Products
The careHPV Accessories are intended for use only in combination with the careHPV Test. CARE is a registered trademark of COOPERATIVE FOR ASSISTANCE AND RELIEF EVERYWHERE, INC. (“CARE”). CARE and the members and affiliates of CARE International are not affiliated with QIAGEN and do not sponsor, endorse, support, participate in or control the development, manufacture, use or sale of any QIAGEN product.
Features
- Suitable for physician-collected or self-collected specimens
- Easy-to-use in a low-resource setting
- Specimens can be stored at room temperature for up to 14 days
Product Details
The careHPV Collection Medium is for use with a careBrush for the collection of specimens that will be tested with the careHPV Test. Cervical specimens may be collected by physicians or trained medical professionals and vaginal specimens may be self-collected under the guidance of a medical professional.
Performance
Shelf life of careHPV Collection Medium and careBrushes is 24 months between 15°C and 30°C. Clinical specimens can be stored in careHPV Collection Medium between 15°C and 30°C for 14 days or between 2°C and 8°C for 30 days.
Principle
The careHPV sample collection accessories, comprising careHPV Collection Medium and careBrushes, are effective and simple to use in a low-resource setting. Refrigeration of the accessories is not required prior to collection of samples for testing with the careHPV Test. Cervical specimens may be collected by physicians or trained medical professionals and vaginal specimens may be self-collected under the guidance of a medical professional. Clinical specimens collected with a careBrush and careHPV Collection Medium may be stored and transported between 15°C and 30°C for 14 days without loss of quality.
Procedure
The careHPV Collection Medium is for use with a careBrush for the collection of specimens that will be tested with the careHPV Test.
Cervical specimens may be collected by physicians or trained medical professionals. If a Pap smear specimen is to be collected, collect the Pap smear specimen before obtaining the specimen for the careHPV Test. Do not use the careBrush for Pap collection (see figure careBrush). If a colposcopy will be performed, collect the careHPV Test cervical specimen prior to application of acetic acid or iodine. Gently insert the careBrush 1–1.5 cm into the cervical os until the largest outer bristles of the careBrush touch the ectocervix. Rotate the careBrush 3 full turns in a counter-clockwise direction. Carefully remove the careBrush and insert the careBrush to the bottom of the careHPV Collection Medium tube (see figure careHPV Collection Medium). Cervical specimens collected with a careBrush and placed in careHPV Collection Medium tubes may be shipped and stored at room temperature (15–30°C) for 14 days or at 2–8°C for 30 days.
Vaginal specimens may be self collected under the guidance of a medical professional. Insert the careBrush into the vagina until resistance is encountered. Hold the brush in place and count from 1 to 10. Rotate the brush in a circle 5 times then remove the careBrush. Put the careBrush in to a careHPV Collection Medium tube. A patient should immediately give self-collected specimens to a medical professional. If the self-collected specimen is not given immediately to a medical professional, specimens collected with a careBrush and placed in careHPV Collection Medium tubes may be shipped and stored at room temperature (15–30°C) for 14 days or at 2–8°C for 30 days after collection.
See figures
Applications
The careHPV Collection Medium and a careBrush are used together for the collection of specimens for testing with the careHPV Test. Cervical specimens may be collected with the careHPV sample collection accessories by physicians or trained medical professionals. Vaginal specimens may be self-collected with the accessories under the guidance of a medical professional. The careHPV Test assay detects 14 high-risk types of HPV DNA in cervical and vaginal specimens and identifies women at risk of developing cervical cancer. The combination of simple careHPV sample collection procedures and the careHPV Test is a cost-effective primary screening tool for cervical cancer in developing countries.
Supporting data and figures
careBrush
The careBrush (cat. no. 619024) is intended for use with careHPV Collection Medium for the collection of cervical or vaginal specimens for subsequent testing with the careHPV Test.
Resources
Package Insert (3)
Safety Data Sheets (1)
Certificates of Analysis (1)