# SARS-CoV-2 Serological Antibody Testing for Disease Surveillance and Clinical Use

> **NIH NIH U01** · KAISER FOUNDATION RESEARCH INSTITUTE · 2023 · $1,014,171

## Abstract

Abstract
Serologic testing for presence of SARS-CoV-2 antibodies is a critical tool for understanding the epidemiology
and designing control strategies for the COVID-19 pandemic. Our understanding of the epidemiology of this
pandemic is primarily derived from real-time data on the number of polymerase chain reaction (PCR)-positive
COVID-19 patients in outpatient and inpatient settings, and thus misses patients with asymptomatic infection or
who have not had SARS-CoV-2 PCR testing. Serologic testing for SARS-CoV-2 antibodies can identify
persons who have been exposed and infected with SARS-CoV-2 at any time and might be a correlate of
protective immunity. This project aims to advance our understanding of SARS-CoV-2 serological testing at the
individual and population-level. To achieve this we will develop and implement a large-scale, population-
based, flexible platform to assess SARS-CoV-2 sero-prevalence, sero-incidence, risk of sero-conversion and
longevity of antibody response in a large, integrated health system with linked rich demographic, behavioral
and clinical data. For Aim 1 we will establish a community cohort of Kaiser Permanente Northern California
(KPNC) members; a random sample of community dwelling persons, age 7 years and older, will be invited to
participate in ongoing surveillance of antibody development to assess population-level sero-prevalence and
sero-incidence. For Aim 2, we will enroll a cohort of persons who are positive for SARS-CoV-2 PCR or
antibodies and will follow them prospectively with repeat SARS-CoV-2 antibody testing for immune surveillance
and to determine longevity of antibody response. For Aim 3, we will establish a data-only cohort of all persons
who have been diagnosed with COVID-19 disease, or had SARS-CoV-2 PCR or antibody testing; As of July
15, 2020, there are about 290,000 such persons in KPNC and the number increases daily as we test ~10,000
persons per day. In this cohort, we will assess risk of SARS-CoV-2 re-infection and will have the opportunity to
examine interactions with a personal history of cancer or cancer treatment and other clinical factors or
comorbid conditions, to determine if these conditions influence the likelihood of development of COVID-19 or
reinfection. For Aim 4, we will establish mechanisms for collaboration with other scientists in the Serological
Sciences Network, including mechanisms for additional sample collection. This series of linked studies
embedded in a large, integrated health system with a large number of COVID-19 patients and high SARS-
CoV-2 testing capacity will enhance our understanding of the utility of commercially available, large-scale
SARS-CoV-2 antibody testing for population-level and individual-level disease control.

## Key facts

- **NIH application ID:** 10855011
- **Project number:** 3U01CA260584-02S2
- **Recipient organization:** KAISER FOUNDATION RESEARCH INSTITUTE
- **Principal Investigator:** Jacek Skarbinski
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2023
- **Award amount:** $1,014,171
- **Award type:** 3
- **Project period:** 2020-09-30 → 2025-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10855011

## Citation

> US National Institutes of Health, RePORTER application 10855011, SARS-CoV-2 Serological Antibody Testing for Disease Surveillance and Clinical Use (3U01CA260584-02S2). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10855011. Licensed CC0.

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