Request for Influenza and SARS-CoV-2 Molecular Diagnostic Performance Evaluation Panel

CDC’s Influenza Division is offering an Influenza and SARS-CoV-2 Molecular Diagnostic Performance Evaluation Panel to qualified public health laboratories during the month of October 2021. This panel consists of ten specimens requiring identification of influenza type (A/B), SARS-CoV-2 and characterization of subtype and/or genotype to evaluate the performance of the CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel kits for Influenza A/B typing (VER 2) (FluIVD03-9), Influenza A subtyping (VER 3) (FluIVD03-10), Influenza B Lineage Genotyping (VER 1.1) (FluIVD03-7), Influenza A/H5 subtyping (VER 4) (FluIVD03-11) and Influenza A/H7 (Eurasian Lineage) subtyping (FluEUA-01) and CDC Influenza SARS-CoV-2 Multiplex assay (FluSC2-EUA). The purpose of this exercise is to assist public health laboratories in evaluating performance of laboratories using molecular diagnostic methods for influenza and SARS-CoV-2 detection and characterization, and to assist APHL and CDC in understanding performance of the CDC Flu rRT-PCR Dx Panel and CDC FluSC2 EUA reagent kits in US public health laboratories. For the laboratories that do not perform CDC FluSC2 EUA assay, please only perform CDC Flu rRT-PCR Dx panel.  This exercise is not a CLIA or CAP certified proficiency testing program. Although participation in this exercise is encouraged, it is strictly voluntary.

Public health laboratories interested in participating in this performance evaluation exercise are requested to submit the enrollment from November 15th to December 6th, 2021.

If you have any questions, please direct them to FluPEP@cdc.gov.

Note: Beginning November 16th, 2021, kits FR-1801 will be available to order through IRR ( www.internationalreagentresource.orgexternal icon )  (Catalog Number: PT0069, Lot Number: 21-0055).

All fields are required unless otherwise indicated.






For general assistance and questions regarding submitting requests, please contact FluPEP@cdc.gov.