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Tables
- Table 1
Specificity of UAD assay's 13 serotype-specific monoclonal antibodies to 91 strains of S. pneumoniae bacteria
S. pneumoniae serotype MFI for MAb specific for the following S. pneumoniae serotype: Control mouse IgG 1 3 4 5 6A 6B 7F 9V 14 18C 19A 19F 23F 1 123 16,569a 334 339 315 335 315 264 343 328 350 380 426 366 3 55 46 17,647 58 40 48 56 65 47 54 52 52 51 46 4 344 260 269 52,681 255 269 265 285 305 297 281 265 467 263 5 122 78 68 69 8,186 77 64 68 64 66 70 65 129 70 6A 184 53 64 61 73 10,868 62 49 70 69 59 57 72 55 6B 127 92 79 113 75 -37 20,255 90 67 94 94 61 172 100 7F 150 91 113 154 144 104 61 11,986 95 57 130 75 139 82 9V 157 122 80 106 14 103 115 114 16,617 164 76 88 107 67 14 202 159 156 186 168 201 191 187 136 6,308 205 161 213 123 18C 184 133 173 177 181 144 145 170 190 173 7,387 121 213 129 19A 198 107 66 66 315 81 56 49 59 61 134 18,778 60 58 19F 125 57 46 39 42 46 45 52 56 70 44 48 16,545 45 23F 182 218 196 225 228 185 158 199 175 114 195 205 204 12,842 6C 73 40 31 25 43 4,770 38 31 32 35 50 3 47 31 7A 139 57 32 47 40 47 48 45,187 55 46 47 47 109 40 9A 68 50 49 51 46 46 53 55 973 57 51 49 75 46 18A 321 100 90 89 128 98 106 149 122 118 16,031 85 112 115 18B 37 77 32 46 47 52 42 53 46 58 16,930 51 71 33 18Fb 69 48 263 268 47 36 38 40 38 43 6,344 40 67 41 - Table 2
Specificity of S. pneumoniae UAD assay
S. pneumoniae serotype Signal produced by MAb-coated microspheres 1 3 4 5 6A 6B 7F 9V 14 18C 19A 19F 23F MFI S/N MFI S/N MFI S/N MFI S/N MFI S/N MFI S/N MFI S/N MFI S/N MFI S/N MFI S/N MFI S/N MFI S/N MFI S/N 1 21,067a 744 24 1 9 1 49 1 22 1 39 1 29 1 56 1 29 1 18 1 30 1 40 1 59 1 3 32 1 22,335 967 10 1 46 1 24 1 37 1 29 1 47 1 33 1 19 1 30 1 42 1 76 1 4 30 1 25 1 11,629 1,264 46 1 25 1 48 1 27 1 49 1 33 1 18 1 32 1 44 1 79 1 5 41 1 26 1 11 1 15,841 362 35 2 38 1 31 1 45 1 30 1 19 1 30 1 44 1 79 1 6A 31 1 27 1 11 1 52 1 22,817 1,061 37 1 30 1 49 1 33 1 19 1 33 1 42 1 82 1 6B 32 1 28 1 11 1 47 1 39 2 23,040 705 29 1 56 1 33 1 21 1 30 1 42 1 105 1 7F 32 1 26 1 11 1 46 1 25 1 38 1 21,107 800 47 1 31 1 19 1 29 1 41 1 112 1 9V 27 1 25 1 11 1 44 1 22 1 35 1 25 1 19,962 476 30 1 21 1 28 1 37 1 91 1 14 29 1 25 1 10 1 46 1 24 1 35 1 27 1 42 1 23,065 759 18 1 30 1 51 1 95 1 18C 30 1 26 1 10 1 46 1 22 1 33 1 28 1 44 1 29 1 16,354 962 28 1 39 1 99 1 19A 28 1 26 1 10 1 48 1 24 1 34 1 26 1 40 1 29 1 19 1 23,555 850 43 1 83 1 19F 26 1 25 1 9 1 43 1 23 1 32 1 26 1 44 1 30 1 18 