Posted on 03/29/2020 3:42:14 PM PDT by daniel1212
In the United States, the Centers for Disease Control and Prevention (CDC) is distributing its 2019-Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel to public health labs through the International Reagent Resource...Tests using two components were not determined to be reliable until 28 February 2020, and it was not until then that state and local laboratories were permitted to begin testing. The test was approved by the Food and Drug Administration under an Emergency Use Authorization.
From the CDC, updated March 15, 2020 regarding the above:
Is this test FDA -approved or cleared? No. This test is not yet approved or cleared by the United States FDA. When there are no FDA -approved or cleared test s available, and other criteria are met, FDA can make tests available under an emergency access mechanism called an Emergency Use Authorization (EUA) .
COVID-19 is caused by the SARS-CoV-2 virus. The test is designed to detect the virus that causes COVID
-19 in respiratory specimens. If you have a positive test result, it is very likely that you have COVID -19. Therefore, it is also likely that you may be placed in isolation. A negative test result means that the virus that causes COVID-19 was not found in your sample. However, i t is possible for this test to give a negative result that is incorrect (false negative) in some people with COVID -19. (https://www.cdc.gov/coronavirus/2019-ncov/downloads/Factsheet-for-Patients-2019-nCoV.pdf)
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“To summarize, we have (a) people who get COVID-19 and have reported; (b) people who get the SARS-CoV-2 virus and have reported, and who may not necessarily develop COVID-19 (although they are counted as if they have done so); (c) people who report because they fear they have the virus, but who test negative (so we assume they have not had the virus); (d) people who have the virus but do not report (meaning we can only estimate how many such people there are); and (e) people who have other conditions that could be mistaken for the virus and who do not report (meaning that counting them would skew our already uncertain estimate of virus cases that have gone unreported).” ...looking at the national numbers since the outbreak started, Worldometer reports (as of midafternoon Thursday) that the fatality rate remains 1.4 percent (1,136 out of 78,796). To repeat, that is based on reported positive cases. That is, if we know you have the virus, there is a 98.6 percent chance of survival (good odds, but not nearly as good as flu, with its 99.9 percent survival rate).... Some perspective, then: Out of 330 million Americans, fewer than 1 percent have been tested. While testing should have been more widely available early on, it is increasingly available now, and of those who have been tested, the vast majority (85 percent) have tested negative. |
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"Testing for the respiratory illness named coronavirus disease 2019 (COVID-19) and the associated SARS-CoV-2 virus is possible with two main methods: molecular recognition and serology testing. Molecular methods leverage polymerase chain reaction (PCR) along with nucleic acid tests, and other advanced analytical techniques, to detect the genetic material of the virus using real-time reverse transcription polymerase chain reaction for diagnostic purposes. Serology testing, leverages ELISA antibody test kits to detect the presence of antibodies produced by the host immune system against the virus. (https://medicalsciences.stackexchange.com/questions/21337/how-accurate-are-coronavirus-tests) |
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In the United States, One of three genetic tests in older versions of the [Real-Time RT-PCR Diagnostic Panel] test kits caused inconclusive results due to faulty reagents, and a bottleneck of testing at the CDC in Atlanta; this resulted in an average of fewer than 100 samples a day being successfully processed throughout the whole of February 2020. US commercial labs began testing in early March 2020. As of 5 March 2020 LabCorp announced nationwide availability of COVID-19 testing based on RT-PCR.[114] Quest Diagnostics similarly made nationwide COVID-19 testing available as of 9 March 2020. On 12 March 2020, Mayo Clinic was reported to have developed a test to detect COVID-19 infection. On 13 March 2020, Roche Diagnostics received FDA approval for a test which could be performed within 3.5 hours, thus allowing one machine to do approximately 4,128 tests in a 24-hour period. On 19 March 2020, the FDA issued emergency use authorization (EUA) to Abbott Laboratories for a test on Abbott's m2000 system; the FDA had previously issued similar authorization to Hologic, LabCorp, and Thermo Fisher Scientific. On 21 March 2020, Cepheid Inc similarly received EUA from the FDA for a test that takes ~45 minutes. A test which uses a monoclonal antibody which specifically binds to the nucleocapsid protein (N protein) of the novel coronavirus is being developed in Taiwan, with the hope that it can provide results within 15 to 20 minutes just like a rapid influenza test. Part of the immune response to infection is the production of antibodies including IgM and IgG...In late March 2020, Euroimmun Medical Laboratory Diagnostics and Epitope Diagnostics received European approvals for their test kits, which can detect IgG and IgA antibodies against the virus in blood samples. The testing capacity is several hundred samples within hours and therefore much faster than the conventional PCR assay of viral RNA. The antibodies are usually detectable 14 days after the onset of the infection. One of the early PCR tests was developed at Charité in Berlin in January 2020 using real-time reverse transcription polymerase chain reaction (rRT-PCR), and formed the basis of 250,000 kits for distribution by the World Health Organization (WHO).[107] The South Korean company Kogenebiotech developed a clinical grade, PCR-based SARS-CoV-2 detection kit (PowerChek Coronavirus) on 28 January 2020. In China, BGI Group was one of the first companies to receive emergency use approval from China's National Medical Products Administration for a PCR-based SARS-CoV-2 detection kit. Other companies in the country, such as Solgent and Seegene, also developed versions of clinical grade detection kits, named DiaPlexQ and Allplex 2019-nCoV Assay, respectively, in February 2020. (https://en.wikipedia.org/wiki/COVID-19_testing) |
