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WHO information notice for users of in vitro diagnostics 2020/4


Name of the product: TaqPath ™ COVID-19 CE-IVD RT-PCR kit produced Thermo Fisher Scientific (Product code A48067) is used with:

  • Applied Biosystems COVID-19 Interpretive Software v1.2 (used with 7500 series real-time PCR instruments)
  • Applied Biosystems COVID-19 Interpretive Software v2.1 or v2.2 (used with QuantStudio real-time PCR platforms)

Date: September 1, 2020

WHO identifier: 2020/4, version 2

Action type: Tips for users

Purpose of this notice: In order for Thermo Fisher Scientific TaqPath P COVID-19 CE-IVD RT-PCR kit users to be aware of the mandatory software update and to reinforce certain parts in the instructions for use that must be followed to avoid misclassification of test results.

Problem description: Thermo Fisher Scientific has identified the need to implement safety corrective measures in the field to reduce the risk associated with the use of their products, and problems have been identified by customer feedback and internal review.

1st edition:

Poorly taken patient samples were called valid using the MS2 test. A cycle threshold limit (Ct) of 37 was not appropriate for the detection of samples with poor extraction efficiency or a large amount of impurities after extraction. This edition May potentially causing a weakly positive sample that is sub-optimally extracted to be falsely referred to as a valid negative sample, thus making a false negative. However, to date, no customer has reported false negative results due to this problem.

2nd edition:

The MS2 test, which detects Internal Positive Control (IPC), was mistakenly called amplified in a small percentage of Positive Control (PC) samples. Due to this problem, the plate was incorrectly marked as invalid, which required unnecessary re-examination of the entire batch of samples.

As a result of the above two editions, Thermo Fisher Scientific recommends a mandatory upgrade of the Applied Biosystem COVID-19 Interpretive Software used with the TaqPath COVID-19 CE-IVD COVID-19 RT-PCR Kit:

  • If you use Applied Biosystems COVID-19 Interpretive Software v1.2 (used with 7500 series real-time PCR instruments) you need to upgrade to software v1.3,,
  • If you use Applied Biosystems COVID-19 Interpretive Software v2.1 or v2.2 (used with QuantStudio real-time PCR platforms), you need to upgrade to software v2.3,,

3rd edition:

Thermo Fisher Scientific has updated the Instructions for Use (IFU) to emphasize the importance of vortex RT-PCR reaction plates to mitigate the potential for false-positive results. The vortexing instructions are described in detail in the “Preparation of RT-PCR Reactions” step of the Operating Instructions, recorded under publication number MAN0019215 Revision E and all translations of this publication.

Thermo Fisher Scientific warmly recommends all users to participate in training on how to properly run the workflow, as offered by a local representative.

Tips on actions to be taken by users:

1. Please check that your local Thermo Fisher Scientific representative has sent a safety notice to the facility.

  1. a. If so, follow the instructions contained in the field safety notice that is specific to your regulatory jurisdiction. Thermo Fisher Scientific will provide a subscriber code to access and complete e-learning. You will be required to pass an exam and confirm that you have reviewed the data for the COVID-19 Interpreted Biosystems Interpreted Software Upgrade.
  2. b. If they are not, contact your local Thermo Fisher representative or the economic operator who supplied you with the product.

2. Discontinue Applied Biosystems COVID-19 CE-IVD Interpretive Software v1.2, v2.1, and v2.2.

3. Do not test samples until mandatory e-learning and software upgrades have been performed.

4. Consider any positive result (SARS-CoV-2 detected) or negative result (SARS-CoV-2 not detected) in combination with clinical observations, medical history, and epidemiological information.

5. Be sure to sign and return the acknowledgment of receipt of the field safety notice issued by Thermo Fisher Scientific, upon their request.

Transmission of this WHO Information Notice to Users:

This notice should be passed on to anyone who needs to be aware of your organization or any organization in which the potentially affected product is installed and used.

Contact person for further information:

Anita SANDS, Regulations and Prequalification, World Health Organization, e-mail: [email protected]

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