/india-reported-1-64-lakh-dengue-cases-during-2021-against-2-05-lakh-cases-in-2019-govt-to-rajya-sabha/articleshow/88009894.cms

***https://www.mohfw.gov.in/pdf/GuidelinesformanagementofcoinfectionofCOVID19withotherseasonalepidemicpronediseases.pdf

Authored by:

Ajinkya Upasani

Asst. Product Manager- Immunology

Transasia Bio-Medicals Ltd.