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*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 may indicate 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. Because the test checks for antibodies, it may also confirm that your body produced antibodies in response to vaccine administration.

This type of test may indicate whether or not a person has been exposed to SARS-CoV-2 and/or the SAR-CoV-2 vaccine and therefore developed antibodies against the virus. 

Patient Registers With Physician 360

(Optional)

Pharmacy Personnel Performs Test*

Results in 10-20 Minutes

Patient Receives Telemedicine Consultation**

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

** While a consult is not required, a Physician 360 Medical Professional is available if the patient has follow-up questions

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Due to high demand, 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. Because the test checks for antibodies, it may also confirm that your body produced antibodies in response to vaccine administration.

CoronaChek 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/or the SAR-CoV-2 vaccine and therefore developed antibodies against 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?

A member of the pharmacy staff would perform the finger stick on the patient. If the patient wishes to have a consult, 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.

The main role of the pharmacy staff is to only administer the finger stick test on patientsand report the results to the necessary public health authorities.

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.

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.

If a patient has received the COVID-19 vaccine, how will the vaccine impact the results of the COVID-19 antibody test?

The performance of the IDS SARS-CoV-2 IgG has not been established in individuals that have received a COVID-19 vaccine. The clinical significance of a positive antibody result for individuals that have received a COVID-19 vaccine is unknown. The clinical significance of a negative antibody result for individuals that have received a COVID-19 vaccine is unknown.

Does my pharmacy need to provide a CLIA ID # to purchase this test?

Yes. At checkout, you will need to put your CLIA ID # in the field below.

Is this test CLIA-waived?

Yes, the CoronaChek™ is CLIA-waived.

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

What is the cost and MSRP of the test?

The 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?

After the pharmacist performs the test, if the patient wants a consultation with a P360 medical provider, 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)

 

Reported Cases of COVID-19 in the US

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, inventory cannot be guaranteed beyond our initial purchase order.

Disclaimer: This COVID-19 serology antibody diagnostic test is being 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. Physician 360 is not expressly or implicitly providing a legal interpretation of the HHS Guidance or the PREP Act. Physician 360’s COVID-19 serology antibody diagnostic test has received Emergency Use Authorization from the FDA.