TABLE 1

Calculated cutoff values for each serotype, based on results from negative-control urine in repeatability assaysa

Stated serotype specificity (bead region)Human MAb designationMean normalized negative-control ratiobSDCalculated cutoff value
1 (77)pn082p5B061.30.0921.59
2 (19)pn201p3C021.40.0671.58
3 (41)pn201p6E031.30.0911.55
4 (65)pn082p3C051.40.1321.77
5 (28)pn225p1A021.40.1511.88
6A (13)pn134p1D041.30.0761.55
6B (25)pn201p4G011.40.0901.66
7F (42)pn132p8C041.20.0631.39
8 (46)pn201p4C011.40.0701.61
9N (34)pn201p2D021.30.0751.48
9V (38)pn082p4D061.30.0591.49
10A (29)pn219p4B041.20.0401.34
11A (57)pn082p8F051.30.1111.66
12F (54)pn134p3A051.30.1181.65
14 (43)pn225p1A031.00.0211.08
15B (61)pn225p1G051.30.0961.63
17F (66)pn219p1D031.20.0671.37
18C (27)pn082p3G051.40.1141.77
19A (35)pn219p4A051.40.1611.89
19F (59)pn132p7B061.40.1141.78
20 (52)pn219p2D061.10.2621.86
22F (26)pn201p3C031.10.0711.27
23F (18)pn132p2C051.40.0961.64
33F (63)pn219p1C010.90.0380.99
CWPc (73)pn082p3C041.80.1192.19
  • a Calculated as 3 standard deviations greater than the mean of the normalized negative-control ratios.

  • b Mean t/n ratio, from six repeatability runs, of negative urine mFI/negative urine mFI (initially 1.0) following the plate normalization procedure.

  • c CWP, cell wall polysaccharide antigen target.