Are the COVID 19 Tests FDA Approved?
Our serology tests received Emergency Use authorization from the FDA on May 29, 2020. The FDA has published further information regarding EUA usage and guidelines that can be found here.
Who can use the antibody tests?
The Covid 19 Rapid Antibody test can be used in high- and moderate-complexity laboratories. For more information please refer to the FDA’s guidelines.
Who can purchase the tests?
Our tests can be sold to hospitals, urgent care, outreach clinics, physicians offices, and other patient care settings that employ trained medical personnel and or currently distribute medical products to these settings.
Does Insurance reimburse for the tests?
For reimbursement information and CPT codes please visit the links below:
Reimbursement for COVID 19 Tests
CPT Codes for COVID 19 Tests
Which antibodies can be detected with the test.
The test detects both IgG and IgM. Please refer to the graphic found on our technical information page for more information on both IgG and IgM and what the detection means. If you have further questions please email email@example.com
What action do I take if a patient tests positive?
Please refer to the Letter to Health Care Providers included on the FDA website.
What is the accuracy of these tests?
Please refer to the National Cancer Institute’s evaluation report for more details. The sensitivity and specific stats can be found below.
|Antibody||Performance Measure||Estimate of Performance||95% Confidence Interval|
|IgM||Sensitivity||100% (30/30)||(88.7%; 100%)|
|IgM||Specificity||100% (80/80)||(95.4%; 100%)|
|IgG||Sensitivity||96.7% (29/30)||(83.3%; 99.4%)|
|IgG||Specificity||97.5% (78/80)||(91.3%; 99.3%)|
|Combined||Sensitivity||100% (30/30)||(88.7%; 100%)|
|Combined||Specificity||97.5% (78/80)||(91.3%; 99.3%)|
|Combined||PPV at prevalence = 5%||67.8%||(35.0%; 88.4%)|
|Combined||NPV at prevalence = 5%||100%||(99.4%; 100%)|
What is the price?
For pricing information and payment terms please fill out our information form and a representative will be in touch with you.