WHO Information Notice for IVD Users 2020/05

WHO Information Notice for IVD Users 2020/05 Nucleic acid testing (NAT) technologies that use polymerase chain reaction (PCR) for detection of SARS-CoV-2 20 January 2021 Medical product alert Geneva Reading time: 1 min (370 words) Français Español Product type: Nucleic acid testing (NAT) technologies that use polymerase chain reaction (PCR) for detection of SARS-CoV-2 Date: 13 January 2021 WHO-identifier: 2020/5, version 2 Target audience: laboratory professionals and users of IVDs. Purpose of this notice: clarify information previously provided by WHO. This notice supersedes WHO Information Notice for In Vitro Diagnostic Medical Device (IVD) Users 2020/05 version 1, issued 14 December 2020. Description of the problem: WHO requests users to follow the instructions for use (IFU) when interpreting results for specimens tested using PCR methodology. Users of IVDs must read and follow the IFU carefully to determine if manual adjustment of the PCR positivity threshold is recommended by the manufacturer. WHO guidance Diagnostic testing for SARS-CoV-2 states that careful interpretation of weak positive results is needed (1). The cycle threshold (Ct) needed to detect virus is inversely proportional to the patient’s viral load. Where test results do not correspond with the clinical presentation, a new specimen should be taken and retested using the same or different NAT technology. WHO reminds IVD users that disease prevalence alters the predictive value of test results; as disease prevalence decreases, the risk of false positive increases (2). This means that the probability that a person who has a positive result (SARS-CoV-2 detected) is truly infected with SARS-CoV-2 decreases as prevalence decreases, irrespective of the claimed specificity. Most PCR assays are indicated as an aid for diagnosis, therefore, health care providers must consider any result in combination with timing of sampling, specimen type, assay specifics, clinical observations, patient history, confirmed status of any contacts, and epidemiological information. Actions to be taken by IVD users: Please read carefully the IFU in its entirety. Contact your local representative if there is any aspect of the IFU that is unclear to you. Check the IFU for each incoming consignment to detect any changes to the IFU. Provide the Ct value in the report to the requesting health care provider. Contact person for further information: Anita SANDS, Regulation and Prequalification, World Health Organization, e-mail: rapidalert@who.int References: 1. Diagnostic testing for SARS-CoV-2. Geneva: World Health Organization; 2020, WHO reference number WHO/2019-nCoV/laboratory/2020.6. 2. Altman DG, Bland JM. Diagnostic tests 2: Predictive values. BMJ. 1994 Jul 9;309(6947):102. doi: 10.1136/bmj.309.6947.102.

ΑΝΟΣΙΑ ΑΓΕΛΗΣ (HERD IMMUNITY)

