Get the answers you need about International Reagent Resource (IRR) catalog and COVID-19 diagnostic supplies and reagents.
Table of Contents
- What supplies are being distributed by IRR for COVID testing?
- I can't find a commercial COVID-19 reagent that used to be a part of IRR's catalog. Where is it?
- Can I register this lab/hospital with IRR to receive COVID-19 testing supplies? If my lab is currently receiving COVID-19 testing supplies, can I also receive influenza IVD reagents?
- Should I use the Flu SC2 Multiplex Assay for COVID-19 testing or influenza testing? Is there a difference?
- What is the difference between the Flu SC2 Multiplex Assay available under catalog numbers RR-1 (Flu SC2PP-EUA) and RR-15 (Flu SC2PPB-EUA)? Will I need to perform a validation before using the other version?
- Is the Flu SC2 Multiplex Assay able to detect the COVID-19 variants?
- Will IRR be providing enzyme and extraction kits for US influenza surveillance?
- Will US laboratories be required to re-extract RNA to subtype samples that are determined to be influenza A positive by the Flu SC2 Multiplex Assay?
- Will CDC continue to provide the CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel (EUA) (Catalog No. 2019-nCoVEUA-01) to US Domestic Labs?
General IRR FAQs
- Do you need to be funded by CDC to obtain IRR materials?
- How do I register with IRR?
- What is the relationship between IRR and ATCC?
- Who establishes the requirements for access and use of IRR materials?
- Who decides which reagents will be distributed by IRR?
- When is my order shipping?
- What email communications will I receive from IRR regarding pending orders?
- If I need to modify my order, should I reorder?
- Why was my order quantity reduced or canceled?
- Why is [this item] out of stock? When can I order this?
- Why do I have multiple sales order numbers for my order?
- How can I facilitate the acceptance of my permit when received by IRR?
- What is the international shipping process and what can I do to receive my shipment efficiently?
1. What supplies are being distributed by IRR for COVID testing?
IRR provides CDC-manufactured kits and controls associated with its EUA applications to US laboratories. These include:
| Name of Product
| Frequency of Shipping
| RT-PCR Kits and Components
|| Influenza SARS-CoV-2 Multiplex Assay (EUA) (Catalog No. Flu SC2PP-EUA) (aqueous primers and probes)
|| Influenza SARS-CoV-2 Multiplex Assay (EUA) (Catalog No. Flu SC2PPB-EUA) (lyophilized primers and probes)
|| Influenza SARS-CoV-2 Multiplex Assay Positive Controls Kit (EUA) (500 reactions) (Catalog No. Flu SC2PC-EUA)
|| CDC Human Specimen Control (IVD) (10 x 0.5 mL) (Catalog No. KT0189)
IRR provides CDC-manufactured kits and controls associated with its RUO applications to non-US laboratories. These include:
| Name of Product
| Frequency of Shipping
| RT-PCR Kits and Components
|| Influenza SARS-CoV-2 Multiplex Assay (RUO) lyophilized primers and probes
|| Influenza SARS-CoV-2 Multiplex Assay Positive Controls Kit (RUO)
|| Quantabio® qScript® Virus 1-Step ToughMix® (Catalog No. 95131-500)
*In agreement with the World Health Organization (WHO), CDC’s Influenza Division is only providing enzyme (FR-1772) for the Flu SC2 Multiplex Assay to laboratories participating in the Global Influenza Surveillance and Response System (GISRS) from the world’s 50 least developed countries. IRR will notify laboratories regarding any changes in availability status in the future.
2. I can’t find a commercial COVID-19 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.
3. Can I register this lab/hospital with IRR to receive COVID-19 testing supplies? If my lab is currently receiving COVID-19 testing supplies, can I also receive influenza IVD reagents?
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. IRR does not supply clinicians, hospitals, or healthcare professionals with testing kits directly.
During the SARS-CoV-2 pandemic, CDC will defer the decision to authorize new public health laboratories to access COVID-19 testing supplies from IRR to their 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.
Public health laboratories approved for access to COVID-19 testing supplies are not automatically approved for access to influenza IVD reagents. Approval for influenza IVD reagents will be based on a joint determination of the CDC’s Influenza Division and the state’s main public health laboratory.
4. 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. CDC recommends that the public health labs use the Flu SC2 assay as the primary assay for Influenza surveillance. 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 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 essential testing materials in short supply.
5. What is the difference between the Flu SC2 Multiplex Assay available under catalog numbers RR-1 (Flu SC2PP-EUA) and RR-15 (Flu SC2PPB-EUA)? Will I need to perform a validation before using the other version?
