Covid-19 Rapid Test, the FDA amended their emergency policy around diagnostic testing for SARS-CoV-2, the novel coronavirus that causes COVID-19
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Following on a change made March 16, the agency opened the door for a number of specific private entities and labs to develop and distribute tests that can provide results on the spot in as little as Covid-19 Rapid Test, 15 minutes ‚ÄĒ but there are some pretty big caveats to keep in mind as you hear about more of these coming to market.
Covid-19 Rapid Test, the tests, which are ‚Äúserological,‚ÄĚ meaning they identify the presence of antibodies in a person‚Äôs blood, differ considerably from the molecular testing that is currently in use under Emergency Use Authorization (EUA) by FDA-approved labs and drive-through testing sites.
The serological tests show that a person has developed antibodies to SARS-CoV-2, which means they very likely came into contact with it (and either have it, or have already recovered from having it).
Covid-19 Rapid Test, the molecular tests actually detect the presence of viral DNA in the blood stream, which is a much more definitive indicator that they currently have an active infection (at least at the time the swab was taken).
IN ITALY: The test is perfectly valid in accordance with the European directive CE 98/79. The device is also regularly registered for marketing in the Directory of Medical Devices of the Italian Ministry of Health at number 1923329
USER INFORMATION REGION LAZIO (ITALY)
‚ÄĘ Sensitivity: 95%
‚ÄĘ Specificity: 99%
‚ÄĘ Accuracy in healthy subjects: 100%
‚ÄĘ Accuracy in affected subjects: IgG 95% – IgM 92%.
¬† BROCHURE CORONA TR+CLIA¬†¬† (Brochure – click for view)¬†
¬† COVID-19 lgGlgM¬† ¬†(Instructions for use – click for view)¬†
¬† COVID-19 lgGlgM¬† ¬†(Italian Language – Instructions for use – click for view)¬†
¬† COVID-19 lgGlgM Declaration of Conformity¬† ¬†(Decl. Conformity – click for view)¬†
¬† U.S. FOOD & DRUG ADMINISTRATION¬† ¬†(Official Letter – click for view)¬†
¬† AUSTRALIAN GOVERNMENT – DEP. OF HEALT¬† ¬† (Official Document – click for view)¬†
¬† CE – EUROPEAN CERTIFICATE¬† ¬†(European Certificate – click for view)¬†
Serological tests have still been used widely in countries where the response to the COVID-19 pandemic has been shown to be effective, including in China, Taiwan and Singapore.
They‚Äôve also been used in different communities in the U.S., based on earlier guidelines around private lab diagnostics.
But on March 26, the FDA named 29 entities that provided notification to the agency as required and are now therefore able to distribute their tests.
Covid-19 Rapid Test, still, in the absence of better options like expanded availability of the tests that are approved under the EUA, these serological tests (many of which can provide on-site results with just a pinprick of blood) will be useful in painting a more accurate picture of the overall spread and reach of the coronavirus, especially for smaller clinics, GP clinics and local labs that don‚Äôt have priority access to the equipment and supplies needed for the molecular testing efforts.
For instance, one test on this list, the COVID-19 IgG/IgM (Whole Blood/Serum/Plasma) Rapid Test Device, requires no instrumentation and can provide results in just 15 minutes.
These are real devices for all types of viruses and bacteria that allow us maximum protection with this disposable.
The key role of rapid test kits is the detection of antibodies; is unable to detect the virus.
“Antibody detection is used to test the level of antibodies in human blood,” said Feng Luzhao, a researcher at the Chinese Center for Disease Control and Prevention.
“Patients in the early stage of a disease may not yet have antibodies in their blood,” he said. “Antibody detection can be used as an auxiliary diagnosis for patients who test negative on nucleic acid tests, but cannot replace nucleic acid tests.”
Covid-19 Rapid test kits should be used when a patient has shown symptoms for five consecutive days.
For nucleic acid tests, the sensitivity of different types of test kits and the operational approach by medical personnel can also cause false positive or negative results in coronavirus tests.
What is the advantage of the integrated test compared to the simple antibody test?
The integrated test has the undisputed advantage of investigating the presence, even initially, of a condition of inflammation and in particular of vasculitis that we know to be present even in the first phase of the disease even when the antibodies are absent.
Does having a positive PCR result mean that I was infected with the Covid-19 (coronavirus) ?
Absolutely not! It means that an inflammation is underway which may depend on multiple factors but which, given the pandemic condition, induces to report its positivity to the doctor so that he can plan any further investigations (possibly even the nose-pharyngeal swab if necessary) and a check antibodies after 7/14 days.
Does having a positive PCR and Interleukin 6 result mean that I was infected with the coronavirus?
Not necessarily. The coexistence of this biomarker, however, is strongly an indicator of an inflammatory problem that can be related to infection in subjects where positive antibodies are present. In this case it is recommended to contact the attending physician and to proceed as soon as possible with the dosage of D-Dimer which is a protein fragment of fibrin and which indicates that an intravascular coagulation process has started which must be carefully evaluated.
Should the test be repeated?
On the judgment of the attending physician, the test can be repeated, when doubts remain about its interpretation or in its evaluation of the subject’s antibody response with COVID-19 RAPID TEST.
If I find out I have antibodies already present, don’t I risk anything?
If you find a high positivity to IgG antibodies you are obviously very protected from the virus and the possibility of developing a disease is low. The simultaneous persistence of the IgM means that the infection has been given for less than 2 months.
If this test is negative, does it mean that I have not contracted the infection?
It means that you have not contracted the infection for 10/15 days.
If this test is positive, will you tell me that I am protected from infections?
The positivity of the test means that the virus has already been contracted and you are developing resistance.
If the IgM are positive, it means that the virus was contracted 10 to 15 days after the primary exposure.
Evaluation of A Rapid IgM-IgG Combined Antibody Test for SARS-CoV-2 Infection: Single Italian center study. “
Submitted: American Journal of Infectious Diseases