RApid PCR
Detect a Recent COVID-19 Infection
Viral tests determine whether a person has an active COVID-19 infection. We use one of the highest performing rapid tests in the market for detecting active COVID-19 infections. With rapid tests, results are available within 45 minutes of sample collection.
Assay: Mesa Biotech Accula System
How to Use
PREPARE THE SWAB
Remove swab from the sterile pouch without touching the swab tip
SWAB NOSE
Insert at least 1 cm (1/2 inch) and rotate in place for 10-15 seconds
INSERT & SNAP
Insert sample into the transport tube and snap the swab at the breakpoint
SEAL
Securely tighten the cap on the transport tube and prepare
What Will My Results Tell Me?
Your test results will confirm whether or not you are actively infected with COVID-19.
- Positive Results
You will be notified by a licensed physician if you test positive for a COVID-19 infection. Limit your exposure to other people and monitor your symptoms. As the CDC instructs, please alert healthcare providers of your test results before receiving medical care. However, do not delay seeking care if you are experiencing a medical emergency.
- Negative Results
You will receive an email notification to view your results on our testing portal if you test negative. A negative result indicates the virus was not detected in the sample you provided. However, tests may not detect the virus in early stage infections or poor quality nasal swab samples. If you were exposed to COVID-19 but tested negative, follow up with a healthcare provider for further evaluation.
- Incoclusive Results
It is possible for your test results to be inconclusive. This can happen for a variety of reasons. A licensed physician will contact you for further evaluation.
Mesa Biotech Accula RDT(Raid Diagnostic Test)
Senneca Dx has selected the Mesa Accula Rapid Diagnostic Test for use in patient care setting based on its low LoD compared to other RDT systems. The Mesa Accula System has received FDA Emergency Use Authorization. This test provides qualitative, rapid PCR-based test results within ~ 30 minutes.
*This test is only for use under the Food and Drug Administration’s Emergency Use Authorization. This laboratory-developed test has been validated in accordance with CLIA and FDA’s Guidance Document (Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency Immediately in Effect Guidance for Clinical Laboratories, Commercial Manufacturers, and Food and Drug Administration Staff Document). This test service has not been FDA cleared or approved.
More Information: Patients | Healthcare Providers
PCR (Polymerase Chain Reaction) is the gold standard for SARS CoV-2 diagnostic virology and the most accurate laboratory method for detecting the SARS-CoV-2 virus. [1] Performance of these assays is dependent on the amount and quality of template RNA purified from human nasal matrix specimens.
The LOD of this test is 150 copies/mL, a low value for a RDT. This test targets the nucleocapsid protein (N) gene and the result is determined by visual readout of a lateral flow component.
[1] Gandhi, R.T., Lynch, J.B., & del Rio, C. (2020). Mild or Moderate Covid-19., 1757-1766. DOI: 10.1056/NEJMcp2009249
Thirty (30) contrived positive samples and 30 negative samples were tested with the Accula SARS-CoV-2 Test to assess clinical performance. Samples were contrived by spiking a known concentration of extracted SARS-CoV-2 viral genomic RNA into uninfected nasal matrix.
Clinical Evaluation Results
- 30/30 contrived positive specimens tested positive for SARS-CoV-2, no false negative results
- 30/30 negative specimens tested negative for SARS-CoV-2, no false positives
- 100% Positive Percent Agreement
- 100% Negative Percent Agreement
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.
