Frequently Asked Questions

 

 

 

About the Product

What is the swab made of?

The ORAcollect·RNA (ORE-100/ORE-100.025) sponge/foam tip is made from reticulated polyurethane foam and the stick is molded polypropylene. The foam is attached to the stick by heat-staking; no adhesives are used. The plastic components of the ORAcollect·RNA (ORE-100/ORE-100.025) kit are either polypropylene or polyethylene. The kits are manufactured in clean factory conditions and assembled and packaged in a controlled clean area either by robotics or appropriately trained, gowned, masked and gloved personnel. Additionally, manufacturing occurs in a latex-free environment and the sponges are latex free (i.e. no latex-containing products are manufactured in the same space and assembly workers wear latex-free gloves).

The ORE-100 kits are not sterilized or treated after production. The manufacturing factory complies with ISO13485:2015 Quality management system ensuring cleanroom management and general facility cleaning is audited regularly through and Internal Audit Program.

The components of the ORE-100 kit/swab are considered non-toxic. That being said, it does not preclude specific individuals from reacting to it if they have a particular sensitivity or allergy to polyurethane or polypropylene plastics. Biocompatibility testing of the ORAcollect swab has classified the device as a non-sensitizer, as defined by the classification system of the USP (United States Pharmacopeia). The ORAcollect swab also meets the requirements of ISO 10993-5 and 10993-10, where the device did not cause in vitro cytotoxicity, irritation or skin sensitization.

A full list of materials can be found here. 

Has the kit been exposed to Ethylene Oxide?

Ethylene Oxide is NOT contained in or used in the manufacturing process for the swabs (ORE-100) or spit (OME-505) collection devices. The swabs are NOT sterilized with Ethylene Oxide, and Ethylene Oxide is NOT present anywhere in the manufacturing process.

What is the liquid solution in the collection device?

The liquid solution is for the stabilization of RNA.  The solution contains sodium dodecyl sulphate, glycine, N, N’- trans-1, 2-cyclohexanediylbis[N-(carboxymethyl)-, hydrate, and lithium chloride.

Is the solution hazardous?

This material is not considered hazardous by OSHA Hazard Communication Standard (29 CFR 1910.1200).  There are no additional ingredients present which, within the current knowledge of the supplier and in the concentrations applicable, are classified as hazardous to health or the environment and hence require reporting.

Is the solution on the swab?

No, the swab comes in a dry, sealed package. The swab applicator does not come in contact with the solution in the collection device until the swab is removed, inverted and sealed into the solution after the sample is collected.

How is the swab sterilized?

OMNIgene•ORAL (OME-505 spit collector) and ORAcollect (ORE-100 swab collector) kits are manufactured in clean factory conditions, and assembled and packaged in a controlled clean area either by robotics or appropriately trained, gowned, masked and gloved personnel. However, the kits are not sterilized or treated after production. The manufacturing factory complies with ISO13485:2015 Quality management system ensuring cleanroom management and general facility cleaning is audited regularly through an Internal Audit Program.

Testing/Results

I only want diagnostic testing not pool testing – what is your test?

While the Clarifi COVID-19 assay used the pooled testing technique, all patient results are individual diagnostic results. If you have further questions or concerns as it relates to the Pooled Testing methodology, please speak with your Organization Manager/Covid Testing Coordinator who will be able provide additional details.

What are the performance characteristics of this surveillance testing?

The test kit we are using has been successful in identifying as few as 1 infected person in every 12 pooled samples.



Where are the test instructions for use?

For the ORE-100 (swab) and OME-505 (spit) : Clarifi COVID-19 Saliva Test Manual

Is there separate testing for symptomatic patients? Can we test symptomatic people?

The same oral swabs used for non symptomatic testing can also be used for symptomatic patients. When registering the test, answering "yes" to "does this patient have any symptoms" will automatically flag the lab for them to be reflexed and not pooled. We ask that if you would like to do symptomatic testing, that you do not place these tests in the same bag as the non-symptomatic tests.

I have been vaccinated. Why do I need to be tested?

According to guidance by the CDC, if you are fully vaccinated and have come in contact with a known exposure or someone with suspected or confirmed COVID-19, you should be tested within 3-5 days of the exposure. 
https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/testing.html

Is there anyone who should not be tested?

