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Comparing the diagnostic accuracy of rapid antigen detection tests to real time polymerase chain reaction in the diagnosis of SARS-CoV-2 infection: A systematic review and meta-analysis.
Lee, Jonghoo; Song, Jae-Uk; Shim, Sung Ryul.
  • Lee J; Department of Internal Medicine, Jeju National University Hospital, Jeju National University School of Medicine, Jeju, Republic of Korea. Electronic address: lovlet@jejunu.ac.kr.
  • Song JU; Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.
  • Shim SR; Department of Preventive Medicine, Korea University College of Medicine, Seoul, Republic of Korea.
J Clin Virol ; 144: 104985, 2021 11.
Article in English | MEDLINE | ID: covidwho-1437501
ABSTRACT

BACKGROUND:

Timely and accurate diagnosis of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection is crucial to reduce the risk of viral transmission. We investigated the diagnostic accuracy of rapid antigen detection tests (RADTs) in the diagnosis of SARS-CoV-2 infection.

METHODS:

A systematic literature search was performed using Pubmed, Embase, and the Cochrane Central Register. The sensitivity, specificity, diagnostic odds ratio (DOR), and a hierarchical summary receiver-operating characteristic curve (HSROC) of RADTs were pooled using meta-analysis. We used commercial and laboratory-developed reverse transcriptase-polymerase chain reaction (RT-PCR) as reference standards.

RESULTS:

We identified 24 studies comprising 14,188 patients. The overall pooled sensitivity, specificity, and DOR of RADTs for diagnosis of SARS-CoV-2 were 0.68 (95%CI, 0.59 - 0.76), 0.99 (95%CI, 0.99 - 1.00), and 426.70 (95% CI, 168.37 - 1081.65), respectively. RADTs and RT-PCR had moderate agreement with an estimated pooled Cohen's kappa statistic of 0.75 (95%CI, 0.74-0.77), and area under the HSROC of 0.98 (95%CI, 0.96 - 0.99). The pooled sensitivity of RADTs was significantly increased in subjects with viral load of Ct-value ≤25 or in those within 5 days after symptom onset than it was in subjects with lower viral loads or longer symptom duration.

CONCLUSIONS:

The overall sensitivity of RADTs was inferior to that of the RT-PCR assay. The RADTs were more sensitive for samples of Ct-value ≤ 25 and might be suitable for subjects in the community within 5 days of symptom onset.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: SARS-CoV-2 / COVID-19 Type of study: Diagnostic study / Prognostic study / Reviews / Systematic review/Meta Analysis Topics: Long Covid Limits: Humans Language: English Journal: J Clin Virol Journal subject: Virology Year: 2021 Document Type: Article

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Full text: Available Collection: International databases Database: MEDLINE Main subject: SARS-CoV-2 / COVID-19 Type of study: Diagnostic study / Prognostic study / Reviews / Systematic review/Meta Analysis Topics: Long Covid Limits: Humans Language: English Journal: J Clin Virol Journal subject: Virology Year: 2021 Document Type: Article