Content on this page has been derived from a variety of resources including, but not limited to, the Centers for Disease Control and Prevention, the Food and Drug Administration, the Centers for Medicare & Medicaid Services, and the U.S. Department of Health and Human Services. This content is subject to change as more information becomes available on the COVID-19 pandemic. Due to the frequency of changes amidst the pandemic, this information should be compared to the latest recommendations from those agencies providing guidance on this topic.
Molecular (Diagnostic) Testing:
Can you provide specifics regarding the SARS-CoV-2 molecular diagnostic test provided by Aegis Sciences Corporation?
- Testing Method: Real Time Reverse-Transcriptase Polymerase Chain Reaction (Real Time RT-PCR).
- Aegis currently utilizes a molecular real-time RT-PCR assay manufactured by Thermo Fisher Scientific, Inc. known as the TaqPath COVID-19 Combo Kit, which is used in accordance with the manufacturer's EUA authorization.
- Aegis' in-house verification of the performance of the aforementioned assay demonstrated
- Limit of detection: 0.4 copies of virus/microliter (µl) of sample
- >98% concordance of results with known positive and negative clinical samples
- Specimen Collection: Nasopharyngeal, oropharyngeal, nasal mid-turbinate, anterior nares, and saliva specimens to be collected in accordance with the guidance provided by the Centers for Disease Control and Prevention (CDC). Collection devices that are provided by Aegis are in alignment with those recommended for collection by the CDC. Transport of specimens after collection in viral transport media is required for assurance of specimen stability for up to 14 days at room temperature. For more information on PrimeStore® MTM stability please visit: PrimeStore® MTM. Pre-analytical stability studies demonstrated specimen stability at a range of temperatures during transit.
- Viral Transport Media: PrimeStore® MTM
- Cost: $100 per test (same for all CPT codes)
- Coding: U0003
How do I decide if a patient needs to be tested for COVID-19?
- According to the CDC’s “Interim Guidelines for Collecting, Handling, and Testing Clinical Specimens for COVID-19”:
- All testing for SARS-CoV-2 should be conducted in consultation with a healthcare provider. Specimens should be collected as soon as possible once a decision has been made to pursue testing, regardless of the time of symptom onset.
- The CDC’s “Overview of Testing for SARS-CoV-2 (COVID-19)” provides extensive information regarding various testing methods that are currently available and scenarios in which testing should be utilized. Determination of need for testing is categorized based on symptoms, exposure, risk for community spread, residence, workplace, and prior health conditions.
- According to the CDC, “People with COVID-19 have had a wide range of symptoms reported – ranging from mild symptoms to severe illness. Symptoms may appear 2-14 days after exposure to the virus. People with these symptoms may have COVID-19:
- Fever or chills
- Shortness of breath or difficulty breathing
- Muscle or body aches
- New loss of taste or smell
- Sore throat
- Congestion or runny nose
- Nausea or vomiting
Which providers have the capability to order COVID-19 diagnostic testing?
- The CDC recommends that all testing for SARS-CoV-2 be conducted in consultation with a healthcare provider.
- The Centers for Medicare and Medicaid Services (CMS) has issued guidance on temporary flexibilities afforded to providers and facilities in fighting COVID-19. Physician extenders may have increased ordering capabilities. Supervisory guidelines may be altered, including for resident trainees. Telehealth opportunities are also increased. Physicians and extenders should consult their local state boards to ensure that any COVID-19-related practice initiatives align with state law and the provider's scope of practice.
Has there been any guidance regarding the "best" time for a molecular test to diagnose a patient with SARS-CoV-2?
- At this time, guidance varies regarding the most appropriate time to test patients. Although we are still awaiting larger clinical trials to gain greater understanding of the virus, some preliminary evidence is available. An overview of this information has been provided by the Sanford Guide online.
- Mean incubation time is estimated to be ~5 days after exposure (range 4.1 - 7.0 days, but as short as 36 hours or as long as 14 days). Transmission can occur from an infected person who is asymptomatic (prior to onset of symptoms), although transmission is likely more efficient once symptoms develop.
- Viral loads collected in patients with SARS-CoV-2 were highest in the early symptomatic period, declining slowly and remained detectable into the second or third week after onset of illness, despite resolution of symptoms.
- Seroconversion, or detection of antibodies, was not followed by a rapid decline in viral RNA. Thus, it would be possible for a patient with detectable antibodies present to still cause viral transmission.
Do I need to wear personal protective equipment (PPE) while collecting a patient's specimen?
How will Aegis be reporting results?
Results will be reported as "positive", "negative", or "indeterminate." If a result is reported as indeterminate, then it has undergone two rounds of testing, and neither positive or negative results were reportable.
I collected a sample for a patient, and the results were negative. What does that mean?
