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Due to high demand and orders filling fast, inventory cannot be guaranteed beyond our initial purchase order.

*Test to be performed by the pharmacist at the pharmacy.

Coronavirus Rapid Test*

Physician 360 is using CoronaChek™ to aid in the diagnosis of novel coronavirus SARS-CoV-2 (COVID19). This test is a rapid serology test. It detects IgM and IgG antibodies against SARS-CoV-2 in the blood, which indicates that a person has been exposed to and developed antibodies against the virus. This blood test analyzes a small blood sample, from a finger stick, similar to when a Diabetic checks their blood sugar. In the blood, the test looks for antibodies to SARS-CoV-2.

This type of test will indicate whether or not a person has been exposed to SARS-CoV-2 and therefore developed antibodies against the virus. Serological testing is helpful in identifying large numbers of infected patients AND asymptomatic carriers (those who have been exposed but are not currently sick). This is helpful in many practical matters, such as risk stratification for returning to work and supporting containment efforts to slow the spread of the virus.

 

Patient Submits Purchase Authorization

Pharmacy Personnel Performs Test*

Results in 10-20 Minutes

Patient Completes Medical Questionnaire

Patient Receives Telemedicine Consultation

* Test must be administered by pharmacy personnel. It can not be self-administered and is not approved for home use.

ORDER NOW

Due to high demand and orders filling fast, inventory cannot be guaranteed beyond our initial purchase order.

Frequently Asked Questions

What kind of test is the CoronaChek™ Rapid Test?

Physician 360 is using CoronaChek to aid in the diagnosis of novel coronavirus SARS-CoV-2 (COVID19). This test is a rapid serology test. It detects IgM and IgG antibodies against COVID19 in the blood, which indicates that a person has been exposed to and developed antibodies against the virus. 

CoronChek is a blood test that analyzes a small blood sample, from a finger stick, similar to when a Diabetic checks their blood sugar. In the blood, CoronaChek looks for antibodies to COVID19.

Are there other types of tests for COVID19?

Yes, there is a molecular test. Using that test, a swab is placed into the nose of the patient and then it is sent to a laboratory. A process called polymerase chain reaction (PCR) is performed on machinery in the lab. This type of test is looking for the actual genetic material of the virus.  

What are the advantages of this type of test (CoronaChek™)?

This type of test will indicate whether or not a person has been exposed to COVID19 and therefore developed antibodies against the virus. Serological testing is helpful in identifying large numbers of infected patients AND asymptomatic carriers (those who have been exposed but are not currently sick). This is helpful in many practical matters like deciding who can return to work and school and supporting containment efforts to slow the spread of the virus.

What are the disadvantages of this type of test (CoronaChek™)?

Overall, the results may be less accurate than PCR tests. A patient’s body needs time to develop antibodies. CoronaChek may not detect an infection early on if antibodies haven’t been produced yet.

This is why it is so important that a medical professional needs to explain the results of the CoronaChek in the context of your exposure risk and your symptom time course.  

What is the process for the patient? Is there a screening?

To obtain the test, the patient will first have to complete an online intake questionnaire. A doctor or nurse practitioner will evaluate their answers, and if appropriate, will order the test. You will receive a fax confirmation of this.

At that time, a member of the pharmacy staff would perform the finger stick on the patient. While the test is processing, they would create an account and initiate their telemedicine consultation. During the consultation, the medical provider will review and interpret the results of the test, make recommendations about treatment and isolation and report the results to necessary public health authorities.

The main role of the pharmacy staff is to only administer the finger stick test on those patients you receive an order for.

What is the criteria for getting a prescription sent for the test? How would one be warranted?

Our medical providers assess appropriateness of prescriptions for the test after the patients answer a few basic questions related to: cough, fever, shortness of breath, chest discomfort, abdominal pain, diarrhea, tiredness, runny nose, or sore throat.

Is this going to put the pharmacy staff at risk when testing the patients?

Given the fact that completely asymptomatic people can still have coronavirus and be contagious, personal contact with anyone poses a risk. It is for this reason that we recommend proper personal protection equipment (PPE) as outlined by the CDC. Please refer to the CDC’s website for details about this: 

https://www.cdc.gov/coronavirus/2019-ncov/hcp/ppe-strategy/index.html

What prescriptions will your medical team write?

The providers will assess each individual patient before determining a treatment plan. As I’m sure you’re aware, there are frequent updates as to the recommendations for treatment, and our providers will continue to monitor the treatment guidelines and adapt accordingly.

Is this test approved by the FDA?

As stated in Section IV.D of the FDA’s Policy for Diagnostic Tests for Coronavirus Disease-2019, the FDA does not intend to object to the development and distribution by commercial manufacturers, or development and use by laboratories, of serology tests to identify antibodies to SARS-CoV-2, where the test has been validated, notification is provided to FDA, and information along the lines of the following is included in the test reports:

  • This test has not been reviewed by the FDA.
  • Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus. Follow-up testing with a molecular diagnostic should be considered to rule out infection in these individuals.
  • Results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status.
  • Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E.

