Accula™ SARS-CoV-2 Tests

SKU
MB-COV4100
$1,150.00
(25 Tests per Kit)

Buy 4 Kits Get 1 Free!

*Add 4 kits to your order and we will ship one Free. No limit, promo expires 03/31/2023.

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.

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. 

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

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
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