Unique Oral Fluid sample – easy and painless for the patient.
Easy 4 step test procedure.
Only rapid test that detects all Ig A, G and M – Pan Ig.
Quick result in 15 minutes.
Room Temperature storage.
No instrument required.
Developed and manufactured in America.
Medicare reimbursement for this test is $45.23 and the CPT code is 86328.
The test kit can be stored between 2°C and 30°C or between 35.6°F and 86°F.
12 months.
Yes, both positive and negative controls will be available for this test. Storage conditions are the same as the test. Shelf life of controls is 12 months before opening and one month after opening.
We sell only through distributors. You can add your contact details in the Contact Us section and a distributor salesperson will get in touch with you within 24 hours.
Yes it has to be validated as per CLIA guidelines.
The sensitivity is 97.6% and specificity is 98.8% at >14 days following the onset of symptoms.
It uses GCF (gingival crevicular fluid), the component of saliva from the gingiva, the space between the teeth and the gums, to find antibodies. GCF contains the same antibodies found in blood.
A positive test result with the CovAbScreen™ SARS-CoV-2 Antibody Test indicates that antibodies to SARS-CoV-2 were detected, and the individual has potentially been exposed to the virus that causes COVID-19.
Antibodies to SARS-CoV-2 are generally detectable in blood several days after initial infection or vaccination (seroconversion). Individuals may have detectable virus present for several weeks following seroconversion. A positive result can indicate a recent or past infection but does not exclude recently infected individuals who are still contagious.
False positive results may occur due to cross-reactivity from pre-existing antibodies or other possible causes.
A negative test result with this test means that SARS-CoV-2 specific antibodies were not present in the specimen above the limit of detection of the assay.
Individuals tested early after infection may not have detectable antibodies despite active infection; in addition, not all patients will develop a detectable antibody response to SARS-CoV-2 infection. A negative result should not be used to rule out infection. Direct testing of SARS-CoV-2 should be performed if acute infection is suspected.
The test is very simple to perform. Please refer to the Quick Reference Guide or view our instructional video to learn how to perform the test. Please go to our training website and go through the materials. You can then take the Quiz and after successful completion of the Quiz, you will be sent a Training Certificate.
For additional support or questions, please email our support team at support@CovAbScreen.com and receive a response within 1 business day, or call our technical service line at 877-748-9355 and a live person will be available between 8:00 AM PST and 5:00 PM PST.