***** Απο που προκυπτει το 25%-40% της ανοσιας αγελης ... 1. Herd immunity thresholds for SARS-CoV-2 estimated from unfolding epidemics. "Our inferences result in herd immunity thresholds around 10-20%, considerably lower than the minimum coverage needed to interrupt transmission by random vaccination, which for R0 higher than 2.5 is estimated above 60%." https://www.medrxiv.org/con.../10.1101/2020.07.23.20160762v3 2.A New Understanding of Herd Immunity The portion of the population that needs to get sick is not fixed. We can change it. “We just keep running the models, and it keeps coming back at less than 20 percent,” Gomes said. “It’s very striking.” "If that proves correct, it would be life-altering news. It wouldn’t mean that the virus is gone. But by Gomes’s estimates, if roughly one out of every five people in a given population is immune to the virus, that seems to be enough to slow its spread to a level where each infectious person is infecting an average of less than one other person. The number of infections would steadily decline. That’s the classic definition of herd immunity. It would mean, for instance, that at 25 percent antibody prevalence, New York City could continue its careful reopening without fear of another major surge in cases. " https://www.theatlantic.com/.../herd-immunity.../614035/ Οποιος θελει διαβαζει τις ερευνες, οποιος θελει διαβαζει τα αρθρα... ****** Απο που προκυπτει οτι η D3, και οχι μονο, ειναι εργαλειο ανοσοποιησης ?? 3. The immunological implication of the new vitamin D metabolism. "Vitamin D is a neuro-hormone regulating calcium-phosphate homeostasis, cell proliferation, and immunomodulation. Active hormone produced by brain and immune cells mediates immune system response; lung calcitriol is involved in fighting respiratory tract infections; finally, prostate and placenta vitamin D regulates cells growth and proliferation within such tissues. Immune modulation by vitamin D includes enhancing innate immune response, attenuating and stimulating Th1 and Th2 cell proliferation, respectively, and promoting self-tolerance. Hypovitaminosis D is a common finding in several autoimmune diseases." https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6305614/ 4. Can Vitamin D Lower Your Risk of COVID-19? "Having healthy vitamin D levels can enhance immune health and may be helpful in people with COVID-19." https://www.healthline.com/nutri.../vitamin-d-coronavirus... Οποιος θελει διαβαζει τις ερευνες, οποιος θελει διαβαζει τα αρθρα... ***** Για τον Ψευδαργυρο ? 5. Potential role of zinc supplementation in prophylaxis and treatment of COVID-19 Amit Kumar, Yuichi Kubota,⁎ Mikhail Chernov, and Hidetoshi Kasuya Administration of Zn supplement has a potential to enhance antiviral immunity, both innate and humoral, and to restore depleted immune cell function or to improve normal immune cell function, in particular in immunocompromised or elderly patients. Zn may also act in a synergistic manner when co-administered with the standard antiviral therapy, as was demonstrated in patients with hepatitis C, HIV, and SARS-CoV-1. Effectiveness of Zn against a number of viral species is mainly realized through the physical processes, such as virus attachment, infection, and uncoating. Zn may also protect or stabilize the cell membrane which could contribute to blocking of the virus entry into the cell. On the other hand, it was demonstrated that Zn may inhibit viral replication by alteration of the proteolytic processing of replicase polyproteins and RNA-dependent RNA polymerase (RdRp) in rhinoviruses, HCV, and influenza virus, and diminish the RNA-synthesizing activity of nidoviruses, for which SARS-CoV-2 belongs. Therefore, it may be hypothesized that Zn supplementation may be of potential benefit for prophylaxis and treatment of COVID-19. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7247509/ Για λιγο περισσοτερη κατανοηση του Ψευδαργυρου δειτε το παρακατω: 6. Zinc and SARS‑CoV‑2: A molecular modeling study of Zn interactions with RNA‑dependent RNA‑polymerase and 3C‑like proteinase enzymes " Zn is recommended by the National Institutes of Health (NIH) for inducing the immune system and preventing viral infections; however, the amount of Zn people requires each day depends on age (74). While Zn supplementation is necessary to correct any deficiency, an overabundance of Zn can also lead to a variety of physiological dysfunctions. Excess Zn can lead to copper deficiency, alter lymphocyte response and inhibit T-cell function (75). Therefore, the use of Zn for therapeutic purposes should still be monitored based on food intake and use of supplements. Although Zn is relatively non-toxic to humans with an median lethal dose of 3 g/kg weight, extreme excess Zn (>100-300 mg/day) should be avoided; the NIH considers 40 mg of zinc a day for adults and 4 mg of zinc a day for infants under 6 months to be the upper limit dose (75)." και αυτο για να ισορροπουν και καποιοι αρνητες ... ναι θελει διελευκανση το πως εχει τετοια αποτελεσματικοτητα ο Ψευδαργυρος. "Most people obtain their daily required Zn through a healthy diet. However, the dietary oral intake supplements of 15-25 mg Zn tablets per day is recommended to help aid immune response in the short term (4). Currently, there is no consensus that Zn is helpful for the prevention and treatment of COVID-19 infection. However, the present bioinformatics and molecular modeling analysis supported the hypothesis that Zn would bind and regulate the enzymatic activities of 3CLpro and RdRp of SARS-CoV-2 and thus inhibit viral replication." https://www.spandidos-publications.com/10.../ijmm.2020.4790 BONUS material : Απο το 2005 στο Virology Journal του FAUCI ... εχει δημοσιευτει το αρθρο για την αποτελεσματικοτητα της ΧΛΩΡΟΚΙΝΗΣ (+Ψευδαργυρου ΠΡΟΦΑΝΩΣ) απεναντι στους Κορονοιους και μαλιστα στον SARS-CoV-1 τον αδελφο του SARS-CoV-2... Chloroquine is a potent inhibitor of SARS coronavirus infection and spread. https://virologyj.biomedcentral.com/.../1743-422X-2-69 Ο FAUCI ξερει απο το 2005 και πιο πριν θα πω εγω οτι ο Ψευδαργυρος σταματαει τον πολλαπλασιασμο των ιων CoV και του HIV που ειναι της ιδιας συνομοταξιας και χρησιμοποιουν τα ιδια ενζυμα, με τον δευτερο να εχει και περισσοτερους μηχανισμους !! Περαν αυτου απο το 1950 οι ερευνες εχουν αποδειξει επανειλημμενα οτι ο Ψευδαργρυρος ειναι πανισχυρο αντιικο στοιχειο απεναντι σε RNA μονης αλυσιδας + sense ιους !! γιατι κλειδωνει το ενζυμο πολλαπλασιασμου τους το RdRP !! https://www.medrxiv.org/content/10.1101/2020.07.23.20160762v3?fbclid=IwAR25SqDX3WHRPHaY0S5sf5TBs2BPHJHJ-HdcB8aRYeCfWZh9ss9PQR0Gk9I