1 30 1 22,579 591 96 1 23F 32 1 22 1 10 1 43 1 24 1 33 1 28 1 42 1 29 1 17 1 29 1 38 1 24,240 316 2b 36 1 9 1 6 1 42 1 40 1 72 1 23 1 46 1 30 1 8 1 30 1 87 1 11 1 8b 36 1 15 1 6 1 42 1 37 1 80 1 27 1 47 1 31 1 6 1 34 1 86 1 12 1 9Nb 37 1 12 1 5 1 42 1 41 1 76 1 29 1 47 1 33 1 7 1 33 1 89 1 10 1 10Ab 36 1 11 1 6 1 40 1 39 1 72 1 27 1 44 1 30 1 7 1 31 1 82 1 10 1 11Ab 36 1 11 1 6 1 43 1 39 1 79 1 27 1 50 1 33 1 8 1 38 1 93 1 11 1 12Fb 39 1 12 1 6 1 55 1 39 1 78 1 27 1 47 1 32 1 8 1 33 1 90 1 13 1 15Bb 45 1 13 1 7 1 41 1 45 1 66 1 27 1 63 1 35 1 12 1 32 1 204 3 16 1 17Fb 41 1 12 1 7 1 37 1 43 1 59 1 21 1 61 1 27 1 10 1 24 1 71 1 17 1 20b 36 1 11 1 6 1 41 1 37 1 70 1 24 1 220 5 98 3 8 1 31 1 87 1 16 1 22Fb 33 1 10 1 5 1 47 1 57 2 71 1 22 1 44 1 28 1 8 1 30 1 79 1 12 1 33Fb 37 1 11 1 7 1 42 1 39 1 75 1 25 1 47 1 31 1 7 1 33 1 80 1 12 1 - Table 3
Accuracy of UAD assay
Serotype Positivity cutoff value (PnPS U/ml) Assay range based on accuracy Lower limit Upper limit GMC RSD (%) GMC RSD (%) 1 17.8 1.1 8.8 1,034.1 2.3 3 330.5 1.0 8.8 997.2 2.8 4 27.3 0.7 7.1 917.0 11.8 5 2.5 1.2 10.3 746.8 5.5 6A 106.7 1.1 10.0 1,033.2 3.8 6B 79.7 1.3 11.1 796.6 5.5 7F 6.6 1.2 4.5 502.0 7.3 9V 15.6 8.4 8.8 2,984.8 9.1 14 1.7 0.5 11.6 344.9 4.8 18C 4.3 0.6 9.5 724.0 5.5 19A 9.8 2.3 21.2 760.1 6.0 19F 150.0 1.2 7.5 504.8 1.6 23F 8.0 1.4 6.6 906.3 3.5 - Table 4
Precision and sample linearity of UAD assay
Serotype Positivity cutoff value (PnPS U/ml) Assay range based on: Precision Sample linearity GMC (PnPS U/ml) % RSD range GMC (PnPS U/ml) % biasa range Lower limit Upper limit Lower limit Upper limit 1 17.8 9.1 477.2 5.5–25.5 9.1 477.2 82.6–117.5 3 330.5 8.6 1,153.3 5.7–24.1 8.6 1,153.3 71.4–114.0 4 27.3 1.9 192.5 6.5–13.2 1.9 192.5 94.6–110.6 5 2.5 0.8 32.9 8.5–15.2 1.1 32.9 82.2–119.8 6A 106.7 4.8 644.7 2.9–12.3 4.8 472.1 77.1–123.8 6B 79.7 4.3 504.2 5.7–21.3 4.3 504.2 89.6–114.8 7F 6.6 0.5 211.3 5.1–14.5 0.6 165.4 80.4–121.1 9V 15.6 4.3 1,480.5 10.3–27.8 5.9 1,480.5 72.5–122.5 14 1.7 0.6 16.4 5.7–15.1 0.6 16.4 90.2–110.6 18C 4.3 0.6 15.2 11.0–15.1 0.6 15.2 88.8–116.2 19A 9.8 9.8 174.3 10.6–26.7 2.0 174.3 68.1*–115.3 19F 150.0 5.3 428.6 5.4–6.4 5.3 428.6 85.3–111.5 23F 8.0 2.9 122.4 8.1–14.5 2.9 85.6 72.9–119.0 ↵a Sample linearity is considered acceptable if the percent relative bias for any one dilution is outside of the acceptance criterion but the percent relative bias for the dilutions immediately above and below this dilution is within the acceptance criterion.
