By working literally around the clock, a sizeable team of scientists out of Stanford Medicine (Stanford University) have developed a compelling test to detect antibodies against SARS-CoV-2 in blood samples. This is in contrast to the existing diagnostic tests used for COVID-19, which detect genetic material from the virus in respiratory secretions. Rather, this test probes for antibodies to the virus in plasma, the liquid in blood as a means to generate data about an individual’s immune response to an infection. This represents a breakthrough as this kind of test will be required for opening up the U.S. to business as usual as the pandemic is contained.
TrialSite News provides the Q&A breakdown of this great news for the TrialSite Network.
Why is this a significant breakthrough?
First an early scientific report published in JAMA suggests that convalescent plasma—collected from the blood of people recovering from the disease and containing anti-SARS-CoV-2 antibodies—could help treat people with acute COVID-19. If these results are true in larger studies, serology testing, such as the one the Stanford test makes possible, will be a strategic approach for identifying people with antibodies who could donate blood to treat current patients. Hence, this method could be key for the period that there is no vaccine or treatment to SARS-CoV-2.
And it should be noted that Dr. Anthony Fauci with NIAID has suggested that mass antibody testing may be a key capability to move the American society back to normal. Perhaps Stanford is contributing to that cause!
When was the Test Launched?
April 6 at Stanford Health Care
What are the benefits of this test?
First and foremost, speed! The Stanford-developed test takes two to three-days for results. Now, Stanford Health Care can test 500 samples per day, and the organization hopes to scale up quickly.
When did the team start working on the test?
March 22, 2020
Who led the test development efforts?
Scott Boyd, MD, PhD, associate professor of pathology and a leading expert in antibody research
How does it work?
The Stanford test detects two different types of antibodies; IgM antibodies, which are made early in an immune response, and whose levels usually quickly wane and IgG antibodies, whose levels rise more slowly after infection but persist longer.
What were considerations around scalability that the team took into account?
Since the start of the test, the Stanford team has centered attention on the ability to scale up manufacturing of reagents needed, especially the receptor building domain of the SARS-CoV-2 spike protein, and validating the test.
How did the Stanford team validate test results?
The Stanford team validated the test samples from patients who tested positive for SARS-COV-2 on tests that detect viral genetic material, as well as plasma samples known to be negative because they were collected over two years ago.
What are next steps?
Now, Stanford experts are assessing who should receive the serology test, with health care workers and others in the hospital setting being prioritized. The team also seeks to expand testing capacity!
What are the teams short/Intermediate & long-term goals?
They have built sufficient inventory to support about 6 months’ worth of tests reports Stanford Medicine. The team seeks is currently limited by the number of robots needed to run the test. They are looking to buy more such robots but they are not easy to come by. The team’s intermediate to longer-term goal is to test as many people as possible in Northern California.
Is the Stanford Team applying to the FDA?
Yes, they are applying to the U.S. FDA for Emergency Use Authorization.
What Answers can This Test Provide? How Does it Differ from Current PCR Tests?
This serological test can answer many questions not addressable with the current COVID-19 diagnostic test, which uses polymerase chain reaction methods to detect viral genetic material.
For example, the test can help answer how common mild infections are in the general population. The test can also be used to help show whether, and for how long, someone with antibodies is protected against reinfection. Understanding the immune response to the virus could also help inform when it is safe for individuals to return to normal activity.
Scott Boyd, MD, PhD, associate professor of pathology
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