To increase availability, CDC has added a second authorized manufacturer of primer and probe reagents for use with the CDC Flu SC2 Multiplex Assay. Laboratories can use both versions (RR-1 and RR-15) available through IRR interchangeably in conjunction with RR-14, the Influenza SARS-CoV-2 Multiplex Assay Positive Control Kits (EUA) (Flu SC2PC-EUA). The only differences between RR-1 and RR-15 are the reporter and quencher probe chemistries and condition of the primers and probe provided in the packaging - RR-1 (Flu SC2PP-EUA) are aqueous, whereas the primers and probes for RR-15 (Flu SC2PPB-EUA) are lyophilized. Visit the CDC Influenza SARS-CoV-2 (Flu SC2) Multiplex Assay Primer and Probe page for detailed information. No calibration or instrument changes are required to use the primers and probes in RR-15 (Flu SC2PPB-EUA).
Laboratories should refer to CLIA requirements to determine whether they should perform separate verifications for each authorized manufacturer of the Flu SC2 Multiplex Assay. A revalidation of the Flu SC2 Multiplex Assay is not required as long as instructions are followed within the Instructions For Use. For questions regarding calibration, please contact technical support.
6. Is the Flu SC2 Multiplex Assay able to detect the COVID-19 variants?
The SARS component of the Flu SC2 assay targets a highly-conserved region of the genome. Currently, the CDC Influenza SARS-CoV-2 (Flu SC2) multiplex assay reliably detects the SARS-CoV-2 variants in circulation. CDC continues to assess assay performance via frequent in silico analysis. If evidence emerges that the performance of the multiplex assay is compromised for a specific variant, CDC will communicate with public health partners. On March 30, 2021, the U.S. Food and Drug Administration (FDA) posted a new Web page about the impact of viral mutations on COVID-19 molecular tests. The FDA will update this page as significant new information becomes available.
7. Will IRR be providing enzyme and extraction kits for US influenza surveillance?
To support Influenza surveillance, the Influenza Division is maximizing quantities of Flu SC2 Multiplex and subtyping enzymes for each state in accordance with states’ weekly influenza subtyping goals for novel virus detection. CDC has established state-specific reserve quantities of the enzymes. Each state’s main public health lab can submit orders for the influenza surveillance and subtyping enzymes against their state reserve between September 1, 2021, and August 31, 2022. CDC defers subsequent allocation from this reserve to local or branch laboratories at the discretion of their main state public health laboratory. Additional enzyme for use with the Flu SC2 Multiplex Assay can be purchased directly from commercial manufacturers and include: QuantaBio® Ultraplex® 1-Step ToughMix® - (95166-100), (95166-500), (95166-01K) and TaqPath™ 1-Step Multiplex Master Mix (No ROX) - (A28521), (A28522), (A28523).
Extraction kits under FR catalog numbers will not be available for ordering for influenza surveillance during the 2021-2022 influenza season.
8. Will US 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.
9. Why did CDC discontinue support for the CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel (EUA) (Catalog No. 2019-nCoVEUA-01) to US domestic labs?
Given the availability of commercial options for clinical diagnosis of SARS-CoV-2 infection, including multiplexed and high-throughput options, CDC intends to discontinue support for the CDC 2019 Novel Coronavirus (2019 nCoV) Real Time RT-PCR Diagnostic Panel, the assay first introduced in February 2020 for detection of SARS-CoV-2. CDC is encouraging public health laboratories (PHLs) to adopt the CDC Influenza SARS-CoV-2 (Flu SC2) Multiplex Assay to enable continued surveillance for both influenza and SARS-CoV-2, which will save public health laboratories both time and resources.
As of September 30, 2021, CDC no longer distributes the 2019 nCoV Real Time RT-PCR Diagnostics Panel to PHLs through the International Reagent Resource (IRR). As of December 31, 2021, CDC has withdrawn the request to FDA for Emergency Use Authorization (EUA) of the 2019 nCoV Real Time RT-PCR Diagnostic Panel.
CDC will continue to offer a blanket right of reference to the CDC EUA for the Diagnostic Panel (EUA200001) to anyone who wishes to reference CDC data in their own FDA regulatory submission. CDC’s decision to discontinue the Diagnostic Panel and subsequently withdraw the EUA for the Diagnostic Panel will have no impact on those tests that have referenced CDC EUA data in their EUA submission or on those who plan to do so in the future. The data and submission will remain on file at FDA and available for reference.
If not already complete, CDC encourages PHLs to validate and verify the CDC Influenza SARS-CoV-2 (Flu SC2) Multiplex Assay within their laboratory. CDC recommends that the public health labs use the Flu SC2 assay as the primary assay for Influenza surveillance. CDC will continue to support public health use of the CDC Influenza SARS-CoV-2 (Flu SC2) Multiplex Assay through IRR distribution and technical support.
