Abstract
Ovarian cancer has a poor cure rate and rates of relapse are high. Current recurrence detection is limited by non-specific methods such as blood testing and ultrasound. Based on reports that human epididymis four (HE4) / creatinine (CRE) ratios found in urine are elevated in ovarian cancers, we have developed a paper-based device that combines lateral flow technology and cell phone analysis to quantitatively measure HE4/CRE. Surrogate samples were used to test the performance over clinically expected HE4/CRE ratios. For HE4/CRE ratios of 2 to 47, the percent error was found to be 16.0% on average whether measured by a flatbed scanner or cell phone. There was not a significant difference between the results from the cell phone or scanner. Based on published studies, error in this method was less than the difference required to detect recurrence. This promising new tool, with further development, could be used at home or in low-resource settings to provide timely detection of ovarian cancer recurrence.
Highlights
Ovarian cancer has a poor cure rate and rates of relapse are high
Urine Human epididymis protein 4 (HE4) has been found to be a biomarker for ovarian neoplasms with improved sensitivity in early disease compared to HE4 in serum[10]; HE4 is detectable in urine earlier than in s erum[11]
We describe the development of an at-home paper-based test to measure both HE4 and creatinine in one device
Summary
Ovarian cancer has a poor cure rate and rates of relapse are high. Current recurrence detection is limited by non-specific methods such as blood testing and ultrasound. Even though OC patients undergo longterm surveillance to improve recurrence detection, current diagnostic methods, such as pelvic examination, transvaginal ultrasonography, and blood tests such as cancer antigen 125 (CA-125), are invasive and require a clinic visit. Factors such as making an appointment to have blood work done, traveling to the location, a lack of confidence in their symptoms (cramping, bloating, frequent urination), being too busy, not wanting to bother a doctor and the lack of frequency of testing were highlighted concerns of OC p atients[2,3]. Et al reported that urine HE4 may be more useful than serum HE4 in differentiating low malignant potential cysts from early ovarian cancer[15]
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