Aperiomics’ Xplore-COVID-19™ Testing detects Coronavirus – SARS-CoV-2
Aperiomics and related services are performed to CLIA and GMP medical device quality standards by Aperiomics, Inc. and/or related partners. This test must be ordered and collected by a healthcare provider.
For up to date information on COVID-19, please refer to the CDC website.
Aperiomics’ Xplore-COVID-19™ PCR testing uses the same method as the CDC testing. Due to the high demand for testing, labs have experienced a shortage of most reagents needed for the CDC test.
Striving for same-day turnaround time when possible
$140 per sample
We now offer Medicare billing! Medicare patients pay nothing out of pocket for COVID-19 testing with Aperiomics. All other patients pay up front. We provide an invoice to patients for patient-submitted private insurance reimbursement.
To identify SARS-CoV-2 viral RNA
Required Collection Kit
Aperiomics Cough Swab Collection Kit
Per FDA regulations, the COVID-19 samples must be collected by a healthcare provider.
Sample Collection Details
Per FDA regulations, the COVID-19 samples must be collected by a healthcare provider. Aperiomics utilizes a cough throat swab sample collection. Once the cough swab sample is collected and put into the DNA/RNA Shield vial, all microorganisms on the swab are inactivated and no longer infectious. Our sample collection method stabilizes viral RNA for up to 30 days at ambient temperatures.
Current Capacity: up to 2,500 samples per week
COVID-19 virus nucleic acid is extracted from cough swab samples. Real-time reverse transcriptase PCR (RT-PCR) is performed by use of 1-step reverse transcription of RNA from the sample and then amplified by PCR. Internal positive and negative controls are included to ensure that each test performs correctly. The US Centers for Disease Control and Prevention (CDC) designed RT-PCR assays for the detection of 2019-nCoV. Our test uses the same primers and probes used in CDC assays and has comparable in sensitivity and specificity to CDC assays. Sensitivity is ~98% and specificity is ~99.9%.
Aperiomics has submitted an application for FDA EUA (for emergency use) for Xplore-COVID-19™ testing. The testing is only for the detection of RNA from COVID-19 virus and not for any other viruses or pathogens.
Is Xplore-COVID-19™ test the same as or similar to the CDC’s test?
Aperiomics’ Xplore-COVID-19™ PCR testing uses the same method as the CDC testing. Due to the high demand for testing, labs have experienced a shortage of most reagents needed for the CDC test. Aperiomics made some modifications because of these shortages to the extraction process. Sensitivity and specificity rates are as good or better than the CDC test
How is the sample preserved?
The cough swab is placed into a vial that contains DNA/RNA Shield. This DNA/RNA Shield stabilizes the sample for up to 30 days at ambient temperatures (vs the CDC collection requires cold storage) and deactivates the virus. The CDC sample collection method does not include the DNA/RNA Shield. Compared to CDC sample collection, Aperiomics’ sample collection method is more robust, stable, and NON-INFECTIOUS.
What does your test identify?
Aperiomics’ Xplore-COVID-19™ testing qualitatively detects Coronavirus – SARS-CoV-2. The testing method utilizes real-time reverse transcriptase PCR technology, which confirms the presence of the virus.
Does your test measure viral antibodies or viral load?
Our test is not an antibody test. Our test identifies the presence of virus in the sample received. It does not measure antibodies or viral load.
What is the sensitivity of your test?
Sensitivity (true positive rate) = ~98% (2.0% false negative rate)
What is the specificity of your test?
Specificity (true negative rate) = ~99.9% (0.1% false positive rate)
What is your turnaround time (TAT) for results?
Once the sample collection kit is received, the turnaround time (TAT) for results is within 24-72 hours. Current TAT is same day.
Who receives the results?
The clinician will receive an email with a secure link to their Aperiomics’ Clinician Portal. The clinician will then login to their secure Aperiomics’ Clinician Portal to download all patient reports. It is the clinician’s responsibility to relay the test results to the patient.
What is the cost of the test?
The cost of our testing is $145 per sample. Patients pay this up front and can get reimbursed from their insurance provider. CMS reimbursement rates are currently $143 per sample (as of 4/14/20).
Is this covered by insurance?
Yes, all insurance providers are required to provide coverage for COVID-19 testing. Patients will receive a superbill from Aperiomics that includes the necessary codes to file for reimbursement with their insurance providers.
How do you take the test?
Clinicians will use our Cough Swab Collection Kit to swab each patient’s throat. Detailed collection and shipping instructions will accompany each kit:
INSTRUCTIONS FOR SAMPLE COLLECTION
- Wash or sanitize hands.
- Do NOT eat or drink anything at least 30 minutes before collecting the sample.
- Cover mouth with tissue or mask and cough 5-10 times. Do NOT swallow before swabbing throat.
- Carefully remove swab from package and avoid touching swab tip against any surface.
- Insert swab into mouth, careful not to touch teeth or tongue, and swab back and sides of throat, rotating swab, for at least 10 seconds.
- Immediately remove swab, being careful not to touch swab tip against any surface.
- Open cap of collection tube and insert swab tip all the way into the solution. Snap the shaft at the breakpoint, leaving swab tip in collection tube, discard plastic swab handle.
- Cap tube TIGHTLY, ensuring swab tip is immersed in solution. Ensure tube is labeled with name and noted on Requisition Form properly. Stretch and wrap the parafilm wrapping film around cap of tube to seal the tube and to prevent sample loss.
INSTRUCTIONS FOR SHIPMENT
- Ensure tube is tightly closed and sealed with parafilm wrapping film.
- Place specimen(s) into zippered biohazard bag with absorbent paper and seal
- Place FULLY completed Requisition Form into outer pocket of biohazard bag.
- Place frozen cold pack in bubble pouch.
- Place bagged specimen(s) into bubble pouch and seal.
- Place pouch into pre-addressed, pre-paid UPS Laboratory Pak, seal and UPS.
- Samples do not require refrigeration and can be shipped any day of the week, including weekends.
Are your COVID-19 sample collection kits in-stock and ready to ship?
Yes, our sample collection kits are in-stock and ready to ship.
How soon will sample collection kits ship out and arrive?
Orders received by 3 pm Eastern will ship out that day and will arrive the next day via UPS Next Day Air.
Who can order the testing?
Only clinicians may order the Xplore-COVID-19™ testing. The FDA has announced that “at home” self-collection for COVID-19 nasopharyngeal/throat swabs are not allowed. Cough throat swab collection must be administered by a healthcare provider.
Can you ship collections kits directly to patients?
No, Xplore-COVID-19™ sample collection kits can only be shipped to clinicians. With the current FDA guidelines regarding sample collection, we will not drop-ship directly to patients.
COVID-19 viral nucleic acid is extracted from cough throat swab samples. Real-time reverse transcriptase PCR (RT-PCR) is performed by use of 1-step reverse transcription of RNA from the sample and then amplified by PCR. Internal positive and negative controls are included to ensure that each test performs correctly. The US Centers for Disease Control and Prevention (CDC) designed RT-PCR assays for the detection of 2019-nCoV. Our test uses the same primers and probes used in CDC assays and has comparable in sensitivity and specificity to CDC assays. Sensitivity is ~98% and specificity is ~99.9%. This test is recommended by the FDA only under the current EUA (for emergency use) guidance, unless the authorization is terminated or revoked sooner. Aperiomics has submitted an application for FDA EUA (for emergency use) for Xplore-COVID-19™ testing. The testing is only for the detection of RNA from COVID-19 virus and not for any other viruses or pathogens.
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