Did CoronaChek™ provide notification to the FDA?

Yes, the manufacturer is Hangzhou Biotest Biotech’s COVID19 IgG/IgM Rapid test Cassette and you can see it listed here:

www.fda.gov/medical-devices/emergency-situations-medical-devices/faqs-diagnostic-testing-sars-cov-2#whatserologytest

When FDA authorizes a SARS-CoV-2 test for use at the point of care, does that mean it is CLIA waived?

FDA does not CLIA categorize tests authorized under EUA. Instead, the settings in which an EUA authorized test may be used are described in the Letter of Authorization. We note that the terms “patient care settings outside of the clinical laboratory environment,” “near-patient testing,” and “point of care” in the EUAs, Policy for Diagnostic Tests for Coronavirus Disease-2019, and generally refer to settings that are equipped with the instrumentation and appropriately trained personnel necessary to perform the test, and may include settings such as hospitals, physician offices, urgent care, outreach clinics, and temporary patient care settings. These terms generally do not apply to home specimen collection or at-home testing unless otherwise specified.

Are there additional resources you would recommend?

The Physician 360 team is always available to help answer questions during this uncertain time. Everything is changing rapidly, including regulatory recommendations. Please feel free to call or email us or refer to the FDA’s FAQ page below:

https://www.fda.gov/medical-devices/emergency-situations-medical-devices/faqs-diagnostic-testing-sars-cov-2

What type of PPE is required to perform the test? Does P360 provide PPE?

Physician 360 does recommend that any pharmacy staff member who is interacting directly with patients, for purposes of performing our test kit or any other reason, take proper precautions. PPE, such as laboratory coats, mask, disposable gloves, and eye protection, is required. However, Physician 360 will not be supplying or including any PPE with orders. 

What are the proper disposal methods for used test components?

Used tests, specimens, and potentially contaminated material should be discarded according to local regulations.

Does the test that Physician 360™ uses have an Emergency Use Authorization?

Hangzhou Biotest Biotech (HBB) is the manufacturer of the CoronaChek™ technology, which is the serology antibody test that Physician 360 is using to care for patients during the COVID-19 pandemic. HBB has achieved an EUA that can be read here.

Do serology tests need an EUA?

As stated in Section IV.D of the FDA’s Policy for Diagnostic Tests for Coronavirus Disease-2019, the FDA does not intend to object to the development and distribution by commercial manufacturers, or development and use by laboratories, of serology tests to identify antibodies to SARS-CoV-2, where the test has been validated, notification is provided to FDA, and information along the lines of the following is included in the test reports:

  • This test has not been reviewed by the FDA.
  • Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus. Follow-up testing with a molecular diagnostic should be considered to rule out infection in these individuals.
  • Results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status.
  • Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E.

Is this test CLIA-waived?

 Tests being offered prior to an EUA under the policies outlined in the FDA’s Policy for Diagnostic Tests for Coronavirus Disease-2019 that have not yet been reviewed by the FDA, are not FDA authorized, and have not received a CLIA categorization.  While FDA has indicated that such tests may be appropriate for use in clinical laboratories and by healthcare workers at the point of care, the policies in the Policy for Diagnostic Tests for Coronavirus Disease-2019 do not provide a CLIA categorization and do not override any CLIA requirements.  Therefore, in accordance with CLIA, tests offered under these policies are considered high complexity by default until or unless they are authorized and deemed to be appropriate, through an EUA authorization or general FDA review processes, to be performed as moderate or waived complexity tests. The FDA position on CLIA is subject to change as HHS continues to address testing shortages.

What is CLIA categorization?

The FDA categorizes diagnostic tests by their complexity—from the least to the most complex: waived tests, moderate complexity tests, and high complexity tests. You can learn more about the criteria here

I want to help patients access much needed testing, but I am still worried that my pharmacy is going to be negatively impacted, what can I do?

At Physician 360™ we partner with you to change the face of healthcare. The regulatory landscape is evolving daily during this pandemic and we are doing our best to stay informed so we can keep you up-to-date. That said, this COVID-19 serology antibody diagnostic test is being offered to address an unprecedented public health emergency. It is offered to pharmacies specifically pursuant to the U.S. Department of Health & Human Services, FDA’s parent Department, April 8, 2020, Guidance for Licensed Pharmacists titled, “COVID-19 Testing, and Immunity under the PREP Act.” The Guidance deems licensed pharmacists “covered persons” under the Public Readiness and Emergency Preparedness Act (PREP Act) and authorizes licensed pharmacists to order and administer COVID-19 tests, including serology tests, that the Food and Drug Administration (FDA) has authorized. P360 is not expressly or implicitly providing a legal interpretation of the HHS Guidance or the PREP Act. P360’s COVID-19 serology antibody diagnostic test has been properly notified to FDA and complies with Section IV.D of the FDA’s Policy for Diagnostic Tests for Coronavirus Disease-2019. Physician 360™ licensed medical providers are ordering and interpreting the tests. A licensed pharmacist does not require special equipment, training, or knowledge to order and properly perform the COVID-19 serology antibody diagnostic tests.

