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PCR ප්රෝඩාව 3 CDC withdraws the support for PCR tests
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<blockquote data-quote="imhotep" data-source="post: 27208521" data-attributes="member: 562115"><p>Both CDC and the FDA regularly updates on these... The FDA in-vitro diagnostics EUA page carries more info.</p><p><a href="https://t.emailupdates.cdc.gov/r/?id=h4c129f9a,147a6e6f,147a9998&ACSTrackingID=USCDC_2146-DM61940&ACSTrackingLabel=Lab%20Alert%3A%20Changes%20to%20CDC%20RT-PCR%20for%20SARS-CoV-2%20Testing" target="_blank">https://t.emailupdates.cdc.gov/r/?id=h4c129f9a,147a6e6f,147a9998&ACSTrackingID=USCDC_2146-DM61940&ACSTrackingLabel=Lab Alert: Changes to CDC RT-PCR for SARS-CoV-2 Testing</a></p><p></p><p>As you say some kits could be outdated. Covid tests generally tests for certain Covid genes: Spike (S), N and ORF1ab. Many would have heard the name S Gene Target Failure (or SGTF).</p><p>S Gene Target Failure is defined when the PCR test detects the N and ORF1ab genes, but NOT the S gene. The position 69–70 deletion causes the S Gene to fail but this SGTF can be <strong>used as a marker</strong> for the B.1.1.7 or for the Omicron variant.</p><p></p><p>The new High-Mutiplex assays are able to detect the S gene, E gene, RdRP gene, N gene, plus five notable S-gene mutations: HV69/70 deletion, Y144 deletion, E484K, N501Y, and P681H in <strong>one go</strong>. So without any detailed sequencing Omicron can be confirmed in one test.</p><p></p><p>Also even if the PCR is the Gold standard, sometimes it can cause false positives. A conservative estimate could be around 3%.</p></blockquote><p></p>
[QUOTE="imhotep, post: 27208521, member: 562115"] Both CDC and the FDA regularly updates on these... The FDA in-vitro diagnostics EUA page carries more info. [URL='https://t.emailupdates.cdc.gov/r/?id=h4c129f9a,147a6e6f,147a9998&ACSTrackingID=USCDC_2146-DM61940&ACSTrackingLabel=Lab%20Alert%3A%20Changes%20to%20CDC%20RT-PCR%20for%20SARS-CoV-2%20Testing']https://t.emailupdates.cdc.gov/r/?id=h4c129f9a,147a6e6f,147a9998&ACSTrackingID=USCDC_2146-DM61940&ACSTrackingLabel=Lab Alert: Changes to CDC RT-PCR for SARS-CoV-2 Testing[/URL] As you say some kits could be outdated. Covid tests generally tests for certain Covid genes: Spike (S), N and ORF1ab. Many would have heard the name S Gene Target Failure (or SGTF). S Gene Target Failure is defined when the PCR test detects the N and ORF1ab genes, but NOT the S gene. The position 69–70 deletion causes the S Gene to fail but this SGTF can be [B]used as a marker[/B] for the B.1.1.7 or for the Omicron variant. The new High-Mutiplex assays are able to detect the S gene, E gene, RdRP gene, N gene, plus five notable S-gene mutations: HV69/70 deletion, Y144 deletion, E484K, N501Y, and P681H in [B]one go[/B]. So without any detailed sequencing Omicron can be confirmed in one test. Also even if the PCR is the Gold standard, sometimes it can cause false positives. A conservative estimate could be around 3%. [/QUOTE]
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