Thermo Fisher Scientific

Accula™ SARS-CoV-2 Test

Catalog number: COV4100
Thermo Fisher Scientific

Accula™ SARS-CoV-2 Test

Catalog number: COV4100
Catalog Number
COV4100
Unit Size
25 pack
Price (USD)
Catalog NumberUnit SizePrice (USD)
COV410025 packRequest A Quote
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The Accula SARS-CoV-2 Test combines RT-PCR accuracy with a simple workflow to provide fast and convenient rapid PCR-based test results. The test’s patented PCR technology enables rapid exponential amplification while reducing overall thermocycling times, resulting in faster test results.
 
The Accula SARS-CoV-2 Test performed on the Accula Dock is a molecular in vitro diagnostic test utilizing PCR and lateral flow technologies for the qualitative, visual detection of nucleic acid from SARS-CoV-2 in clinician-collected nasal or nasal mid-turbinate swab specimens or clinician-instructed self-collected (collected on site) nasal swab specimens, collected from individuals suspected of COVID-19 by their healthcare provider.
 
Features of the Accula SARS-CoV-2 Test include:
  • Rapid testing results—RT-PCR SARS-CoV-2 results in ∼30 minutes
  • Streamlined process—CLIA-waived workflow
  • Simplified sample collection—nasal swabs and nasal mid-turbinate swabs
  • Easy—store at room temperature, no need for refrigeration
  • Accurate results— Positive percent agreement (PPA) 95.8% to 100% and negative percent agreement 100% in prospective and retrospective clinical studies.
 
The Accula SARS-CoV-2 Test is a nucleic acid amplification test (NAAT) for detection of SARS-CoV-2 viral RNA in approximately 30 minutes. To perform the test, nasal or nasal mid-turbinate specimens are added to the SARS-CoV-2 buffer to solubilize the sample. An aliquot of the SARS-CoV-2 buffer is then dispensed into an Accula SARS-CoV-2 test cassette. The test cassette contains  positive and negative internal controls, enzymes, OscAR™ reagents, and a detection strip necessary for the full completion of the assay. There are four steps in the process:
1. Lysis of the virus
2. Reverse transcription (RT) of viral RNA to cDNA
3. Nucleic acid amplification by PCR
4. Detection
 
In approximately 30 minutes, clinicians can quickly and reliably identify patients who are positive for COVID-19. Mutations in the following SARS-CoV-2 Variants have been demonstrated to have no impact on the performance of the Accula SARS-CoV-2 Test:
  • Alpha: B.1.1.7
  • Beta: B.1.351
  • Delta: B.1.617.2
  • Gamma: P.1 
  • Omicron: B.1.1.520, B.1.1.529, BA.1, BA.1.1, BA.2, BA.2.10, BA.2.12, BA.2.75, BA.2.75.2, BA.3, BA.4, BA.4.6, BA.5, BF.7, BQ.1, BQ.1.1, and XBB 
Intended use
The Accula SARS-CoV-2 Test performed on the Accula Dock or the Silaris™ Dock is a molecular in vitro diagnostic test utilizing polymerase chain reaction (PCR) and lateral flow technologies for the qualitative, visual detection of nucleic acid from SARS-CoV-2 in clinician-collected anterior nasal or nasal mid-turbinate swab specimens or clinician-instructed self-collected (collected on site) anterior nasal swab specimens, collected from individuals suspected of COVID-19 by their healthcare provider. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform high, moderate, or waived complexity tests. The Accula SARS-CoV-2 Test is authorized for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.

Accula SARS-CoV-2 Test results are for the identification of SARS-CoV-2 RNA. The SARS-CoV-2 RNA is generally detectable in upper respiratory specimens during the acute phase of infection. Positive results are indicative of the presence of SARS-CoV-2 RNA; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. Testing facilities within the United States and its territories are required to report all results to the appropriate public health authorities.

Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information.

The Accula SARS-CoV-2 Test is intended for use by trained operators who are proficient in performing tests on the Accula Dock and Silaris Dock. The Accula SARS-CoV-2 Test is only for use under the Food and Drug Administration’s Emergency Use Authorization. View Terms and Conditions Here 

Specifications

Certifications/Compliance
FDA Emergency Use Authorized (EUA)
Control Sets
High, Low, Negative
CE Marker
No
Clia Complexity
Waived
Detectable Analytes
SARS-CoV-2 RNA
DoA Calibrators
No
Format
Test Cassette Kit
Sample Type
Nasal swab
Sensitivity
Product LoD is 150 copies/mL with inactivated virus or 4.75 x 102 NDU/mL with the FDA Reference Panel
Type
SARS-CoV-2 Assay
For Use With (Application)
RT-PCR, Rapid PCR
Organism Group
Virus
Quantity
25
Shelf Life
Up to 18 months
Test Time
∽30 min.

Contents & Storage

  • Collection swabs (25): sterile swabs for nasal sample collection
  • SARS-CoV-2 buffer (25): single-use vial of solution containing 5 mL of buffer
  • Transfer pipette (25): single-use, fixed volume pipette used to transfer sample from the SARS-CoV-2 Buffer vial into the test cassette. Extra pipettes provided for your convenience.
  • Accula SARS-CoV-2 test cassette (25): single-use, foil-pouched with desiccant and test cassette containing lyophilized reagents for the targeted amplification and detection of viral nucleic acid
  • SARS-CoV-2 high positive, low positive, and negative control swab (1 each): DNA-based synthetic oligo dried onto a swab well above the limit of detection of the test