International Reagent Resources



IRR Frequently Asked Questions (FAQs)

Get the answers you need about International Reagent Resource (IRR) catalog and emergency response related diagnostic supplies and reagents.

 

Table of Contents

Mpox FAQs

  1. What supplies are being distributed by IRR for mpox testing?
  2. When can I expect to receive my order?
  3. Can I register this lab/hospital with IRR to receive mpox testing supplies?
  4. Where can I get more information?

COVID-19 FAQs

  1. What supplies are being distributed by IRR for COVID testing?
  2. Should I use the Flu SC2 Multiplex Assay for COVID-19 testing or influenza testing? Is there a difference?
  3. What is the difference between the Flu SC2 Multiplex Assays Flu SC2PP-EUA and Flu SC2PPB-EUA? Will I need to perform a validation before using the other version?
  4. Is the Flu SC2 Multiplex Assay able to detect the COVID-19 variants?
  5. 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?
  6. Did IRR change the amount of Flu SC2 multiplex kits and influenza enzymes available to my lab?
  7. Is IRR still offering the FTD-21 kit?

General IRR FAQs

  1. Do you need to be funded by CDC to obtain IRR materials?
  2. How do I register with IRR?
  3. What is the relationship between IRR and ATCC?
  4. Who establishes the requirements for access and use of IRR materials? 
  5. Who decides which reagents will be distributed by IRR?
  6. When is my order shipping?
  7. What email communications will I receive from IRR regarding pending orders? 
  8. If I need to modify my order, should I reorder?
  9. Why was my order quantity reduced or canceled?
  10. Where do I find specific information about an item (e.g., product availability, expiration date extension and related documentation, and other important information?
  11. Why is [this item] out of stock? When can I order this? 
  12. Why do I have multiple sales order numbers for my order?
  13. How can I facilitate the acceptance of my permit when received by IRR? 
  14. Does it cost anything to receivereagents from IRR?
  15. What is the international shipping process and what can I do to receive my shipment efficiently?
  16. Why does IRR use a 10-digit HS code to export my international shipment?
  17. What are IRR's terms and conditions?
  18. Can another lab order on my behalf?
  19. Can someone else use my account to order on my behalf?

 

Mpox FAQs

 

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

*Qualified lots only 

IRR is not currently distributing CDC’s Non-variola Orthopoxvirus Real-time PCR Primer and Probe Sets. Inquiries into availability of these RT-PCR reagents should be directed to the LRN via the “contact us” feature on the LRN website or by emailing lrn@cdc.gov.

 

2.  When can I expect to receive my order? 

Replenishment orders for mpox are being processed on a weekly basis to ensure equitable distribution, maximize efficiency, and reduce potential shipping bottlenecks. All orders submitted before 5:00 PM EST on Wednesday will be processed by the end of the week. Labs can expect room temperature items early the following week and frozen items in the latter half. When placing an order, please indicate your availability for Saturday delivery within the order comments on each order. If you have questions regarding your order, please contact us.

If you have already submitted an order but it has not shipped, please do not resubmit. If you need to modify it, email IRR Customer Service (contact@internationalreagentresource.org) and request a modification to your existing order. Orders that have already shipped cannot be modified and duplicate orders may be canceled. If you are requesting quantities over the order limits, provide a justification in the order comments.

 

3.  Can I register this lab/hospital with IRR to receive mpox testing supplies? 

CDC limits IRR registration and mpox diagnostic reagent distribution to labs participating in the Laboratory Response Network (LRN). Other labs interested in testing can design an LDT to perform a full validation per CLIA regulations.

 

4.  Where can I get more information? 

Please visit CDC’s Emergency Preparedness and Response Laboratory Response Network Site for more information.

 

COVID-19 FAQs

 

5.  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:

 

IRR provides CDC-manufactured kits and controls associated with its RUO applications to non-US laboratories. These include: 

 

6.  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.

 

7.  What is the difference between the Flu SC2 Multiplex Assays Flu SC2PP-EUA and Flu SC2PPB-EUA? Will I need to perform a validation before using the other version?

Laboratories can use both versions of the Flu SC2PP and Flu SC2PPB interchangeably in conjunction with the Influenza SARS-CoV-2 Multiplex Assay Positive Control Kits (Flu SC2PC). The only differences are the reporter and quencher probe chemistries and condition of the primers and probe provided in the packaging - Flu SC2PP-EUA are aqueous, whereas the primers and probes for Flu SC2PPB are dried. Visit the www.cdc.gov/coronavirus/2019-ncov/lab/multiplex.html for detailed information. No calibration or instrument changes are required.

Domestic 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.

 

8.  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.

 

9.  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.

 

10.  Did IRR change the amount of Flu SC2 multiplex kits and influenza enzymes available to my lab? 

CDC is committed to providing assays to our public health for the diagnosis and surveillance of Influenza and COVID-19. As the pandemic has officially ended, CDC will be providing the Influenza SARS-CoV-2 Multiplex Assay at quantities comparable to pre-pandemic (2019) levels to support influenza and now SARS-CoV-2 surveillance.

Domestically, CDC's Influenza Division is continuing to provide ancillary reagents to support the weekly influenza subtyping goals for novel virus detection. Enzyme selections are based on last year’s preference unless IRR is notified otherwise and are proportional to the number of test kits available to each lab.

