Evaluation of a New Monoclonal Chemiluminescent Immunoassay Stool Antigen Test for the Diagnosis of Helicobacter pylori Infection: A Spanish Multicentre Study
Abstract
:1. Introduction
2. Materials and Methods
2.1. Patients and Design
2.2. Stool Antigen Test
2.3. Urea Breath Test
2.3.1. Isotope Ratio Mass Spectrometry (IRMS)
2.3.2. Non-Dispersive Isotope-Selective Infrared Spectrometry (NDIRS)
2.4. H. pylori Detection by PCR
2.5. Statistical Analysis
3. Results
4. Discussion
5. Conclusions
Supplementary Materials
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
References
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Variables | |
---|---|
Age (mean ± SD) | 47.1 ± 14.4 |
N (%) | |
Gender (female) | 207 (67) |
Clinical indication | |
| 145 (47) |
| 162 (53) |
UBT method | |
| 118 (38) |
| 189 (62) |
History of peptic ulcer | 14 (5) |
H. pylori infection prevalence (by UBT) | % (95% CI) |
| 21 (16–26%) |
| 29 (21–37%) |
| 14 (8–19%) |
N = 307 |
Comparison SAT vs. UBT | Sensitivity (95% CI) | Specificity (95% CI) | PPV (95% CI) | NPV (95% CI) | LR+ (95% CI) | LR− (95% CI) | Global Accuracy (95% CI) | AUC (95% CI) |
---|---|---|---|---|---|---|---|---|
Naïve | 74% (59–88) | 96% (92–100) | 89% (77–100) | 90% (84–96) | 19 (7–51) | 0.27 (0.16–0.45) | 90% (84–95) | 0.88 (0.80–0.96) |
NDIRS naïve | 73% (54–92) | 93% (86–100) | 83% (65–100) | 89% (80–97) | 11 (4–29) | 0.29 (0.15–0.55) | 87% (80–95) | 0.86 (0.75–0.96) |
IRMS naïve | 75% (51–99) | 100% (99–100) | 100% (96–100) | 92% (82–100) | - | 0.25 (0.11–0.58) | 93% (86–100) | 0.91 (0.79–1.0) |
Comparison SAT vs. UBT | Sensitivity (95% CI) | Specificity (95% CI) | PPV (95% CI) | NPV (95% CI) | LR+ (95% CI) | LR− (95% CI) | Global Accuracy (95% CI) | AUC (95% CI) |
---|---|---|---|---|---|---|---|---|
Post-treatment | 55% (31–78) | 98% (95–100) | 80% (56–100) | 93% (89–98) | 25 (8–82) | 0.46 (0.29–0.73) | 92% (87–96) | 0.79 (0.65–0.93) |
NDIRS post-treatment | 53 % (26–80) | 99% (96–100) | 90% (66–100) | 91% (85–98) | 46 (6–336) | 0.48 (0.29–0.79) | 91% (85–97) | 0.81 (0.67–0.95) |
IRMS post-treatment | 60% (7–100) | 96% (90–100) | 60% (7–100) | 96% (90–100) | 16 (3–75) | 0.42 (0.14–1.22) | 93% (86–100) | 0.78 (0.44–1.0) |
Comparison SAT vs. UBT | Sensitivity (95% CI) | Specificity (95% CI) | PPV (95% CI) | NPV (95% CI) | LR+ (95% CI) | LR− (95% CI) | Global Accuracy (95% CI) | AUC (95% CI) |
---|---|---|---|---|---|---|---|---|
Overall | 94% (85–100) | 97% (95–99) | 86% (75–97) | 99% (97–100) | 35 (17–73) | 0.07 (0.02–0.20) | 97% (95–99) | 0.96 (0.91–1.0) |
Naïve | 91% (80–100) | 96% (93–100) | 89% (77–100) | 97% (94–100) | 25 (10–67) | 0.09 (0.03–0.27) | 95% (91–99) | 0.996 (0.99–1.0) |
Post-treatment | 100% (96–100) | 98% (95–100) | 80% (56–100) | 100% (99–100) | 50 (16–153) | 0.00 | 98% (96–100) | 0.94 (0.88–1.0) |
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Resina, E.; Donday, M.G.; Martínez-Domínguez, S.J.; Laserna-Mendieta, E.J.; Lanas, Á.; Lucendo, A.J.; Sánchez-Luengo, M.; Alcaide, N.; Fernández-Salazar, L.; De La Peña-Negro, L.; et al. Evaluation of a New Monoclonal Chemiluminescent Immunoassay Stool Antigen Test for the Diagnosis of Helicobacter pylori Infection: A Spanish Multicentre Study. J. Clin. Med. 2022, 11, 5077. https://doi.org/10.3390/jcm11175077
Resina E, Donday MG, Martínez-Domínguez SJ, Laserna-Mendieta EJ, Lanas Á, Lucendo AJ, Sánchez-Luengo M, Alcaide N, Fernández-Salazar L, De La Peña-Negro L, et al. Evaluation of a New Monoclonal Chemiluminescent Immunoassay Stool Antigen Test for the Diagnosis of Helicobacter pylori Infection: A Spanish Multicentre Study. Journal of Clinical Medicine. 2022; 11(17):5077. https://doi.org/10.3390/jcm11175077
Chicago/Turabian StyleResina, Elena, María G. Donday, Samuel J. Martínez-Domínguez, Emilio José Laserna-Mendieta, Ángel Lanas, Alfredo J. Lucendo, Marta Sánchez-Luengo, Noelia Alcaide, Luis Fernández-Salazar, Luisa De La Peña-Negro, and et al. 2022. "Evaluation of a New Monoclonal Chemiluminescent Immunoassay Stool Antigen Test for the Diagnosis of Helicobacter pylori Infection: A Spanish Multicentre Study" Journal of Clinical Medicine 11, no. 17: 5077. https://doi.org/10.3390/jcm11175077
APA StyleResina, E., Donday, M. G., Martínez-Domínguez, S. J., Laserna-Mendieta, E. J., Lanas, Á., Lucendo, A. J., Sánchez-Luengo, M., Alcaide, N., Fernández-Salazar, L., De La Peña-Negro, L., Bujanda, L., Arbulo, M. G.-R. d., Alcedo, J., Pérez-Aísa, Á., Rodríguez, R., Hermida, S., Brenes, Y., Nyssen, O. P., & Gisbert, J. P. (2022). Evaluation of a New Monoclonal Chemiluminescent Immunoassay Stool Antigen Test for the Diagnosis of Helicobacter pylori Infection: A Spanish Multicentre Study. Journal of Clinical Medicine, 11(17), 5077. https://doi.org/10.3390/jcm11175077