CDC has developed two laboratory assessments that determine SARS-CoV-2, the virus that causes COVID-19. The newer of those assessments additionally assessments for influenza A and B viruses. Testing for all three viruses on the similar time will present public well being officers with data they should assist scale back the unfold of those viruses locally whereas conserving sources which can be in brief provide.
CDC Influenza SARS-CoV-2 Multiplex Assay
CDC’s latest laboratory take a look at, detects two varieties of influenza viruses (A and B) and SARS-CoV-2 on the similar time. This take a look at is known as the CDC Influenza SARS-CoV-2 (Flu SC2) Multiplex Assay.
A single take a look at that diagnoses present an infection with a number of of those viruses will enable public well being laboratories to proceed influenza surveillance whereas they’re additionally testing for SARS-CoV-2. Details about each viruses will assist public well being officers to manage the unfold of influenza and COVID-19 locally and should assist well being care suppliers handle remedy of influenza and COVID-19. The take a look at may even enable laboratories to preserve vital testing supplies which can be in brief provide and course of as much as 3 times as many assessments as they’ll with the prevailing take a look at for SARS CoV-2.
The Flu SC2 take a look at package was evaluated in CDC laboratories and three different public well being laboratories to make sure that the take a look at works as meant. The Flu SC2 Multiplex Assay was designed utilizing knowledge about SARS-CoV-2 genomes that weren’t accessible when the sooner take a look at was designed, which is probably going to enhance efficiency of the take a look at.
The U.S. Meals and Drug Administration (FDA) issued an Emergency Use Authorizationexterior icon (EUA) to be used of the Flu SC2 Multiplex Assay on July 2, 2020. The EUA course ofexterior icon allows FDA to think about and authorize using unapproved however doubtlessly lifesaving medical or diagnostic merchandise throughout a public well being emergency. The usSecretary of Well being and Human Providers declared SARS-CoV-2 to be a U.S. public well being emergency on January 31, 2020.
CDC 2019-nCoV RT-PCR Diagnostic Panel
In early 2020, CDC developed its first laboratory take a look at package to be used in testing affected person specimens for SARS-CoV-2. The take a look at package is known as the CDC 2019 Novel Coronavirus (2019-nCoV) Actual-Time Reverse Transcriptase (RT)–PCR Diagnostic Panel.
On February 3, 2020, CDC submitted an EUA bundle to expedite FDA-permitted use of the CDC diagnostic panel in the US. FDA issued the EUA the subsequent day, and CDC despatched the take a look at kits to state and native public well being laboratories.
Earlier than laboratories use a brand new take a look at on samples from sufferers, they have to confirm the take a look at efficiency (be certain it really works as anticipated) utilizing “constructive” and “unfavourable” management supplies. The constructive management ought to at all times take a look at constructive, and the unfavourable management ought to at all times take a look at unfavourable. Throughout validation of the CDC SARS-CoV-2 take a look at, some laboratories found an issue with one of many take a look at’s three reagents—chemical compounds required to run a take a look at. The reagent produced a constructive consequence with the unfavourable management, so laboratories couldn’t confirm take a look at efficiency.
To resolve the difficulty, CDC laboratories decided that this reagent may very well be ignored with out affecting take a look at accuracy due to the built-in redundancy in take a look at design. The redundant design saved time by permitting the kits for use with out the reagent. FDA approved this modification, and new take a look at kits with the 2 essential reagents have been manufactured and distributed to states. These kits are nonetheless in use.
Excessive demand for the reagents wanted with this take a look at has resulted in international shortages. Some public well being laboratories have been unable to get testing reagents to help their testing volumes, leading to testing delays. Subsequently, CDC laboratories validated alternate options for processing the take a look atexterior icon:
- 4 extra extraction reagents that can be utilized within the current extraction strategies
- An extra extraction instrument and related reagents
- A brand new course of that can be utilized instead of the extraction methodology when supplies for the present methodology are restricted
FDA permitted these modifications on June 12, 2020, in an modificationexterior icon to the take a look at’s EUA to permit state public well being laboratories and others to make use of these alternate options. Moreover, FDA permitted an modificationexterior icon on July 13, 2020, so as to add the Promega Maxwell® RSC 48 as a certified extraction instrument to be used with the CDC 2019-nCoV rRT-PCR Diagnostic Panel.
Who Can Use These Assessments?
CDC assessments are offered to U.S. state and native public well being laboratories and Division of Protection laboratories that have been both beforehand certified for with the ability to carry out the same kind of take a look at used to detect influenza or have been not too long ago permitted by their state public well being laboratory for SARS-CoV-2 testing.