Assessment of a Multiplex LAMP Assay (Eazyplex® CSF Direct M) for Rapid Molecular Diagnosis of Bacterial Meningitis: Accuracy and Pitfalls
Abstract
:1. Introduction
2. Materials and Methods
2.1. Clinical Samples
2.2. Ethics Approval
2.3. Eazyplex® CSF Direct M Testing
2.4. Routine Testing
2.5. Data Analysis and Discrepancy Investigation
2.6. Eazyplex® Panel Performance Analysis
2.7. Statistical Analysis
3. Results
3.1. Population and Sample Description
3.2. Impact of CSF Protein Concentration, WBC and RBC Counts on LAMP Inhibition
3.3. Amplification Curves Analysis
3.4. Eazyplex® Panel Results
3.5. Eazyplex® Panel Performance
4. Discussion
5. Conclusions
Supplementary Materials
Author Contributions
Funding
Acknowledgments
Conflicts of Interest
References
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All Samples | Results by Age Groups | |||||
---|---|---|---|---|---|---|
N = 230 | ≤2 Months | 3–11 Months | 1–15 Years | 16–64 Years | ≥65 Years | |
N = 24 | N = 6 | N = 29 | N = 117 | N = 54 | ||
Positive results, number (% of total) | 32 (13.9) | 3 (12.5) | 3 (50) | 8 (27.6) | 14 (12) | 4 (7.4) |
N. meningitidis, number (% of positive samples) | 16 (50) | 0 (0) | 2 (66.7) | 5 (62.5) | 8 (57.2) | 1 (25) |
S. pneumoniae, number (% of positive samples) | 9 (28) | 0 (0) | 1 (33.3) | 2 (25) | 3 (21.5) | 3 (75) |
E. coli, number (% of positive samples) | 2 (6.3) | 1 (33.3) | 0 (0) | 0 (0) | 1 (7.1) | 0 (0) |
S. agalactiae, number (% of positive samples) | 2 (6.3) | 1 (33.3) | 0 (0) | 0 (0) | 1 (7.1) | 0 (0) |
H. influenzae, number (% of positive samples) | 2 (6.3) | 0 (0) | 0 (0) | 1 (12.5) | 1 (7.1) | 0 (0) |
L. monocytogenes, number (% of positive samples) | 1 (3.1) | 1 (33.3) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
Negative results, number (% of total) | 182 (79.1) | 18 (75) | 3 (50) | 20 (69) | 93 (79.5) | 48 (88.9) |
Invalid results, number (% of total) | 16 (7) | 3 (12.5) | 0 (0) | 1 (3.4) | 10 (8.5) | 2 (3.7) |
Target | PPA | NPA | PPV | NPV | ||||
---|---|---|---|---|---|---|---|---|
TP/(TP + FN) | % | TN/(TN + FP) | % | TP/(TP + FP) | % | TN/(TN + FN) | % | |
N. meningitidis | 16/17 | 94.1 | 170/170 | 100 | 16/16 | 100 | 170/171 | 99.4 |
S. pneumoniae | 9/9 | 100 | 170/170 | 100 | 9/9 | 100 | 170/170 | 100 |
E. coli | 2/4 | 50 | 170/170 | 100 | 2/2 | 100 | 170/172 | 98.8 |
S. agalactiae | 2/2 | 100 | 170/170 | 100 | 2/2 | 100 | 170/170 | 100 |
H. influenzae | 2/2 | 100 | 170/170 | 100 | 2/2 | 100 | 170/170 | 100 |
L. monocytogenes | 1/1 | 100 | 170/170 | 100 | 1/1 | 100 | 170/170 | 100 |
Overall | 32/35 | 91.4 | 170/170 | 100 | 32/32 | 100 | 170/173 | 98.3 |
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Leroy, A.-G.; Persyn, E.; Gibaud, S.-A.; Crémet, L.; Le Turnier, P.; Benhamida, M.; Launay, E.; Guillouzouic, A.; Bémer, P.; Corvec, S.; et al. Assessment of a Multiplex LAMP Assay (Eazyplex® CSF Direct M) for Rapid Molecular Diagnosis of Bacterial Meningitis: Accuracy and Pitfalls. Microorganisms 2021, 9, 1859. https://doi.org/10.3390/microorganisms9091859
Leroy A-G, Persyn E, Gibaud S-A, Crémet L, Le Turnier P, Benhamida M, Launay E, Guillouzouic A, Bémer P, Corvec S, et al. Assessment of a Multiplex LAMP Assay (Eazyplex® CSF Direct M) for Rapid Molecular Diagnosis of Bacterial Meningitis: Accuracy and Pitfalls. Microorganisms. 2021; 9(9):1859. https://doi.org/10.3390/microorganisms9091859
Chicago/Turabian StyleLeroy, Anne-Gaëlle, Elise Persyn, Sophie-Anne Gibaud, Lise Crémet, Paul Le Turnier, Myriam Benhamida, Elise Launay, Aurélie Guillouzouic, Pascale Bémer, Stéphane Corvec, and et al. 2021. "Assessment of a Multiplex LAMP Assay (Eazyplex® CSF Direct M) for Rapid Molecular Diagnosis of Bacterial Meningitis: Accuracy and Pitfalls" Microorganisms 9, no. 9: 1859. https://doi.org/10.3390/microorganisms9091859