Accula™ COVID-19 test discontinued -- What is your replacement?

By Alison Adduono, Director of Marketing Communications

Well, it’s back. COVID-19 had been somewhat dormant most of this summer but for the last few weeks we have started to see an uptick in cases again.¹ Whether it be kids headed back to school or people gathered indoors to escape the heatwaves or maybe even the new variants Eris and Pirola being more contagious --- this is officially the beginning of a respiratory season.

Accula Discontinued

In recent months, there may have been limited attention towards the stock and expiration dates of COVID-19 testing kits. It's crucial to assess and replenish these resources. For those utilizing the Accula dock and the associated COVID-19 test, it is pertinent to note that Thermo Fisher ceased production in April.² If this is new information for you, or if you're contemplating alternative options, it's essential to be informed. Thermo Fisher's official announcement stated that Accula test supplies, which include the Accula Dock, Accula SARS-CoV-2 Test and Control Kit, would be available exclusively via authorized distributors until stocks were depleted.³ Based on current market feedback, it seems that these supplies are becoming scarce.

Photo Credit: iStock by Getty Images

Accula Replacement

Well, there are options out there whether they be lab-based PCR send-out, point-of-care NAATs (Nucleic Acid Amplification Tests) or rapid antigen tests. But ultimately choosing a test that meets your patient’s needs, providing accurate, timely, and affordable results is what matters most.

Why should you be using an NAAT instead of a rapid antigen test?

While antigen tests can provide results in about 15 minutes and are somewhat accurate, they do have an increased potential for false negatives. The reason is that instead of detecting RNA (like a NAAT does), the rapid antigen test is designed to detect proteins located on the surface of the virus. To be detected, the donor sample must have a high viral load present whereas a small viral load can be detected by a rapid NAAT, thereby providing actionable results at the earliest possible opportunity, and enabling healthcare providers to move forward with treatment plans much sooner.

What are NAATs?

NAAT stands for Nucleic Acid Amplification Test. It is a molecular diagnostic test targeting specific genetic sequences (nucleic acids).  In the case of SARS-CoV-2 (COVID-19), NAATs specifically target RNA (ribonucleic acid) sequences of the virus.

NAAT begins by amplifying—or replicating—the virus’ genetic material in a sample if present. Through the amplification of nucleic acids, a well-designed NAAT can detect small amounts of COVID-19 RNA in a sample, making the test highly sensitive, reliable, and less likely to return a false negative result of an active infection.

There are several different methodologies of NAATs with the most popular including RT-PCR (RT- Polymerase Chain Reaction - i.e. the discontinued Accula NAAT), NEAR (Nicking Endonuclease Amplification Reaction) and RT-LAMP (Reverse Transcriptase/Reverse Transcription Loop-mediated Isothermal Amplification).

Anavasi’s AscencioDx® COVID-19 Test and Molecular Detector is an RT-LAMP platform. Like RT-PCR, you can obtain actionable molecular results in a point-of-care setting; however, it incorporates newer technology. Affordable, positive results in as little as 20 minutes, simple workflow, portable and reusable --- the perfect choice for your COVID-19 testing needs.

To learn more about our AscencioDx or to purchase, please visit our website or contact us at sales@anavasidx.com.

Resources:

  1. CDC COVID Data Tracker: Maps by Geographic Area

  2. April 2023 - Point of Care Update - Direct Customer Notification Letter_Updated_OUT (thermofisher.com)

  3. Accula™ SARS-CoV-2 Test (thermofisher.com)

  4. COVID-19 Testing FAQs (asm.org)

  5. Nucleic Acid Amplification Tests (NAATs) | CDC

  6. NAAT Comparison — Anavasi Diagnostics (anavasidx.com)

  7. What is RT-LAMP Technology? (news-medical.net)

Where Speed, Efficiency, & Accuracy Align

The AscencioDx® Covid-19 Test and The AscencioDx® Molecular Detector have not been FDA cleared or approved, but have been authorized for emergency use by FDA under an EUA for use by authorized laboratories. This product has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.

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My Pirola -- Staying vigilant with the variants