The year 2020 has witnessed the devastating advent of the coronavirus and the fallout of the outbreak has led to a major shortage of detection kits. In response, diagnostic test manufacturers have upped the production of easy-to-use test kits outside of laboratory settings. Ever since the World Health Organization (WHO) declared infections caused by SARS-CoV-2 a pandemic in March, the production of detection kits has surged.
 
On January 31, the U.S. Secretary of Health and Human Services declared SARS-CoV-2 as a U.S. public health emergency. The CDC has come up with a laboratory test kit—2019-nCoV Real-Time Reverse Transcriptase (RT)-PCR Diagnostic Panel—for use in testing patient specimens for SARS-CoV-2. The U.S. FDA gave the green signal with Emergency Use Authorization (EUA) for the test on February 4.
 
Unprecedented demand for reagents has led to their shortage, as several public health laboratories have grappled to get testing reagents to underpin their testing volumes. Several scientists have painted a gloomy picture, predicting that 40 percent of the people infected with COVID-19 can transmit the virus to others without ever having symptoms or before they have symptoms of the disease.

At a time when COVID-19 has swept the entire world, governments and NGOs are pitching for massive and fast testing.
 
View from the Past: MERS and SARS
The Middle East Respiratory Syndrome (MERS) outbreak in early 2010s compelled governments to introduce the urgent use approval system for diagnostic products for unknown infectious and high-risk diseases to ward-off the outbreak and emergence of new contagious diseases.
 
Since the turn of the century, coronaviruses—MERS, SARS, and COVID-19—have caused respiratory disease outbreaks. Though SARS and MERS had higher case fatality rates vis-à-vis COVID-19, the latest coronavirus is more infectious. That said, the number of deaths caused by COVID-19 has outnumbered MERS and SARS.
 
Detection kits using RT-PCR, an innate method to augment viral DNA in a patient’s sample to determine the absence or presence of a virus, has received a green signal from the World Health Organization, governments, and other stakeholders globally.
 
Most Dominant Testing: RT-PCR
Mass production of RT-PCR tests is being witnessed in Europe, North America, and Asia Pacific as COVID-19 RT-PCR tests continue to gain traction in a global scale. An RT-PCR test is a real-time reverse transcription polymerase chain reaction test for a nucleic acid’s qualitative detection from SARS-CoV-2 in lower and upper respiratory specimens, including oropharyngeal and nasopharyngeal swabs, bronchoal veolar lavage, lower respiratory tract aspirates, and nasopharyngeal aspirate/wash and upper respiratory specimens.
 
The COVID-19 RT-PCR test has become popular for the qualitative detection of nucleic acid from the coronavirus in pooled samples having up to five individual upper respiratory swab specimens, including oropharyngeal swabs, nasopharyngeal swabs, and mid-turbinate per pool.
 
RT-PCR has become second to none in the global healthcare systems for testing COVID-19, with the significance of accessible and reliable testing to screen for the disease becoming indispensable.
 
A larger pie of current COVID-19 tests has emanated from PCR testing as it tends to detect RNA—the genetic information of the virus—which is only possible if the virus is present and the individual is actively infected.
 
PCR testing kits detect the presence of an antigen and will potentially help in scaling the testing to screen swathes of nasopharyngeal swab samples and enable health officials to get a bird’s eye view of the disease.
 
Lately, lateral flow assay has become talk of the town for a robust screening test as it can produce results in five to 15 minutes. More importantly, lateral flow assays have the innate ability to test an ocean of samples, including saliva, blood, urine, sweat, serum, and other fluids.
 
RT-PCR is perceived as the gold standard frontline test as the U.S. FDA granted emergency-use authorization to over 200 various tests to detect past or current infections from SARS-CoV-2.
 
A low-cost saliva test that will leverage people to collect their own samples without invasive throat or nasal swabs and minimal discomfort could be the way forward in COVID-19 detection kits industry.
 
Several stakeholders have claimed saliva-based COVID-19 diagnosis may outperform standard nasopharyngeal swab testing, as people can collect their own samples. Moreover, it does not need a separate nucleic acid (RNA) extraction step. It is worth mentioning that saliva-based testing needs an RT-PCR machine and a few reagents.
 
Currently, nasopharyngeal swab has become one of the most dominant testing methods to diagnose COVID-19. Amid the COVID-19 pandemic, public health strategy tends to be based on an early detection of suspicious cases.
 
Health bodies are emphasizing use of nasopharyngeal and oropharyngeal swabs in the screening of coronavirus. It is worth mentioning oropharyngeal swab testing is easier to perform as the swab is directed toward the rear wall of the oropharynx.
 
Trends for the use of real-time PCR assays for qualitative detection of nucleic acid from SARS-CoV-2 include nasopharyngeal/oropharyngeal/nasal swabs, mid-turbinate, tracheal aspirates, sputum, and bronchoalveolar lavage from people suspected of coronavirus.
 
On-the-Spot COVID-19 Test Kits Are Around the Corner
COVID-19 detection test kits that can show results in 15 to 30 minutes are likely to be launched across the globe, saving thousands of lives and derailing the outbreak. While one test got emergency approval from the WHO, the other will potentially get the approval in the ensuing period.
 
The high-quality, easy and quick tests will streamline mass screening of health workers. For instance, Australian regulators have given the nod for rapid COVID-19 testing kits which will enable doctors to screen patients within 15 minutes at hospitals and clinics.
 
One of the Australian companies, MD Solutions, which secured Therapeutic Goods Administration approval, is planning to supply half a million kits in its initial shipment. Tests from SD BioSensor, a South Korean company, also recently received emergency approval from the WHO.
 
Abbott has reported they have been issued EUA (emergency use authorization) for the fastest available molecular point-of-care test meant for the detection of COVID-19, providing positive results in minutes.
 
In March 2020, CTK rolled out test two diagnostic test kits—a real-time PCR based nucleic acid detection kit and a serological rapid screening test—for the global industry. During the same time period, the CDC authorized LGC Biosearch Technologies’ COVID-19 detection kits. The company’s probes and primers are said to be the part of the CDC 2019-nCoV RT-PCR diagnostic panel.
 
Advanced technologies are foraying into detection kits industry—companies are introducing mobile COVID-19 detection technology. In September 2020, DetectaChem reported that their MobileDetect Bio BCC19 COVID-19 test kit received green signal from FDDA for EUA. The test kit can allegedly run around 96 tests per device in 30 minutes.
 
At the time when stakeholders, including doctors and global authorities are urging countries across the world to up testing to contain the spread of virus, production of detection kits is likely to gain an uptick. With COVID-19 pandemic fought on multiple fronts, detection kits have become second to none and governments and other stakeholders will look to bridge the demand-supply gap.

---

Sunil Jha has been a part of the content industry for more than two years now. Having previously worked as a voice over artist and sportswriter, he now focuses on penning down articles across numerous topics, ranging from business, technology, core industry, to trade and finance. With a business-oriented educational background, Sunil brings forth the expertise of intensive research and a strategic approach in his pieces.