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Volume 27, Number 5—May 2021
Research

Engineered NS1 for Sensitive, Specific Zika Virus Diagnosis from Patient Serology

Thai Leong Yap1, Shin Yee Hong1, Jun Hui Soh, Lekha Ravichandraprabhu, Vanessa W.X. Lim, Hsi-Min Chan, Tommy Z.X. Ong, Ying Ping Chua, Shi En Koh, Huajing Wang, Yee Sin Leo, Jackie Y. Ying, and William SunComments to Author 
Author affiliations: Experimental Drug Development Centre, Singapore (T.L. Yap, S.Y. Hong); Institute of Bioengineering and Nanotechnology, Singapore (T.L. Yap, S.Y. Hong, L. Ravichandraprabhu, T.Z.X. Ong, Y.P. Chua, S.E. Koh, H. Wang, W. Sun); NanoBio Lab, Singapore (J.H. Soh, H.-M. Chan, J.Y. Ying); National Centre for Infectious Diseases, Singapore (V.W.X. Lim, Y.S. Leo); Tan Tock Seng Hospital, Singapore (Y.S. Leo); Yong Loo Lin School of Medicine, National University of Singapore (Y.S. Leo, W. Sun).

Main Article

Table 2

Sensitivity and specificity results for validation set in blinded evalution for study of Zika diagnosis, Singapore*

Phase Sensitivity, % (95% CI)
 Specificity, % (95% CI)
ELISA Lateral flow
 ELISA Lateral flow
F1 F2 F1 F2
Acute, 1–6 dpo
IgM 41.4 (29.8–53.8) 51.4 (39.2–63.6) 50.0 (37.8–62.2) 100.0 (95.5–100.0) 95.1 (87.8–98.6) 97.5 (0.91–1.00)
IgG 22.9 (13.7–34.4) 44.3 (32.4–56.7) 20.0 (11.4–31.3) 98.8 (93.3–100.0) 92.6 (84.6–97.2) 98.8 (0.93–1.00)
IgM/IgG 52.9 (40.6–64.9) 68.6 (56.4–79.1) 60.0 (47.6–71.5) 98.8 (93.3–100.0) 88.9 (80.0–94.8) 96.3 (0.90–0.99)
NS1 41.4 (29.8–53.8) NP NP 97.5 (91.4–99.7) NP NP
IgM/NS1 55.7 (43.3–67.6) NP NP 97.5 (91.4–99.7) NP NP
IgG/NS1 61.4 (49.0–72.8) NP NP 96.3 (89.6–99.2) NP NP
IgM/IgG/NS1
 67.1 (54.9–77.9)
 NP
 NP
96.3 (89.6–99.2)
 NP
 NP
Convalescent, 7–21 dpo
IgM 79.2 (65.0–89.5) 70.8 (55.9–83.0) 70.8 (55.9–83.0) 95.7 (88.0–99.1) 87.1 (77.0–93.9) 94.3 (86.0–98.4)
IgG 83.3 (69.8–92.5) 89.6 (77.3–96.5) 79.2 (65.0–89.5) 84.3 (73.6–91.9) 78.6 (67.1–87.5) 90.0 (80.5–95.9)
IgM/IgG 89.6 (77.3–96.5) 89.6 (77.3–96.5) 87.5 (74.8–95.3) 80 (68.7–88.6) 68.6 (56.4–79.1) 84.3 (73.6–91.9)

*ELISA and IA assays were evaluated for the detection of NS1, IgM, and IgG with TTSH plasma samples (ZIKV: n = 70 with 1–6 dpo, and n = 48 with 7–16 dpo; DENV: n = 81 with 1–6 dpo, and n = 70 with 7–21 dpo. Sensitivity and specificity were determined with positive plasmas divided by the total number of respective ZIKV and DENV plasma samples. DENV, dengue virus; dpo, days postonset of symptoms; F1, capture format; F2, detector format; IA, immunochromatographic assay; NP, not performed (NS1 antigen test was not performed in the lateral flow formats because of low sensitivity); NS1, nonstructural protein 1; ZIKV, Zika virus.

Main Article

1These authors contributed equally to this article.

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