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. Where can I get the Abbott® ID NOW™ COVID-19 Assay and/or sample collection kits with swabs and viral transport medium?
  5. If I need to modify my order, should I reorder?
  6. Why was my order quantity reduced or canceled?
  7. Why is [this item] out of stock? When can I order this? 
  8. Can I register this lab/hospital with IRR?
  9. Where can I find a complete product list of items for COVID testing?
  10. How many Flu SC2 Multiplex Assays can I order? 
  11. Will there be other sources of the Flu SC2 Multiplex Assay besides CDC?
  12. Should I use the Flu SC2 Multiplex Assay for COVID-19 testing or influenza testing? Is there a difference?
  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)?
  15. What is the timeline for IRR’s ordering changes for COVID-19 related kits, reagents, and consumables?
  16. What products are affected by IRR’s ordering changes?
  17. Who do I contact to avoid gaps in ordering and testing?
  18. Will I still be able to receive CDC’s diagnostic tests for COVID-19?

 

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

The U.S. Department of Health and Human Services (HHS) consolidated testing supplies under IRR to simplify the resource request process for public health laboratories in states and territories, alleviate the financial burden on public health labs, and optimize testing capacity across the public health system. IRR fulfills orders to maximize public health laboratory testing using a data-driven algorithm.

The IRR catalog of COVID diagnostic supplies includes:  

  • Extraction kits, to isolate the viral genetic material (RNA)
  • Test kits, to determine the presence of COVID-19

 

2.  When is my order shipping?

To reduce processing and shipping times, IRR will coordinate distribution of some supplies directly from manufacturers. Laboratories should continue to indicate their availability for Saturday delivery on each order.  

Supplies produced by CDC or included within the “Instructions for Use” associated with the CDC 2019-Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel and the CDC Influenza SARS-CoV-2 Multiplex Assay (Flu SC2) will continue to ship from IRR directly, typically within 2-3 business days from order approval. These items are denoted by an ER or RR catalog number, respectively.

Supplies purchased by IRR from other commercial manufacturers will ship directly from manufacturers upon receipt of approved orders from CDC, in accordance with the manufacturers’ available shipping schedule. These items are denoted by a HR, JR or KR catalog number.

See table associated with FAQ #9 for vendor-specific details. 

 

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. This email is sent directly from manufacturer or distributor. 

 

4.  Where can I get the Abbott® ID NOW™ COVID-19 Assay and/or sample collection kits with swabs and viral transport medium?  

The US Department of Health and Human Services (HHS) is directly managing the distribution Abbott® ID NOW™ COVID-19 Assay and external controls and the allocation of swabs and media, including viral transport medium (VTM). 

 

5.  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. 

 

6.  Why was my order quantity reduced or canceled?

Due to intermittent supply limitations for some reagents and high demand, 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.

IRR encourages laboratories to order reagent quantities that correlate to 1–1 ½ weeks of testing in order to ensure continued equitable nationwide testing. 

 

7.  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.

We understand that back orders delay your laboratory’s critical testing processes and cause uncertainty that impedes your ability to implement effective contingency plans. Rather than accumulate back orders, IRR encourages laboratories to review the availability of alternative supplies available from the IRR catalog. 

 

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.

 

9.  Where can I find a complete product list of items for COVID testing?

A comprehensive list of all diagnostic testing supplies available through IRR is provided below. New reagents may be added to the IRR catalog as the emergency response progresses.

 

 

10.  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.

 

11.  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.

 

12.  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.

 

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. However, CDC encourages states to gradually transition to the Flu SC2 Multiplex Assay over time, as supplies allow, and plans to reduce production of the CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel (EUA) (Catalog No. 2019-nCoVEUA-01) when demand becomes low.

 

15.  What is the timeline for changes in availability of COVID-19 related kits, reagents, and consumables from IRR?

  • November 1, 2020 - Commercially available reagents that are unrelated to the performance of a CDC EUA assay will no longer be available to order through the IRR. These include testing kits, extraction kits, and consumables purchased from Perkin Elmer, ThermoFisher, and Abbott Molecular. Catalog number prefixes: JR, HR & KR.

  • December 31, 2020 - Commercially available reagents that are used with a CDC EUA but manufactured outside of CDC will no longer be available to order through the IRR. These include consumables, extraction kits, and enzyme purchased from Roche, Qiagen, and ThermoFisher. Catalog number prefixes: ER & OR.

  • January 1, 2021 - All reagents manufactured by CDC associated with current EUAs will continue to be available to order through the IRR, including primer and probe kits and controls. Catalog number prefixes: ER & RR.

 

16.  What products are affected by upcoming changes to IRR’s COVID-19 reagent catalog?

As of November 1, 2020, commercially available reagents that are unrelated to the performance of a CDC EUA assay will no longer be available to order through IRR. These include:

 

As of December 31, 2020, commercially available reagents that are used with a CDC EUA but manufactured outside of CDC will no longer be available to order through IRR. These include:

 

 

17.  Who do I contact to avoid gaps in ordering and testing?

Laboratories should contact manufacturers directly to establish ordering processes, outside of the IRR, to ensure continuity of affected reagent supplies after December 31, 2020. Laboratories may contact IRRorders@cdc.gov if they need assistance identifying manufacturer points of contacts. IRR recommends that laboratories confirm that independent ordering processes are in place within their organization ahead of deadlines.

 

18.  Will I still be able to receive CDC’s diagnostic tests for COVID-19?

Yes, IRR will continue to provide the CDC-manufactured kits associated with its EUA applications for the duration of the COVID-19 emergency response. These include:

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