The Extended Stability of Cervical Swabs in careHPV™ Collection Medium
Introduction: The careHPV™ Test is a US FDA approved, CE mark, and WHO prequalified in vitro diagnostic test designed to screen for 14 high-risk human papillomavirus (HRHPV) genotypes. The careHPV™ Test is one of the commercial HPV test validated to be used in low resource settings, boasting the e...
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Main Author: | |
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Format: | Article |
Language: | English |
Published: |
Faculty of Medicine and Health Sciences, Universiti Putra Malaysia
2021
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Online Access: | http://ir.unimas.my/id/eprint/37092/1/papillomavirus-1.pdf http://ir.unimas.my/id/eprint/37092/ https://medic.upm.edu.my/jurnal_kami/malaysian_journal_of_medicine_and_health_sciences_mjmhs/mjmhs_vol_17_no_3_july_2021-62220 |
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Summary: | Introduction: The careHPV™ Test is a US FDA approved, CE mark, and WHO prequalified in vitro diagnostic test
designed to screen for 14 high-risk human papillomavirus (HRHPV) genotypes. The careHPV™ Test is one of the
commercial HPV test validated to be used in 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. According to the manufacturer, cervical swabs stored in careHPV™ Collection Medium are stable for 30 days when stored between 2-8°C. However,
we often had difficulty consolidating enough samples for a full batch-test within 30 days, especially when screening
women living in the low-density villages in rural Sarawak, Malaysian Borneo. This study aimed to evaluate the stability and repeatability of cervical swabs preserved in careHPV™ Collection Medium stored at 4°C exceeding 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 the careHPV™ Test at Day -38, -123, -131, -223, and -395. Results: All cervical swabs in the
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 careHPV™ Collection Medium, which were stored at 4°C for at least 395 days. |
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