Fast & reliable COVID-19 testing


We are a CLIA certified and CAP accredited lab specializing in high complexity diagnostic testing in and out of the lab. On May 13, 2020, our SARS-COV-2 test received Emergency Use Authorization (EUA) from the FDA.

Learn more about One Health Lab's SARS-CoV-2 PCR Test

Our SARS-CoV-2 PCR Test


The lack of access to fast, accurate testing is a major challenge to effectively responding to the COVID-19 pandemic. Our test will help detect the presence or absence of SARS-CoV-2 RNA in under 80 minutes.

Workplace Screening


Unlike traditional labs, our solution is truly mobile. We can set up and run tests virtually anywhere. We understand that delivering samples to a lab for analysis and waiting days for results is not always practical.

COVID-19 Overflow Testing


Do you need to send off some of your laboratory testing to keep up with increasing demand and fulfill the needs of your patients, physicians, or clients? We can likely help as an independent reference lab.

Validation Assistance Program


One Health Labs has developed a SARS-CoV-2 Validation Assistance Program to alleviate the stress of implementing our test in your clinical lab. Labs must have CLIA high complexity license in order to particpate.

Get Started


One Health Labs offers this test with an FDA Emergency Use Authorization (EUA). This test has only been authorized for the detection of nucleic acid from SARS-CoV-2 and not for any other virus or pathogen. Please see the Patient Fact Sheet and the Health Care Provider Fact Sheet for additional information.

Thanks for reaching out!


We appreciate you contacting us about our COVID-19 testing. One of our team members will be getting back to you shortly.

While we do our best to respond quickly, it may take up to 24 hours to receive a response during peak hours.

Thanks in advance for your patience. Have a great day!

HIPAA Notice of Privacy Practices

(This Notice of Privacy Practices is effective as of 12/05/2019)

THIS NOTICE DESCRIBES HOW MEDICAL INFORMATION ABOUT YOU MAY BE USED AND DISCLOSED AND HOW YOU CAN GET ACCESS TO THIS INFORMATION. PLEASE REVIEW IT CAREFULLY.


One Health Laboratories (“OHL”) is a full-service, clinical reference laboratory serving clients and their patients. At OHL, we pledge to give you the highest quality health care and to have a relationship with you built on trust. This trust includes our commitment to respect the privacy and confidentiality of a patient’s protected health information, or PHI. Your PHI is information about you, including demographic information, that can be used to identify you and that relates to your past, present or future physical or mental health or condition or the provision of health care services to you. The PHI that OHL typically processes begins with the personal identifying and medical history information (such as your name, address, date of birth, test ordered, test result, etc.) that we obtain from your physician, health plan or other sources. In addition to safeguarding that patient data, we are also committed to protecting the confidentiality of an individual’s new PHI as generated by OHL, such as the laboratory test results that we collect, create, or communicate as part of our diagnostic testing activities completed on your behalf.

Our Obligations

OHL is committed to gathering, processing, maintaining, and disclosing PHI only in a manner that is fully in compliance with all applicable local, state and federal laws and regulations seeking to protect patient confidentiality. OHL is and shall be in compliance with all applicable federal, state and local laws and regulations regarding the use and disclosure of PHI.

Under the federal Health Insurance Portability and Accountability Act of 1986 (“HIPAA”) and its regulations related to patient privacy (the “Privacy Rule”), OHL is required to provide you with this Notice of Privacy Practices (“NOTICE”) to inform you, the patient, ahead of time about: how OHL will work with your PHI, OHL’s legal duties related to your PHI, and your own rights with respect to your PHI. OHL is also required to abide by the terms of the NOTICE currently in effect. Your other health care provider(s) may have different notices regarding the use and disclosure of your PHI maintained by them.

OHL reserves the right to change the terms of this notice, in which case, the new revised notice will be available upon request or on our website. We urge you to read this NOTICE carefully so that you will understand our commitment to the privacy and protection of your confidential health care information, and learn how you can involve yourself in the protection of this information.

