Clinical Performance of Self-Collected Nasal Swabs and Antigen Rapid Tests for SARS-CoV-2 Detection in Resource-Poor Settings
Abstract
:1. Introduction
2. Materials and Methods
2.1. Study Setting and Participants
2.2. Sample Collection
2.3. Sample Size
2.4. Antigen Rapid Test (Ag-RDT) Testing
2.5. Real-Time PCR Testing
2.6. Data Analysis
3. Results
3.1. Characteristics of Study Population
3.2. Performance of Nasal Swabs for SARS-CoV-2 Detection
3.3. Performance of Nasal Swab-Based Antigen Rapid Tests for SARS-CoV-2 Detection
4. Discussion
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
References
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Nasal Swabs Self-Collection 1 | Abbott Panbio 2 | Covios 3 | Lumira Dx 4 | ||||||
---|---|---|---|---|---|---|---|---|---|
N = 1498 | % | N = 400 | % | N = 1123 | % | N = 696 | % | ||
Gold standard 5 (RT-PCR or OP 6 swabs) | Negative | 1229 | 82.04 | 186 | 46.5 | 586 | 53.0 | 310 | 44.54 |
Positive | 269 | 17.96 | 214 | 53.5 | 520 | 47.0 | 386 | 55.46 | |
Invalid | -- 7 | -- | -- | -- | -- | -- | -- | -- | |
Indeterminate | -- | -- | -- | -- | -- | -- | -- | -- | |
Technology under evaluation 8 | Negative | 1227 | 81.91 | 228 | 57.0 | 773 | 68.8 | 379 | 54.45 |
Positive | 260 | 17.36 | 172 | 43.0 | 346 | 30.8 | 314 | 45.11 | |
Invalid | -- | -- | -- | -- | 4 | 0.4 | 3 | 0.43 | |
Indeterminate | 11 | 0.73 | -- | -- | -- | -- | -- | -- | |
Study sites | CSM 9 | 200 | 13.35 | -- | -- | -- | -- | 256 | 36.78 |
HGM 10 | 225 | 15.02 | -- | -- | 343 | 30.5 | 300 | 43.10 | |
HGC 11 | 384 | 25.63 | 400 | 100 | 395 | 35.2 | -- | -- | |
HPM 12 | 577 | 38.52 | -- | -- | 385 | 34.3 | 140 | 20.11 | |
HCM 13 | 112 | 7.48 | -- | -- | -- | -- | -- | -- | |
Age | Median in years | 35.0 | -- | 38.02 | -- | 33.0 | -- | 36.23 | -- |
Sex | Female | 764 | 52.04 | 228 | 57.0 | 644 | 57.4 | 381 | 54.74 |
Male | 734 | 48.9 | 172 | 43.0 | 479 | 42.6 | 315 | 45.26 | |
Symptoms | Yes | 1356 | 90.52 | 397 | 99.25 | 1115 | 99.3 | 575 | 82.61 |
No | 141 | 9.48 | 3 | 0.75 | 8 | 0.7 | 121 | 17.39 | |
Onset symptoms | ≤7 days | 1168 | 86.13 | 369 | 92.95 | 1033 | 92.0 | 519 | 90.26 |
>7 days | 188 | 13.87 | 28 | 7.05 | 82 | 7.3 | 56 | 9.74 | |
Ct Value of PCR in OP samples, median (min-max) | 24.7 (5.7–36.5) | NA 14 | 26.7 (9.0–37.3) | NA | 25.2 (5.1–39.0) | NA | 25.1 (3.7–35.9) | NA |
Diagnostic Test | Patient Type | Sensitivity | Specificity | PPV | NPV | Observed Agreement | Cohen’s Kappa |
---|---|---|---|---|---|---|---|
Self-collected nasal swab | Overall N = 1498 | 80.6% [75.3–85.2%] | 96.4% [95.2–97.4%] | 83.1% [78.0–87.4%] | 95.8% [94.5–96.8%] | 93.5% [34.7–94.7%] | 0.78 [0.77–0.79] |
Symptomatic N = 1356 | 81.0% [75.5–85.7%] | 96.7% [95.5–97.7%] | 84.5% [79.2–88.9%] | 95.9% [94.5–97.0%] | 93.9% [34.7–95.1%] | 0.79 [0.78–0.79] | |
Asymptomatic N = 141 | 90.5% [69.6–98.8%] | 93.1% [86.9–97.0%] | 70.4% [49.8–86.2%] | 98.2% [93.8–99.8%] | 92.7% [31.0–96.4%] | 0.75 [0.67–0.83] | |
Symptoms ≤ 7 d 1 N = 1168 | 81.1% [75.2–86.2%] | 96.5% [95.1–97.6%] | 83.9% [78.1–88.7%] | 95.8% [94.3–97.0%] | 93.7% [34.6–95.0%] | 0.79 [0.78–0.80] | |
Symptoms > 7 d N = 188 | 93.3% [68.1–99.8] | 98.1% [93.4–99.8%] | 87.5% [61.7–98.4%] | 99.0% [94.8–100.0%] | 97.5% [30.7–99.5%] | 0.89 [0.78–0.99] | |
Abbott Panbio Nasal RDT | Overall N = 400 | 79.7% [73.3–85.1%] | 97.2% [93.5–99.1%] | 96.8% [92.8–99.0%] | 81.4% [75.5–86.4%] | 88.0% [41.9–91.2%] | 0.71 [0.70–0.72] |
