WHO Information Notice for Users of In Vitro Diagnostics 2020/4

Product title:  TaqPath™ COVID-19 CE-IVD RT-PCR equipment manufactured by Thermo Fisher Scientific (product code A48067) used with:

  • Applied Biosystems COVID-19 Interpretive Software v1.2 (used with the 7500 sequence Real-Time PCR devices)
  • Applied Biosystems COVID-19 Interpretive Software v2.zero or v2.2 (used with the QuantStudio Real-Time PCR platforms)

Date: 25 August 2020                                                           

WHO-identifier: 2020/4, model 1

Type of motion: Advice to customers   

Purpose of this discover: To guarantee customers of Thermo Fisher Scientific TaqPath™ COVID-19 CE-IVD RT-PCR equipment are conscious of a compulsory software program replace and reinforce sure components within the directions to be used that should be adopted to keep away from misclassification of check outcomes.

Description of the issue: Thermo Fisher Scientific recognized the necessity to conduct a discipline security corrective motion to cut back the chance associated to make use of of their product, the problems had been recognized by means of buyer suggestions and inside assessment.

Issue 1:

Poorly extracted affected person specimens had been referred to as legitimate utilizing MS2 Assay. A cycle threshold (Ct) cutoff of 37 was not satisfactory to detect specimens with poor extraction effectivity or a considerable amount of impurities post-extraction. This subject could

probably trigger a weakly constructive specimen that sub-optimally extracted to be falsely referred to as a sound unfavorable specimen, thereby constituting a false unfavorable. However, no buyer has reported false unfavorable outcomes resulting from this subject thus far.

Issue 2:

The MS2 assay, which detects the Internal Positive Control (IPC), was erroneously referred to as amplified in a small proportion of Positive Control (PC) samples. This subject precipitated a plate to be designated incorrectly as invalid, thereby requiring pointless retesting of a complete batch of specimens.

As a results of the above two points, Thermo Fisher Scientific recommends a compulsory improve for the Applied Biosystems COVID-19 Interpretive Software used with the TaqPath COVID-19 CE-IVD COVID-19 RT-PCR Kit:

  • If you might be utilizing Applied Biosystems COVID-19 Interpretive Software v1.2 (used with the 7500 sequence Real-Time PCR devices) it is advisable to improve to software program v1.3.
  • If you might be utilizing Applied Biosystems COVID-19 Interpretive Software v2.zero or v2.2 (used with the QuantStudio Real-Time PCR platforms
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    ), it is advisable to improve to software program v2.3.

Issue 3:

Thermo Fisher Scientific has up to date the Instructions for Use (IFU) to spotlight the significance of vortexing the RT-PCR response plates to mitigate potential for false constructive outcomes. The vortexing directions are detailed within the “Prepare RT-PCR reactions” step of the Instructions for Use, recorded below the publication quantity MAN0019215 Revision E and all translations of this publication.

Thermo Fisher Scientific strongly recommends that every one customers take part in coaching on correctly run the workflow as provided by the native consultant.

Advice on motion to be taken by customers:

1. Please verify in case your native consultant for Thermo Fisher Scientific has communicated a discipline security discover to your facility on this matter.

  1. a. If they’ve, please comply with the directions contained within the discipline security discover particular in your regulatory jurisdiction. Thermo Fisher Scientific will present a subscription code to entry and full e-learning. You will likely be required to cross an examination and acknowledge that you just reviewed info to improve the Applied Biosystems COVID-19 Interpretive Software.
  2. b. If they haven’t, please contact your native consultant for Thermo Fisher instantly, or the financial operator who offered you with the product.

2. Stop utilizing Applied Biosystems COVID-19 CE-IVD Interpretive Software v1.2, v2.zero and v2.2.

3. Do not check specimens till the obligatory e-learning and software program improve has been performed.

4. Consider any constructive outcome (SARS-CoV-2 detected) or unfavorable outcomes (SARS-CoV-2 not detected) together with scientific observations, affected person historical past, and epidemiological info.

5. Ensure that you just signal and return acknowledgement of receipt of the sector security discover issued by Thermo Fisher Scientific, as per their request.

Transmission of this WHO Information Notice for Users:

This discover must be handed on all those that have to be conscious inside your group or to any group the place the doubtless affected product has been deployed and used.

Contact particular person for additional info:

Anita SANDS, Regulation and Prequalification, World Health Organization, e-mail: sandsa@who.int

 

 

Sources By WHO