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Is the Test for COVID-19 Coronavirus Reliable? Medical Editor: Charles Patrick Davis, MD, PhD Some of the tests look for part of the viral genome (molecular tests). Other tests – some of the newest ones that are coming out that are more rapid – test the blood for antibodies of the virus (serology tests). The first test, if positive, tells you the virus is onboard – you’re currently infected. The second type of test tells you that you’ve been exposed to COVID-19 virus, whether you are currently infected, or if you have been infected and cleared the virus. After your symptoms have remitted, it takes two of the first kind of test administered 24 hours apart with nasopharyngeal swabs to test negative for the virus to be reasonably sure it has cleared your system. Still, there are outliers that this test may not catch. I haven’t seen data for COVID-19 immunity post-infection, but in general, once you’re infected with a corona-type virus, you are protected from that particular strain for at least a while, and usually you don’t come down with it again. Did the CDC work out its COVID-19 test accuracy problems? In February, the CDC decided the virus DNA test needed a legal designation for widespread use under emergency authorization, according to the American Association of Medical Colleges (AAMC), a non-profit that administers tests to medical students and advocates for medical schools, students and patients in Washington, D.C. Shortly thereafter, the CDC announced the tests had accuracy problems, meaning some results already returned were useless, the AAMC states. The replacement kits took two weeks to come. Meanwhile, academic researchers had new tests they developed that the law prevented them from administering to the public, the AAMC states. The FDA March 11 approved a second type of test developed by the New York State Health Department for use in diagnosing COVID-19 throughout the country. The FDA has gone on to approve COVID-19 test kits for commercial use; they are as follows: Nucleic acid detection kit, manufactured by Shanghai GenoeDx Biotech Co. Ltd.-Shanghai, China. It is distributed by S&S Enterprise. Novel coronavirus 2019 nucleic acid detection kit (fluorescence PCR method), manufactured by Beijing Applied Biological Technologies Co. Ltd. It is distributed by Sahar International. AllplexTM 2019-nCoV Assay, manufactured by Seegene Inc. – Seoul, South Korea. It is distributed by Endure Medical Inc. SOLGENT DiaPlexQ Novel Coronavirus (2019-nCoV) Detection Kit, manufactured by Solgent Co. Ltd – 3F, 32, Techno 6-ro, Yuseong-gu, Daejeon, South Korea. It is distributed by Wellness Pro Inc. The CDC's test for viral DNA is a polymerase chain reaction test, which is used to identify DNA in all sorts of contexts, including the criminal justice system, genomics, and other disease testing. The tests also require RNA material from the SARS-CoV-2 virus that causes the COVID-19 coronavirus disease. This allows the tests to identify potential virus genes in swab samples from the respiratory tract, according to the CDC. (https://www.medicinenet.com/coronavirus_covid-19_sars_cov_2_news_updates/article.htm) |
Also, on FR: Communist Quality Control: Beijing Sends 150,000 Wuhan Virus Testing Kits to Prague, 80% Fail (PJ Media | 03/25/2020 | Stephen Green)
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Virus test results in minutes? Scientists question accuracy (March 27, 2020,) MADRID -- Some political leaders are hailing a potential breakthrough in the fight against COVID-19: simple pin-prick blood tests or nasal swabs that can determine within minutes if someone has, or previously had, the virus. Hopes are hanging on two types of quick tests: antigen tests that use a nose or throat swab to look for the virus, and antibody tests that look in the blood for evidence someone had the virus and recovered. The tests are in short supply, and some of them are unreliable. “The market has gone completely mad," Spanish Health Minister Salvador Illa said Thursday, lamenting the l ack of face masks, personal protection equipment and rapid tests, "because everybody wants these products, and they want the good ones.” The Spanish government on Thursday sent 9,000 rapid antigen tests that were deemed unreliable back to a manufacturer that, according to the Chinese government, had no license to sell them. In the past few months, much of the testing has involved doctors sticking something akin to a long cotton swab deep into a patient’s nose or throat to retrieve cells that contain live virus. Lab scientists pull genetic material from the virus and make billions of copies to get enough for computers to detect the bug. Results sometimes take several days. (https://abcnews.go.com/Business/wireStory/virus-test-results-minutes-scientists-question-accuracy-69834536) |
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