June 27, 2022

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Roche may have false positive results in diagnosis of COVID-19 and flu

Roche may have false positive results in diagnosis of COVID-19 and flu


Roche may have false positive results in diagnosis of COVID-19 and flu.  FDA stated that the Roche Diagnostics Cobas Liat system had false positives for Cobas SARS-CoV-2 and A/B influenza nucleic acid tests.

Recently, the U.S. Food and Drug Administration issued an email warning clinical laboratories, field nurses, and healthcare practitioners that Roche SARS-CoV-2 and A/B influenza tests may have false positive results.

Roche may have false positive results in diagnosis of COVID-19 and flu

The FDA stated that the Roche Diagnostics Cobas Liat system had false positives for Cobas SARS-CoV-2 and A/B influenza nucleic acid tests. There are two reasons for judging false positives:

 

The test tube may occasionally leak and block the light path in the Cobas Liat analyzer, resulting in abnormal PCR growth curves. This can lead to invalid or false positive results, especially for influenza B testing. The FDA added that if the test tube does leak, subsequent tests may increase the possibility of false positive results for influenza B.



Abnormal PCR cycles in the reaction tube may produce abnormal PCR growth curves, resulting in false positives. The FDA stated that this problem is sporadic and may be caused by hardware positioning, volume movement and curve interpretation. This problem may cause false alarms for all analytes in the run.


In the letter, the FDA recommended that those using the test should “monitor for unexpected clusters of positive influenza B results” and repeat the test when two or three analytes are positive, because different results from repeated tests may indicate abnormal PCR cycles. The FDA wrote that if users want any of these two problems to occur, they should stop using the system and contact Roche. The agency added that it is working with Roche to resolve these issues.


A Roche spokesperson said in an e-mail that the company recently found “some false results” in tests, especially false positives, especially in influenza B tests, which are sporadic. At present, Roche is conducting an in-depth investigation to understand the cause and determine the next steps, and actively report the incident to the FDA.


In 2020, Roche Diagnostics received an emergency use authorization from the FDA in September, which can be used in medium or high complexity laboratories and points of care. The test uses a nasal swab to distinguish viral nucleic acid from SARS-CoV-2 and influenza A and B, and can return results within 20 minutes.


The FDA stated that the Roche Diagnostics Cobas Liat system had false positives for Cobas SARS-CoV-2 and A/B influenza nucleic acid tests.

Recently, the U.S. Food and Drug Administration issued an email warning clinical laboratories, field nurses, and healthcare practitioners that Roche SARS-CoV-2 and A/B influenza tests may have false positive results.

 

The FDA stated that the Roche Diagnostics Cobas Liat system had false positives for Cobas SARS-CoV-2 and A/B influenza nucleic acid tests. There are two reasons for judging false positives:

 

The test tube may occasionally leak and block the light path in the Cobas Liat analyzer, resulting in abnormal PCR growth curves. This can lead to invalid or false positive results, especially for influenza B testing. The FDA added that if the test tube does leak, subsequent tests may increase the possibility of false positive results for influenza B.



Abnormal PCR cycles in the reaction tube may produce abnormal PCR growth curves, resulting in false positives. The FDA stated that this problem is sporadic and may be caused by hardware positioning, volume movement and curve interpretation. This problem may cause false alarms for all analytes in the run.


In the letter, the FDA recommended that those using the test should “monitor for unexpected clusters of positive influenza B results” and repeat the test when two or three analytes are positive, because different results from repeated tests may indicate abnormal PCR cycles. The FDA wrote that if users want any of these two problems to occur, they should stop using the system and contact Roche. The agency added that it is working with Roche to resolve these issues.


A Roche spokesperson said in an e-mail that the company recently found “some false results” in tests, especially false positives, especially in influenza B tests, which are sporadic. At present, Roche is conducting an in-depth investigation to understand the cause and determine the next steps, and actively report the incident to the FDA.


In 2020, Roche Diagnostics received an emergency use authorization from the FDA in September, which can be used in medium or high complexity laboratories and points of care. The test uses a nasal swab to distinguish viral nucleic acid from SARS-CoV-2 and influenza A and B, and can return results within 20 minutes.

(source:internet, reference only)


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