If you have any questions about this NOTICE you can write us at the following address:

One Health Laboratories, LLC
1015 Chestnut Street, STE 1401
Philadelphia, PA 19107
Attn: Compliance Officer
215-515-3342

Permissible Uses and Disclosures of Your PHI that OHL Can Make Without Your Authorization

Your PHI will be used or disclosed for treatment, payment, or healthcare operations purposes related to the care provided to you and for other purposes as permitted or required by law. While we cannot list every possible use or disclosure, all of the ways we may use or disclose your PHI without your authorization will fall into one of the categories listed below.

If we want or need to use or disclose your PHI for purposes that do not fall into these general categories, we will first have to obtain your written authorization. In the event you have issued us an authorization, you have the right to withdraw your authorization in writing at any time, except if we have relied on the authorization before you inform us of your withdrawal.

OHL does not need your authorization of permission to use or disclose your PHI for the following purposes:

  1. Treatment: OHL, as a health care provider that provides physicians with clinical laboratory testing for their patients, uses the PHI it receives from your physicians as part of its testing processes (to identify and enter your specimens and tests into our system). Additionally, after completing the testing, OHL reports your results, as new PHI, back to your physicians and/or other authorized health care professionals who are treating you based on those results. In addition to your treating physician, we may provide your PHI to a consulting specialist physician. In those instances, because we are not local to you and your physician, we will need to confirm this type of request, so we will ask that you forward us an authorization from your physician’s office, informing us of your desired disclosure to a specialist. We may also disclose your PHI to another testing laboratory if we are unable to perform the testing ourselves and need to refer your specimen to that laboratory to perform the requested testing.

  2. Payment: Our OHL billing department will use and disclose your PHI to the insurance companies, health plans, hospitals, and other providers for any necessary payment purposes. For example; we will send your name, date of service, test performed, diagnosis code, and other information to the health plan you are a member of so that the plan will pay us for the services we have provided you. This right of use extends to third parties/agencies we may need to use to assist us in collecting payment for our services.

  3. Health Care Operations: Your PHI will be used in the course of activities required to support OHL’s health care operations, such as tracking our utilization of resources, detecting fraud, reviewing our billing and claims processing efficiencies, or for performing quality checks on our information systems. This information will be used internally in an effort to continually improve the quality and effectiveness of the healthcare services we provide. We may also disclose your PHI to other health care providers or payers for their health care operations, but only if they already have a relationship with you and only if the purpose is for quality assurance activities, peer review activities, detecting fraud, or for other limited purposes.

  4. Disclosures to Business Associates: OHL may disclose your PHI to other companies or individuals who need your PHI in order to provide specific services to us. Because these entities are not normally providing services related to the type of what we are providing you, they are called “Business Associates”. They must comply with the specific terms of a contract, or “Business Associate Agreement”, designed to ensure that they will use and maintain the privacy and security of your PHI in the same manner that we do. Additionally, in compliance with the Privacy Rule and its own policies, OHL will make every effort possible to ensure that whatever disclosure is made of your PHI, it will be limited to that which is minimum necessary for the support services to be provided. For example, your PHI may be disclosed to couriers we use to transport specimens to us. We will only provide the couriers with just the piece of PHI they need to perform their services.

OHL may also use or disclose your PHI without your authorization for the following purposes, as permitted or required by law:

  1. When required by law: in order to comply with federal or state laws, the order of the court, or the orders of a governmental agency.

  2. Public health: to public health authorities for preventing or controlling disease, injury, or disability, such as reporting vital, or communicable or sexually transmitted disease information.

  3. Health oversight activities: to health oversight agency for oversight activities authorized by law (for example as part of mandated laboratory inspection of our facilities by state regulators).

  4. Judicial and administrative proceedings: to courts, parties to a lawsuit or government agencies as may be required during the course of a judicial or administrative proceeding.

  5. Law enforcement: to law enforcement officials relating to crimes and other law enforcement purposes.

  6. Coroners/ Medical Examiners: to coroners, medical examiners, or funeral directors for the purpose of identification or determining the cause of death or for other duties authorized by law.