- According to the CDC, a negative test for COVID-19 by a viral test means that the individual was not infected at the time the sample was collected. However, this does not mean that the individual will not get sick. The test results only means that the individual did not have COVID-19 at the time of testing.
- Proper collection of specimens is the most important step in the laboratory diagnosis of infectious diseases. A specimen that is not collected correctly may lead to false negative test results. Additional information from the CDC regarding specimen collection is available here.
Can you provide specifics regarding the SARS-CoV-2 + Flu A/B combination tests?
Who is indicated for the combination COVID-19/Flu test?
- Symptomatic patients who show signs/symptoms of either SARS-CoV-2 or Influenza A/B. This is a provider judgment. See the requisition form for specific ICD-10 codes, such as “J22-Unspecified acute lower respiratory infection.”
What testing platform are we using for the combination test?
- TaqMan SARS-CoV-2, Flu, A, Flu B Multiplex Assay. Specimens can be collected using nasopharyngeal, oropharyngeal, nasal mid-turbinate, and anterior nares specimens. Stability of these specimens is 7 days at room temperature.
What if my provider mistakenly checks COVID-19 ONLY testing, can we add-on Flu testing?
- No. Providers must select the combination test to have Flu testing included. This is also true if no test is requested, only COVID-19 testing will be performed--no add-on for Flu.
Can providers order only Flu testing?
- No. Providers must order the combination test if they want an individual to be tested for Flu A and Flu B.
What are the molecular targets for SARS-CoV-2 with the combination test?
- N and S gene
Can test results be indeterminate for the combination test?
- Yes, if amplification is abnormal, the sample will be retested. If still abnormal, the results will be reported as indeterminate.
How is Flu different than COVID-19?
- Flu infection usually does not have the change or loss of taste/smell like COVID
- Thought that people will remain infectious longer with COVID-19 infection (up to 10 days vs. 5-7 with Flu)
- Symptoms from COVID-19 are thought to take longer to develop than Flu
What symptoms are similar for both Flu and COVID-19 infection?
- Muscle aches
Will Aegis provide instructions on how to collect and ship specimens?
- A comprehensive set of instructions have been developed for specimen collection and shipment. Contact Aegis with any questions on this process at 1-800-533-7052.
Are there any additional resources available on specimen collection?
Are Aegis personnel capable of collecting SARS-CoV-2 specimens?
- Aegis personnel are not able to collect specimens for SARS-CoV-2 diagnostic testing. At this time, the CDC recommends that specimens be collected either by a healthcare professional or under the supervision of a healthcare professional.
How long are COVID-19 diagnostic specimens stable after collection, and how should they be stored prior to shipment?
Aegis utilizes a transport media (PrimeStore MTM) to improve stability of COVID-19 diagnostic specimens while in transit. Our internal studies have demonstrated stability of viral specimens up to 14 days at room temperature in PrimeStore MTM. For more information on PrimeStore® MTM stability please visit: PrimeStore® MTM
Downstream effects of COVID-19 on your patients
Date and Time:
Length: 30 minutes
If you are a patient that had COVID-19 testing performed by Aegis Sciences click below to retrieve your results:
COVID-19 Fact Sheets
Aegis' COVID-19 Fact Sheets provides information for patients and providers regarding the risks and benefits of using Aegis' tests for COVID-19. For both providers and patients, the test used can be found in the "Sample Comments" section of the Laboratory Report.
Patient Fact Sheet
This Fact Sheet contains information to help you understand the risks and benefits of using this test for the diagnosis of COVID-19. After reading this Fact Sheet, if you have questions or would like to discuss the information provided, please talk to your healthcare provider.
Taq-Path™ COVID-19 Combo Kit : Download Patient Fact Sheet (English - Taq-Path)
TaqPath™ COVID-19, FluA, FluB Combo Kit: Download Patient Fact Sheet (English - Thermo Fisher)
This Fact Sheet informs you of the significant known and potential risks and benefits of the emergency use of the TaqPath™ COVID-19 Combo Kit.
Provider Fact Sheet
This Fact Sheet informs you of the significant known and potential risks and benefits of the emergency use of a Molecular Laboratory Developed Test (LDT) COVID-19 Authorized Test (Molecular LDT COVID-19 Authorized Test) that has been issued an Emergency Use Authorization (EUA) by FDA. The Molecular LDT COVID-19 Authorized Test is authorized for use on respiratory specimens collected from individuals suspected of COVID-19 by their healthcare provider.
Taq-Path™COVID-19 Combo Kit : Download Provider Fact Sheet (English - Taq-Path)
TaqPath™ COVID-19, FluA, FluB Combo Kit : Download Provider Fact Sheet (English Thermo Fisher)
Three Key Steps to Take While Waiting for your COVID-19 Test Result