Evaluation of VIDAS® Diagnostic Assay Prototypes Detecting Dengue Virus NS1 Antigen and Anti-Dengue Virus IgM and IgG Antibodies
Abstract
:1. Introduction
2. Materials and Methods
2.1. Patients and Samples
2.2. Study Design and Definition
2.3. VIDAS® Assays
2.4. Competitor Assays
2.5. Statistical Analyses
3. Results
3.1. Patients’ Characteristics
3.2. VIDAS® Index Distribution
3.3. Positive Agreement of Dengue NS1 Antigen Assays with RT-PCR as Gold Standard
3.4. Comparison of VIDAS® DENGUE NS1 Ag Assay with Competitor Assays
3.5. Comparison of VIDAS® Anti-DENGUE IgM Assay with Competitor Assays
3.6. Comparison of VIDAS® Anti-DENGUE IgG Assay with Competitor Assays
3.7. Negative Agreement of the VIDAS® NS1 Antigen and Anti-DENV IgM and IgG Assays with Competitor Assays Conducted on Healthy Donor Samples
4. Discussion
5. Conclusions
Supplementary Materials
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
References
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Study population, N (%) | 91 (100.0%) |
Adults | 57 (62.6%) |
Children | 34 (37.4%) |
Age in years, median (range) | |
Total | 21.0 (5–63) |
Adults | 27.0 (19–63) |
Children | 11.5 (5–18) |
Gender, N (%) | |
Female | 51 (56.0%) |
Male | 40 (44.0%) |
Serotype, N (%) | |
DENV-1 | 3 (3.3%) |
DENV-2 | 4 (4.4%) |
DENV-3 | 10 (11.0%) |
DENV-4 | 3 (3.3%) |
Unknown | 71 (78.0%) |
Time to symptom onset in days, median (range) | |
Total (N = 87) | 4.0 (0.0–12.0) |
Adults (N = 54) | 4.5 (0.0–12.0) |
Children (N = 33) | 3.0 (0.0–8.0) |
Unknown (N = 4) | N/A |
Acute infection status, N (%) | |
PCR+/NS1+ (FOCUS) | 47 (51.6%) |
PCR−/NS1+ (FOCUS) | 35 (38.5%) |
PCR+/NS1− (FOCUS) | 9 (9.9%) |
Reference Test | Population | VIDAS | FOCUS | RDT 1 | |||
---|---|---|---|---|---|---|---|
n/N | % [95% CI] | n/N | % [95% CI] | n/N | % [95% CI] | ||
RT-PCR | Total | 48/56 | 85.7% [74.3–92.6] | 47/56 | 83.9% [72.2–91.3] | 40/55 | 72.7% [59.8–82.7] |
Adults | 31/39 | 79.5% [64.5–89.2] | 31/39 | 79.5% [64.5–89.2] | 24/38 | 63.2% [47.3–76.6] | |
Children | 17/17 | 100.0% [80.5–100.0] | 16/17 | 94.1% [73.0–99.0] | 16/17 | 94.1% [73.0–99.0] |
Reference Test | Population | Positive Agreement | Negative Agreement | Overall Agreement | |||
---|---|---|---|---|---|---|---|
n/N | % [95% CI] | n/N | % [95% CI] | n/N | % [95% CI] | ||
Dengue NS1 Antigen DxSelect™ (Focus) | Total | 80/82 | 97.6% [91.5–99.7] | 7/9 | 77.8% [45.3–93.7] | 87/91 | 95.6% [89.1–98.8] |
Adults | 48/49 | 98.0% [89.1–99.9] | 7/8 | 87.5% [52.9–97.8] | 55/57 | 96.5% [87.9–99.6] | |
Children | 32/33 | 97.0% [84.2–99.9] | 0/1 | 0.0% [0.0–97.5] | 32/34 | 94.1% [80.9–98.4] | |
NS1 RDT 1 | Total | 70/70 | 100.0% [94.9–100.0] | 9/19 | 47.4% [27.3–68.3] | 79/89 | 88.8% [80.5–93.8] |
Adults | 41/41 | 100.0% [91.4–100.0] | 8/15 | 53.3% [30.1–75.2] | 49/56 | 87.5% [76.4–93.8] | |
Children | 29/29 | 100.0% [88.1–100.0] | 1/4 | 25.0% [4.6–69.9] | 30/33 | 90.9% [76.4–96.9] |