- Table 5
Final UAD assay range
Serotype Positivity cutoff value (PnPS U/ml) Final assay GMC range (PnPS U/ml) Lower limit Upper limit 1 17.8 9.1 477.2 3 330.5 8.6 997.2 4 27.3 1.9 192.5 5 2.5 1.2 32.9 6A 106.7 4.8 472.1 6B 79.7 4.3 504.2 7F 6.6 1.2 165.4 9V 15.6 8.4 1,480.5 14 1.7 0.6 16.4 18C 4.3 0.6 15.2 19A 9.8 9.8 174.3 19F 150.0 5.3 428.6 23F 8.0 2.9 85.6 - Table 6
Clinical validation of UAD assay
Blood culture-confirmed serotype No. of urine samples UAD assay UAD clinical sensitivity compared to blood culture (%) No. of samples positive by BinaxNOW S. pneumoniae urine antigen test No. of positive samples No. of negative samples Clinical specificity (%) Prevnar13 S. pneumoniae serotypes 1 7 7 0 100 100 3 3 1 0 1 100 0 0 4 3 3 0 100 100 2 5 1 1 0 100 100 1 6A/C 1 1 0 100 100 0 6B 0 0 0 NAa NA 0 7F/A 4 4 0 100 100 3 9V/A 2 2 0 100 100 2 14 7 7 0 100 100 5 18 0 0 0 NA NA 0 19A 6 6 0 100 100 5 19F 0 0 0 NA NA 0 23F 2 2 0 100 100 2 Total 34 33 1 100 97.1 23 Non-Prevnar13 S. pneumoniae serotypes 8 3 0 3 100 3 8A 1 0 1 100 0 9N 2 0 2 100 1 10A 1 0 1 100 1 11A 1 0 1 100 0 16F 3 0 3 100 2 20 1 0 1 100 0 22F 5 0 5 100 1 Total 17 0 17 100 8 ↵a NA, not applicable.
- Table 7
Comparison of results from UAD assay and BinaxNOW assay in bacteremic and nonbacteremic CAP
CAP cases No. of cases UAD assay BinaxNOW S. pneumoniae urine antigen test No. of positive samples No. of negative samples Sensitivity compared to blood culture (%) No. of positive samplesd Sensitivity compared to blood culture (%) Total blood culture positive (bacteremic CAP) 69 34 35 34 S. pneumoniae positive Prevnar 13 serotypes 34 33 1 97 23 67.6 Non-Prevnar 13 serotypes 17 0 17 NAe 8 47.1 Nonserotypeable 3 1 2 NA 2 NA Non-S. pneumoniae 15 0 15 NA 1 NA Total blood culture negative (nonbacteremic CAP) 707 141 566 NA 126c NA Indeterminate 1/707 NA NA NA 1/707 NA Total CAP (bacteremic and nonbacteremic) 776 175a 601 NA 160b NA a 22.6% (175/776) of total CAP samples were UAD assay positive.
↵b 20.6% (160/776) of total CAP samples were BinaxNOW assay positive.
↵c Seventy-one of the 126 BinaxNOW-positive samples (nonbacteremic CAP) were also UAD assay positive.
↵d 12.1% (23 + 71/776) of all BinaxNOW-positive samples were also UAD positive (Prevnar 13 serotypes).
e NA, not applicable.
Additional Files
Supplemental material
Files in this Data Supplement:
- Supplemental file 1 -
Table S1. Specificity of the UAD assay’s 13 serotype-specific monoclonal antibodies to 407 non-S. pneumoniae organisms. Table S2. Clinical validation of the UAD assay blood culture-confirmed non-S. pneumoniae organisms.
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- Supplemental file 1 -