We encourage you to share this information with your city and state government officials and have provided a letter template here.

What is the cost and MSRP of the test?

Cost is $683.40 for a 12 pack, and the MSRP for individual tests is $79.95.

How soon are the tests received after placing an order?

Shipments are received within 3-5 business days after your order is shipped. Tests are typically shipped within 24-48 hours of orders received.

Are there any expediting shipping options?

Not at this moment. 

What are the next steps for a patient?

The test result will be interpreted by a Physician 360™ medical provider*. During the time when the test is processed, have the patient login to our telemedicine platform. If they have not been a patient of ours previously, they will need to create an account (which simply requires an email and password). With the click of a button, the patient will be cared for by the medical provider through the video consult on their smartphone. At that time, after the medical provider reviews the patient’s clinical information and the result of the test, they can provide:

  1. A diagnosis
  2. Recommended treatments (both OTC and prescription medications)
  3. Proper reporting to state and local officials 

*While the pharmacist is administering the test, as stated in the terms and conditions of sale, it is the medical provider who is ordering and interpreting the test. 

Does FDA expect my antibody test kit to have an EUA before distributing it?

As stated in Section IV.D of the FDA’s Policy for Coronavirus Disease-2019 Tests, the FDA does not intend to object to a commercial manufacturer’s development and distribution of serology tests to identify antibodies to SARS-CoV-2 for a reasonable period of time, where the test has been validated and while the manufacturer is preparing its EUA request, where the manufacturer gives notification to the FDA and information along the lines of the following is included in the instructions for use:

  • This test has not been reviewed by the FDA.
  • Negative results do not preclude acute SARS-CoV-2 infection.  If acute infection is suspected, direct testing for SARS-CoV-2 is necessary.
  • Results from antibody testing should not be used to diagnose or exclude acute SARS-CoV-2 infection.
  • Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E.

As noted in the guidance, FDA believes that 10 business days is a reasonable period of time to prepare an EUA submission for such tests. Unless and until an EUA is issued that authorizes additional testing environments for a specific test, under CLIA, use of that test is limited to laboratories certified to perform high complexity testing, and at the point-of-care when covered by the laboratory’s CLIA certificate for high-complexity testing.

This policy does not apply to at-home testing, including at-home specimen collection. You can read more here:

https://www.fda.gov/medical-devices/emergency-situations-medical-devices/faqs-testing-sars-cov-2

Where can I find more information specifically about serology tests that are being offered prior to an EUA?

The FDA has provided guidance here and continues to update policy regularly. 

https://www.fda.gov/medical-devices/emergency-situations-medical-devices/faqs-testing-sars-cov-2

 

Have more questions?

Listen to our recent Webinar below for more information on our Rapid COVID-19 Tests.

Reported Cases of COVID-19 in the US, According to the CDC

These numbers are directly from the CDC. Visit the CDC website for more information. 

Be a part of the solution and let's flatten the curve together!

Give your customers peace of mind by offering Physician 360’s COVID-19 rapid tests. Purchase yours today, or contact us with any questions you may have!

ORDER NOW

Due to high demand and orders filling fast, inventory cannot be guaranteed beyond our initial purchase order.

Disclaimer: This COVID-19 serology antibody diagnostic test is being offered to address an unprecedented public health emergency. It is offered to pharmacies specifically pursuant to the U.S. Department of Health & Human Services, FDA’s parent Department, April 8, 2020, Guidance for Licensed Pharmacists titled, “COVID-19 Testing, and Immunity under the PREP Act.” The Guidance deems licensed pharmacists “covered persons” under the Public Readiness and Emergency Preparedness Act (PREP Act) and authorizes licensed pharmacists to order and administer COVID-19 tests, including serology tests, that the Food and Drug Administration (FDA) has authorized. P360 is not expressly or implicitly providing a legal interpretation of the HHS Guidance or the PREP Act. P360’s COVID-19 serology antibody diagnostic test has been properly notified to FDA and complies with Section IV.D of the FDA’s Policy for Diagnostic Tests for Coronavirus Disease-2019. A licensed pharmacist does not require special equipment, training, or knowledge to order and properly administer the COVID-19 serology antibody diagnostic tests.
*Notes:
• This test has not been reviewed by the FDA.

• Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus. Follow-up testing with a molecular diagnostic should be considered to rule out infection in these individuals.
• Results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status.
• Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E.