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A Rapid, Multiplex Dual Reporter IgG and IgM SARS-CoV-2 Neutralization Assay for a Multiplexed Bead-Based Flow Analysis System
Published on: April 6, 2021
SARS-CoV-2 antigen rapid tests and universal screening for COVID-19 Omicron variant among hospitalized children
Kai-Qian Kam1, Matthias Maiwald2, Chia Yin Chong1
1Infectious Disease Service, Department of Pediatrics, KK Women's and Children's Hospital, Singapore; Duke-NUS Medical School, Singapore; Lee Kong Chian School of Medicine, Imperial College London, Nanyang Technological University, Singapore; Yong Loo Lin School of Medicine, National University of Singapore, Singapore.
Insights
Universal antigen rapid tests (ART) show good performance in hospitalized children aged 5 and older, helping to prevent COVID-19 spread. Optimizing ART use with clinical factors can enhance its effectiveness in pediatric settings.
Area of Science:
- Pediatric Infectious Diseases
- Diagnostic Test Performance
- Hospital Epidemiology
Background:
- The clinical utility of universal antigen rapid tests (ART) in pediatric healthcare settings remains largely uncharacterized.
- Preventing nosocomial transmission of COVID-19 in hospitalized children is a critical public health concern.
Purpose of the Study:
- To evaluate the performance and utility of universal ART in hospitalized children aged 5 years and older.
- To assess the role of ART in preventing hospital-acquired COVID-19 transmission within this demographic.
Main Methods:
- A cross-sectional study design was employed, including all hospitalized pediatric patients aged 5 years and older during two distinct periods of the Omicron wave.
- Collected data included clinical information, results from ART, and confirmatory polymerase chain reaction (PCR) testing.
Main Results:
- Out of 444 patients, 93.7% showed concordant results between ART and PCR.
- ART demonstrated an overall sensitivity of 83.3% and specificity of 97.5%.
- Negative predictive values varied by case group and Omicron wave period, while positive predictive values exceeded 85% for probable and suspect cases. Notably, 75% of false negatives had viable virus, yet no large nosocomial clusters were detected.
Conclusions:
- Universal ART screening in hospitalized children may serve as a valuable tool to mitigate nosocomial outbreaks.
- Optimizing ART performance can be achieved by integrating clinical symptoms, exposure history, and the specific phase of COVID-19 waves.
Background:
Clinical utility of universal antigen rapid test (ART) in the pediatric setting is unknown. We aimed to assess the performance and utility of universal ART in hospitalized children (≥5-year-old) to prevent nosocomial COVID-19 transmission.
Methods:
Cross-sectional study involving all hospitalized pediatric patients aged ≥5-year-old from 2 periods during Omicron wave. Clinical data, ART and polymerase chain reaction test results were collected.
Results:
A total of 444 patients were included from the 2 study periods, and 416 patients (93.7%) had concordant results between ART and polymerase chain reaction. The overall sensitivity and specificity of ART were 83.3% (95% CI: 75.2-89.3) and 97.5% (95% CI: 95.0-98.8), respectively. Negative predictive values of ART between the Omicron emergence and Omicron peak periods for a probable case group were 71.4% and 66.7%, respectively, and for a suspect case group 91.4% and 75.0%, respectively. Negative predictive values for an unlikely case group was >95% in both periods. Positive predictive value of ART was >85% for probable and suspect case groups in both periods. Seventy-five percent of patients (n = 15) who were incorrectly classified as SARS-CoV-2 negative by ART had potentially viable virus. No large nosocomial transmission clusters were detected.
Conclusions:
Universal ART screening may limit nosocomial outbreaks in hospitalized children. The performance can be optimized by considering clinical symptoms, exposure and periods within COVID waves.

