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Review
. 2023 Mar 6;8(2):353-371.
doi: 10.1093/jalm/jfac058.

Summarizing Study Characteristics and Diagnostic Performance of Commercially Available Tests for Respiratory Syncytial Virus: A Scoping Literature Review in the COVID-19 Era

David I Bernstein  1 , Asuncion Mejias  2   3 , Barbara Rath  4   5   6 , Christopher W Woods  6   7 , Jamie Phillips Deeter  6   8
Affiliations
Review

Summarizing Study Characteristics and Diagnostic Performance of Commercially Available Tests for Respiratory Syncytial Virus: A Scoping Literature Review in the COVID-19 Era

David I Bernstein et al. J Appl Lab Med. .

Abstract

Background: Nonpharmaceutical interventions to prevent the spread of coronavirus disease 2019 also decreased the spread of respiratory syncytial virus (RSV) and influenza. Viral diagnostic testing in patients with respiratory tract infections (RTI) is a necessary tool for patient management; therefore, sensitive and specific tests are required. This scoping literature review aimed to summarize the study characteristics of commercially available sample-to-answer RSV tests.

Content: PubMed and Embase were queried for studies reporting on the diagnostic performance of tests for RSV in patients with RTI (published January 2005-January 2021). Information on study design, patient and setting characteristics, and published diagnostic performance of RSV tests were extracted from 77 studies that met predefined inclusion criteria. A literature gap was identified for studies of RSV tests conducted in adult-only populations (5.3% of total subrecords) and in outpatient (7.5%) or household (0.8%) settings. Overall, RSV tests with analytical time >30 min had higher published sensitivity (62.5%-100%) vs RSV tests with analytical time ≤30 min (25.7%-100%); this sensitivity range could be partially attributed to the different modalities (antigen vs molecular) used. Molecular-based rapid RSV tests had higher published sensitivity (66.7%-100%) and specificity (94.3%-100%) than antigen-based RSV tests (sensitivity: 25.7%-100%; specificity:80.3%-100%).

Summary: This scoping review reveals a paucity of literature on studies of RSV tests in specific populations and settings, highlighting the need for further assessments. Considering the implications of these results in the current pandemic landscape, the authors preliminarily suggest adopting molecular-based RSV tests for first-line use in these settings.

Keywords: clinical; infectious disease; molecular diagnostics; nucleic-acid-based testing; point-of-care testing systems; viral diseases.

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Figures

Fig. 1.
Fig. 1.
Flow chart summarizing data sources and study selection. Duplicate articles and ineligible publication types were excluded at the screening step (n = 1297). Where 1 article reported several relevant sensitivity and specificity values (e.g., when more than 1 RSV test was studied), then each test was extracted as a subrecord. The 77 included studies corresponded to 133 included subrecords.
Fig. 2.
Fig. 2.
Trends in study design and patient and setting characteristics in studies included in the review. DFA, direct fluorescent antibody test; IFA, immunofluorescence assay; NP, nasopharyngeal.
Fig. 3.
Fig. 3.
Published sensitivity and specificity of RSV tests under CLIA guidance. The published sensitivity, specificity, and analytical time are shown for the RSV tests included in this review that were CLIA-waived (A) and classed as moderate/high complexity (B). To support interpretation of the diagnostic performance data, the number of studies that were used to extract the published sensitivity and specificity values can be found in Table 3.
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