International Reagent Resources



COVID-19 Diagnostic Supplies Frequently Asked Questions (FAQs)

 

Get the answers you need about International Reagent Resource (IRR) catalog and COVID-19 diagnostic supplies and reagents.

 

Table of Contents

  1. What supplies are being distributed by IRR for COVID testing?
  2. When is my order shipping?
  3. What email communications will I receive from IRR regarding pending orders? 
  4. If I need to modify my order, should I reorder?
  5. Why was my order quantity reduced or canceled?
  6. Why is [this item] out of stock? When can I order this? 
  7. I can't find a commercial COVID-19 or a Flu reagent that used to be a part of IRR's catalog.  Where is it?
  8. Can I register this lab/hospital with IRR?
  9. How many Flu SC2 Multiplex Assays can I order? 
  10. Will there be other sources of the Flu SC2 Multiplex Assay besides CDC?
  11. Should I use the Flu SC2 Multiplex Assay for COVID-19 testing or influenza testing? Is there a difference?
  12. Will IRR be providing extraction kits for influenza surveillance?
  13. Will laboratories be required to re-extract RNA to subtype samples that are determined to be influenza A positive by the Flu SC2 Multiplex Assay?
  14. Will CDC continue to provide the CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel (EUA) (Catalog No. 2019-nCoVEUA-01)?

 

1.  What supplies are being distributed by IRR for COVID testing? 

IRR provides CDC-manufactured kits and controls associated with its EUA applications. These include:

 

2.  When is my order shipping? 

Reagents will typically ship within 2-3 business days from order approval. Laboratories should continue to indicate their availability for Saturday delivery on each order.  

 

3.  What email communications will I receive from IRR regarding pending orders?  

Laboratories will receive the following email updates after submitting orders: 

  • Order received: This email acknowledges receipt of order before orders are confirmed or approved.  
  • Order confirmed: This email informs the laboratory of items that are approved, reduced or cancelled. 
  • Order shipped: This email indicates when items have shipped, and may contain FedEx tracking numbers if available. 

 

4.  If I need to modify my order, should I reorder? 

If you have already submitted an order but it has not shipped, please do not resubmit the order if you need to modify it. Instead, send an email to IRR Customer Service (contact@internationalreagentresource.org) to request a modification to your existing order.

Orders that have already shipped cannot be modified. 

 

5.  Why was my order quantity reduced or canceled? 

CDC may reduce or cancel some of the quantities ordered to ensure that states and counties across the United States can continue critical testing. Adjustments to quantities in your order reflects what IRR can supply at this time. IRR staff will continue to work diligently to secure additional inventory and fulfill as many requests as possible. 

 

6.  Why is [this item] out of stock? When can I order this? 

IRR will update the availability status to “Temporarily Out of Stock” when inventory is not available. Supplies with this status cannot be ordered at this time. 

 

7.  I can’t find a commercial COVID-19 or a Flu reagent that used to be a part of IRR’s catalog. Where is it? 

Commercially available COVID-19 reagents unrelated to the performance of a CDC EUA assay are no longer offered, as of November 1, 2020. These include testing kits, extraction kits, and consumables purchased from Perkin Elmer, ThermoFisher, and Abbott Molecular. Commercially available reagents that are used with a CDC EUA but manufactured outside of CDC are no longer offered as of January 1, 2021. These include consumables, extraction kits, and enzyme purchased from Roche, Qiagen, and ThermoFisher.

Enzymes for influenza A subtyping/B lineage testing are no longer offered, as of December 31, 2020. In accordance with each states’ novel virus detection goals for the 2020-2021 influenza season, CDC’s Influenza Division had set aside a quantity of enzyme for influenza A subtyping/B lineage testing in September 2020. For states that have not ordered the full quantity of enzyme within their reserve as of December 31, 2020, contact IRROrders@cdc.gov to submit a request for the remainder. Only the states’ main public health labs can request enzymes against their state reserve. CDC defers subsequent allocation from this reserve to local or branch laboratories at the discretion of their main state public health laboratory. 

