Potential Use of Exhaled Breath Condensate for Diagnosis of SARS-CoV-2 Infections: A Systematic Review and Meta-Analysis
Abstract
:1. Introduction
2. Materials and Methods
2.1. Search Strategy
2.2. Eligibility Criteria
- Written in Italian, English, German, French or Spanish, i.e., the languages spoken by the investigators;
- Reporting on original results, with the exclusion of reports, case series, meeting reports and conference abstracts;
- Reporting data on human samples;
- Dealing with COVID-19 cases diagnosed by means of conventional RT-qPCR tests on nasopharyngeal swabs [27];
- Reporting the raw number of true positive/true negative, and false positive/false negative results;
- Assessing the diagnostic accuracy of EBC in the diagnosis of SARS-CoV-2 infection.
2.3. Study Selection and Data Extration
- Settings of the study;
- Characteristics of reference cases;
- Characteristics of the EBC collecting device;
- Total number of true positive, true negative, false positive, false negative cases.
2.4. Quality Assessment
2.5. Quantitative Analysis
3. Results
4. Discussion
5. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
References
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Item | Definition |
---|---|
Population of interest | Adults with suspected diagnosis of SARS-CoV-2 infection |
Investigated test result | Results on RT-qPCR testing for SARS-CoV-2 infection performed on specimens collected as EBC |
Comparator test result | Results on RT-qPCR testing for SARS-CoV-2 infection performed on specimens collected by means of nasal swabs |
Outcome | SARS-CoV-2 positive status (or not) |
Reference | Location (Settings) | Design | Characteristics of the Samples | Tester | Sample Collection |
---|---|---|---|---|---|
Ryan et al. 2021 [4] | Ireland (Hospital) | Prospective Observational Single center | Convenience sample; 40 patients including: 16 NPS positive, 15 NPS negative but clinical diagnosis of COVID, 9 negative cases with another respiratory disorder | RTube Condenser (Commercial) | Participants breathed for 2 min through the mouthpiece. |
Maniscalco et al. 2021 [14] | Italy (Hospital) | Prospective Cross-Sectional Multicenter (2 independent hospitals) | Convenience Sample; 4 groups of subjects (i.e., 1 clinically suspected COVID19; 2 convalescent COVID19; 3 asymptomatic individuals at risk for COVID19; 4 asymptomatic individuals not at risk for COVID19) | Inflammacheck (Commercial) | Participants breathed into a disposable breath collection unit until enough condensate is formed (20–30 µL; usually 45 to 90 s) |
Li et al. 2021 [17] | China (Laboratory + Hospital) | Prospective Proof of Concept Cross-Sectional Multicenter (2 independent hospitals) | Convenience 27 COVID-19 cases 12 healthy volunteers | In house | Participants breathed into a exhalation tube connected to a sampling head, that in turn is connected to a collection bottle, until enough condensate is collected (1.5 mL; usually 3–5 min) |
Viklund et al. 2022 [18] | Sweden (Hospital) | Prospective Observational Single center | Convenience Samples from Healthcare workers either tested positive (No. 25) or negative (No. 11) at medical surveillance. | PExA AB (Commercial) | Participants inhaled air through a high-efficiancy particle arresting (HEPA) filter to remove ambient particles in order to remove external particles, then breathed through a mouthpiece. Three procedures were performed (normal breathing, airway opening maneuver; cough) with collection of 1.5 mL (time not specified). |
Sawano et al. 2021 [16] | Japan (Hospital) | Prospective Observational Single center | Convenience sample, 50 patients with a previous diagnosis of COVID-19 | RTube/R-tube Vent Condenser (Commercial) | Participants breathed freely through the mouthpiece to collect 0.5–1.0 mL of EBC (usually, 5 to 7 min) |
Loconsole et al. 2022 [13] | Italy (Hospital) | Prospective Observational Single center | Convenience Sample from ICU with ARDS; 17 consecutive patients | Turbo DECCS System (Commercial) | Within 24 h from the collection of conventional specimens; participants breathed freely through the mouthpiece up to 20 min in order to collect up to 1.0 mL of EBC. |
Malik et al. 2021 [31] | Germany (Hospital) | Prospective Proof of Concept Single center | Convenience sample of 100 EBC samples from 15 hospitalized patients with previous diagnosis of COVID-19 | Sens-Abues (Commercial) | Participants breathed through a filter-based device consisting of a mouthpiece, a polymeric electret filter enclosed in a plastic collection chamber. Patients inhale through the nose and tidally exhale 20 times though the mouthpiece. |
Reference | No. of Samples | TP | FP | FN | TN | Se. | Sp. | PPV | PNV | Accuracy | Cohen’s Kappa |
---|---|---|---|---|---|---|---|---|---|---|---|
Ryan et al. 2021 [4] | 25 | 15 | 0 | 1 | 9 | 93.8% | 100% | 100% | 90.0% | 96.0% | 0.915 |
Maniscalco et al. 2021 [14] | 105 | 12 | 1 | 1 | 91 | 92.3% | 98.9% | 92.3% | 98.9% | 98.1% | 0.912 |
Li et al. 2021 [17] | 39 | 3 | 0 | 7 | 29 | 30.0% | 100% | 100% | 80.6% | 82.1% | 0.389 |
Viklund et al. 2022 [18] | 36 | 7 | 2 | 16 | 11 | 30.4% | 84.6% | 77.8% | 40.7% | 50.0% | 0.122 |
Sawano et al. 2021 [16] | 39 | 16 | 0 | 24 | 0 | 38.5% | - | - | - | - | - |
Loconsole et al. 2022 [13] | 17 | 1 | 0 | 16 | 0 | 5.9% | - | - | - | - | - |
Malik et al. 2021 [31] | 100 | 70 | 0 | 30 | 0 | 70.0% | - | - | - | - | - |
Value | 95%CI | |
---|---|---|
Sensitivity | 69.5% | 26.8 to 93.4 |
Specificity | 98.3% | 87.8 to 99.8 |
Positive Likelihood Ratio | 23.608 | 20.752 to 26.464 |
Negative Likelihood Ratio | 0.433 | 0.384 to 0.482 |
Positive Predictive Value | 92.5% | 91.2% to 93.8% |
Negative Predictive Value | 77.6% | 74.3% to 80.8% |
Accuracy | 81.5% | 78.7% to 84.3% |
DOR | 51.8 | 3.276 to 821.554 |
Cohen’s K Score | 0.585 | 0.535 to 0.635 |
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Riccò, M.; Zaniboni, A.; Satta, E.; Ranzieri, S.; Marchesi, F. Potential Use of Exhaled Breath Condensate for Diagnosis of SARS-CoV-2 Infections: A Systematic Review and Meta-Analysis. Diagnostics 2022, 12, 2245. https://doi.org/10.3390/diagnostics12092245
Riccò M, Zaniboni A, Satta E, Ranzieri S, Marchesi F. Potential Use of Exhaled Breath Condensate for Diagnosis of SARS-CoV-2 Infections: A Systematic Review and Meta-Analysis. Diagnostics. 2022; 12(9):2245. https://doi.org/10.3390/diagnostics12092245
Chicago/Turabian StyleRiccò, Matteo, Alessandro Zaniboni, Elia Satta, Silvia Ranzieri, and Federico Marchesi. 2022. "Potential Use of Exhaled Breath Condensate for Diagnosis of SARS-CoV-2 Infections: A Systematic Review and Meta-Analysis" Diagnostics 12, no. 9: 2245. https://doi.org/10.3390/diagnostics12092245