ZRT Laboratory’s Dried Blood Spot (DBS) COVID-19 IgG Antibody Testing Methodology and Validation Published in a Peer-Reviewed Journal

Share Article

ZRT Laboratory’s manuscript “Validation of dried blood spot sample modifications to two commercially available COVID-19 IgG antibody immunoassays” published in the peer-reviewed journal Future Science – Bioanalysis.

"As the COVID-19 vaccine rollout begins there will be an increased need for identifying a successful vaccine-stimulated immune antibody response to the SARS-CoV-2 spike protein, which is made possible with the ZRT DBS COVID-19 IgG S1 Spike Antibody Test." - Theodore Zava

The modification of two commercially available COVID-19 IgG antibody assays for use with capillary finger stick dried blood spots (DBS) was successfully validated and published in the peer-reviewed journal Future Science – Bioanalysis. The clinical comparison study between DBS and serum, which had Institutional Review Board (IRB) approval, is the most comprehensive analysis related to DBS COVID-19 antibody testing to date.

A total of 177 matching DBS and serum samples were analyzed and showed 100% positive and 99.3% negative concordance between serum run according to manufacturer instructions and the ZRT DBS COVID-19 IgG S1 Spike Antibody Test, and 100% positive and 98% negative concordance between serum run according to manufacturer instructions and the ZRT DBS COVID-19 IgG Nucleocapsid Antibody Test. ZRT DBS COVID -19 IgG S1 Spike and Nucleocapsid assay validation included precision, hematocrit effect, interference, hook effect, drying and shipping conditions, blood spot size and punch location, dry time, and filter paper lot comparisons.

The use of DBS allows for a health care professional assisted finger stick collection in place of a venous blood draw, and the potential for at-home collection. DBS are easy to collect, transport, and store for future use. As the COVID-19 vaccine rollout begins there will be an increased need for identifying a successful vaccine-stimulated immune antibody response to the SARS-CoV-2 spike protein, which is made possible with the ZRT DBS COVID-19 IgG S1 Spike Antibody Test. The ZRT DBS COVID-19 IgG S1 Spike and Nucleocapsid assays can also detect an immune response from a native COVID-19 infection.

Currently the ZRT DBS COVID-19 IgG S1 Spike Antibody Test is available for commercial use, while the ZRT DBS COVID-19 IgG S1 Spike and Nucleocapsid Antibody Test combination is available for research use only. ZRT Laboratory submitted data to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) in October for the ZRT DBS COVID-19 IgG S1 Spike Antibody Test.

ZRT Laboratory is a CLIA-certified high complexity testing facility that offers a wide range of dried blood spot, dried urine, saliva, and serum testing. With over 10 million clinical tests performed over the past 20+ years, coupled with our signature personalized test report, ZRT Laboratory has become a world recognized leader in hormone and wellness testing. Individuals, health care providers in all 50 states and in over 100 countries, as well as research-oriented government, private, and academic organizations worldwide use our testing. Learn more at http://www.zrtlab.com.

Share article on social media or email:

View article via:

Pdf Print

Contact Author

Keri Wright
@ZRTLab
Follow >
ZRT Laboratory
Like >
Visit website