CCAMP-InDx Round Table - Shared screen with speaker view
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There are 15 sequences of various strains prevailing in different parts of the world, which positive control is most relevant for India?Many lab still uses Wuhan original sequence of last year. please comment.
1. What are the models we could use to predict evaluation of the virus and how does determine natural selection fit? 2. what is the frequency of sequencing :iñfected individualsour country is undertaking currently all efforts summed up?
Dr Suresh Thakur
What could be the possible effect of mutations on the serology based test such as IgM/IgG ELISA and virus neutralization assays.
Dr Raja M
When academic and government labs are struggling to meet the targets why government is not getting the several Commercial Genomics service providers to get the samples sequenced at lower costs and better TAT and qualities - many have streamlined workflows and ISO CERTIFIED
Dr Raja M
Serology based tests won’t be affected as they are looking for polyclonal response to S and N antigens
evolution of the virus *** sorry
Dr.Vinod, based in the studies you have done , could you recommend ICMR to revalidation of all RT PCR kits Approval for detecting mutated viruses (1) sensitivity, specificity, LOD (2) Cross reactivity
Related to mentioning of primer and probes sequence in IFU, by an large no manufacturer keep the sequence in IFU anywhere in the world. However we do share the data with regulator and approval agencies like ICMR and CDSCO. If required by research labs we can share that but can not be shared in public domain.
how frequently we need to submit data to CDSCO.
Suresh Thakur: agree that the primer and probe sequence are not presented in the IFU being published for public domain but a reference is provided in it. However the technical file submitted to regulatory will contain the probe and primer sequence detail.
munpally shesheer: Frequency of data submission to CDSCO depends on the manufacturer / sponsor who seek an approval or change in the existing data which will have an impact on the product performance.
Thank you Dr. Lalith