Accula™ SARS-CoV-2 Tests

SKU
MB-COV4100
$1,225.00

(25 Tests per Kit)

FREE NEXT DAY AIR SHIPPING ON ORDERS OF 3 OR MORE KITS.

Note: Free shipping applies only to 48 continental USA states and additional fees may be required for Hawaii, Alaska, Puerto Rico and other outlying areas. 

You can be contacted after check out for additional fees. You may contact us at [email protected] for formal quotation outside continental USA. 

The Accula SARS-CoV-2 Test combines RT-PCR accuracy with a portable platform and elegantly 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
• Trusted partner to health care providers—use of system helps prevent transmission during medical procedures and helps protect immuno-compromised patients
• Easy—store at room temperature, no need for refrigeration
• Accurate results—100% positive and negative percent agreement (PPA and NPA) in prospective clinical study

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 two process positive and negative 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 just 30 minutes, clinicians can quickly and reliably identify patients who are COVID-19 positive for isolation or deferment of treatment. None of the mutations in the SARS-CoV-2 Variants of Concern - B.1.1.7 (Alpha), B.1.351 (Beta), B.1.617.2 (Delta), and P.1 (Gamma) – are known to impact the Accula SARS-CoV-2 Test performance.

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 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. 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.

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 with dimethyl sulfoxide and < 0.01% sodium azide
• 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
 

Specifications

Certifications/Compliance: FDA Emergency Use Authorized (EUA)
Clia Complexity: Waived
Control Sets: High, Low, Negative
DoA Calibrators: No
Final Product Type: In vitro diagnostic
Format: Test Cassette Kit
Kit Size: 25
Organism Group: Virus
Sample Type: Nasal swab
Sensitivity: Product LoD is 4.75 x 102 NDU/mL
Shelf Life: Minimum of 6 months from date of manufacture
Storage Requirements: Room temperature
Technology: RT-PCR, Rapid PCR
Test Time: 30 minutes
Type: SARS-CoV-2 Assay
CE Marker: No
Detectable Analytes: SARS-CoV-2 RNA
© 2020 Cliawaived, Inc. All Rights Reserved. All product and company names are trademarks™ or registered® trademarks of their respective holders. Use of them does not imply any affiliation with or endorsement by them.