  7. Cadaveric organ, eye, or tissue donation purposes: to organizations regarding organ, eye or tissue donation at death.

  8. Research: to researchers when the individual’s waiver or alteration of authorization and the researcher’s proposed research and established research protocols have been approved by either an institutional review board or a privacy board to ensure the privacy of PHI.

  9. Threat to health or safety: consistent with law, to prevent a serious threat to personal health or safety to others (an agency’s investigation of a physician’s license).

  10. Specialized government functions: to military command authorities, veterans’ administration, and national security and intelligence officials for activities deemed necessary to carry out their respective missions, or to law enforcement officials having custody of an inmate.

  11. Workers compensation: to the extent authorized by and to the extent necessary to comply with laws relating to workers’ compensation or similar programs.

Your Rights Concerning the Privacy and Confidentiality of Your PHI

1. Access:

You have the right to look at, and get a copy of, your PHI. You must ask for this in writing. We will respond within thirty (30) days from receipt of your request. If your request is denied, we must explain the reasons why in writing and tell you what rights you have. If we do not have the information you seek but we do know where it is, we must inform you of that.

2. Changes:

  • You have the right to ask us to change your PHI related to your treatment and bills if you think there has been a mistake or that information is missing.

  • You must make your request in writing and give the reason for the request.

  • OHL has sixty (60) days to respond to the request.

  • If we are unable to act on the request within the 60 days, we will notify you that we are extending the response time by 30 days.

  • If we extend the response time, we will explain the delay to you in writing and give you a new date of when to expect a response.

  • We may deny your request.

  • If we deny your request, we must give you a written statement with the reasons for your denial and what other steps are available to you.

  • If we grant your request, we will ask you to tell us the persons you want to receive the changes. You need to agree to have us notify them along with any other who received the previous information before the changes were made, and who may have relied on that information to treat you.

3. Accounting:

You have the right to get a record of the times your health information has been shared. You must make your request in writing. You may request this as far back as six years. The listing you get will include the date, name, and address (if known) of the person or organization receiving your information. It will also include a brief explanation of the information given and the reasons for the disclosure. The following exceptions apply:

  • sharing your PHI for the purposes of treatment, payment or health care operations

  • sharing your PHI if you gave permission in writing (signed an authorization form)

  • sharing your information in our data systems

  • sharing your information with persons involved in your care

  • sharing your information to communicate with you about your health condition

OHL has sixty (60) days to respond to the request. If we are unable to act on the request within the 60 days, we will notify you that we are extending the response time by 30 days. If we extend the response time, we will explain the delay to you in writing and give you a new date of when to expect a response. Your first request for a record in any 12-month period is free. Subsequent requests will be at a cost. We will notify you of the fee before we do the work so that you may stop the request if you do not wish to pay the fee.

4. Restrictions:

You have the right to ask for restrictions on the uses of your health information for treatment, payment or health care operations. OHL is not required to agree to your request. You may not ask us to restrict uses and disclosures that we are legally required to make.

5. Confidential Communications:

You have the right to request how and where OHL is to send your PHI or communicate with you regarding any PHI, including billing information. It is your responsibility to provide us with contact information we can use to contact you. We may ask that you put your request in writing, but we do not have the right to ask you the reason for this.

6. Notice of Privacy Practices:

You have the right to receive a paper copy of this NOTICE upon request, even if you previously agreed to receive this NOTICE electronically.

How to exercise your rights

To exercise any of your privacy rights, please write to us at the address at the beginning of this NOTICE with your specific written request. Be sure to include sufficient information for us to identify all of your records. For additional details, or for instructions regarding how to exercise these rights, please contact us.

How to file a complaint

If you believe your privacy rights have been violated, you have the right to register a complaint with OHL , the Office for Civil Rights, U.S. Department of Health & Human Services, 26 Federal Plaza – Suite 3313, New York, NY 10278, (212) 264-3313 (TEL), (212) 264-2355 (TDD), (212) 264-3039 (FAX) , or e-mail your complaint to OCRComplaint@hhs.gov. OHL will not retaliate against any individual for filing a complaint. You may file a complaint by writing to us at the address at the beginning of this NOTICE.

