Diagnostic Performance of SARS-CoV-2 Rapid Antigen Test in a Large, German Cohort
Abstract
:1. Introduction
2. Materials and Methods
2.1. Study Cohort and Recruiting Period
2.2. Diagnostic Procedures
2.3. Clinical Data
2.4. Statistical Analysis
3. Results
3.1. Patient Characteristics
3.2. Performance of the Rapid Antigen Test
4. Discussion
5. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
Appendix A
SARS-CoV-2 RT-PCR+ | SARS-CoV-2 RT-PCR− | ||
---|---|---|---|
SARS-CoV-2 rapid antigen test+ | 22 (0.6%) | 15 (0.4%) | 37 (1.0%) |
SARS-CoV-2 rapid antigen test− | 58 (1.6%) | 3591 (97.4%) | 3649 (99.0%) |
80 (2.2%) | 3606 (97.2%) | 3686 (100.0%) |
Overall Asymptomatic Subjects | Overall Symptomatic Subjects | |
---|---|---|
Se | 20.6% [11.5–32.7%] | 52.9% [27.8–77.0%] |
Sp | 99.6% [99.3–99.8%] | 99.6% [99.3–99.7%] |
PPV | 46.4% [30.1–63.6%] | 37.5% [23.4–54.1%] |
NPV | 98.6% [98.5–98.8%] | 99.8% [99.6–99.9%] |
Pediatric 0–4 Years | Pediatric 5–14 Years | Pediatric 15–17 Years | |
---|---|---|---|
Se (95% CI) | 23.1% 5.0–53.8% | 25.0% 0.6–80.6% | 14.3% 0.4–57.9% |
Sp (95% CI) | 98.7% 97.1–99.6% | 99.3% 97.4–99.9% | 99.4% 96.9–99.9% |
N-Gene Ct-Value | ||||
<23 | ≤25 | ≤30 | ≤35 | |
Se (95% CI) | 100% 76.8–100% | 88.9% 65.3–98.6% | 76.9% 56.4–91% | 45.7% 30.9–61% |
RdRP-gene Ct-value | ||||
<23 | ≤25 | ≤30 | ≤35 | |
Se (95% CI) | 100% 71.5–100% | 91.7% 61.5–99.8% | 76.2% 52.8–91.8% | 53.5% 34.4–71.7% |
E-gene Ct-value | ||||
<21 | ≤25 | ≤30 | ≤35 | |
Se (95% CI) | 100% 54.1–100% | 84.6% 54.6–98.1% | 60% 36.1–80.9% | 38.7% 21.9–57.8% |
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Adults ≥ 18 Years (n = 2810) | Pediatric < 18 Years (n = 876) | |
---|---|---|
Demographic characteristics | ||
Gender (female) | 1820 (64.8%) | 440 (50.2%) |
Age in years, Median [IQR] | 43 (31–71) | 6 (1–14) |
Clinical characteristics of positive RT-PCR SARS-CoV-2 tested (n = 80 *) | ||
Fever > 38.5 °C | 7 (14.3%) n = 49 | 4 (16.7%) n = 24 |
Cough | 6 (12.2%) n = 49 | 3 (12.5%) n = 24 |
Rhinitis | 6 (12.2%) n = 49 | 4 (16.7%) n = 24 |
Anosmia and/or ageusia | 0 (0%) n = 49 | 1 (8.3%) n = 12 |
Diarrhea | 0 (0%) n = 49 | 2 (8.3%) n = 24 |
Vomiting | 0 (0%) n = 49 | 0 (0%) n = 24 |
Age in Years | Number of Subjects | Gender (Female) |
---|---|---|
0–4 | 410 (11.1%) | 185 (45.1%) |
5–14 | 283 (7.7%) | 151 (53.3%) |
15–17 | 183 (5.0%) | 104 (84.1%) |
18–34 | 1010 (27.4%) | 913 (90.4%) |
35–59 | 751 (20.4%) | 460 (61.2%) |
60–79 | 639 (17.3%) | 247 (38.7%) |
>80 | 410 (11.1%) | 200 (48.7%) |
Overall Study Population | Adults ≥ 18 Years | Pediatric < 18 Years | |
---|---|---|---|
Se | 27.5% [18.1–38.6%] | 30.4% [18.8–44.1%] | 20.8% [7.1–42.2%] |
Sp | 99.6% [99.3–99.8%] | 99.8% [99.5–99.9%] | 99.1% [98.2–99.6%] |
PPV * | 59.5% [44.2–73.1%] | 70.8% [51.2–84.9%] | 38.5% [18.1–63.9%] |
NPV * | 98.4% [98.2–98.6%] | 98.6% [98.3–98.8%] | 97.8% [97.3–98.2%] |
TOTAL Ct Value < 30 | TOTAL Ct Value ≥ 30 | ≥18 Years Ct Value < 30 | ≥18 Years Ct Value ≥ 30 | <18 Years Ct Value < 30 | <18 Years Ct Value ≥ 30 | |
---|---|---|---|---|---|---|
Se | 80% [59.3–93.2%] | 2.2% [0.1–11.8%] | 75% [50.1–91.3%] | 3.23% [0.1–16.7%] | 100% [47.8–100%] | 0% [0–23.2%] |
Sp | 99.6% [99.3–99.8%] | 99.6% [99.3–99.8%] | 99.8% [99.5–99.9%] | 99.8% [99.5–99.9%] | 99,6% [98.2–99.6%] | 99.1% [98.2–99.6%] |
PPV | 57.1% [43.7–69.6%] | 6.3% [0.9–33.1%] | 68.2% [49.5–82.4%] | 12.5% [1.8–53.0%] | 38.5% [23.9–55.5%] | 0 |
NPV | 99.9% [99.7–99.9%] | 98.8% [98.7–98.8%] | 99.8% [99.6–99.9%] | 98.2% [98.9–99.0%] | 100.0% | 98.4% [98.3–98.4%] |
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Mboma, O.; Rieke, E.; Ahmad-Nejad, P.; Wirth, S.; Aydin, M. Diagnostic Performance of SARS-CoV-2 Rapid Antigen Test in a Large, German Cohort. Children 2021, 8, 682. https://doi.org/10.3390/children8080682
Mboma O, Rieke E, Ahmad-Nejad P, Wirth S, Aydin M. Diagnostic Performance of SARS-CoV-2 Rapid Antigen Test in a Large, German Cohort. Children. 2021; 8(8):682. https://doi.org/10.3390/children8080682
Chicago/Turabian StyleMboma, Olivier, Elmar Rieke, Parviz Ahmad-Nejad, Stefan Wirth, and Malik Aydin. 2021. "Diagnostic Performance of SARS-CoV-2 Rapid Antigen Test in a Large, German Cohort" Children 8, no. 8: 682. https://doi.org/10.3390/children8080682