Table 2.
Analytical performance of enteric TaqMan Array Carda
| Organism | Linearityb R2 (efficiency, %) | LOD (equiv. no. of copies)c | Low- and high-concn CV (%) ford: |
Accuracy (%)d |
||
|---|---|---|---|---|---|---|
| Repeatability | Reproducibility | Sensitivitye | Specificity | |||
| Adenovirus | 0.997 (99.7) | 106 (100) | 1.1, 1.7 | 2.6, 4.8 | 100 | 100 |
| Astrovirus | 0.999 (93.0) | 5 × 106 (500) | 2.2, 2.6 | 3.2, 5.3 | 95 | 100 |
| Norovirus GII | 0.998 (99.2) | 5 × 106 (500) | 1.9, 1.1 | 3.5, 5.3 | 97 | 100 |
| Rotavirus | 0.993 (98.4) | 5 × 106 (500) | 1.5, 1.8 | 4.2, 7.5 | 100 | 100 |
| Sapovirus | 0.994 (94.9) | 5 × 106 (500) | 1.8, 2.9 | 5.8, 7.9 | 97 | 100 |
| EAEC | ||||||
| aaiC | 0.995 (99.7) | 105 (10) | 1.4, 2.8 | 4.2, 6.6 | 100 | 100 |
| aatA | 0.998 (95.5) | 105 (10) | 2.0, 3.0 | 6.3, 7.9 | 98 | 100 |
| STEC | ||||||
| stx1 | 0.999 (96.3) | 105 (10) | 0.9, 2.9 | 3.5, 5.8 | 100 | 100 |
| stx2 | 0.999 (94.6) | 105 (10) | 0.9, 1.8 | 4.2, 5.5 | 100 | 100 |
| EPEC | ||||||
| eae | 0.998 (100.2) | 105 (10) | 1.2, 1.5 | 3.6, 4.9 | 100 | 100 |
| bfpA | 0.998 (96.7) | 105 (10) | 0.9, 1.3 | 4.2, 5.2 | 100 | 100 |
| ETEC | ||||||
| LT | 0.998 (95.8) | 105 (10) | 0.7, 1.3 | 2.5, 3.6 | 100 | 100 |
| ST | 0.998 (95.5) | 105 (10) | 1.0, 1.1 | 3.1, 6.2 | 100 | 100 |
| EIEC/Shigella | 0.997 (104.2) | 105 (10) | 1.2, 1.3 | 3.6, 5.2 | 100 | 100 |
| Campylobacter | 0.997 (95.9) | 106 (100) | 0.9, 2.4 | 4.9, 7.2 | 100 | 100 |
| Salmonella | 0.997 (100.9) | 106 (100) | 2.3, 2.1 | 7.2, 7.5 | 98 | 100 |
| V. cholerae | 0.997 (102.1) | 106 (100) | 1.1, 1.7 | 7.6, 8.4 | 100 | 100 |
| C. difficile | 1.000 (99.4) | 106 (100) | 2.2, 1.9 | 4.2, 5.1 | 97 | 100 |
| Cryptosporidium | 0.998 (100.4) | 103 (0.1) | 2.0, 2.9 | 3.6, 6.3 | 100 | 100 |
| Giardia | 0.998 (101.4) | 103 (0.1) | 1.7, 3.0 | 5.2, 4.7 | 100 | 100 |
| E. histolytica | 0.988 (93.0) | 103 (0.1) | 2.0, 3.6 | 6.8, 6.7 | 100 | 100 |
| Ascaris | 0.993 (90.6) | 106 (100) | 1.3, 2.5 | 4.5, 7.3 | 100 | 100 |
| Trichuris | 0.999 (94.6) | 106 (100) | 0.7, 0.7 | 3.6, 5.2 | 100 | 100 |
| PhHV | 0.998 (98.3) | 3.1, 1.8 | 4.2, 3.5 | |||
| MS2 | 0.999 (96.8) | 1.4, 2.1 | 7.2, 8.4 | |||
| Bacterial 16S rRNA gene | 0.995 (91.0) | 4.9, 4.2 | 5.1, 4.7 | |||
Linearity was tested with combined positive controls. LOD and precision (repeatability and reproducibility) were tested with pooled positive materials spiked into healthy donor stool. LOD is the number of copies per gram of stool that were 100% detectable with 10 distinct extractions/amplifications.
The linearity range was 10 to 106 copy numbers per reaction for all the targets.
LOD, copy number of an organism or artificial template per gram of stool; equiv. no. of copies, equivalent copy numbers per 1-μl volume of reaction mixture prior to extraction.
Coefficients of variance (CVs) at both low (LOD) and high spiked concentrations are shown. High-concentration spikes were 1,000-fold higher for viral targets and 100-fold higher for bacterial and parasitic targets than LOD. The same concentrations were applied to accuracy tests.
Sensitivity was calculated on the total number of PCRs for each target.