Severe Acute Respiratory Syndrome Coronavirus 2 Diagnostic Tests for Border Screening During the Very Early Phase of Coronavirus Disease 2019 Pandemic: A Systematic Review and Meta-Analysis

Abstract

Diagnosis of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) during border screening among returning residents and prioritized travelers during the early phase of a pandemic can reduce the risk of importation and transmission in the community. This study aimed to compare the accuracy of various SARS-CoV-2 diagnostics and assess their potential utility as border screening for infection and immunity. Systematic literature searches were conducted in six electronic databases for studies reporting SARS-CoV-2 diagnostics (up to April 30, 2020). Meta-analysis and methodological assessment were conducted for all included studies. The performance of the diagnostic tests was evaluated with pooled sensitivity, specificity, and their respective 95% confidence intervals. A total of 5,416 unique studies were identified and 95 studies (at least 29,785 patients/samples) were included. Nucleic acid amplification tests (NAAT) consistently outperformed all other diagnostic methods regardless of the selected viral genes with a pooled sensitivity of 98% and a pooled specificity of 99%. Point-of-care (POC) serology tests had moderately high pooled sensitivity (69%), albeit lower than laboratory-based serology tests (89%), but both had high pooled specificity (96-98%). Serology tests were more sensitive for sampling collected at ≥ 7 days than ≤ 7 days from the disease symptoms onset. POC NAAT and POC serology tests are suitable for detecting infection and immunity against the virus, respectively as border screening. Independent validation in each country is highly encouraged with the preferred choice of diagnostic tool/s.

Keywords: COVID-19; acute respiratory infection; diagnostic accuracy test; molecular test; sensitivity and specificity; serologic test; systematic review.

Figure 1

Flow diagram of study selection.

Figure 2

Forest plot on diagnostic accuracy test. Sensitivity and specificity for (A) NAAT, (B) NAAT (POC), (C) serology IgG, (D) serology IgM, (E) serology IgG (POC), (F) serology IgM, and (G) Imaging (AI).

Figure 3

Forest plot on sensitivity of serology test in early and late phases of disease. (A–G) Pooled sensitivity for early phase: (A) IgG and/or IgM, (B) IgG, (C) IgM, (D) Ab, (E) IgG and/or IgM (POC), (F) IgG, and (G) IgM. (H–N) Pooled sensitivity for late phase: (H) IgG and/or IgM, (I) IgG, (J) IgM, (K) Ab, (L) IgG and/or IgM (POC), (M) IgG, and (N) IgM.

Figure 4

Forest plot on diagnostic test accuracy between symptomatic (left) and asymptomatic (right) patients. (A) NAAT, (B) serology IgG and/or IgM, (C) serology IgG and IgM, (D) serology IgG, (E) serology IgM, and (F) serology IgM (POC).

Figure 5

Forest plot on gene targets and specimen sites. (A–D) Pooled sensitivity and specificity on gene target. (A) RdRp gene, (B) ORF1 gene, (C) N gene, (D) E gene. (E–G) Pooled sensitivity and specificity on specimen sites. (E) Unspecified throat, (F) nasopharyngeal, and (G) nasal.