mdi ConsultantsThe FDA is alerting clinical laboratory staff and health care providers of a risk with Thermo Fisher Scientific TaqPath COVID-19 Combo Kit, which is a molecular assay for detection of COVID-19 from respiratory specimens. The risk is of false results based on two issues. The first being related to inadequate vortexing and centrifugation of RT-PCR reaction plates. Inadequate vortexing and centrifugation can lead to false positive results. The second issue relates to the assay Internal Positive Control (IPC) and requires laboratory staff to upgrade their software to reduce the risk of invalid, potential false negatives, or inconclusive tests and to decrease the potential need to retest.
The FDA lists recommendations for clinical laboratory staff and health care providers using the Thermo Fisher Scientific TaqPath COVID-19 Combo Kit:
- Implement promptly the software updates and updated instructions for use from Thermo Fisher Scientific
- Stop using Applied Biosystems COVID-19 Interpretive Software v1.2, v2.0 and v2.2.
- Upgrade your Applied Biosystems COVID-19 Interpretive Software to version 1.3 or 2.3. Go to thermofisher.com/educationconnect and sign in with your thermofisher.com username and password.
- Type in the subscription code C19CKEUAFIS1323 to access and complete the training. You will need to pass an exam and acknowledge that you reviewed information to upgrade the Applied Biosystems COVID-19 Interpretive Software.
- Re-registration is needed for this upgrade.
- Read Thermo Fisher Scientific’s EducationConnect welcome letteror watch the video tutorial for full instructions to learn how to access the new version of the software.
- Read and implement the vortexing and centrifugation instructions Thermo Fisher Scientific added to the latest release of the Instructions for Useto prevent insufficient mixing and/or centrifugation.
- For all positive results, review the amplification curves within the instrument software for controls and patient specimens to determine whether the plate should be retested due to inadequate vortexing and centrifugation. Contact your local Thermo Fisher Scientific Field Applications Scientist for additional information on viewing amplification curves and performing plate level checks.
- Implement routine plate level checks of the amplification curves to ensure your laboratory appropriately adheres to specimen processing instructions for vortexing and centrifugation.
- Healthcare providers should consider positive results in combination with clinical observations, patient history, and epidemiological information.
- Notify all Thermo Fisher Scientific TaqPath COVID-19 Combo Kit and Applied Biosystems COVID-19 Interpretive Software users in your facility of this letter.
- Contact Thermo Fisher Scientific’s Technical Support at 800-955-6288 option 2 or [email protected]for technical questions.
- Report any issues with using the Thermo Fisher Scientific TaqPath COVID-19 Combo Kit and the Applied Biosystems COVID-19 Interpretive Software to Thermo Fisher Scientific and the FDA. See Reporting Problems to the FDA below.
The FDA is working with Thermo Fisher Scientific and public health partners to resolve these issues. The FDA will continue to keep clinical laboratory staff, health care providers, manufacturers, and the public informed of new or additional information.
The FDA is working as fast as possible to make sure that the COVID-19 testing is meeting the required specifications. With the pressure to get testing out to the public it is difficult for the FDA to monitor the quality (since their on-sites inspections have been to a minimal, and these tests have been allowed to be marketed under the EUA and not a full 510(k). Unfortunately, you may see more and more of these notices.
To read the original update, please visit the FDA’s website.
For any further questions about this update or for FDA regulations and compliance information on testing, please email mdi Consultants at [email protected] RE: COVID19Testing.