Reference Test | Population | Positive Agreement | Negative Agreement | Overall Agreement | |||
---|---|---|---|---|---|---|---|
n/N | % [95% CI] | n/N | % [95% CI] | n/N | % [95% CI] | ||
Panbio Dengue IgM Capture ELISA | Total | 40/49 | 81.6% [68.6–90.0] | 26/42 | 61.9% [46.8–75.0] | 66/91 | 72.5% [62.6–80.6] |
Adults | 25/31 | 80.6% [63.7–90.8] | 16/26 | 61.5% [42.5–77.6] | 41/57 | 71.9% [59.2–81.9] | |
Children | 15/18 | 83.3% [60.8–94.2] | 10/16 | 62.5% [38.6–81.5] | 25/34 | 73.5% [56.9–85.4] | |
IgM RDT 1 | Total | 31/36 | 86.1% [71.3–93.9] | 26/47 | 55.3% [41.2–68.6] | 57/83 | 68.7% [58.1–77.6] |
Adults | 21/25 | 84.0% [65.3–93.6] | 16/28 | 57.1% [39.1–73.5] | 37/53 | 69.8% [56.5–80.5] | |
Children | 10/11 | 90.9% [62.3–98.4] | 10/19 | 52.6% [31.7–72.7] | 20/30 | 66.7% [48.8–80.8] |
Reference Test | Population | Positive Agreement | Negative Agreement | Overall Agreement | |||
---|---|---|---|---|---|---|---|
n/N | % [95% CI] | n/N | % [95% CI] | n/N | % [95% CI] | ||
Panbio Dengue IgG Indirect ELISA | Total | 55/72 | 76.4% [65.4–84.7] | 15/19 | 78.9% [56.7–91.5] | 70/91 | 76.9% [67.3–84.4] |
Adults | 37/46 | 80.4% [66.8–89.3] | 8/11 | 72.7% [43.4–90.3] | 45/57 | 78.9% [66.7–87.5] | |
Children | 18/26 | 69.2% [50.0–83.5] | 7/8 | 87.5% [52.9–97.8] | 25/34 | 73.5% [56.9–85.4] | |
IgG RDT 1 | Total | 33/37 | 89.2% [75.3–95.7] | 24/46 | 52.2% [38.1–65.9] | 57/83 | 68.7% [58.1–77.6] |
Adults | 27/29 | 93.1% [78.0–98.1] | 14/24 | 58.3% [38.8–75.5] | 41/53 | 77.4% [64.5–86.5] | |
Children | 6/8 | 75.0% [40.9-92.9] | 10/22 | 45.5% [26.9–65.3] | 16/30 | 53.3% [36.1–69.8] |
Age in Years, Median (Range) | 32.0 (18–69) |
---|---|
Gender, N (%) | |
Female | 34 (66.7%) |
Male | 17 (33.3%) |
Source of samples, N (%) | |
EFS, France | 51 (100.0%) |
Population | VIDAS® NS1 | VIDAS® IgM | VIDAS® IgG | |||
---|---|---|---|---|---|---|
n/N | % [95% CI] | n/N | % [95% CI] | n/N | % [95% CI] | |
Adult healthy donors 1 | 51/51 | 100.0% [93.0–100.0] | 51/51 | 100.0% [93.0–100.0] | 49/51 | 96.1% [86.5–99.5] |
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Somlor, S.; Brossault, L.; Grandadam, M. Evaluation of VIDAS® Diagnostic Assay Prototypes Detecting Dengue Virus NS1 Antigen and Anti-Dengue Virus IgM and IgG Antibodies. Diagnostics 2021, 11, 1228. https://doi.org/10.3390/diagnostics11071228
Somlor S, Brossault L, Grandadam M. Evaluation of VIDAS® Diagnostic Assay Prototypes Detecting Dengue Virus NS1 Antigen and Anti-Dengue Virus IgM and IgG Antibodies. Diagnostics. 2021; 11(7):1228. https://doi.org/10.3390/diagnostics11071228
Chicago/Turabian StyleSomlor, Somphavanh, Ludovic Brossault, and Marc Grandadam. 2021. "Evaluation of VIDAS® Diagnostic Assay Prototypes Detecting Dengue Virus NS1 Antigen and Anti-Dengue Virus IgM and IgG Antibodies" Diagnostics 11, no. 7: 1228. https://doi.org/10.3390/diagnostics11071228