Evaluating real-world data in COVID-19 antigen and PCR testing.
Int J Clin Pharmacol Ther
; 61(4): 172-177, 2023 Apr.
Artigo
em Inglês
| MEDLINE | ID: covidwho-2278757
ABSTRACT
OBJECTIVE:
COVID-19 testing is an important pillar in fighting the SARS-CoV-2 pandemic. Even though billions of tests have been conducted, little is known on performance of testing sites. This is a retrospective observational study with real-world data from a pharmacist-led COVID-19 testing center in Germany during the Omicron subvariant BA.4 and BA.5 wave in June 2022. MATERIALS The rapid antigen tests employed were purchased from Anbio Biotechnology (Xiamen, China). The RT-PCR was performed on Egens YS-qPCR-1 real-time system with Kewei multiple real-time PCR kits for detection of SARS-CoV-2 (Beijing Kewei Clinical Diagnostic Reagent Inc., Beijing, China).METHODS:
The study followed the STARD 2015 guideline. In this retrospective cohort study, the performance of testing sites was compared.RESULTS:
During the study period, 7,112 patients were tested by rapid antigen tests and 1,025 RT-PCR tests conducted. Included were 233 patients who were referred by other testing sites for confirmation of positive results. A positive predictive value of 99.6% was calculated for the antigen tests in the pharmacist-led testing center. Referred positive patients from non-medical sites were antigen and RT-PCR negative in 16 cases, which led to a positive predictive value of 88.8%. Difference between site performance was statistically significant (p < 0.05).CONCLUSION:
Results indicate that nucleic acid amplification confirmation is crucial in the context of the current testing strategy in Germany. Higher standards in antigen-testing, however, can make nucleic acid amplification in active COVID-19 infections unnecessary and testing cost efficient. This study provides the first data in the world on COVID-19 testing performance, and how it can be optimized.
Texto completo:
Disponível
Coleções:
Bases de dados internacionais
Base de dados:
MEDLINE
Assunto principal:
Ácidos Nucleicos
/
COVID-19
Tipo de estudo:
Estudo de coorte
/
Estudo diagnóstico
/
Estudo experimental
/
Estudo observacional
/
Estudo prognóstico
Tópicos:
Variantes
Limite:
Humanos
Idioma:
Inglês
Revista:
Int J Clin Pharmacol Ther
Assunto da revista:
Farmacologia
/
Terapia por Medicamentos
Ano de publicação:
2023
Tipo de documento:
Artigo
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