It’s been a year now since the first few human cases of COVID-19 infection were reported amidst the busy wholesale food market of China’s Wuhan city (1). The disease caused by SARS-CoV-2 virus, thought to have its origin in Bats, soon spread to cause worldwide outbreaks & escalated to a global pandemic. The latest statistics indicate 46.5 Million cases reported to date worldwide with the global mortality rate around 2.5% and India ranking second at 8.23M cases till date (2).
COVID-19 has brought with it the need for SARS-CoV-2 tracking, surveillance & diagnosis. Countries that adopted testing strategies early on were able to test, track & isolate individuals that showed disease symptoms & hence were better able to contain the disease spread. While antibody testing was initially taken up for screening, it was soon evident that Real-time PCR alone had the power for accurate diagnosis, making it the gold-standard confirmatory test for SARS-CoV2. At the start, the sample collection process for RT-PCR testing involved painful & inconvenient nasopharyngeal/oropharyngeal swab collection. This requires skilled technicians, who would additionally run the risk of exposure. This has even led to a couple of neo-natal deaths in India, due to inappropriate sample collection (3).
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More recently, saliva-based testing methods are gaining popularity after studies suggested saliva specimens and nasopharyngeal swab specimens have similar sensitivity in the detection of SARS-CoV-2 (4).
Fluidigm’s Advanta Dx SARS-COV-2 RT-PCR kit is a saliva based diagnostic test (5). This kit facilitates SARS-CoV-2 detection from saliva samples easing the sample collection process & eliminating the need for Viral RNA extraction process. The kit is compatible with Fluidigm’s high-throughput Biomark HD platform. Fluidigm claims that with certain configurations, the Biomark HD system can run a maximum of 6000 samples & controls per day. Modular workflow supports concurrent parallel runs to achieve high throughput (6).
This FDA-EUA approved kit has also now received DCGI-CDSCO license for use in India by ICMR approved testing labs as per their guidelines. This test kit from Fluidigm is sold & marketed by Premas Lifesciences Pvt Ltd, New Delhi in India.
With schools, colleges, corporate offices opening up, saliva-based testing using Biomark HD can add great value for faster, non-invasive & safer testing. Several universities in the US have already started utilizing Fluidigm’s saliva-based assays & Biomark HD for testing their students (7). Fluidigm is also a recipient of a prestigious NIH-RADx grant. The RADx initiative fast-tra