Evaluation of the INDICAID COVID-19 Rapid Antigen Test in Symptomatic Populations and Asymptomatic Community Testing

Autor: Sean Parkin, Raymond Wai-Hung Yung, Matthew Brobeck, Mei Wai Fung, Jeffrey D. Klausner, Dan MArshak, Stephen Ka-Kung Ho, Eric Tsang, Ryan Siu, Jessica Pui Ling Ng, Tsz Hei Choi, Jonpaul Sze-Tsing Zee, Ricky Y.T. Chiu, Koon Kung Lee, Edmond S. K. Ma, Alex Chin-Pang Leung, Felix C. Chao, Tenny Chung, Tsun Leung Chan, Kwok Kin Cheng, Noah Kojima, Garrett L. Mosley, David Y. Pereira, Wai Sing Chan, Harsha Kittur, Ho Yin Lam, Kajal Maran
Jazyk: angličtina
Rok vydání: 2021
Předmět:
Male
Time Factors
Physiology
asymptomatic screening
Polymerase Chain Reaction
Turnaround time
COVID-19 Testing
Mass Screening
Antigens
Viral
False Negative Reactions
Ecology
Middle Aged
QR1-502
Test (assessment)
Infectious Diseases
Rapid antigen test
Hong Kong
Female
Sample collection
medicine.symptom
Clinical evaluation
Research Article
Adult
Microbiology (medical)
medicine.medical_specialty
Coronavirus disease 2019 (COVID-19)
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
Sensitivity and Specificity
Asymptomatic
Microbiology
Specimen Handling
Young Adult
antigen
Internal medicine
Genetics
medicine
Humans
False Positive Reactions
Pandemics
USA
General Immunology and Microbiology
Clinical Laboratory Techniques
business.industry
SARS-CoV-2
Outbreak
COVID-19
Cell Biology
Gold standard (test)
Confidence interval
rapid
Asymptomatic Diseases
business
Zdroj: Microbiology Spectrum, Vol 9, Iss 1 (2021)
Microbiology Spectrum
ISSN: 2165-0497
DOI: 10.1128/Spectrum.00342-21
Popis: As the COVID-19 pandemic progresses, there is an increasing need for rapid, accessible assays for SARS-CoV-2 detection. We present a clinical evaluation and real-world implementation of the INDICAID COVID-19 rapid antigen test (INDICAID rapid test). A multisite clinical evaluation of the INDICAID rapid test using prospectively collected nasal (bilateral anterior) swab samples from symptomatic subjects was performed. The INDICAID rapid test demonstrated a positive percent agreement (PPA) and negative percent agreement (NPA) of 85.3% (95% confidence interval [95% CI], 75.6% to 91.6%) and 94.9% (95% CI, 91.6% to 96.9%), respectively, compared to laboratory-based reverse transcriptase PCR (RT-PCR) using nasal specimens. The INDICAID rapid test was then implemented at COVID-19 outbreak screening centers in Hong Kong as part of a testing algorithm (termed “dual-track”) to screen asymptomatic individuals for prioritization for confirmatory RT-PCR testing. In one approach, preliminary positive INDICAID rapid test results triggered expedited processing for laboratory-based RT-PCR, reducing the average time to confirmatory result from 10.85 h to 7.0 h. In a second approach, preliminary positive results triggered subsequent testing with an onsite rapid RT-PCR, reducing the average time to confirmatory result to 0.84 h. In 22,994 asymptomatic patients, the INDICAID rapid test demonstrated a PPA of 84.2% (95% CI, 69.6% to 92.6%) and an NPA of 99.9% (95% CI, 99.9% to 100%) compared to laboratory-based RT-PCR using combined nasal/oropharyngeal specimens. The INDICAID rapid test has excellent performance compared to laboratory-based RT-PCR testing and, when used in tandem with RT-PCR, reduces the time to confirmatory positive result. IMPORTANCE Laboratory-based RT-PCR, the current gold standard for COVID-19 testing, can require a turnaround time of 24 to 48 h from sample collection to result. The delayed time to result limits the effectiveness of centralized RT-PCR testing to reduce transmission and stem potential outbreaks. To address this, we conducted a thorough evaluation of the INDICAID COVID-19 rapid antigen test, a 20-minute rapid antigen test, in both symptomatic and asymptomatic populations. The INDICAID rapid test demonstrated high sensitivity and specificity with RT-PCR as the comparator method. A dual-track testing algorithm was also evaluated utilizing the INDICAID rapid test to screen for preliminary positive patients, whose samples were then prioritized for RT-PCR testing. The dual-track method demonstrated significant improvements in expediting the reporting of positive RT-PCR test results compared to standard RT-PCR testing without prioritization, offering an improved strategy for community testing and controlling SARS-CoV-2 outbreaks.
Databáze: OpenAIRE
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