The swab used to collect the saliva sample for the Clarifi COVID-19 test is made of polyurethane foam, and if you are allergic to polyurethane, you should not use the Clarifi COVID-19 swab. You can contact Quadrant for an alternative collection device.

My result says Presumed Negative - what does that mean?

A “presumed negative” result is the terminology used to describe a negative outcome from a pooled test.  

A “reflex negative” result is the terminology used to describe a negative result from a test on a single sample (the sample was originally processed in a pool that was presumed positive).

My result says Reflex Positive - what does that mean?

A “reflex positive” result is the terminology used to describe a positive result from a test on a single sample (the sample was originally processed in a pool that was presumed positive) and now has been identified as a positive result.

What is a reflex test?

This is a Clinical Laboratory term that describes an automatic (reflex) follow up based on the result of another test. In the case of our pooled testing program, if there is a positive pool we automatically or reflex all samples to an individual test.

Do we need to collect another sample for the reflex test?

No, there is enough liquid left in the collection device after pooling to process those samples on an individual basis.

Storage/Shipping

How long do collection kits last?

The collection kits have a shelf life of 1 year from the date of manufacture. Kits are marked with an expiration date. Once the collection kit is “activated” by replacing the swab back into the collection tube, we can extract RNA from the sample for up to 6 days.

What are the storage guidelines?

The kits, both before and after collection, should be stored at room temperature (15-25 C or 59-77 F). Avoid extreme temperatures, and extended exposure to UV light until ready for use.

Where should deliveries be made? Who can I contact for more information about our specimen deliveries?

For the Buffalo Lab: Delivery should be made to Farber Hall 301 on the University at Buffalo South Campus (3435 Main Street, Buffalo NY)

When the laboratory is closed, deliveries may be made to the Farber Hall mail room (Room 224A) on the second floor. The mail room is checked for deliveries daily. Parking is available in the Farber Hall lot. 

Any questions should be addressed to Lab Manager Mike Wendel at 716-335-5660

For the Syracuse Lab: Delivery should be made through the rear building entrance (accessible through the garage entrance facing Madison St.) Free parking is provided in the garage for up to 30 minutes. 

The campuses should contact Sarah Gentile via email at Sarah.Gentile@Quadrantbiosciences.com or by phone/text at 315-575-3784.

What are the operating hours for the lab?

Buffalo Lab: Monday - Friday: 7:00am - 9:00pm; Saturday: 9:00am- 6:00pm; Sunday: 9:00am-5:00pm

Syracuse Lab: Monday-Friday: 7:00 am- 8:00pm; Saturday: 8:00am- 6:00 pm; Sunday: 8:00am-5:00pm

How to get started

How do I enroll in pooled testing for my organization?

If you do not already have an account set up, please contact sales@quadrantbiosciences.com to start the process. Our sales team will review contract details with you, and get you everything you need to move forward with testing.

What information do I need to provide to participate in the pooled testing program with Quadrant Biosciences?

Testing plan:  A Testing Plan will need to be filled out that includes details such as the start date of your testing, how many individuals will you be testing, and how often will you test? During this step you will assign your school’s organization managers.  

Be sure to list your school or organization exactly how you want it identified on the registration app.. Example: Chittenango CSD - Bolivar Elementary OR SUNY Upstate Unit 3

Standing order: A Standing Order needs to be signed by an MD, NP or PA authorizing the results of the tests to be released to the patient and the assigned organization manager(s).

Why do you need a standing order?

A standing order is required for the reflex testing (not pooled testing) to comply with NYS and CLIA regulations. We also need a valid NPI number to bill many insurances. The standing order needs to be time limited, so we have set an end date to the end of the calendar year or June 30th. The ordering physician has a responsibility to ensure that a patient receives proper follow-up for a positive result, because both the school and County Health Department will also be notified and will follow up with the patient. This responsibility is mitigated from a practical perspective.

