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Are your Rapid Diagnostic Tests (RDT) providing accurate results?
BryairMedia CoverageAre your Rapid Diagnostic Tests (RDT) providing accurate results?

Are your Rapid Diagnostic Tests (RDT) providing accurate results?

Mr. Deepak Pahwa, Managing Director, Bry-Air (Asia) | ET-HealthWorld | May 24, 2021

There could be various issues comply why the testing kits are not showing the best results. However, one of the issue which we have faced earlier also, and this year as well that ‘Moisture or Humidity’ being a deterrent and hampering the testing kits.

Rapid Test KitIndia is battling with another wave of Covid-19 disease, and this time the pandemic is too dreadful affecting millions of lives. With this, the pharmaceutical industry is witnessing a major challenge, the recent reports that have created tension among people is that RT-PCR test giving inaccurate results. It has been seen that many patients were found Covid-19 negative in the early stages when they got the RT-PCR test done when symptoms like cough, fever or shortness of breathing were prevailing.

We are well- observed with the fact that the dire need for the Covid-19 rapid test kits and other such critical diagnostic kits is one of the major demand drivers in our fight with the disease.

Last year, many reports stated that Rapid Antigen Tests doesn’t give proper results, and doctors shifted their focus to RT-PCR in the battle against Covid-19. With a calamity of such intensity, the sheer volume of tests taking place in India is a challenge that supersedes the available infrastructure and facilities. If the patient has all symptoms of the disease but gets false negative reports then there are high chances that it would delay the diagnosis of disease, obscure the full scope of an outbreak and raise the potential that sick people could unknowingly spread a pathogen. If this continues to happen, it can risk other people who have not exposed to the virus.

There could be various issues comply why the testing kits are not showing the best results. However, one of the issue which we have faced earlier also, and this year as well that ‘Moisture or Humidity’ being a deterrent and hampering the testing kits.

Moisture is the biggest peril for the pharmaceutical industry because a majority of pharmaceutical products are highly hygroscopic and tend to suffer physical, microbiological and biochemical deterioration after coming in contact with moisture. At any given time the humidity of the quick test production room must be controlled because the presence of high humidity causes the absorption of the moisture in the sample surface, absorbent surface and conjugated surface of the sample which means the sample is compromised and will most likely not yield the correct result.

The presence of moisture in the nitrocellulose membrane of the sample can cause the redistribution of active components impregnated on the surface that affects the connection process (c and t) and cause changes in results.

Covid-19 pandemic, as a matter of fact, expedited the uptake of dehumidification technology by the pharmaceutical industry. The Covid rapid test kits manufacturing and lab testing should be done in a controlled environment for accurate diagnosis, thus making the application of dehumidification solutions a necessity for these areas. The dehumidifiers lower the humidity levels to below 15% RH at 20ºC and help meet GMP standards, a specific requirement needed in diagnostic kit for manufacturing/ assembling areas.

The pandemic has shifted the focus once again on the growing need for drugs, testing kits, vaccines and other things thereby putting a lot of stress on the players to make everything available while maintaining the highest quality standards.

Leading companies in Pharma Industry has dehumidification technology for manufacturing the products like Sun Pharma, Fiocruz Paraná, Vida Biotechnology In Vitro, PTSP – Institute of Tropical Pathology and Public Health, Institute of Molecular Biology of Paraná and Ecodiagnóstica, one of the biggest manufacturers of rapid tests in Brazil.

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