For more information, please visit CDC Diagnostic Tests for COVID-19 | CDC
General IRR FAQs
10. Do you need to be funded by CDC to obtain IRR materials?
No, eligible recipients do not need to be funded by CDC.
11. How do I register with IRR?
For individuals to register with IRR, 1) their institution must have a signed User Agreement (UA) with ATCC and 2) the individual must submit the registration paperwork, which includes: an acknowledgement of the UA, an application, and a BSL checklist (for BSL 2 or greater). Registrations, logins, and passwords are tied to the individual registrant. Organizations can have multiple registered users, and IRR recommends having at least two per institution.
You can find information about registration, forms, and eligibility under IRR’s Register tab. If you are a current registrant, and need access to additional material, please contact a customer service representative at Contact Us.
12. What is the relationship between IRR and ATCC?
CDC awarded a contract for establishing a reagent repository to ATCC in February 2019. As a contractor for CDC, ATCC is responsible for production and distribution of reagents defined within their contract’s statement of work.
13. Who establishes the requirements for access and use of IRR materials?
Policies and practices mandated for access and use of IRR materials are set by CDC.
14. Who decides which reagents will be distributed by IRR?
The reagents provided by IRR are received and prepared in response to the needs of the scientific community as determined by researchers at CDC and other HHS agencies. IRR actively solicits recommendations from researchers for materials to acquire and/or produce.
15. When is my order shipping?
Shipping turnaround varies by the destination country. Domestic US orders typically ship within 2-3 business days from order approval.
Non-US shipments may take longer depending on the destination country’s import process, flight availability, and COVID-19 restrictions. Service disruptions due to flight cancelations, diminished operational and transport capacity, lock-downs, and embargos continue to cause significant delays. We are constantly evaluating courier services and regulation changes to determine the most efficient way to ship. See the FAQ below for more information on the international shipping process.
16. 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.
17. 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 at Contact Us to request a modification to your existing order.
Orders that have already shipped cannot be modified.
18. 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.
19. 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.
20. Why do I have multiple sales order numbers for my order?
Once your order is reviewed and approved, you will receive a confirmation email with your sales order number(s). You may receive multiple sales order numbers for your items depending on their catalog number prefixes. The prefixes relate to which CDC program or activity has contributed financial support for these items and are necessary to track ongoing support. Separating orders also avoids program-specific shipping delays potentially affecting large or mixed program orders that may require multiple program approvals. IRR will ship items together when possible; however, separating sales order numbers ensures that orders are shipped as efficiently as possible.
21. How can I facilitate the acceptance of my permit when received by IRR?
When applying for permits and forms, please:
- Do NOT reference IRR or ATCC Catalog Numbers in the Material Description fields found on the permits and/or forms.
- Make sure your name and address on the permit applications and/or forms are exactly as they appear on your IRR account ship-to address.
- Shipper Name must include: International Reagent Resource (ATCC)
22. What is the international shipping process and what can I do to receive my shipment efficiently?
Once you have placed your order, ATCC will coordinate the shipment on behalf of CDC/IRR. You must respond to emails from email@example.com to schedule the shipment.
Step 1: SHIPMENT NOTIFICATION
To initiate the shipment, you will need to provide the following information: 1) The international customs airport closest to your shipping address and (if applicable) provide your intermediate consignee 2) The status of any import permits required by your government 3) Confirmation that you agree to the terms and conditions of the shipment.
Step 2: IMPORT DOCUMENTS
Documentation requirements for import vary by country and occasionally between shipments. You will need to check with your government to identify all import permits required for your order. Sharing information with IRR about your document needs, potential obstacles, and anticipated timeline will enable IRR to better assist you.
Common document requests include: certificates of analysis, donation letters, commercial invoices, packing slips, a copy of the airway bill, certificate of quality, and certificate of origin.
Some adjustments to invoice format may also be possible upon request. However, IRR cannot disguise or remove the name of the intended recipient or destination laboratory.
Step 3: SCHEDULE SHIPMENT
IRR will work with you and couriers to coordinate the shipment. Once the shipment has been scheduled, the freight forwarder will provide you with flight details and notifications for FedEx shipments will be sent from firstname.lastname@example.org. You will be required to pick up the shipment from the international customs airport that you provided during the shipment initiation. To avoid the shipment getting detained at the airport, check with customs to ensure you have all the required paperwork to receive your shipment. If you experience difficulties clearing the shipment, please arrange for the shipment to be placed in cold storage. IRR is not responsible for the order clearing your customs process.
Step 4: RECEIPT CONFIRMATION
Once you have received the shipment, you will need to confirm that the shipment was picked up from customs and received in good condition. This confirmation is very important for troubleshooting delays and reporting damaged goods. Failure to confirm receipt of the shipment could delay IRR’s ability to provide your lab with reagents in the future.