Internationally, according to pre-pandemic (2019) distribution strategies, some laboratories participating in the Global Influenza Surveillance and Response System (GISRS) are eligible to continue receiving ancillaries in quantities proportional to the number of kits available. Eligible laboratories have been notified of available ancillary reagents and supply support via email from IRROrders@cdc.gov.  If this return to pre-pandemic levels of IRR support negatively impacts your surveillance activities and current budget projections, please contact IRR focal points within the Influenza Division, Flusupport@cdc.gov, and IRROrders@CDC.govLabs can submit orders for the new influenza season from September 1, through August 31.

 

11.  Is IRR still offering the FTD-21 kit? 

The Fast-Track Diagnostics Respiratory Pathogens 21 (FTD Catalog No. FTD-2 (RUO) / Siemens Catalog No. 11373928)  is only available for limited distribution. CDC’s technical experts have reevaluated its intended use and have decided to reduce the availability of these kits via IRR. FTD kits are intended for reflex testing of influenza and SARS-CoV-2 negative samples in outbreak settings. FTD kits are NOT intended for use on a routine basis or for routine sentinel surveillance; contact your CDC technical expert for proper use. FTD kits are for international use and require justification before the order can be approved. Please direct all new requests for FTD 21 kits to the CORVD Global Laboratory Team at CORVDSupport@cdc.gov and include IRRorders@cdc.gov

 

General IRR FAQs

 

12.  Do you need to be funded by CDC to obtain IRR materials?

No, eligible recipients do not need to be funded by CDC.

 

13.  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.

 

14.  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.

 

15.  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.

 

16.  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.

 

17.  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.

 

18.  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.

 

19.  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.

 

20.  Why was my order quantity reduced or canceled?

CDC may reduce or cancel some of the quantities ordered if CDC has limited inventory or if a lab has reached the limit for an item ordered (limits reset on Sept 1). Order modifications are made to ensure equitable distribution of to all IRR supported labs. If you have extenuating circumstances or feel that you have been denied in error, please visit IRR’s Contact Us page and let us know. Be sure to include a justification in the order comments of your shopping cart if you are requesting more than what you typically order.  Your reply will be shared with the appropriate CDC POCs and taken into consideration. IRR staff will continue to work diligently to secure additional inventory and fulfill as many requests as possible.

 

21.  Where do I find specific information about an item (e.g., product availability, expiration date extension and related documentation, and other important information?

Visit the item's product page to view important banners and download associated documentation.

 

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

IRR will update the status to “Temporarily Out of Stock” when inventory is unavailable. If you want to know when an item will be back in stock, you can select the bell icon from within the catalog or “Product Notification Request” from the item’s product page. You will receive a confirmation email after clicking “Notify Me” from the pop-up. You will receive another email when the item is back in stock, letting you know it is available to order. Note: If you would like to include this item as part of a larger shipment, please wait until this item is available to place your order.

 

23.  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.

 

24.  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)

 

25.  Does it cost anything to receive reagents from IRR?

IRR ships all reagents at no cost to the laboratory. However, the laboratory is responsible for the nominal fee associated with customs.

 

26.  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 contact@internationalreagentresource.org 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 nonreply@atcc.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.

 

27.  Why does IRR use a 10-digit HS code to export my international shipment? 

In accordance with US federal law, IRR uses a 10 digit Schedule B number to classify products for export. The first 6 digits of the 10 digit US code are the HS code. The US, like many other countries, uses additional digits for country-specific categorizations. For example, US Schedule B number 3800.10.2020 corresponds to HS code 3800.10. IRR can review suspect numbers upon request to determine if there is an error, but cannot change the numbers to fit requests for import on a case by case basis. The Harmonized System (HS) Codes used by IRR are administrated by the World Customers Organization and administered by the U.S. Census Bureau’s Foreign Trade Division. For more information regarding the US HS code, visit the Internal Trade Administration website on HS codes.

 

28.  What are IRR's terms and conditions? 

DUTIES AND TAXES – Your organization is responsible for the Duties and Taxes associated with the shipment.  

IMPORT PERMITS – Your organization is responsible for checking with your government to identify all import permits required for your order. You will need to send the required permits to IRR at contact@internationalreagentresource.org or fax (703-334-2945). Use the “SO” reference number when applying for import permits (this number is used on all shipping documents). Contact IRR for assistance obtaining your import permits. 

SHIPMENT PICKUP –Airport pickup is required for your orders, unless you have been approved for delivery directly to your door. You will be responsible for tracking your shipment from the IRR. The freight forwarder will provide you with flight details once the order has been booked for shipment. Notifications for FedEx shipments will be sent from International Reagent Resource nonreply@atcc.org. Your organization will be responsible for the order clearing customs. Contact customs to ensure you have all the necessary and correct paperwork to receive the shipment. You must confirm the shipment receipt with IRR.

 

29.  Can another lab order on my behalf? 

No, but labs can request to use an intermediate consignee or “broker” which is a 3rd party (for example the MOH or WHO regional officer) that receives and clears goods on behalf of a lab to ensure that the shipment reaches its final destination. Most labs do not need an intermediate. However, if you are concerned that your shipment might encounter issues clearing customs, you can request an intermediate by noting it in the Order Comments of the shopping cart. Ensure you include the name, contact info, and address of the individual who will receive the shipment.

 

30.  Can someone else use my account on my behalf? 

To keep your account secure, we want to remind you that your email and login information are specific to you as the IRR registrant, not your laboratory. IRR username and password should not be shared with others. Further, per the User Agreement, only IRR registrants are authorized to log in to the IRR website, place orders, and receive IRR products. Organizations can have multiple registered users, and IRR recommends having at least two per institution.

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