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

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CDC’s Influenza Division is offering an Influenza and SARS-CoV-2 Molecular Diagnostic Performance Evaluation Panel to qualified public health labs during the month of December 2023. 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 A/B SARS-CoV-2 Multiplex assay panel FluSC2PP-EUA or FluSC2PPB-EUA for oligos, and Flu SC2PC-EUA for control materials. 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. 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 December 18, 2023, to January 18, 2024.

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

Note: Beginning January 15, 2024, kits FR-1875 will be available to order through IRR (www.internationalreagentresource.org) (Catalog Number: PT0071, Lot Number: 23-0078).

All fields are required unless otherwise indicated.

Prefix:

Title / Rank:

First Name:

Last Name:

IRR Account Number:

Laboratory Name:

Shipping Street Address (Please give correct shipping/receiving address):

Street Address (continued, optional):

City:

State:

Postal Code:

CDC Influenza Qualified Point of Contact Name:

Point of Contact Phone Number:

Point of Contact Email Address:

Alternate Point of Contact:

Alternate Point of Contact Email Address:

Is your laboratory performing CDC Influenza SARS-CoV-2 Multiplex Assay (FluSC2-EUA) for diagnosis?

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