How does PhylagenTM COVID-19 / Influenza A+B Indoor Test work?
The Indoor Test Kit incorporates CDC designed analyses into Phylagen’s pre-existing and proven technology platform for characterizing DNA and RNA on surfaces. The CDC analyses are DNA sequences that have been shown to uniquely identify SARS-CoV-2 and Influenza A+B with high sensitivity and specificity. More information about the technology is available in our validation whitepaper.
What does the swabbing/testing look like and involve?
- The PhylagenTM COVID-19 and Influenza A+B Indoor Test Kit is simple to use and anyone can be quickly trained to perform it.
- You briefly dip each swab in a solution, swab it across a surface, deposit it into a plastic tube, and ship it back to our lab using the provided materials for evaluation.
- You will receive the results through a secure web portal.
If I don’t want to collect the samples, can I get someone from Phylagen to take samples?
- Please contact us and we can refer you to our preferred sampling partners.
Do you control for false negatives and false positives?
- Yes. We do control for false positives/negatives.
- False positives are controlled by including negative controls (blank samples) in each batch of samples tested.
- False negatives are controlled for by adding a different viable RNA virus to every sample once the samples arrive in our lab. Samples negative for SARS-CoV-2 and/or Influenza A+B must be positive for the control virus in order to be called “not detected”. Samples that are negative for both viruses are deemed “undetermined.”
Can the virus be present but not “active” on surfaces?
- Yes. Our test is designed to collect thousands of copies of SARS-CoV-2 and/or Influenza A+B on every swab. If the result of a test is positive, there is a chance that the sample is not “active”. However, we believe there is a low probability that the sample would have been 100% inactive at the time of sampling. This is because the more recently the virus was deposited on a surface, the more likely it is to still be active.
Does the indoor test detect live virus?
- Yes. However, our test does not specifically differentiate potentially infectious (“active”) from inactive. Rather, it detects the presence of intact SARS-CoV-2 and/or Influenza A+B.
- Tests capable of making this differentiation require several days to perform and are typically used only for research purposes.
- In other words, our test determines if viral DNA/RNA was present or not in your sample- meaning it will also detect DNA/RNA fragments of the virus (e.g. viruses that have had their outer protein coats destroyed)
- For concerns regarding live virus, it is important to note that contaminated surfaces present less of a risk compared to infected people. Therefore, positives indicate that a person brought that virus into the space and the more often you test, the more meaningful positive results will be.
Approximately how long can the virus be on a surface and still be detectable with a swab?
- Peer-reviewed scientific research has shown that SARS-CoV-2 can remain active on a variety of surfaces for up to 3 days.
- According to the CDC, the flu virus can remain active on some surfaces for up to 2 days.
- How long the virus can continue to be detected on a surface (after it is no longer active) varies significantly with many factors including, how much was originally there, sunlight exposure, and temperature/humidity.
Do disinfectants render it undetectable, as well as non-viable?
- Disinfectants render the virus non-viable, however, do not render them undetectable. In order to render the virus undetectable, a cleaning agent with an oxidizer included is necessary. This is most commonly bleach.
- More frequent testing over time can help you answer high order questions about when the virus was introduced to your space. For example, a negative test yesterday and positive test today from the same location will inform you the virus came in within the last 24 hours.
How have you tested the accuracy of your results?
- We have performed several validation experiments to establish the test accuracy and limit of detection as described in a white paper available on our website.
- On December 18th, 2020 the globally recognized AOAC Research Institute announced that our COVID-19 Indoor Test was certified to detect SARS-CoV-2 on stainless steel surfaces. This certification doesn’t include our Influenza A+B assays.
What is the surface area limit?
- We recommend a 1 foot x 1 foot area as the maximum allowed area sampled per swab. The collection efficiency experiments were conducted on a 10cm x 10cm area.
Is the test safe?
- Yes. We provide detailed instructions on how/where to sample and are also able to guide you through completing the entire process, in the safest way possible, when you contact us
Am I at risk by collecting surface samples with Phylagen’s kit?
- In the event that SARS-CoV-2 and/or Influenza A+B is present in the environment, being in that specific environment clearly carries some risk. A person collecting surface samples who is wearing a mask, and who is following the instructions, should not incur a risk greater than simply being present in the environment.
Is it safe to return the samples through the mail?
- Yes. The wetting solution completely inactivates the virus. The return packaging is designed to minimize any risk of spillage.
- Additionally, our lab is a certified biosafety level two (BSL-2) laboratory equipped to handle agents associated with certain human diseases (i.e. pathogenic or infectious organisms), including SARS-CoV-2 and Influenza A+B.
Do I need to keep the test kit refrigerated/ Do I need to keep the samples cold during shipment?
- No. The test kit and the samples are stable at typical ambient temperatures.
What is the wetting solution and should I be concerned about rubbing it on surfaces in my building?
- The wetting solution is used to protect the DNA and RNA from degradation.
- You shouldn’t be concerned about rubbing it on surfaces in your building as the liquids contained in our Test Kit are non-toxic.
- If liquids come into contact with skin or eyes, rinse the affected area with water.
Can I ship the samples in a different package than the one provided?
- No. The packaging was designed to prevent spillage. Please contact Phylagen if the return package is damaged.
Does the kit have an expiration date?
- Yes. Our Indoor Test kit expireS 6 months from the date of purchase. Phylagen will not process samples from expired kits.
- Return labels included inside the kit expire after 90 days. In the event that you need to return samples from kits between 90 and 180 days after purchase, please contact firstname.lastname@example.org and specify the address and date where you would like the sample to be picked up. Phylagen will schedule a courier pick up. The courier will bring a label and sleeve, so you don’t need to do anything else.
