Discover your immune status to COVID-19 without a blood test. The Amperial® COVID-19 Assay is now available exclusively through Apostle Laboratories as a CLIA Certified Laboratory Developed Test. This assay measures your IgG antibody levels to COVID-19 without the need for blood collection. The report will contain the absolute level of antibodies present and show how your level compares with that of vaccinated individuals in the population. This can give you peace of mind knowing you have ample quantities of antibody or may indicate it is time for a booster shot.
This revolutionary technology developed at research laboratories at UCLA allows measurement of COVID-19 antibodies in saliva using a simple collection brush you place in your mouth for 2 minutes.
The Amperial® COVID-19 Assay has been developed at research laboratories at UCLA, and has been clinically validated, including the following clinical studies.
Journal of Immunology
The Kinetics of COVID-19 Vaccine Response in a Community-Vaccinated Population
Michael K. Tu, Samantha H. Chiang, Richard A. Bender, David T. W. Wong and Charles M. Strom
J Immunol January 17, 2022, ji2100919; DOI: https://doi.org/10.4049/jimmunol.2100919
• The Amperial assay was used to measure salivary SARS-CoV-2 S1 Abs.
• IgG of 42 COVID-19 mRNA vaccinated individuals was longitudinally evaluated.
• Twenty percent of subjects experienced a 90% drop of peak IgG levels over time.
We used a noninvasive electrochemical quantitative assay for IgG Abs to SARS-CoV-2 S1 Ag in saliva to investigate the kinetics of Ab response in a community-based population that had received either the Pfizer or Moderna mRNA-based vaccine. Samples were received from a total of 97 individuals, including a subset of 42 individuals who collected samples twice weekly for 3 mo or longer. In all, >840 samples were collected and analyzed. In all individuals, salivary SARS-CoV-2 S1 IgG Ab levels rose sharply in the 2-wk period after their second vaccination, with peak Ab levels seen at 10–20 d after vaccination. We observed that 20%, 10%, and 2.4% of individuals providing serial samples had a 90%, 95%, and 99% drop, respectively, from peak levels during the duration of monitoring, and in two patients, Abs fell to prevaccination levels (5%). The use of noninvasive quantitative salivary Ab measurement can allow widespread, cost-effective monitoring of vaccine response.
Development and validation of a quantitative, non-invasive, highly sensitive and specific, electrochemical assay for anti-SARS-CoV-2 IgG antibodies in saliva
Samantha H. Chiang, Michael Tu, Jordan Cheng, Fang Wei, Feng Li, David Chia, Omai Garner, Sukantha Chandrasekaran, Richard Bender, Charles M. Strom , David T. W. Wong
PLoS One. July 1, 2021. https://doi.org/10.1371/journal.pone.0251342
Amperial™ is a novel assay platform that uses immobilized antigen in a conducting polymer gel followed by detection via electrochemical measurement of oxidation-reduction reaction between H2O2/Tetrametylbenzidine and peroxidase enzyme in a completed assay complex. A highly specific and sensitive assay was developed to quantify levels of IgG antibodies to SARS-CoV-2 in saliva. After establishing linearity and limit of detection we established a reference range of 5 standard deviations above the mean. There were no false positives in 667 consecutive saliva samples obtained prior to 2019. Saliva was obtained from 34 patients who had recovered from documented COVID-19 or had documented positive serologies. All of the patients with symptoms severe enough to seek medical attention had positive antibody tests and 88% overall had positive results. We obtained blinded paired saliva and plasma samples from 14 individuals. The plasma was analyzed using an EUA-FDA cleared ELISA kit and the saliva was analyzed by our Amperial™ assay. All 5 samples with negative plasma titers were negative in saliva testing. Eight of the 9 positive plasma samples were positive in saliva and 1 had borderline results. A CLIA validation was performed as a laboratory developed test in a high complexity laboratory. A quantitative non-invasive saliva based SARS-CoV-2 antibody test was developed and validated with sufficient specificity to be useful for population-based monitoring and monitoring of individuals following vaccination.