Feng Shen

Early-stage diagnosis of ovarian cancer via digital immunoassay on a SlipChip

Ovarian cancer (OC) is one of the three major gynecologic malignancies and has the highest mortality rate because of the late diagnosis. Liquid biopsy based on serum protein biomarkers has demonstrated great potential for early diagnosis but remains limited by the analysis performance of conventional immunoassay technologies, such as chemiluminescence, and biomarkers, such as CA125. To address this challenge and achieve accurate early-stage diagnosis of OC, we developed a digital immunoassay on a SlipChip (DiSC) for quantitative analysis of a potential serum protein biomarker, Spondin-1 (SPON1). The DiSC system achieved a limit of detection (LoD) of 23 fg/μL for digital quantification of SPON1. The DiSC system was utilized to quantify the serum level of SPON1 in 357 clinical serum samples, including 63 from patients with benign ovarian tumors and 294 from patients with malignant ovarian cancer, ranging from stages I to IV. SPON1 concentrations were significantly different in samples from patients with malignant ovarian cancer. Notably, significantly different SPON1 levels were observed in early stages (I and II), in lymph node-negative cases (N

An Injection Molded SlipChip with Self‐Sampling for Integrated Point‐of‐Care Testing of Human Papilloma Virus

AbstractHigh‐risk human papillomavirus (HPV) screening is crucial for cervical cancer prevention. However, laboratory‐based nucleic acid amplification tests (NAATs) require costly equipment, designated lab space, and skilled personnel. Additionally, cervical swabs collected by healthcare professionals can be inconvenient, uncomfortable, and reduce privacy, limiting broader application and patient compliance. A SlipChip‐based Integrated Point‐of‐Care (SIPOC) system featuring an injection‐molded SlipChip is presented with preloaded reagents for nucleic acid extraction and a portable four‐channel real‐time quantitative PCR instrument for detection. This system incorporates a self‐sampling method that allows participants to collect their own vaginal swabs, with the β‐Globin gene as a control. After testing 130 participants for HPV‐16 and HPV‐18, 97.7% of the self‐collected samples are valid. Among valid samples, 25 tested positive for HPV‐16 and 9 for HPV‐18. Compared to Roche's standard HPV PCR test, the SIPOC system shows 100% positive predictive value (PPV) for both HPV‐16 and HPV‐18 and negative predictive values (NPVs) of 99.0% and 99.1%, respectively. This system is promising for HPV screening in resource‐limited settings and adaptable for other point‐of‐care NAAT applications, including home testing.