Primary arm of present study, conducted at New York City Health + Hospitals / Jacobi (Bronx, New York, NY). Exclusion criteria included: current gynecological infection or discharge, prior cervical surgery, or positive urine pregnancy test. In addition, participants abstained from sexual intercourse for at least 24 hours prior to the study visit.

A speculum was inserted prior to the a/LCI probe for ease of tissue biopsy collection after a/LCI scanning. The scanning a/LCI probe was inserted through speculum and placed against the cervix using white light visual guidance from the probe's integrated camera. The a/LCI imaging sequence was initiated, with 36 scan points spaced across an area of 50 mm2. 80 a/LCI optical biopsy scans were at 4 selected biopsy sites (20 per quadrant). The a/LCI probe was removed and a Wallach colposcope was used to take a digital image of the cervix for co-registration with the a/LCI image. Some women underwent a previously scheduled loop electrosurgical excision procedure (LEEP) immediately following data collection; tissue biopsies were taken either with the assistance of the colposcope or during the LEEP and all specimens were analyzed by pathologists to provide a histological diagnosis for comparison with the a/LCI measurements. Tissue biopsies for each quadrant were assigned a classification (negative, CIN-1, CIN-2, or CIN-3) as well as notes for any additional findings (koilocytic atypia, abnormal acetowhite epithelium, etc.).

Total of all reporting groups

Specificity of the scanning a/LCI probe's ability to detect cervical dysplasia determined by calculating the percentage of correctly identified negative optical biopsies measured by the scanning a/LCI probe when compared to the gold standard, histopathology.

There are two dichotomies of classification used in this study: one that focuses on the morphological differences between cells (histology-based classification), and one that focuses on the urgency of corresponding treatment (response-based classification). In the histology-based classification, a result of benign alone is a negative result and a result of LSIL (low-grade squamous intraepithelial lesion) or HSIL (high-grade squamous intraepithelial lesion) is a positive result. In the response-based classification, both benign and LSIL are treated as negative results and HSIL is treated as a positive result.

40 women enrolled at the Jacobi site, but successful a/LCI scans were only acquired from 20 participants due to equipment failures (mechanical breaks in probe, electrical component failures, software errors). For each participant analyzed, optical biopsies (a/LCI scans) and corresponding physical tissue biopsies were collected at four sites (12, 3, 6, and 9 o'clock). No pilot study participants were analyzed as no physical tissue biopsies were done in the pilot phase.

Ability of scanning a/LCI probe to correctly identify transformation zone (T-zone) compared to colpophotography

Data not collected due to frequent instrument repairs.

Primary arm of present study, conducted at New York City Health + Hospitals / Jacobi (Bronx, New York, NY). Exclusion criteria included: current gynecological infection or discharge, prior cervical surgery, or positive urine pregnancy test. In addition, participants abstained from sexual intercourse for at least 24 hours prior to the study visit.

A speculum was inserted prior to the a/LCI probe for ease of tissue biopsy collection after a/LCI scanning. The scanning a/LCI probe was inserted through speculum and placed against the cervix using white light visual guidance from the probe's integrated camera. The a/LCI imaging sequence was initiated, with 36 scan points spaced across an area of 50 mm2. 80 a/LCI optical biopsy scans were at 4 selected biopsy sites (20 per quadrant). The a/LCI probe was removed and a Wallach colposcope was used to take a digital image of the cervix for co-registration with the a/LCI image. Some women underwent a previously scheduled loop electrosurgical excision procedure (LEEP) immediately following data collection; tissue biopsies were taken either with the assistance of the colposcope or during the LEEP and all specimens were analyzed by pathologists to provide a histological diagnosis for comparison with the a/LCI measurements. Tissue biopsies for each quadrant were assigned a classification (negative, CIN-1, CIN-2, or CIN-3) as well as notes for any additional findings (koilocytic atypia, abnormal acetowhite epithelium, etc.).