COVID-19 Testing Landscape: An Unfolding Situation that Requires Straight Talk

Mar 15, 2020 | Blood Test, Coronavirus, COVID-19, COVID-19 Test, Real-Time Reverse Transcriptase-Polymerase Chain Reaction

COVID-19 Testing Landscape An Unfolding Situation that Requires Straight Talk

According to a recent Tweet from China-based Xinhua News, the coronavirus can now be diagnosed within 15 minutes thanks to a new test kit developed in China. Could this be fake news? No experts have come out and declared this to be legitimate. According to another news source, an American-based company in North Carolina has developed a strikingly similar 15-minute test kit now currently used in China and other parts of the world—that cannot be used in America. What is going on?

Different Rapid Test Alternatives

According to a report in the UK’s Daily Mail, North Carolina-based BioMedomics reports its blood test can detect the virus within 15 minutes; however, it is reported to be less than accurate to that of the test coming out of the U.S. Center for Disease Control and Prevention (CDC). A look at the Chinese Tweet in regard to the 15-minute Chinese test looks strikingly similar to the one developed in North Carolina. Could it be the same technology or approach? Some would argue that a rapid test that is less accurate is better than waiting for a more accurate test for a pandemic such as what COVID-19 represents.

A Russian news outlet called Tass reported that the Chinese in parallel had developed a 15-minute test. The Russian agency declared that the test kits was developed by experts from China’s National Institute for Communicable Disease Control and Prevention along with a “high-tech” company from Wuxi. They reported that the test had been “commissioned for production” and that authorities could test around 4,000 people per day. Interestingly enough, they failed to mention the name of the company that made the test!

Interestingly in the Japanese press (Nippon), it was reported that a firm based in Japan called Kurabo would sell yet another 15-minute COVID-19 test. Apparently, the underlying technology is derived from a “major Chinese reagent firm.” The company, Kurabo, seeks to sell the test for 27,500 yen ($257US) and supply kits with a total capacity of 10,000 tests per day. As will be discussed later in this summary, this test isn’t based on the polymerase chain reaction (PCR) test method, which takes hours longer to generate results.

What about North Carolina-based BioMedomics?

Enter the American venture that has produced the 15-minute test. Founded by Frank Wang in 2007 and based in Morrisville, North Carolina, the privately-held BioMedomics team is on a mission to address global healthcare needs.  They have raised a little over $1 million and employ about 20. According to their website, their COVID-19 IgM/IgG Rapid Test, a lateral flow combined antibody (IgM and IgG) rapid test for coronavirus, helps provide an accurate test in 15 minutes using the whole blood, serum or plasma. For detailed results of this testing product, see the link

Greenlights and Approval in Europe

Recently on March 8, the company announced in a press release that their COVID-19 test received a CE Mark-IVD certification meaning that the test will be used to help diagnose patients in Europe. The company issued another press release with more details a few days later

In Use in other Locations

According to the British press, the product was being used not only in Italy but also in South Korea and some countries within the Middle East by early March. It is not definitive how accurate this test actually is—but some countries appear to be taking a risk-based approach.

Not Approved in the U.S.

Apparently the purported 15-minute COVID-19 test kit hasn’t been approved by United States authorities as of yet

RT-PCR vs. Blood Test

According to this press, the CDC today prefers what is called a ‘real-time reverse transcriptase-polymerase chain reaction’ (RT-PCR) test, which as a Gold Standard requires the taking of a throat and nasal swab from patients. The testing of this type of sample for reactions suggests the samples contain the genetic material of COVID-19. A challenge—in addition to patient and health care worker discomfort—is that this testing process involves multiple components, hence representing a “notoriously complex” process requiring specialized labor (trained technicians) using specialized equipment. BioCompare reports that “the slightest DNA contamination can disrupt results from RT-PCR tests.

The BioMedomics test, on the other hand—known as COVID-19 IgM/IgG Rapid Test—is a blood test, reports the UKs’ Daily Mail.

The CDC updates all here

A somewhat Accurate and Fast Test Better than Slow more Accurate Test?

Founder Wang suggests, “Because there is no medicine or vaccine, the best way to combat this infection is isolation. A lot of people don’t have symptoms. Because of that, quick diagnostics are very important.” Wang continued, “You can identify infection and isolate people.”

No Response from CDC and FDA

According to this British publication, the CDC nor the FDA have specified why the BioMedomics blood test cannot be used and didn’t respond for a request for comment before the time of this publication.

COVID-19 Testing Challenges American Government Health Apparatus

In the meantime, there have been many reports of challenges with CDC diagnostic tools including “inconclusive results.” In one case, the agency had to re-make one of the test components and reissue kits.

In classical fashion, the President went on the offensive about the test debacle, blaming the former president (Obama) and the bureaucracy of the CDC

In the meantime, Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases (NIAID), was at least honest and admitted in front of a House hearing that the U.S. test effort is failing.

Fauci noted in a newscast that the original U.S. testing system worked for certain scenarios but not designed for “a broader blanketing of the country.” One could ask the question: shouldn’t the nation be ready for such a “blanketing” in a pandemic situation? Wouldn’t that be a scenario to be anticipated by government planners? Fauci did assure that the constraints are being rapidly corrected by U.S. government authorities.

Fauci had declared the U.S. would be ready to send out 4 million tests by the end of this coming week but when asked bluntly if the U.S. government was ready for such a commitment, Fauci paused a bit, noting, “There is a difference between a test being sent out and the connection between the test and those who can actually administer the test.” He went on, skirting the question, “What we really need is to get the test in available in venues that people can easily access.” He, of course, acknowledged “that has not been the case” but went on to mention that “looking forward it is very likely we will have that within the next week or so.” Fauci went on to assure the government is very close and that a number of commercial options were close.

U.S. Taxpayer Should be Getting Perturbed

The U.S. taxpayer substantially contributes to the $4 trillion U.S. health care GPD enterprise. No country spends anywhere near this amount. Per capital, the U.S spends nearly $12K per person on healthcare—up from about $2K in 1990. 

Put another way, the U.S. spends about double per person on health care than other wealthy nations. 

Yet, when it comes to matters such as pandemic readiness, although with the best intentions, the U.S. federal government has appeared completely flatfooted when compared to at least some other rich economy governments.  With the most sophisticated health care technologies, companies, and top universities, not to mention supreme talent combined with vast capital markets and tremendous income tax outlays, doesn’t the taxpayer deserve better? Could it be that perhaps the culture has moved too much toward an emphasis on healthcare-related, firm-level wealth accumulation (via fantastic advancements that do help those that can afford to access such breakthroughs) at the expense of the overall public health good? Perhaps such a position could just depend on one’s point of view?

Source: Twitter


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