The Extended Stability of Cervical Swabs in careHPV™ Collection Medium
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 ma...
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| Format: | Article |
| Language: | en |
| Published: |
Springer Nature
2020
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| Subjects: | |
| Online Access: | http://ir.unimas.my/id/eprint/30713/1/The%20Extended%20Stability%20of%20Cervical%20Swabs%20incareHPV%E2%84%A2%20Collection%20Medium.pdf http://ir.unimas.my/id/eprint/30713/ https://www.researchsquare.com/ |
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| Summary: | 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. |
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