One Health Labs SARS-CoV-2 Real-Time RT-PCR Test

The One Health Labs SARS-CoV-2 Real-Time RT-PCR Test is a molecular in vitro diagnostic test that aids in the detection and diagnosis of SARS-CoV-2 and is based on widely used nucleic acid amplification technology. It is only for use under the Emergency Use Authorization (EUA) and with the prescription of a licensed healthcare provider (see Test Requisition Form).


What's measured?

Our test detects two different SARS-CoV-2 genes and is multiplexed together with an RNA Process Control for RNA extraction and RT-PCR in 0.1 mL low-profile, thin-walled, optically clear 3-well strips. Each reaction well of the 3-well strip already contains lyophilized master mix, enzymes, and multiplexed primers/probes for the following triplex reaction:

  • Orf1ab - Open reading frame 1ab gene

  • S - Spike gene

  • RPC - RNA Process Control


What's the collection method?

It is intended for qualitative detection of nucleic acid from SARS-CoV-2 in upper respiratory specimens (nasal, mid-turbinate, nasopharyngeal, and oropharyngeal swab specimens, and nasopharyngeal wash/aspirate or nasal aspirate specimens) collected from individuals suspected of COVID-19.


When are results available?

It's dependent on the number of samples being tested, but results are typically available in under 80 minutes and they are incredibly easy to interpret.


Who should be tested?

  1. Patients with symptoms of potential COVID-19 infection, including: fever, cough, shortness of breath, chills, muscle pain, new loss of taste or smell, vomiting or diarrhea, and/or sore throat.

  2. Patients without symptoms who are prioritized by health departments or clinicians, for any reason, including but not limited to: public health monitoring, sentinel surveillance, or screening of other asymptomatic individuals.

For additional information on who should be tested, please visit the CDC's page for Evaluating and Testing Persons for Coronavirus Disease 2019 (COVID-19).

Sensitivity

Our Limit of Detection (LoD) studies determined the lowest detectable concentration of viral genomic RNA for both ORF1ab and S targets. The LoD study was done using the Biomeme Platform including M1 Sample Prep Cartridges for RNA, SARS-CoV-2 Go-Strips (with RNA Process Control), and their Franklin three9 Real-Time PCR Thermocycler.

Final limit of detection:

VirusMaterialLoD¹
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)Genomic RNA1.8

¹ Concentration is presented in genome equivalent per uL


Clinical Evaluation

The performance of our SARS-CoV-2 Real-Time RT-PCR Test was evaluated using contrived clinical samples. A total of 60 contrived positive samples were prepared for testing by spiking individual negative clinical nasopharyngeal swab (NP) specimen matrix with known concentrations (various multiples of LoD) of genomic RNA from SARS-Related Coronavirus 2, solate USA-WSA1/2020 (BEI NR-522285, Lot: 70033320, Mftg Date: 11FEB2020).

RNA Concentration (relative to LoD)RNA Concentration (GE/uL)Number of PositivesOrf1ab¹
1x1.839/40²34.7533.51
2x3.610/1033.1931.14
3x5.45/533.4632.36
4x7.23/330.9629.71
5x92/231.2430.05
Negative030/30N/AN/A

¹ Mean Ct
² Samples prepared at 1x LoD are the same as those tested in the LoD confirmation

PPA at 1-2X = 97.5% (87.1%-99.6%)
PPA at 3-5X = 100% (72.5-100%)
NPA= 100% (88.65-100%)

To further evaluate the performance of the device with real patient samples, an additional 30 SARS-CoV-2 positive and 30 SARS-CoV-2 negative samples were tested with the One Health Labs SARS-CoV-2 Real-Time RT-PCR Test and a comparator method. All 60 samples produced concordant results.

Questions? Send us an email at hello@onehealthlabs.com.