How do I get testing supplies?
Your initial order will be based on your testing plan. Once the plan has been submitted there are several ways to receive your supplies:  1) you can provide your UPS account number and we can ship them ground, 2) we can add them to our UPS account and bill you for shipping or 3) supplies can be picked up at our Syracuse warehouse located at 6251 Fly Road, East Syracuse, NY 13057
What testing supplies are provided?
  • Barcoded collection devices (1 per person/per test)
  • Instructions on how to swab
  • Biohazard bags for return shipping (12 tubes per bag)
What do I need to provide?
  • Personnel at each site to collect samples
  • PPE, including gloves, fluid masks, disinfecting wipes  and hand sanitizer for personnel collecting samples
  • Sample collection area to include computer, scanner with USB port (optional)
I am having trouble registering my account or resetting my password?

Once the registration or reset process is started you will receive an email with a verification code. The code expires within 60 minutes, if the verification code expires you’ll have to send a new verification code. 

If you have forgotten your password you can reset it here:

https://app.clarifi-covid-19.com/forgot-password

Can a profile be deleted?

Due to legal constraints, Quadrant Biosciences is not authorized to delete any patient profile.  Quadrant is obligated to maintain these records for a minimum of 7 years before these records are destroyed. 

For Schools

How can students/faculty/staff register for Clarifi COVID-19 Testing at our school?

Anyone who participates in the surveillance testing should register at: app.clarifi-covid-19.com 

Under “Organization” be sure to let parents know to register under your school's name exactly as it is listed in your testing plan.

What do students/faculty/staff need to bring with them the day of testing?

Anyone being tested must have created a profile in the registration app.

Those being tested should be instructed NOT to eat or drink anything (with the exception of water), including chewing gum, mints or lozenges, tobacco or smokeless tobacco products, within 30 minutes of reporting to the collection site.

Mouthwash and toothpaste should NOT be used within an hour of testing.

How do we setup on test collection day?

Testing can be set up in two ways:

  • Designated testing area such as a gym or auditorium, with collection station(s).
  • Mobile room-to-room collection station

Click here for a quick video overview.

What should we have at our collection station?

Each collection station should be equipped with hand sanitizer, computer, scanner with USB adapter (optional), gloves, pens and a waste receptacle.

Quadrant Biosciences will provide you with collection devices and biohazard bags.

How do I know when test results are ready?

Individuals: Once your saliva test has been processed, you will receive an email notification that results are ready to review in your account at Clarifi-Covid-19.com. 

Organization Managers:  Once all tests for your organization are processed, anyone listed as an Organization Manager on your testing plan will receive an email notification that results are ready to review.

This email will come from no-reply@mail.clarifi-covid-19.com

How do I view my results?

Log into https://app.clarifi-covid-19.com/login to view your results. Results will be available on the home screen when you log in; if you have multiple profiles under your account (e.g., spouse and child), select the intended profile to view results.

My school will be delivering the pooled saliva specimens to Quadrant Biosciences. How late will Quadrant Biosciences receive samples?

For the Buffalo Lab: Quadrant Biosciences can receive samples from 7 am until 8 pm at the Farber Hall 301 on the University at Buffalo South Campus, 3435 Main Street, Buffalo, NY 14214.

For the Syracuse Lab: Quadrant Biosciences can receive samples from 8 am until 7 pm at the Institute for Human Performance, 505 Irving Ave., Syracuse, NY 13210.

What is the cost to students/employees?

There is no cost to students or employees for either the pooled testing or individual reflex tests. Some insurance carriers may attempt to bill copays or deductibles, this is in violation of the Families First Coronavirus Response Act (Attachment-PLAW-116bubl127) Section 6001 and the CARES Act Section 3202 (Attachment PLAW-116bubl136).

What about insurance?

Insurance does not cover pooled testing, so your school is covering the costs of pooled testing through government funded grants.  It does cover the individual reflex testing. The rationale is that the person is in a positive pool if they were potentially exposed to an individual with COVID. Reflex tests are submitted to insurance, insurance carriers should cover the cost of testing through the government funded, Cares Act.  If for some reason the claim is denied, the insured will NOT be billed.

What if the student does not have insurance?

In that case, the student can select “No Insurance” in the Insurance Section of the registration application and “NA” in the remaining insurance fields.

Can a school have fewer than 12 students per pool? If yes, will there be a different cost/student?

