SARS-CoV-2 Total Antibody

ENZYME IMMUNOASSAY

Serum


The clarus SARS-CoV-2 Total Antibody EIA is a rapid, high-volume test that can identify previous infection of the novel coronavirus, SARS-CoV-2. This assay will help identify those who have been exposed, and developed antibodies against the virus, and those who have not.

This test creates an opportunity for communities to gain greater clarity regarding true exposure rates. Hospitals can test their healthcare workers, businesses can test their employees, cities can test their first responders, schools and universities can test their professors, teachers, and staff.

Performance

Sensitivity: 92% (95% CI: 83, 97)

Specificity: 100% (95% CI: 99, 100)

PPV: 100% (95% CI: 95, 100)

NPV: 98% (95% CI: 96, 99)

Accuracy: 98% (95% CI: 97, 99)

*Results performed on patients that are 8+ days post symptom onset

WHAT?
A serological assay that detects the presence of all antibodies in response to the novel coronavirus, SARS-CoV-2.
HOW?
Serology antibody tests do not detect the virus (SARS-CoV-2) directly, but the immune response that bodies develop to fight off the virus (Total Antibodies). Total antibody detection has been reported as the most sensitive and specific immunoglobulin detection method.1,2
WHEN?
The antibodies are typically present during the middle and final stages of infection, taking an average of 11-14 days to develop this immune response.1,3
WHY?
This assay will help identify those who have been exposed to COVID-19, and developed antibodies against the virus, and those who have not. These individuals have developed disease-fighting antibodies and may have a level of immunity to COVID-19.
The length of immunity is still uncertain, so understanding the presence of antibodies is vital for improving patient care.
WHO?
The purpose of antibody testing is not to test individuals who currently have COVID-19, but individuals who have been infected with the virus and no longer have symptoms.
Including those who were confirmed cases but have since then recovered, experienced mild symptoms but may have never received a diagnosis, or never showed any symptoms at all.

Benefits of Increasing Community Antibody Testing

This test creates an opportunity for communities to gain greater clarity regarding true exposure rates. Serology antibody testing could be a way to safely resume normal life sooner.

Healthcare workers with built immunity could return to the front lines and act as designated caretakers for COVID-19 patients. While healthcare workers with no reported antibodies could be reassigned to non-infected patients, decreasing their risk of becoming infected.

Employers could test their employees to figure out who could return to work first, and safely play a part in reopening society.

Communities could identify volunteers who are not at risk for developing the disease and provide extra help to others in dire need.

Patients could avoid clinic visits and go to appropriate locations to have blood drawn while they wait for the results in the safety of their own homes.

Antibody testing is essential for hospitals, businesses, and public spaces to remain safe and to know when they can return to normal operation.

IVD KIT INFO

Serum

Name: clarus SARS-CoV-2 Antibody EIA

REF#: COV105

Kit Configuration: 5 X 95-well plates + reagents

Specimen Type: Serum

Test Time: <60 minutes

Regulatory: The clarus SARS-CoV-2 Total Antibody EIA is made available as set forth in Section IV.D of the FDA’s Policy for Diagnostic Tests for Coronavirus Disease-2019

Validated Performance

Sensitivity: 92% (95% CI: 83, 97)

Specificity: 100% (95% CI: 99, 100)

PPV: 100% (95% CI: 95, 100)

NPV: 98% (95% CI: 96, 99)

Accuracy: 98% (95% CI: 97, 99)

*Results performed on patients that are 8+ days post symptom onset

Cross-Reactivity

Pathogen Number of Specimens % Positive
anti-HCV70% (0/7)
RSV10% (0/1)
CMV100% (0/10)
Corona (OC43)10% (0/1)
Corona (NL63)10% (0/1)
Flu A/B100% (0/10)
HIV140% (0/14)
anti-HBV170% (0/17)

References

1. Zhao J., Yuan Q., Wang H., Liu W., Liao X., et al. Antibody responses to SARS-CoV-2 in patients of novel coronavirus disease 2019. Clin Infect Dis. 2020; ciaa344, https://doi.org/10.1093/cid/ciaa344.

2. Lassauniere R., Frische A., Harboe Z.B., Neilsen A.C.Y., Fomsgaard A., Krogfelt K.A., Jorgensen C.S. Evaluation of nine commercial SARS-CoV-2 Immunoassays. MedRxiv 2020. 2020.04.09.20056325 https://doi.org/10.1101/2020.04.09.20056325

3. Lei Liu, Wanbing Liu, Shengdian Wang, Shangen Zheng. A preliminary study on serological assay for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in 238 admitted hospital patients. medRxiv 2020.03.06.20031856; doi: https://doi.org/10.1101/2020.03.06.20031856