Evaluation of an Innovative Point-of-Care Rapid Diagnostic Test for the Identification of Imported Malaria Parasites in China
Abstract
:1. Introduction
2. Materials and Methods
2.1. Study Setting, Participants and Design
2.2. Interpretation of the Results for RDTs
2.3. Data Analysis
3. Results
3.1. Diagnostic Performance of the Novel and Wondfo RDTs
3.2. Additive NRI and Absolute NRI
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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Valid | Mixed infection of P. falciparum, P. vivax and P. ovale or/and P. malariae | Invalid | ||
Positive result for P. falciparum only | ||||
Positive result for P. vivax only | ||||
Positive result for P. ovale and/or P. malariae | ||||
Mixed infection of P. falciparum and P. vivax | ||||
Mixed infection of P. falciparum and P. ovale and/or P. malariae | ||||
Mixed infection of P. vivax and P. ovale and/or P. malariae | ||||
Negative for any Plasmodium |
Characteristics | The Novel RDTs | Wondfo RDTs | χ2 * | p-Value |
---|---|---|---|---|
Sensitivity [95% CI] | 78.37 [73.83–82.91] | 86.21 [82.40–90.01] | 11.294 * | 0.001 |
Specificity [95% CI] | 95.05 [92.51–97.59] | 89.05 [85.39–92.71] | 13.474 * | <0.001 |
PPV [95% CI] | 94.70 [91.98–97.42] | 89.87 [86.47–93.27] | 4.543 | 0.033 |
NPV [95% CI] | 79.59 [75.27–83.90] | 85.14 [81.06–89.21] | 3.318 | 0.069 |
Diagnostic accuracy rate [95% CI] | 86.21 [83.45–88.97] | 87.54 [84.90–90.19] | 0.466 | 0.495 |
Kappa value [95% CI] | 0.726 [0.779–0.673] | 0.751 [0.698–0.804] | NA | NA |
Species * | Type of RDTs | N | Results of RDTs (n) | Sensitivity (%) | χ2 # | p-Value | |
---|---|---|---|---|---|---|---|
Positive | Negative | ||||||
P. falciparum | The novel | 154 | 134 | 20 | 87.01 | 12.071 | <0.001 |
Wondfo | 154 | 148 | 6 | 96.10 | |||
P. ovale | The novel | 123 | 87 | 35 | 71.31 | 0.036 | 0.850 |
Wondfo | 123 | 88 | 34 | 72.13 | |||
P. vivax | The novel | 22 | 18 | 4 | 81.82 | 0.500 | 0.500 |
Wondfo | 22 | 20 | 2 | 90.91 | |||
P. malariae | The novel | 13 | 8 | 5 | 61.54 | 2.250 | 0.134 |
Wondfo | 13 | 12 | 1 | 92.31 |
Positive Samples (n = 309) | ||||
---|---|---|---|---|
The Novel RDTs | ||||
Wondfo RDTs | Negative | Positive | Total | |
Negative | 31 | 38 | 69 | |
Positive | 13 | 237 | 250 | |
Negative samples (n = 283) | ||||
The novel RDTs | ||||
Wondfo RDTs | Negative | Positive | Total | |
Negative | 251 | 18 | 269 | |
Positive | 1 | 13 | 14 | |
Additive NRI | 1.83% | Absolute NRI | 1.33% | |
Z | 0.673 | Z | 1.317 | |
p | 0.501 | p | 0.188 |
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Lin, K.; Wang, S.; Sui, Y.; Zhang, T.; Luo, F.; Shi, F.; Qian, Y.; Li, J.; Lu, S.; Cotter, C.; et al. Evaluation of an Innovative Point-of-Care Rapid Diagnostic Test for the Identification of Imported Malaria Parasites in China. Trop. Med. Infect. Dis. 2023, 8, 296. https://doi.org/10.3390/tropicalmed8060296
Lin K, Wang S, Sui Y, Zhang T, Luo F, Shi F, Qian Y, Li J, Lu S, Cotter C, et al. Evaluation of an Innovative Point-of-Care Rapid Diagnostic Test for the Identification of Imported Malaria Parasites in China. Tropical Medicine and Infectious Disease. 2023; 8(6):296. https://doi.org/10.3390/tropicalmed8060296
Chicago/Turabian StyleLin, Kangming, Shuqi Wang, Yuan Sui, Tao Zhang, Fei Luo, Feng Shi, Yingjun Qian, Jun Li, Shenning Lu, Chris Cotter, and et al. 2023. "Evaluation of an Innovative Point-of-Care Rapid Diagnostic Test for the Identification of Imported Malaria Parasites in China" Tropical Medicine and Infectious Disease 8, no. 6: 296. https://doi.org/10.3390/tropicalmed8060296
APA StyleLin, K., Wang, S., Sui, Y., Zhang, T., Luo, F., Shi, F., Qian, Y., Li, J., Lu, S., Cotter, C., Wang, D., & Li, S. (2023). Evaluation of an Innovative Point-of-Care Rapid Diagnostic Test for the Identification of Imported Malaria Parasites in China. Tropical Medicine and Infectious Disease, 8(6), 296. https://doi.org/10.3390/tropicalmed8060296