LordsMed, the pharma division of Lord’s Mark Industries Pvt. Ltd. on Monday announced that it has entered into an “exclusive partnership” with Singapore-based diagnostics kit manufacturer Sensing Self Pte. Ltd. to bring the world’s first Covid-19 saliva-based rapid antigen test kit to India.
The company claims in a statement that it is the first-of-its-kind non-invasive rapid antigen test kit with a reduced turn-around time. The company also claimed that it will make COVID-19 mass screening scalable and it has a 99 percent accuracy rate i.e., gold standard, affordable and accessible to facilitate the prevention of pandemic spread whenever there is a spike in the infection rate.
“The innovative technology collaboration marks LordsMed foray into the fast-growing rapid antigen diagnostic kit segment. It has plans to venture into the OEM manufacturing space in the diagnostics sector with its advanced manufacturing facility at Vasai near Mumbai which will be operational soon,” the company said in a statement on Monday.
Under this agreement with Sensing Self, Lord’s Mark Industries will collaborate with various government agencies and authorities to offer the Covid-19 saliva-based rapid antigen kits to support large-scale mass screening for Covid at various passenger transit points like airports apart from offices and manufacturing units.
Moreover, the company will also tie up with primary health centres (PHCs) in various rural areas to strengthen the COVID-19 mass-screening facility in the hinterland of the country.
“The collaboration with Sensing Self is in line with our vision to make diagnostics and disease prevention services more accessible and affordable for the majority of the population. The world’s first saliva-based rapid antigen test kit of Sensing Self will act as a game-changer at the mass-level Covid-19 antigen screening in India by making it easy and convenient, cost-efficient, and accessible. The idea behind the collaboration is to explore the technology collaborations to make Covid-19 antigen screening scalable and deployable to the remote parts of the country,” Sachidanand Upadhyay, Founder, Lord’s Mark Industries Pvt. Ltd., said in a statement.
Meanwhile, Lord’s Mark Industries is working on exploring the use of saliva-based methods other than Antigen tests as well.
“Our unique Covid-19 saliva-based rapid antigen test kit makes covid infection detection faster, thus facilitating effective curbing of pandemic spread. Blood-based rapid antigen test often causes unease in people due to their invasive nature. On the other hand, the convenience makes our non-invasive saliva-based rapid antigen test kit effective for point-of-care and mass testing. We are pleased to partner exclusively with Lord’s Mark Industries to launch our kit in India,” Shripal Gandhi, Co-Founder and CEO, Sensing Self Pte. Ltd., stated on Monday.
In April 2020 the US Food and Drug Administration (FDA) granted emergency use authorization for the first saliva test for diagnosis of Covid-19. In the initial results, it was found to detect the alpha and delta variants, while later it was also found to detect the other variants, such as Gamma, Epsilon, Kappa, and Omicron variants.
What are saliva-based COVID-19 tests?
Saliva is a clear and complex fluid with a slightly acidic pH. This fluid is secreted by the various major and minor salivary glands. Usually, 1-1.5 L of saliva is produced daily by the salivary glands and it contains a variety of hormones, antibodies, enzymes, growth factors, and antimicrobial constituents.
Several experts have opined that a rapid saliva-based test for COVID-19 can test and diagnose within a reduced time period to confirm whether a patient has the infection and needs to be treated. According to a study published in Cureus, saliva has also been reviewed as a non-invasive diagnostic tool for the detection of COVID-19. The affordability of the salivary diagnostic process makes it an effective process for detecting COVID-19 viruses.
Usually, a saliva-based COVID-19 test uses a DNA aptamer which is a short, synthetic oligonucleotide that binds to a specific molecular target and that shows high affinity for the SARS-CoV-2 spike protein and its variants.
“A recent study has shown that a rapid test using saliva was faster and more sensitive than the rapid tests involving a nasal swab. It was also able to detect asymptomatic patients earlier and at lower viral loads than other rapid tests. This test requires a small sample of saliva to be added to a chemical reagent in a cartridge, which is then inserted into a reader, like a glucometer, thus enabling the physician to test, diagnose, and treat a patient in a single visit,” Dr. V Nagarjuna Maturu, Consultant Pulmonology and Sleep Medicine, Yashoda Hospitals Hyderabad told Financial Express.com.
Which is better: Saliva-based test or RT-PCR?
According to Dr. V Nagarjuna Maturu, even after more than 2 and a half years since its beginning, early and rapid detection of COVID-19 disease, especially in an asymptomatic patient remains a challenge.
“Current gold-standard COVID-19 tests are based on reverse transcription-polymerase chain reaction (RT-PCR), which are sensitive but are time taking, costly, complicated, and require to be performed by a healthcare professional. Scientists have hence, been in search of a self-administered, rapid, and cost-effective test to diagnose covid-19 disease,” Dr. Maturu told Financial Express.com.
“As it is easy to use, rapid and has a relatively higher sensitivity it has the potential be used in mass screening and contact testing. However, the data available at present is limited. Further testing on a large number of patients is required before it can replace the existing tests,” Dr. Maturu added.
According to experts, a key feature that distinguishes the saliva-based test from nasopharyngeal or oropharyngeal (throat) swabs is that this kit allows self-collection.
“The RTPR test has been very effective in detecting covid cases with a sensitivity of 65 percent-70 percent. On the other hand, the saliva-based rapid antigen test has an efficacy of 50 percent to 55 percent. RAT may be used for screening in areas where facilities for RT PCR are not available or for screening close asymptomatic high-risk contacts. There is no concrete data on if the saliva-based rapid antigen test is effective in detecting the newer variants,” Dr Pruthu Narendra Dhekane, Consultant Infectious Diseases, Fortis Hospital, Bannerghatta Road told Financial Express.com.