Saliva samples should be grouped into pools of 12 wherever possible. If on occasion it is not feasible to have a pool of 12 samples, you may create a pool with as few as 6 samples. Quadrant based the price that it is offering this testing at on most pools containing 12 samples. There may be an additional charge if there is a significant number of pools with fewer than 12 samples to cover Quadrant’s increased costs in performing the testing. In no event should you create a pool of more than 12 samples.

What reporting will each participating school receive?

 Following our laboratory processes, Quadrant Biosciences will report back to the campuses the following information:

  • Results of all Students/Faculty/Staff who participated in the surveillance testing (including  Last Name, First Name, and DOB); regardless of negative or positive result. Results are available in the web application. 
  • Results are also reported to the Health Department through ECLRS.
Who interprets my test results?

Beyond reporting results and issuing corrections to results reported in the app, Quadrant Biosciences is not legally permitted to personally discuss results with the patient. If a patient has any questions or concerns, they will need to address those concerns with their campus Organization Manger or the Healthcare Provider who signed off on the  organization's standing order.  Please note that in the instance where a previously issued result has been corrected, the Organization Manager will be advised of the samples and patients that were affected with the expectation that they will communicate these corrections to the patients, but Quadrant Biosciences will not contact patients directly to inform them of these corrected results. 

How can parent/guardian opt out of testing or revoke consent?

A number of organizations have opted to utilize their own consent forms in addition to the consent included on the app. Parents should not contact Quadrant Biosciences to revoke the consent given on the school level. They should contact their child's school organization to revoke that consent, when possible, so that their child is excluded from the school's testing program. While there is a consent statement in the creation of the patient profile, we are unable to 'revoke' that consent due to the constraints laid out in the above paragraph.

What are the quarantine requirements?

Quadrant Biosciences does not prescribe the protocol relating to positive cases. Therefore, we can not and will not advise patients or Organization Managers as to how they should create and employ protocol when a positive case occurs, nor do we possess the authority to put a patient into or release a patient from quarantine/isolation.

The school is responsible for creating a quarantine protocol.

For Organizations

How can employees register for Clarifi COVID-19 Testing at our organization?

Anyone who participates in the surveillance testing should register at: app.clarifi-covid-19.com 

Under “Organization” be sure to let employees know to register under your organization's name exactly as it is listed in your testing plan.

What do employees need to bring with them the day of testing?

Anyone being tested must have created a profile in the registration app.

Those being tested should be instructed NOT to eat or drink anything (with the exception of water), including chewing gum, mints or lozenges, tobacco or smokeless tobacco products, within 30 minutes of reporting to the collection site.

Mouthwash and toothpaste should NOT be used within an hour of testing.

How do we set up on test collection day?

Testing can be set up in two ways:

  • Designated testing area such as a lobby, break room or meeting room, with a collection station(s).
  • Direct collection at an employee’s work station.

Click here for a quick video overview.

What should we have at our collection station?

Each collection station should be equipped with hand sanitizer, computer, scanner with USB adapter (optional), gloves, pens and a waste receptacle.

Quadrant Biosciences will provide you with collection devices and biohazard bags.

How do I know when test results are ready?

Individuals: Once your saliva test has been processed, you will receive an email notification that results are ready to review in your account at Clarifi-Covid-19.com. 

Organization Managers:  Once all tests for your organization are processed, anyone listed as an Organization Manager on your testing plan will receive an email notification that results are ready to review.

This email will come from no-reply@mail.clarifi-covid-19.com

How do I view my results?

Log into https://app.clarifi-covid-19.com/login to view your results. Results will be available on the home screen when you log in; if you have multiple profiles under your account (e.g., spouse and child), select the intended profile to view results.

My organization will be delivering the pooled saliva specimens to Quadrant Biosciences. How late will Quadrant Biosciences receive samples?

For the Buffalo Lab: Quadrant Biosciences can receive samples from 7 am until 8 pm at the Farber Hall 301 on the University at Buffalo South Campus, 3435 Main Street, Buffalo, NY 14214.

For the Syracuse Lab: Quadrant Biosciences can receive samples from 8 am until 7 pm at the Institute for Human Performance, 505 Irving Ave., Syracuse, NY 13210.

What is the cost to employees?

Please refer to your organization manager as same organizations are covering the costs and others are employee paid testing.

