Table 1.
Clinical and cytological characteristics of the study population
| Characteristics | Number | Percentageg |
|---|---|---|
| Clinical | ||
| Agea | ||
| Median (IQR) | 28 | (24–35) |
| Range (year) | 19–67 | |
| Race/ethnicitya | ||
| Asian [NILM, LSIL, HSIL] | 9 [5, 3, 1] | (3) |
| Black [NILM, LSIL, HSIL] | 40 [14, 15, 11] | (14) |
| White [NILM, LSIL, HSIL] | 124 [48, 40, 36] | (45) |
| Other [NILM, LSIL, HSIL] | 65 [21, 28, 16] | (24) |
| Unknown [NILM, LSIL, HSIL] | 39 [12, 14, 13] | (14) |
| Cytologicalb | ||
| Total LBC samples collected | 400 | (100) |
| LBC samples excludedc | 123 | (31) |
| NILM | 33 | |
| LSIL | 85 | |
| HSIL | 5 | |
| LBC samples included | 277 | (69) |
| NILM | 100 | |
| LSIL | 100 | |
| HSIL | 77 | |
| Sourced | ||
| Cervical | 276 | (99.6) |
| Vaginal | 1 | (0.4) |
| Diagnostic categoryd | ||
| Normal | 100 | (36) |
| Abnormal | 177 | (64) |
| Cellular DNA concentrationd,e,f | ||
| NILM | 100 | |
| Median (ng/μL) (IQR) | 48.1 | (37.1–74.3) |
| Range (ng/μL) | 20.8–181.5 | |
| LSIL | 100 | |
| Median (ng/μL) (IQR) | 46.3 | (35.6–63.1) |
| Range (ng/μL) | 20.5–182.8 | |
| HSIL | 77 | |
| Median (ng/μL) (IQR) | 51.8 | (34.9–71.3) |
| Range (ng/μL) | 11.5–154.0 | |
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
aAge and race/ethnicity of subjects (N = 277) are based on the demographic data of included samples. The number of samples by race/ethnicity and cytological diagnosis are placed in square brackets. The distribution of the five categories of race/ethnicity (inclusive of Other and Unknown) among the three cytological grades were not significantly different (χ 2, p = 0.777)
bCytopathology results are ascribed to the specimens collected on the day of the study enrollment
cExclusion criteria included: low cell pellet volume (<200 μL); low cellular DNA concentration (<20 ng/μL); low nucleic acid purity (spectrophotometry absorbance ratio 260/230 nm <0.7); excess samples (>100) (see text for details)
dData based on included samples (N = 277)
eConcentration of total cellular DNA per sample after manual or semi-automated DNA extraction
fComparison of DNA concentrations between NILM, LSIL, and HSIL samples were not significantly different (p = 0.519) by Kruskal-Wallis test
gValues are N (%) unless otherwise denoted