- If you are in the San Francisco Bay Area and would like to expedite obtaining your results you can prearrange to drop the samples off at Phylagen rather than using a courier. Please contact email@example.com to arrange a drop-off.
Who should use the COVID-19/ Influenza A+B Indoor Test?
The PhylagenTM COVID-19 Indoor Test Kit is for anyone who wants to know if SARS-CoV-2 is present in their facilities and use that information to protect people from COVID-19.
The PhylagenTM COVID-19/ Influenza A+B Indoor Test Kit is for anyone who wants to know if SARS-CoV-2 and/or the flu (strain A, B, or both) is present in their facilities and use that information to protect people from the virus.
From offices and universities preparing to reopen, to distribution centers and assisted living facilities working to operate through the pandemic safely, both Indoor Test Kits are for organizations who want to understand what is circulating in there and if there is an infected person, unknowingly shedding the virus, in order to take additional operational and safety precautions.
For example, the PhylagenTM COVID-19/ Influenza A+B Indoor Test Kit can be used to:
- Prepare to reopen a closed office, campus, facility or store
- Detect COVID-19 or flu outbreaks quickly through surface testing, even if cases are pre-symptomatic or asymptomatic
- Evaluate cleaning protocols (including cleaning team performance)
- Ensure safety and confidence to return following a known COVID-19 or flu case
- Assess the safety of operations specific to particular businesses
- Foster employee and customer confidence
Can the PhylagenTM COVID-19/ Influenza A+B Indoor Test Kit be used on human subjects?
- No. The indoor test was not designed to test humans and therefore has not been evaluated or approved by the FDA for human subjects.
Can I use the PhylagenTM Indoor Test Kit to determine whether people are infected?
- Indirectly, yes. Organizations are using the test to determine whether employees or others have introduced the virus into their facilities. This test can complement other monitoring protocols (e.g. temperature checks) to help maintain a healthy environment.
Can I use the PhylagenTM Indoor Test Kit to determine whether or not I can resume operations?
- As stated in the OSHA Guidance on Preparing Workplaces for COVID-19, employers should identify risk levels in workplace settings. This test, used as a monitoring tool, could identify areas and job tasks with potential exposure to COVID-19 to support other efforts to prevent outbreaks in your organization. As you resume operations, these test results can help you to adjust the level and type of operations to maintain safety.
Can I use the PhylagenTM Indoor Test Kit to determine whether or not my cleaning is effective?
- Yes. The PhylagenTM Indoor Test Kit can be used to monitor cleaning and disinfecting practices by sampling before and after the cleaning protocol is performed.
- Even if you are using EPA-approved disinfectants, not following the instructions correctly may result in ineffective disinfection outcomes, discoverable only by testing.
What will the test tell me?
The PhylagenTM COVID-19 Indoor Test Kit will identify the presence or absence of SARS-CoV-2 virus on sampled surfaces. When using the PhylagenTM COVID-19 Indoor Test Kit, you will track where you have sampled to help in making certain decisions to keep your customers, clients and community safe once you receive your results.
The PhylagenTM COVID 19/ Influenza A+B Indoor Test Kit will identify the presence or absence of COVID-19 and/or Influenza (strain A, B or both) virus on sampled surfaces.
What kinds of results have other organizations had?
- Test results have indicated areas that appear to be cleaned effectively, weren’t so clean after all, because the virus was present. Conversely, results have also indicated that areas, where the virus was present before cleaning, were able to return a “not detected” result after heightened cleaning efforts.
- Test results identified hard to reach spots (e.g. at the top of a vending machine) tested positive for presence of the virus, indicating that aerosolized virus is being dispersed within the building by diffusion and air turbulence.
- Test results indicated areas that persons who recently tested positive for COVID-19 had frequently touched or come into repeated contact with.
- Test results distinguished between otherwise identical environments, where one was occupied by a person infected with SARS-CoV-2 and the other was not.
Can I apply these learnings to other facilities within my organization?
- Yes. The learnings about cleaning protocols and the general locations where the virus is likely to be present are applicable to other similar facilities.
- Phylagen recommends gathering baseline surface data from new environments compared to customer’s facilities that are already being routinely tested (e.g. in facilities with differing activities, cleaning protocols, occupancy loads, and climates).
Will Phylagen recommend a monitoring strategy based on the sample data?
- Yes. We can help develop a test plan that will suit your organization and facility. For example, we recommend repeating test points after a positive identification of the virus to ensure that the virus has been successfully disinfected.
How do I tell what the viral load is?
- At this time, we do not disclose what the viral load is. The PhylagenTM COVID-19/ Influenza A+B Indoor Test Kit will identify the presence or absence of SARS-CoV-2 and/ or Influenza A+B virus on sampled surfaces.
How long does the process take?
- The amount of time the actual swabbing process will take depends on the kit size purchased and how many samples you are taking.
- You will receive your online results within 24 hours of us receiving your samples.
How will I receive the results?
- Phylagen provides fast, data-driven results within 24 hours of samples arriving to the lab, excluding weekends. Samples received over the weekend will be processed on Monday. Results will be uploaded and ready to view on your personal account through our secure web portal.
What do I do with positive or negative results?
- Negative samples reassure that your people are virus-free; positive samples reveal someone is infected so you can take action to stop a spreading event.
- Use the location of a positive sample to identify the subset of individuals who might be infected.
- Implement your protocol to stop potential spread accordingly, such as isolating or targeted human diagnostic testing.