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WHO 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 COVID-19 interpretive software for biosystems v1.2 (used with 7500 series real-time PCR instruments)
- Applied COVID-19 interpretation software for biosystems v2.0 or v2.2 (used on real-time QuantStudio PCR platforms)
Date: August 25, 2020
WHO identifier: 2020/4, version 1
Action type: Tips for users
Purpose of this notice: To ensure that users of the Thermo Fisher Scientific TaqPath ™ COVID-19 CE-IVD RT-PCR Kit are aware of the mandatory software update and reinforce certain parts in the operating instructions that must be followed to avoid misclassification of test results.
Problem description: Thermo Fisher Scientific has identified the need to implement corrective action in the field to reduce the risk associated with the use of their products, problems have been identified by 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 to detect samples of poor extraction efficiency or large amounts of impurities after extraction. This question May potentially causing a weakly positive sample that is suboptimally extracted to be falsely called a valid negative sample, which is a false negative. To date, however, no customer has posted false negatives due to this issue.
2nd edition:
The MS2 assay, 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, so it required unnecessary re-testing of the entire batch of samples.
As a result of the above two releases, Thermo Fisher Scientific recommends a mandatory upgrade for the applied COVID-19 software for applied biosystems 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 v2.0 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 highlight the importance of vortex RT-PCR reaction plates to mitigate the potential for false-positive results. The vortex instructions are described in detail in the “Preparation of RT-PCR Reactions” step of the Instructions for Use, recorded under publication number MAN0019215, Revision E and all translations of this publication.
Thermo Fisher Scientific warmly recommends that all users participate in training on how to properly start the workflow, as offered by a local representative.
Tips on actions to be taken by users:
1. Make sure your local Thermo Fisher Scientific representative has sent a field safety notice on this topic.
- a. If you have them, please follow the instructions contained in the Field Safety Notice specific to the regulatory jurisdiction. Thermo Fisher Scientific will provide a subscriber code for access and full e-learning. You will be required to pass an exam and confirm that you have reviewed the data for the Applied Biosystems COVID-19 Interpretive Software upgrade.
- b. If they are not, please contact your local Thermo Fisher representative or the economic operator who supplied you with the product immediately.
2. Stop using the applied biosystems COVID-19 CE-IVD interpretation software v1.2, v2.0 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, patient history, and epidemiological data.
5. Verify that you have signed and returned the acknowledgment of receipt of the Field Safety Notice issued by Thermo Fisher Scientific, at their request.
Transmission of this WHO Notice to Users:
This notice must be passed on to anyone who must be aware of your organization or any organization in which the potentially affected product is deployed and used.
Contact person for additional information:
Anita SANDS, Regulation and Prequalification, World Health Organization, e-mail: [email protected]
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