Rapid Test Ag 2019-nCoV (PROGNOSIS, BIOTECH, Larissa, Greece); Performance Evaluation in Hospital Setting with Real Time RT-PCR
Abstract
:1. Introduction
- To estimate the sensitivity and specificity of a local produced and recently approved RAT, Rapid Test Ag 2019-nCoV (PROGNOSIS, BIOTECH, Larissa, Greece), in a hospital setting.
- To evaluate its accuracy for viral load determination in comparison to the reference method RT-qPCR.
2. Material and Methods
2.1. Ethics Statement
2.2. Principal of the Assay
2.3. Limit of Detection (LOD) Estimation
2.4. Determination of Clinical Sensitivity-Specificity
2.5. Reader Description and Standard Curve
2.6. Statistical Analysis
3. Results
3.1. Determination of the Lower Limit of Detection (LOD)
3.2. Clinical Evaluation
3.3. Semi-Quantification Using the Standard Curve
4. Discussion
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
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Viral Load (gc/mL) | N Gene Ct Value | Test Line Density (T) | Control Line Density (C) | Ratio T/C | |
---|---|---|---|---|---|
1 | 187 500 | 22.6 | 387.817 | 266.465 | 1.452 |
2 | 18 750 | 27.5 | 111.206 | 252.339 | 0.441 |
3 | 1 875 | 30.7 | 16.153 | 237.341 | 0.068 |
4 | 937.5 | 31.6 | 10.191 | 226.687 | 0.045 |
5 | 468.8 | 32.5 | 7.152 | 217.968 | 0.033 |
6 | 0 (negative control) | undetermined | 0.255 | 203.568 | 0.001 |
Sensitivity (%) | Specificity (%) | Inter-Rater Agreement (Kappa) | PPV (%) | NPV (%) | |||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Positive Samples (n) | 95% CI | Negative Samples (n) | 95% CI | 95% CI | Prevalence | Prevalence | |||||||||||
1‰ | 1% | 5% | 1‰ | 1% | 5% | ||||||||||||
Total | 141/165 | 85.5 | 79.1 | 90.5 | 458/459 | 99.8 | 98.8 | 100.0 | 0.89 | 85.1 | 93.3 | 28.2 | 79.9 | 95.4 | 99.99 | 99.9 | 99.2 |
Ct < 30 | 141/156 | 90.4 | 84.6 | 94.5 | 0.93 | 89.5 | 96.3 | 28.6 | 80.7 | 95.6 | 99.99 | 99.9 | 99.5 |
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Kyritsi, M.; Vontas, A.; Voulgaridi, I.; Matziri, A.; Komnos, A.; Babalis, D.; Papadogoulas, A.; Oikonomou, A.; Mouchtouri, V.A.; Speletas, M.; et al. Rapid Test Ag 2019-nCoV (PROGNOSIS, BIOTECH, Larissa, Greece); Performance Evaluation in Hospital Setting with Real Time RT-PCR. Int. J. Environ. Res. Public Health 2021, 18, 9151. https://doi.org/10.3390/ijerph18179151
Kyritsi M, Vontas A, Voulgaridi I, Matziri A, Komnos A, Babalis D, Papadogoulas A, Oikonomou A, Mouchtouri VA, Speletas M, et al. Rapid Test Ag 2019-nCoV (PROGNOSIS, BIOTECH, Larissa, Greece); Performance Evaluation in Hospital Setting with Real Time RT-PCR. International Journal of Environmental Research and Public Health. 2021; 18(17):9151. https://doi.org/10.3390/ijerph18179151
Chicago/Turabian StyleKyritsi, Maria, Alexandros Vontas, Ioanna Voulgaridi, Alexia Matziri, Apostolos Komnos, Dimitris Babalis, Antonios Papadogoulas, Aikaterini Oikonomou, Varvara A. Mouchtouri, Matthaios Speletas, and et al. 2021. "Rapid Test Ag 2019-nCoV (PROGNOSIS, BIOTECH, Larissa, Greece); Performance Evaluation in Hospital Setting with Real Time RT-PCR" International Journal of Environmental Research and Public Health 18, no. 17: 9151. https://doi.org/10.3390/ijerph18179151