What about insurance?

Insurance does not cover pooled testing. It does cover the individual reflex testing if you're in a positive pool. The rationale is that the person is in a positive pool if they were potentially exposed to an individual with COVID. Reflex tests are submitted to insurance, insurance carriers should cover the cost of testing through the government funded, Cares Act.

I have received a positive test – how long do I need to quarantine for, when can I go to work?

Please refer to your organizations guidelines on quarantine protocols, each county has custom guidelines tailored to their community transmission levels.

Can an organization have fewer than 12 employees per pool? If yes, will there be a different cost/employee?

Saliva samples should be grouped into pools of 12 wherever possible. If on occasion it is not feasible to have a pool of 12 samples, you may create a pool with as few as 6 samples. Quadrant based the price that it is offering this testing at on most pools containing 12 samples. There may be an additional charge if there is a significant number of pools with fewer than 12 samples to cover Quadrant’s increased costs in performing the testing. In no event should you create a pool of more than 12 samples.

What reporting will each participating organization receive?

Following our laboratory processes, Quadrant Biosciences will report back to the campuses the following information:

  • Results of all employees who participated in the surveillance testing (including  Last Name, First Name, and DOB); regardless of negative or positive result. Results are available in the web application. 
  • Results are also reported to the Health Department through ECLRS.
Who interprets my test results?

Beyond reporting results and issuing corrections to results reported in the app, Quadrant Biosciences is not legally permitted to personally discuss results with the patient. If a patient has any questions or concerns, they will need to address those concerns with their organization's Organization Manager or the Healthcare Provider who signed off on the  organization's standing order.  Please note that in the instance where a previously issued result has been corrected, the Organization Manager will be advised of the samples and patients that were affected with the expectation that they will communicate these corrections to the patients, but Quadrant Biosciences will not contact patients directly to inform them of these corrected results. 

What are the quarantine requirements?

Quadrant Biosciences does not prescribe the protocol relating to positive cases. Therefore, we can not and will not advise patients or Organization Managers as to how they should create and employ protocol when a positive case occurs, nor do we possess the authority to put a patient into or release a patient from quarantine/isolation.

For Organization Managers

Why don’t I have organization manager access yet?

In order to be granted organization manager access you will first need to register your email address to the website app.clarifi-covid-19.com. Once you have completed this process, please have your covid testing administrator request you be granted access by sending an email to covid-support@quadrantbiosciences.com providing your Name, Email and Organization that you should be granted access. Once this request is received our Tech team will provide confirmation once your profile has been updated. After receiving this confirmation, please sign out of the app and sign back in. You will be able to confirm you have been granted this access by clicking ‘User Roles’ in the top right corner of the web page and selecting ‘Organization Manager.

Where do I find a list of people who have registered a profile with my organization?

To locate a list of patients who have registered a profile, please sign into your Organization Manager dashboard on app.clarifi-covid-19.com. When you are on your OM dashboard you will see three tabs below ‘Organization Manager’ click ‘Profile Search’ In the search filters located on the left side of your screen choose your organization in the ‘Search for your Organization’ field and click the blue ‘Search’ button. The results will populate on the page to the right of the search fields. You can create an excel version of your patient search by clicking ‘Export CSV’ located on the bottom right side of the search result field.

Do you have any information on how to handle exceptions?

Please refer to the Exception section of the Clarifi Testing Manual for instructions on how to correct exceptions. If you require further assistance please reach out to Peter Rasmussen peter.rasmussen@quadrantbiosciences.com.

I was notified of an exception – I logged in and there was no exception – why?

If your organization has more than 1 person with Organization Manager access, first consult with them to see if these exceptions were corrected prior to you signing into the app. If that is not the case, our Lab team may have realized a sample was added to the exception list in error and has proceeded to remove that sample from your exception list.

Do you have a recommended label and label template I can use to make labels?
  1. We recommend using 1”x1.5” Printable Rectangle Labels. While we do not have any templates to create these labels, organizations have found success by exporting the patient profile list found under the ‘Patient Search’ tab on your Organization Manger Dashboard and using that file to print patient’s names and DOB. Please keep in mind when printing labels to follow the following syntax of patient information 

Name: First Name Last Name DOB: MM/DD/YY