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About the Product

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.

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.

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.

The ORAcollect·RNA (ORE-100) stabilization chemistry is considered a non-toxic solution and has a toxicity similar to that of toothpaste or mouthwash. If solution is accidentally ingested, medical attention is not required unless symptoms occur. Additionally, 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.

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.

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.

By virtue of our position as a CLIA/CLEP clinical laboratory and healthcare provider operating under the Health Insurance Portability and Accountability Act (HIPAA), your saliva specimen and your data are very well protected under both federal and state laws.  Here's some detailed information about our processes:
Your saliva specimen will be processed in our clinical laboratory which operates pursuant to a Clinical Laboratory Evaluation Program (CLEP) permit issued by the New York State Department of Health; we further comply with the federal standards promulgated under the Clinical Laboratory Improvement Amendments (CLIA).  By federal and New York State law, our clinical laboratory is precluded from using a patient’s personal information to perform any clinical tests other than those tests ordered by an appropriately credentialed clinician (such as an MD or a PA).  In this case, our use of a patient’s personal information to perform clinical testing is strictly limited to (i) determining if the patient specimen contains measurable quantities of the SARS-CoV-2 virus, and (ii) if the patient specimen is "positive" for SARS-CoV-2, determining the phylogenetic classification of the virus.
As a licensed CLIA/CLEP laboratory, we are required by federal law to retain your information and the results of your clinical test for a period of six years.  Regardless, your data and clinical results are very well protected by Quadrant: our policies and procedures are designed to strictly adhere to the 5 main HIPAA rules:
  • HIPAA Privacy Rule (45 CFR §164.530) - The Privacy Rule protects the Personal Health Information (PHI) and medical records of individuals. It places limits and conditions on the various uses and disclosures that can and cannot be made without patient authorization.
  • HIPAA Security Rule (45 CFR §164.308) - The security rule defines and regulates the standards, methods, and procedures related to the protection of electronic PHI on storage, accessibility, and transmission.  There are three safeguard levels of security:
    • Administrative safeguards deal with the assignment of a HIPAA security compliance team
    • Technical safeguards deal with the encryption and authentication methods used to have control over data access
    • Physical safeguards deal with the protection of any electronic system, data, or equipment within your facility and organization. The risk analysis and risk management protocols for hardware, software, and transmission fall under this rule.
  • Transactions Rule - This rule deals with the transactions and code sets used in HIPAA transactions, including: ICD-9,ICD-10, HCPCS, CPT-3, CPT-4 and NDC codes. Correct use of these codes ensures the safety, accuracy, and security of medical records and PHI.
  • Identifiers Rule – HIPAA uses three unique identifiers for covered entities who use HIPAA-regulated administrative and financial transactions. These identifiers are:
    • National Provider Identifier (NPI): a 10-digit number used for covered healthcare providers in every HIPAA administrative and financial transaction
    • National Health Plan Identifier (NHI): an identifier used to identify health plans and payers under the Center for Medicare & Medicaid Services (CMS)
    • Standard Unique Employer Identifier: identifies an employer entity in HIPAA transactions and is considered the same as the federal Employer Identification Number (EIN).
  • Enforcement Rule – Derived from the ARRA HITECH ACT provisions for violations that occurred before, on, or after the February 18, 2015 compliance date, this rule expands those under HIPAA Privacy and Security. It increases the penalties for any violations. The enforcement rule addresses five main areas in regards to covered entities (such as Quadrant) and business associates:
    • Application of HIPAA security and privacy requirements.
    • Establishment of mandatory federal privacy and security breach reporting requirements.
    • Creation of new privacy requirements and accounting disclosure requirements, and restrictions on sales and marketing.
    • Establishment of new criminal and civil penalties and enforcement methods for HIPAA non-compliance.
    • A stipulation that all new security requirements must be included in all Business Associate contracts.

Testing / Results

While the Clarifi COVID-19 assay uses 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.

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

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

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.

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

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.

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.

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

Storage / Shipping

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.

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.

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 [email protected] or by phone/text at 315-575-3784.

Summer hours in effect starting May 31, 2022:

Syracuse Lab: Monday - Friday 7:00 am-6:00 pm, Saturday 7:00 am-5:00 pm, Closed Sunday

How to get started

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

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).

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.

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

  • Barcoded collection devices (1 per person/per test)
  • Instructions on how to swab
  • Biohazard bags for return shipping (12 tubes per bag)

  • 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)

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

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.

Insurance companies are obligated to provide coverage of this COVID-19 diagnostic testing, without co-pay or cost sharing to the patient.

Health Resources and Services Administration (HRSA), an arm of the federal government, has established a fund so that people who are uninsured can obtain COVID-19 diagnostic testing without any co-pay or cost-sharing to the patient.  Accordingly, even if you have no insurance, you are welcome to test with us.  That said, we do ask that you provide us with certain information so that we can confirm your lack of coverage for compliance with applicable federal laws.

If you would like more information about the HRSA uninsured program please visit https://www.hrsa.gov/coviduninsuredclaim/frequently-asked-questions.

For Schools

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.

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.

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.

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.

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 [email protected].com

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.

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.

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).

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.

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

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.

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.

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.

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.

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

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.

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.

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.

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.

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 [email protected]

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.

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.

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

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.

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

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.

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.

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.

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

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 [email protected] 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.

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.

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 [email protected]

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.

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).

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.

  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

Quadrant Laboratories