 

8.  Can I register this lab/hospital with IRR? 

CDC limits IRR registration and CDC’s SARS-CoV-2 diagnostic reagent distribution to U.S. state and/or local public health laboratories qualified by CDC to perform seasonal influenza surveillance testing and to local laboratories approved by their state public health laboratory to perform SARS-CoV-2 testing. During the SARS-CoV-2 pandemic, CDC will defer the decision to authorize new laboratories to the corresponding state public health laboratory. Qualified laboratories must have the appropriate certifications (CLIA) to serve as a diagnostic laboratory as well as appropriate equipment, training, and demonstration of testing proficiency under their state laboratory’s stewardship in order to maintain their status as a qualified laboratory.

The WHO Collaborating Center at CDC has limited Research Use Only (RUO) COVID-19 reagents for use by specific international public health laboratories.  Initially, these will only be available to other WHO Coordinating Centers and those laboratories performing influenza surveillance during the 2020-2021 northern hemisphere season with a history of reporting and specimen submission to the Global Influenza Surveillance Response System (GISRS). Laboratories will be notified directly by IRR regarding availability of these reagents. For information on the instructions for use, visit https://www.cdc.gov/flu/clsis/. Filling out the out the registration request is required to access the website. 

 

9.  How many Flu SC2 Multiplex Assays can I order?

CDC has established state specific reserve quantities of the Flu SC2 Multiplex Assay. These reserves are based on a data-driven algorithm informed by available inventory and multiple data sources including states’ reported testing volumes, population, and high incidence areas. Each states’ main public health lab will be able to submit orders for the Flu SC2 Multiplex Assay against their state reserve. CDC defers subsequent allocation from this reserve to local or branch laboratories at the discretion of the main state public health laboratory.

 

10.  Will there be other sources of the Flu SC2 Multiplex Assay besides CDC?

CDC has published the Flu SC2 Multiplex Assay primer and probe sequences to encourage commercial production of these reagents for supplementing laboratories’ total testing needs. States may contact their preferred commercial suppliers of other COVID-19 diagnostic testing reagents to inquire about plans to pursue commercial versions of CDC’s latest assay.

 

11.  Should I use the Flu SC2 Multiplex Assay for COVID-19 testing or influenza testing? Is there a difference?

The Flu SC2 Multiplex Assay can be used for COVID-19 and influenza testing. This assay can be used as a direct replacement for the Influenza A/B Typing Kit (VER 2) (IVD) (Catalog No. FluIVD03-9). The benefits of using this assay for both COVID-19 and influenza testing include increased processing of tests within a given period of time, supporting ongoing flu surveillance while also testing for SARS-CoV-2, and conserving important testing materials that are in short supply.

 

12.  Will IRR be providing extraction kits for influenza surveillance?

No. Extraction kits under FR catalog numbers will not be available for ordering for influenza surveillance during the 2020-2021 influenza season.

 

13.  Will laboratories be required to re-extract RNA to subtype samples that are determined to be influenza A positive by the Flu SC2 Multiplex Assay?

If laboratories are using an extraction method that is also cleared for use with CDC’s Human Influenza Virus Real-Time RT-PCR Diagnostic Panels (IVD), then they do NOT need to re-extract RNA from COVID-19 samples for subtyping.

For extraction chemistries that are not cleared for use with CDC’s Human Influenza Virus Real-Time RT-PCR Diagnostic Panels (IVD), laboratories are encouraged to use the Flu SC2 Multiplex Assay for diagnosis to meet CLIA requirements. They can then proceed under research use only (RUO) conditions, with influenza A subtyping and influenza B lineage typing assays for surveillance purposes only, so that re-extraction of the sample is not required.

 

14.  Will CDC continue to provide the CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel (EUA) (Catalog No. 2019-nCoVEUA-01)?

CDC will continue to provide the CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel (EUA) (Catalog No. 2019-nCoVEUA-01) as long as states’ demand for this item remains high. Labs are strongly encouraged to continue to maintain diversified RT-PCR testing strategies in order to mitigate supply chain bottlenecks.

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