Scientists have scrambled to develop a wide range of diagnostic tests for coronavirus variants using genomic sequence. Researchers are working to identify mutations quickly and prevent the spread of new strains.

According to the New York Times, a new vaccination developed to fight a coronavirus variant currently in trial in Brazil, Japan, Mexico, and Thailand may be a “game changer.” “A modern formulation entering clinical trials...could transform how the world battles the pandemic.” 

PATH sponsored the advancement of the new vaccine technology to an ever-changing strain, but most importantly, linked, encouraged, and informed, offering vital linkages between innovations, research and stakeholders in the search to fill needs left unmet by market-driven vaccine development.

A dire message is being sent from the hospitals of Brazil already over capacity, literally at their breaking point and treating only Covid patients infected with a new P1 variant.  It is reported, there is no room for any other patients other than those being treated for the coronavirus.  This variant has found to be in at least have the United States.  The P1 variant is 2.5 times more transmissible and infectious than the original strain, says Dr. Miguel Nicolelis Professor of Neuroscience at Duke University.

Dr. Nicolelis, says “Be very worried.”

New variant strains have evolved into new Covid variants only weeks after the first Covid-19 cases were identified in China.  As the coronavirus has progressed, so has the research landscape. The appearance of new strains has ignited a surge of interest in designing testing for complex virus mutations and questions about the accuracy of specific current tests.

The Food and Drug Administration has cautioned that new coronavirus mutations may make certain tests less successful.

So far, scientists have agreed that there is no evidence that the established variants of concern are causing experiments to fail.

Lorraine Lillis, PATH’s scientific program officer, a public health charity that has been monitoring coronavirus samples. said…

“With these Covid diagnostics, we were on a time crunch; we needed to bring something out there.”

 “Normally, diagnostics take a long, long time, and we’d normally challenge them with multiple variants.”  

“And we’re doing that, but we’re doing it in real-time.”

If a test produces an incorrect false-positive result with a variant, the individual can not know they need to separate themselves. Gary Schoolnik, a physician and infectious disease specialist at Stanford University and the chief medical officer at Visby Medical, a coronavirus diagnostics firm, said…

“And that individual is then authorized to be unquarantined, to propagate in the population, and potentially spread the variant to others.”

 “And this is how, if a diagnostic procedure is lacking variants, it will help facilitate the dissemination of the variant.”

The Federal District Administration says that four separate molecular tests “might be affected” but believes they are still accurate. Three of the experiments have several targets; a fourth could be less alert when the virus has a specific mutation. These are the Taq Route, Linea, Xpert Xpress, and Xpert SARS-2 coV, along with the Accula SARS co-2.

Dr. Tim Stenzel, director of the Food and Drug Administration’s office of in vitro diagnostics and radiological health, said...

“We don’t think that those four assays are significantly impacted.”

 “It was more out of an abundance of caution and transparency that we made that information public.”

An antigen assay is less sensitive but commonly used in the detection of coronaviruses. These studies recognize virus-specific proteins. Some genetic mutations enabled them to escape detection.

Nevertheless, scientists are of the view that mutations already occur in any test. “So far, there’s no concrete proof that any single molecular test has it wrong,” noted Neha Agarwal, PATH’s associate director of pathology. Still, circumstances will improve.

The F.D.A. is monitoring the coronavirus databases weekly to see whether the virus is changing in a manner that might be able to evade checks.  Dr. Stenzel said…

“We’re very vigilant.”

“And we will stay vigilant.”

As the variants proliferate, researchers are working to establish and refine detection tests. Currently, defining a variant is usually a two-step operation. To begin, a typical coronavirus test, such as a P.C.R. test, is used to assess the presence of the virus. If the test results in a good result, a sample is submitted for genomic sequencing.

Experts are now working to develop integrated treatments that will assess if an individual is afflicted with the virus and if they have a specific version.

A variety of firms are now releasing coronavirus tests that they claim can distinguish between various strains, but these are mainly for testing purposes. Developing a diagnosis that can definitively detect anyone with a certain variation is “infinitely harder,” according to Dr. Grubaugh.

Similar mutations appear in different variants, complicating differentiation. The mutations of concern will shift as the virus evolves, and sequencing will remain the only effective method for obtaining a complete image of the virus.

                     Deadly variant fuels Brazil's COVID-19 crisis