Symptomatic N = 397 | 79.9% [73.3–85.1%] | 97.1% [93.4–99.1%] | 96.8% [92.8–99.0%] | 81.2% [75.2–86.2%] | 87.9% [42.1–91.1%] | 0.71 [0.70–0.72] | |
Asymptomatic N = 3 | NA | NA | NA | NA | NA | NA | |
Symptoms ≤ 7 d N = 369 | 80.0% [73.3–85.7%] | 96.9% [93.0–99.0%] | 96.6% [92.1–98.9%] | 81.9% [75.7–87.0%] | 88.2% [41.7–91.4%] | 0.71 [0.70–0.72] | |
Symptoms > 7 d N = 28 | 76.5% [50.1–93.1%] | 100.0% [69.2–NA] | 100.0% [75.3–NA] | 71.4% [41.9–91.6%] | 85.2% [34.1–95.8%] | 0.72 [0.59–0.85] | |
Overall N= 1102 | 59.6% [55.2–63.8%] | 94.9% [92.8–96.5%] | 91.1% [87.6–93.9%] | 72.6% [69.3–75.8%] | 78.3% [37.0–80.7%] | 0.56 [0.551–0.560] | |
Symptomatic N= 1094 | 59.7% [55.3–64.0%] | 94.8% [92.7–96.5%] | 91.1% [87.5–93.9%] | 72.7% [69.3–75.8%] | 78.3% [37.0–80.7%] | 0.56 [0.552–0.561] | |
COVIOS Ag COVID-19 | Asymptomatic N= 8 | 33.3% [0.8–90.6%] | 100.0% [47.8–NA] | 100.0% [2.5–NA] | 71.4% [29.0–96.3%] | 75.0% [13.3–96.8%] | 0.38 [-0.628–1.397] |
Symptoms ≤ 7 d N= 1013 | 60.9% [56.5–65.2%] | 94.6% [92.2–96.4%] | 91.6% [88.0–94.3%] | 71.4% [67.8–74.7%] | 78.0% [37.6–80.5%] | 0.56 [0.553–0.562] | |
Symptoms > 7 d N= 81 | 20.0% [4.3–48.1%] | 97.0% [89.5–99.6%] | 60.0% [14.7–94.7%] | 84.2% [74.0–91.6%] | 82.7% [25.8–90.2%] | 0.23 [-0.156–0.613] | |
LumiraDx SARS-CoV-2 Ag Test | Overall N = 696 | 78.0% [73.5–82.0%] | 95.8% [92.9–97.7%] | 95.9% [93.0–97.8%] | 77.6% [73.0–81.7%] | 85.9% [43.7–88.4%] | 0.72 [0.72–0.73] |
Symptomatic N = 575 | 79.9% [75.4–83.9%] | 95.7% [92.0–98.0%] | 97.0% [94.4–98.6%] | 73.4% [67.7–78.5%] | 85.7% [47.2–88.5%] | 0.71 [0.70–0.72] | |
Asymptomatic N = 121 | 47.8% [26.8–69.4%] | 95.9% [89.8–98.9%] | 73.3% [44.9–92.2%] | 88.6% [80.9–94.0%] | 86.7% [28.7–92.2%] | 0.50 [0.36–0.65] | |
Symptoms ≤ 7 d N = 519 | 81.6% [77.0–85.6%] | 96.2% [92.4–98.5%] | 97.5% [94.9–99.0%] | 74.6% [68.6–80.0%] | 86.8% [47.9–89.6%] | 0.73 [0.72–0.74] | |
Symptoms > 7 d N = 56 | 62.5% [43.7–78.9%] | 91.7% [73.0–99.0%] | 90.9% [70.8–98.9%] | 64.7% [46.5–80.3%] | 75.0% [32.2–85.6%] | 0.52 [0.44–0.59] |
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Sitoe, N.; Sambo, J.; Mabunda, N.; Nguenha, N.; Chilaúle, J.; Rafael, J.; Macicame, A.; Chelene, I.; Mudenyanga, C.; Sacks, J.; et al. Clinical Performance of Self-Collected Nasal Swabs and Antigen Rapid Tests for SARS-CoV-2 Detection in Resource-Poor Settings. Biomedicines 2022, 10, 2327. https://doi.org/10.3390/biomedicines10092327
Sitoe N, Sambo J, Mabunda N, Nguenha N, Chilaúle J, Rafael J, Macicame A, Chelene I, Mudenyanga C, Sacks J, et al. Clinical Performance of Self-Collected Nasal Swabs and Antigen Rapid Tests for SARS-CoV-2 Detection in Resource-Poor Settings. Biomedicines. 2022; 10(9):2327. https://doi.org/10.3390/biomedicines10092327
Chicago/Turabian StyleSitoe, Nádia, Júlia Sambo, Nédio Mabunda, Neuza Nguenha, Jorfélia Chilaúle, Júlio Rafael, Anésio Macicame, Imelda Chelene, Chishamiso Mudenyanga, Jillian Sacks, and et al. 2022. "Clinical Performance of Self-Collected Nasal Swabs and Antigen Rapid Tests for SARS-CoV-2 Detection in Resource-Poor Settings" Biomedicines 10, no. 9: 2327. https://doi.org/10.3390/biomedicines10092327
APA StyleSitoe, N., Sambo, J., Mabunda, N., Nguenha, N., Chilaúle, J., Rafael, J., Macicame, A., Chelene, I., Mudenyanga, C., Sacks, J., Viegas, S., Loquiha, O., & Jani, I. (2022). Clinical Performance of Self-Collected Nasal Swabs and Antigen Rapid Tests for SARS-CoV-2 Detection in Resource-Poor Settings. Biomedicines, 10(9), 2327. https://doi.org/10.3390/biomedicines10092327