Additional Resources

ResourceLink
Letter Granting Inclusion Under EUAView/Download
EUA SummaryView/Download
Healthcare Provider Fact SheetView/Download
Patient Fact SheetView/Download
Test Requisition FormView/Download

Workplace Screening

The most unique part of our COVID-19 testing solution in comparison to others is that it's completely mobile if you want it to be. Our entire testing platform, including a day's worth of testing kits, fits into a small backpack and does not require electricity. This leaves you with a couple of options:

  1. We set up everything needed to screen your personnel, residents, patients, or others, at or near, your workplace.

  2. Or, if you have a nurse or doctor on-site, you can collect your own samples and send them to our lab here in Philadelphia for processing.

Bottom line - we are, and will continue to be, flexible during these unprecedented times.

Step 1

Symptoms Check

In an effort to reserve tests for the people with the highest need, a healthcare provider will start by reviewing patient symptoms and risk factors to determine if they should be tested.


Step 2

Order Test

A Test Requisition Form will be submitted by the healthcare provider for those experiencing symptoms of COVID-19 such as fever, cough or shortness of breath or for those who may have been exposed to COVID-19.


Step 3

Sample Collection

Collection for our SARS-CoV-2 test is primarily done using nasopharyngeal swabs, but we will work with you to determine the best sample type for your team. Depending on your location and preference, we can either come to you or you may send samples to us for processing.


Step 4

Detection

One Health Labs uses Polymerase Chain Reaction (RT-PCR) technology to detect the presence or absence of RNA from the SARS-CoV-2 virus in
about 80 minutes to ensure everyone remains safe.


Step 5

Results

On-site testing results are available the same day. All other results are typically available within 24 hours of receipt of a specimen (depending on volume). To keep things simple yet secure, results can be delivered by fax or encrypted email. Should you require an alternative method, let us know and we will work to meet your needs.


The One Health Labs SARS-CoV-2 Real-Time RT-PCR Test is only for use under the Food and Drug Administration's Emergency Use Authorization (EUA).

Who should be tested?

  1. Patients with symptoms of potential COVID-19 infection, including: fever, cough, shortness of breath, chills, muscle pain, new loss of taste or smell, vomiting or diarrhea, and/or sore throat.

  2. Patients without symptoms who are prioritized by health departments or clinicians, for any reason, including but not limited to: public health monitoring, sentinel surveillance, or screening of other asymptomatic individuals.

For additional information on who should be tested, please visit the CDC's page for Evaluating and Testing Persons for Coronavirus Disease 2019 (COVID-19).


For Providers & Labs

One Health Laboratories, LLC is a CLIA certified clinical laboratory specializing in high complexity molecular diagnostic testing. Through highly sensitive qPCR testing, One Health Labs provides results to clinicians and their patients in about 24 hours to assist in the detection, diagnosis, and treatment of infectious diseases.

To assist with the overwhelming demand, we are currently offering molecular diagnostic testing of respiratory specimens for COVID-19 infection using our SARS-CoV-2 Real-Time RT-PCR Test. This test is only for use under the Food and Drug Administration's Emergency Use Authorization (EUA).

If you are interested in partnering with us, please send an email to hello@onehealthlabs.com.

Specimen Collection & Labeling

Only one nasopharyngeal swab specimen is needed for COVID-19 testing and specimens should be collected as soon as possible regardless of the time of symptom onset.

  • All labels must include at least two patient-specific identifiers (e.g. patient name, date of birth, collection date & time, external accession ID if applicable).

  • Specimens should be labeled in a way that minimizes the risk of the specimen being separated from the label. So, label the specimen container and not the lid.

  • Specimens are stable at room temperature for up to 48 hours. However, the best recovery is obtained when specimens are refrigerated at 2-8°C or kept on wet ice following collection and while in transit.

  • All samples must be accompanied with a completed One Health Labs Test Requisition Form. Complete all required sections highlighted in yellow and the test must be ordered by a licensed physician.


Specimen Packaging

We will supply you with packaging materials to be used before placing your specimen(s) in your One Health Labs Lockbox or sending them directly to our lab for processing.

  1. Insert an absorbant pad into the biohazard bag.

  2. Insert your labeled collection tube into the biohazard bag.

  3. Be sure to include the Test Requisition Form for each specimen in the front pocket of the biohazard bag.

  4. Place bubble wrap in the bottom of the provided box. Then, place up to 6 samples in the box. Finish by placing another sheet of bubble wrap on top.

