IgG and IgM
Results in as fast as...
TEST INFORMATION and SPECIFICATIONS
> This test is authorized to be distributed pursuant to FDA EUA guidance.
See FDA Information section below.
> This test detects IgG and IgM antibodies to SARS-CoV-2 in human blood.
> This is a 1-step, Point of Care Test that can produce results in a little as 5 minutes.
> This test is not for at home use. It is intended for Healthcare Professionals to administer.
In fact, a valid NPI number is required to order these test kits.
> This test has a 91% Clinical Sensitivity and a 99% Clinical Specificity.
Statistics are based on independent clinical trials, See Clinical Trials Information section below.
> These tests were created by Pinnacle BioLabs, headquartered in Nashville, TN, U.S.A.
ACG (Advocate Consulting Group) has a strategic partnership with Pinnacle BioLabs through Covid Care
> These tests are proudly manufactured in the U.S.A. in an ISO-13485 Certified Facility.
There is no higher degree of standard or accreditation.
Our medical professionals need a simple and accurate solution for testing
Testing with the COVID Care test is easy and resembles the tests diabetics use to test their blood sugar.
Simply “prick” a finger with the included lance, drip 2 drops of blood into the included testing cassette, drip 2 drops of testing solution into the cassette, and wait approximately 5 minutes for results. Interpreting results is a very straightforward process.
Click Here to download a copy of the detailed instructions that accompany every kit.
Every Kit Includes:
- 1x Finger lancet (similar to diabetic lance)
- 1x Alcohol Prep Pad
- 1x Blood Pipette (to help transfer blood to test cassette)
- 1x COVID-19 Testing Cassette
- 1x Dropper Of COVID Care Testing Solution
- 1x Package Insert
FDA EUA Information
COVID Care is authorized to be distributed pursuant to FDA EUA guidance.
On March 28th, Pinnacle BioLab's COVID Care received its acknowledgement letter from the FDA (PEUA200240). Under the announced FDA policy, upon filing its submittal, COVID Care was authorized to market and distribute SARS-CoV-2 IgM / IgG Rapid Test kits to any licensed healthcare practitioner in the United States for diagnostic use while it awaits a final decision on its FDA EUA application. While the policy does not apply to at-home testing, the policy does allow testing in laboratories or by healthcare workers at the point-of-care.
The FDA has granted Pinnacle BioLabs the right to market and distribute pursuant to EUA guidelines set forth by the FDA for the novel Coronavirus Pandemic. 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.
Click HERE to view a picture from the FDA website of Pinnacle BioLab's COVID Care Test "Active" Listing status and number
Click HERE to view a copy of the FDA's Acknowledgement Letter, sent to Pinnacle BioLab's on March 28th, 2020.
Clinical Trials Information
Ongoing Clinical Trials
Pinnacle BioLabs’ COVID-19 IgG and IgM Rapid Test are currently undergoing clinical trials at:
Pinnacle BioLabs’ COVID-19 IgG and IgM Rapid Test underwent a clinical trial conducted by the Fifth Affiliated Hospital of Sun Yat-Sen University, 600 miles from the initial breakout.
All specimens were tested according to the user instruction of the test kit. The results obtained confirm 91% Clinical Sensitivity, and 99% Clinical Specificity.
The COVID Care IgM/IgG Rapid Test was compared with clinical diagnosed positive samples using the Novel Coronavirus Diagnosis and Treatment Plan (Provisional 5th Edition).
The COVID Care IgM/IgG Rapid Test Has undergone a Clinical Trial and has seen strong Diagnostic Specificity
Pinnacle BioLabs is an FDA registered lab (registration number: 3010982075) headquartered in Tennessee.
Pinnacle BioLabs has been in operation since 2013.
Pinnacle BioLabs is the creator of the world's most advanced Colon Cancer Detection Test which is currently available at all CVS Pharmacy locations nationwide. Also available on Amazon with 4.5 star rating.
Pinnacle BioLabs is actively lobbying the AMA for a novel CPT ™ code for its COVID Care IgM/IgG Rapid Tests. Pinnacle BioLabs anticipates the approval of the CPT ™ code being granted in April, 2020.
Covid Care Tests are covered by NDC Number 9999-25437-99. This code applies to Phoenix PBM
Pricing, Payments, Shipping and Ordering Information
Single Test Kits are $79 Each
Prices do not include shipping.
Orders must be placed in groups of 25 kits.
Volume Discount Pricing is available on orders over 1,000 kits
* Due to overwhelming demand, minimum order as of 4/8 is currently 10,000 or more.
**We are working diligently to be able to offer lesser quantities again and will as soon as we are able.
We accept Debit/Credit Cards, ACH and Bank Wires. Prepayment is required. Exceptions are possible in certain situations.
Orders will be shipped 10-14 days from completion of purchase.
Orders are currently being shipped from our fulfillment center in California, USA
Please contact the person who shared this information with you to place your order, or click the Order Test Kits Button Now below.
Only verified orders will be accepted.
Items required for verification included:
Full Legal Name
Photo of Government-issued ID (Back and Front) or Passport
Photo of Employee
Organization Name (LBN, DBA, Former LBN or Other Name)
Provider’s Mailing Address or Provider’s Practice Location Address
*Please note you will be contacted by phone to confirm, verify and complete your order. Thank you for making a difference!