TABLE 1.
Clinical and cytological characteristics of the study population.
| Characteristics | N | (%)h |
| Clinical | ||
| Agea | ||
| Median (IQR) | 30 | (25–37) |
| Range (year) | 20–69 | |
| Race/Ethnicitya | ||
| Asian [NILM, ASC-US, LSIL, HSIL] | 32 [8, 8, 10, 6] | (3.6) |
| Black [NILM, ASC-US, LSIL, HSIL] | 106 [28, 29, 35, 14] | (12.0) |
| White [NILM, ASC-US, LSIL, HSIL] | 333 [84, 96, 82, 71] | (37.7) |
| Unknown [NILM, ASC-US, LSIL, HSIL] | 407 [115, 102, 99, 91] | (46.1) |
| Missing [NILM, ASC-US, LSIL, HSIL] | 5 [2, 0, 3, 0] | (0.6) |
| Cytologicalb | ||
| Total LBC samples collected | 883 | (100) |
| LBC samples missing clinical datac | 5 | (0.6) |
| NILM | 2 | (0.2) |
| ASCUS | 0 | (0) |
| LSIL | 3 | (0.4) |
| HSIL | 0 | (0) |
| LBC samples included | 883 | (100) |
| NILM | 237 | (27) |
| ASCUS | 235 | (26) |
| LSIL | 229 | (26) |
| HSIL | 181 | (21) |
| HSIL/SCC | 1 | (0.1) |
| Sourced | ||
| Cervical | 875 | (99.1) |
| Vaginal | 3 | (0.3) |
| Unspecified | 5 | (0.6) |
| Diagnostic categoryd | ||
| Normal | 237 | (27) |
| Abnormal | 646 | (73) |
| Cellular DNA concentrationd,e,f | ||
| Total LBC samples [Median (ng/uL) (IQR)] | 95.6 | (54.3–168.4) |
| NILM [Median (ng/uL) (IQR)] | 91.6 | (54.2–147.3) |
| ASCUS [Median (ng/uL) (IQR)] | 81.1 | (34.9–147.3) |
| LSIL [Median (ng/uL) (IQR)] | 119.2 | (67.5–202.0) |
| HSIL [Median (ng/uL) (IQR)] | 104.0 | (54.8–178.2) |
ASC-US, atypical squamous cells of undetermined significance; IQR, interquartile range; LBC, Liquid-based Cytology; LSIL, low-grade squamous intraepithelial lesion; HSIL, high-grade squamous intraepithelial lesion; NILM, negative for intraepithelial lesion and malignancy; SCC, squamous cell carcinoma. aAge and Race/Ethnicity of subjects (N = 883) are based on the demographic data of included samples. The number of samples by race/ethnicity and cytological diagnosis are placed in brackets. The distribution of the 5 categories of race/ethnicity (inclusive of Unknown and Missing data) across the 4 cytological grades were not different (χ2, p = 0.354). bCytopathology results are ascribed to the specimens collected on day of study enrollment. cExclusion criteria included: low cell pellet volume (<200 μL). dData based on all included samples (N = 883). Unspecified source (cervix or vagina). eConcentration of total cellular DNA per sample after semi-automated DNA extraction. fComparison of DNA concentrations between NILM, ASC-US, LSIL, and HSIL sample groups showed slightly lower concentration for NILM vs. LSIL, ASC-US vs. LSIL, and ASC-US vs. HSIL (p < 0.05) by the Wilcoxon rank-sum test. hValues are N (%) unless otherwise denoted.