  5. Place the specimen(s) into your One Health Labs Lockbox for courier pick up or ship directly to our lab at 1015 Chestnut Street, Suite 1401 in Philadelphia, PA 19107.

Turnaround Times

Our current turnaround time for SARS-CoV-2 testing is typically less than 24 hours from the time the specimen arrives at our lab in Philadelphia, PA. Please note that this is subject to change based on testing volumes and resource availability.


Results

To keep things secure yet simple, One Health Labs will report positive and negative test results via fax and/or encrypted email. Should you require an alternative method, just let us know and we will work to meet your needs.


Additional Resources

ResourceLink
Letter Granting Inclusion Under EUAView/Download
EUA SummaryView/Download
Healthcare Provider Fact SheetView/Download
Patient Fact SheetView/Download
Test Requisition FormView/Download

The One Health Labs Validation Assistance Program

Access to our SARS-CoV-2 test is not just limited to One Health Labs. During these unprecedented times, we understand how critical it is that we implement and scale COVID-19 testing solutions wherever we can. Via our Validation Assistance Program, we provide CLIA high complexity labs with the tools and resources necessary to quickly get up and running use our SARS-CoV-2 test in their own lab(s).


What's included?

Our Validation Assistance Package includes the following resources to support validation:

  • Validation Plan Template

  • One Health Laboratories SARs-CoV-2 Instructions For Use

  • Biomeme SARS-CoV-2 Playbook

  • Biomeme In-Silico Inclusivity/Exclusivity Data

  • Consultation with a One Health Labs Technical Supervisor


Getting started

To learn more about our Validation Assistance Program or to request a quote, please send an email to hello@onehealthlabs.com.


Careers At One Health Labs

One Health Labs, LLC is a CLIA certified laboratory specializing in high complexity diagnostic testing and we are hiring!


Current Openings (1)

Laboratory Administrative Assistant


Job Summary

This opening is for a Laboratory Administrative Assistant. In this position you are are responsible for assisting with the various clerical tasks required with receiving, processing, reporting, and delivering laboratory test results and other lab reports as they are completed in this department. Exceptional communication skills, attention to detail, professionalism and work ethic, along with the ability to identify opportunities for departmental improvement are key components of this role. This individual must be diligent and able to pick up concepts quickly. The ideal candidate will be able to handle unexpected situations and exercise independent thought, but also promote an environment in which the Laboratory staff can work together cooperatively toward objectives. This position will report directly to the Laboratory Manager.


REQUIREMENTS

  • 2+ years of direct experience preferred

  • Ability to manage logistics of all aspects of laboratory test orders, from sample receipt to result delivery

  • Demonstrates exceptional customer service


Skills

  • Strong communication skills

  • Comfortable with ambiguity and complexity

  • Ability to excel in a fast-paced, start-up environment

  • Attention to detail and ability to multitask

  • Have good communication via phone and email

  • Computer proficiency and documentation skills


Responsibilities

  • Responsible for the accurate processing of patient specimens including receipt and data entry into the Laboratory Information Management System (LIMS)

  • Ensure proper and complete patient identification on requisitions and specimens

  • Appropriately label and prepare specimens for laboratory analysis

  • Performs clerical duties necessary to process specimens including, but not limited to scanning and filing paperwork

  • Determine specimen suitability for analysis and resolve any discrepancies or issues while processing specimens

  • Data entry between laboratory systems

  • Reports final test results to authorized persons, including state health agency

  • Files and/or retrieves lab copies of patient test reports in cabinet files and/or LIMS

  • Maintain confidentiality of all patient and laboratory information

  • Work closely with lab staff to ensure timely processing of specimens

  • Other duties will include answering the phone, processing orders and assisting the laboratory manager

  • Makes pertinent observations in regard to department needs and offers suggestions

  • Billing/invoicing experience a plus


Apply

To be considered for this position, please complete the following application: Laboratory Administrative Assistant