Table 4.
Detection of 13 enteric agents in 122 specimens.
| Pathogen | Qiaxcel+b
referencea+ |
Qiaxcel+ reference− |
Qiaxcel− reference+ |
Qiaxcel− reference− |
Sensitivity | Specificity | Agreement | Kappa value |
|---|---|---|---|---|---|---|---|---|
| Norovirus GI | 5 | 0 | 1 | 116 | 83.33% | 100% | 99.18% | 0.9048 |
| Rotavirus | 30 | 5 | 0 | 87 | 100% | 94.57% | 95.9% | 0.8954 |
| Norovirus GII | 40 | 0 | 5 | 77 | 88.98% | 100% | 95.9% | 0.9099 |
| Human astrovirus | 13 | 0 | 0 | 109 | 100% | 100% | 100% | 1 |
| Enteric adenovirus | 13 | 2 | 0 | 107 | 100% | 98.17% | 98.36% | 0.9194 |
| Human bocavirus | 5 | 0 | 0 | 117 | 100% | 100% | 100% | 1 |
| Shigella c | 4 | 0 | 1 | 117 | 80% | 100% | 99.18% | 0.8847 |
| Vibrio parahaemolyticus | 0 | 0 | 0 | 122 | ||||
| EHEC and EPEC | 1 | 0 | 0 | 121 | 100% | 100% | 100% | 1 |
| Salmonella | 3 | 0 | 0 | 119 | 100% | 100% | 100% | 1 |
| Yersinia | 0 | 0 | 0 | 122 | ||||
| Vibrio cholerae | 0 | 0 | 0 | 122 | ||||
| Campylobacter jejuni | 0 | 0 | 0 | 122 |
aThe definition of “reference results” was described in “Virus, Strains, and Clinical Samples.” Virus was identified using a commercial ELISA kit, reported multiplex PCR assay, and monoplex PCR followed by sequencing at DD-IVDC [13–16]. All specimens were processed by routine isolation/culture to identify different enteropathogenic bacteria at DD-ICDC. The diarrheagenic Escherichia coli were identified using multiplex real-time PCR assay [17].
bThe numbers of positive and negative specimens detected by the two-tube assay were indicated as Qiaxcel+ and Qiaxcel−, respectively. The numbers of positive and negative specimens detected by the reference assay were indicated as reference+ and reference−, respectively.
cThe two-tube assay was not able to distinguish Shigella from EIEC, so Shigella positive detected by the two-tube assay could be Shigella or EIEC. These 5 samples (reference+) were confirmed by sequencing.