FDA alerts providers to false positives with Roche SARS-CoV-2/flu test

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FDA alerts providers to false positives with Roche SARS-CoV-2/flu test
Damareus Barbour CA
Mar 15, 2021

The Food and Drug Administration Friday alerted clinical laboratories staff and health care providers to the potential for positive results from a test made by Roche Molecular Systems to simultaneously detect and differentiate SARS-CoV-2 and influenza A/B.

FDA recommends users monitor for unexpected clusters of positive influenza B results, as this may indicate the cobas Liat System has experienced a tube leak, and stop using the system and contact Roche if they suspect certain issues. FDA authorized emergency use of the test last September.

In other news, FDA Friday issued an emergency use authorization for Propofol-Lipuro 1% injectable emulsion to maintain sedation via continuous infusion in patients over age 16 who require mechanical ventilation in an intensive care unit setting during the COVID-19 public health emergency.

Providers should consult the fact sheet before administering the drug because its formulation is different from FDA-approved propofol drugs, currently in shortage.

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FDA alerts providers to false positives with Roche SARS-CoV-2/flu test
Damareus Barbour CA
Mar 15, 2021

The Food and Drug Administration Friday alerted clinical laboratories staff and health care providers to the potential for positive results from a test made by Roche Molecular Systems to simultaneously detect and differentiate SARS-CoV-2 and influenza A/B.

FDA recommends users monitor for unexpected clusters of positive influenza B results, as this may indicate the cobas Liat System has experienced a tube leak, and stop using the system and contact Roche if they suspect certain issues. FDA authorized emergency use of the test last September.

In other news, FDA Friday issued an emergency use authorization for Propofol-Lipuro 1% injectable emulsion to maintain sedation via continuous infusion in patients over age 16 who require mechanical ventilation in an intensive care unit setting during the COVID-19 public health emergency.

Providers should consult the fact sheet before administering the drug because its formulation is different from FDA-approved propofol drugs, currently in shortage.

COVID-19: CDC, FDA and CMS Guidance

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