Accula™ COVID-19 Rapid Test Cassette
25 tests per box. Does NOT include the Accula Test Dock
- 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
Description
12The 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.
Additional information
| Weight | 4 lbs |
|---|---|
| Dimensions | 11 × 11 × 4 in |
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Can you use this test to travel outside the United States?
The test used must be authorized for use by the relevant national authority for the detection of SARS-CoV-2 in the country where the test is administered. Please consult with the appropriate governing bodies of your travel destination.
What kind of payment methods do you accept?
We prefer credit card payments, however wire transfer is available for larger orders.
How quickly can I get my COVID-19 Rapid Tests?
We ship our tests with FedEx and can provide priority overnight shipping if needed. We provide all standard FedEx shipping methods including Next-Day, 2-day, and Ground. All standard shipping rates and terms apply.
Can I buy COVID-19 Rapid Test Kits for my business?
Yes, you can purchase test kits for your business, as long as a certified medical professional helps administer the tests. A valid CLIA number or waiver is required in order the purchase the COVID-19 rapid test kits.
What is the minimum order size for the Rapid Tests?
The minimum order is 1 box. Each box contains 20 – 25 individual tests.
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