Who should use Phylagen SurfaceTM?What will the test tell me?How does Phylagen SurfaceTM work?How will I receive the results?Is the test safe?
Who should use Phylagen SurfaceTM?
Phylagen SurfaceTM is for anyone who wants to know whether SARS-CoV-2 is present in their facilities and use that information to protect people from COVID-19. From offices and universities preparing to reopen, to distribution centers and elder care facilities working to operate through the pandemic safely, Phylagen SurfaceTM is for organizations who want to understand if cleaning and disinfection is removing the virus, or where the virus is present in order to take additional operational and safety precautions.
For example, Phylagen SurfaceTM can be used to:
- Prepare to reopen a closed office, campus, facility or store
- Detect COVID-19 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 case
- Assess the safety of operations specific to particular businesses
- Foster employee and customer confidence
Can Phylagen SurfaceTM be used on human subjects?
- No. Phylagen SurfaceTM was not designed to test humans and therefore has not been evaluated or approved by the FDA for human subjects.
Can I use Phylagen SurfaceTM 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 Phylagen SurfaceTM to determine whether 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 Phylagen SurfaceTM to determine whether my cleaning is effective?
- Phylagen SurfaceTM 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?
Phylagen SurfaceTM will identify the presence or absence of SARS-CoV-2 virus on sampled surfaces. When using Phylagen SurfaceTM you will track where you have sampled to help you make decisions to keep your customers, clients and community safe once you receive your results.
What kinds of results have other organizations had?
- Test results indicated areas that appear to be cleaned effectively, where the virus was present before cleaning and absent after cleaning.
- Test results identified hard to reach spots (e.g. at the top of a vending machine) that 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 does Phylagen SurfaceTM work?
Phylagen SurfaceTM for SARS-CoV-2 incorporates CDC designed assays into Phylagen’s pre-existing and proven technology platform for characterizing DNA and RNA on surfaces. The CDC assays are DNA sequences that have been shown to uniquely identify SARS-CoV-2 with high sensitivity and specificity. More information about the technology behind Phylagen SurfaceTM is available in our validation whitepaper.
What does the swabbing/testing look like and involve?
- Phylagen SurfaceTM is simple to use and anyone can be quickly trained to perform it.
- Briefly, you 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.
- Our Phylagen SurfaceTM smartphone app (for iPhone or Android) guides you through the process of recording basic data (e.g. location, surface type), reading a barcode on the tube, and taking a photo to allow you to map the results back to a specific location.
- 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 control for false negatives/positives.
- 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 must be positive for the control virus in order to be called “not detected”. Samples that are negative for both viruses are “undetermined.”
Can the virus be present but not “active” on surfaces?
- Our test identifies SARS-CoV-2 virus; however it does not specifically differentiate potentially infectious “active” from inactive virus.
- Our test is designed to collect thousands of copies of SARS-CoV-2 on every swab. If the result of a test is positive, we believe there is a low probability that the sample would have been 100% inactive at the time of sampling.
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.
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.
How will I receive the results?
- Once the samples arrive at our lab, your results will be available through our secure web portal, likely within 24 hours. Just navigate to where you purchased your kits, log in with your account information, and you’ll see your results.
Is the test safe?
Am I at risk by collecting surface samples with Phylagen’s kit?
- In the event that SARS-CoV-2 is present in the environment, being in that specific environment clearly carries some risk. A person collecting surface samples who is wearing gloves (provided in the kit) and 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?
- The wetting solution completely inactivates the virus. The return packaging is designed to minimize any risk of spillage.
- 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.
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?
- This is a solution used to protect the DNA and RNA from degradation.
- Liquids contained in 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?
- Phylagen SurfaceTM kits expire 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 at Phylagen rather than use a courier. Please contact email@example.com to arrange a drop-off.