The Extended Stability of Cervical Swabs in careHPV™ Collection Medium

Abstract

Background: The careHPV™ Test is a US FDA approved, CE mark, and WHO prequalified in vitro diagnostic test that is designed to screen for 14 HRHPV genotypes. The careHPV™ Test is the only commercial HPV tests validated to be used in the low resource settings, boasting the economy of processing a maximum of 90 samples per batch and a near point-of-care turnaround time of 3 hours. Cervical swabs stored in the careHPV™ Collection Medium are stable for 30 days when stored between 2–8 °C according to the manufacturer. However, we often had difficulty to consolidate enough samples for a full batch-test within 30 days, especially when screening women living in the low-density villages in the rural Sarawak, Malaysian Borneo. Objectives: The aim of this study is to determine the stability and repeatability of cervical swabs preserved in careHPV™ Collection Medium stored at 4 °C over the recommended 30 days using the careHPV™ Test. Methods: Two groups of confirmed HRHPV positive and HRHPV negative cervical swab samples in careHPV™ Collection Medium consisting of 4 samples each were maintained at 4 °C and tested using careHPV™ Test at day-38, -123, -131, -223 and − 395. Results: All cervical swabs in careHPV™ Collection Medium stored at 4 °C remained stable for testing and demonstrated 100% repeatability for at least 395 days from the day of collection. Conclusion: The careHPV™ Test can be successfully performed on cervical swabs preserved in the careHPV Collection Medium, which are stored at 4 °C for at least 395 days.