Xpert HPV Assay/10

General description:
The Xpert HPV assay is a qualitative in vitro test for the detection of the E6/E7 region of the viral DNA genome from high-risk Human Papillomavirus (HPV) in patient specimens. The test carries out multiplexed amplification of target DNA by real-time Polymerase Chain Reaction (PCR) of 14 high risk HPV types in a single analysis. Xpert HPV specifically identifies types HPV 16 and HPV 18/45 in two distinct detection channels, and reports 11 other high-risk types (31, 33, 35, 39, 51, 52, 56, 58, 59, 66 and 68) in a pooled result.

Technical specifications:
Specimens are limited to cervical cells collected in PreservCyt Solution (Hologic Corp.). Cervical specimens collected in PreservCyt Solution that have been pre-treated with Glacial Acetic Acid (GAA) to lyse excess red blood cells for cytology review have also been validated for use with the Xpert HPV assay.
For detailed performance characteristics information, visit WHO PQ Public Report page (Link has been provided below)

Manufacture product reference: Cepheid AB, GXHPV-CE-10

Items supplied with:
·10 x Xpert HPV assay cartridges with integrated reaction tubes
·1 bag of 10 x Disposable 1 mL transfer pipettes
·1 x CD with Assay Definition Files (ADF) and instructions for use

Items required, but not supplied:
·GeneXpert Dx (including barcode scanner and operator manual)
·GeneXpert Infinity-48s (including barcode scanner and operator manual)
·GeneXpert Infinity-80 (including barcode scanner and operator manual)
·GeneXpert Software Version 4.3 or higher, and barcode scanner or GeneXpert Infinity system with Xpertise software version 6.1 or higher
·Printer
·Consumables: Bleach, 70% Ethanol, Disposable gloves
·Specimen collection material: PreservCyt Solution (Hologic Corp.), Broom-like device or an endocervical brush/spatula

Shelf life:
18 months from the date of manufacturing; do not use beyond its expiry date.

Weight & volume:
Estimated weight: 0.8kg
Estimated volume: 1.1dm3

Storage & transportation condition:
The test kit should be stored at 2–28 °C.

Packaging & labelling:
Primary packaging: All contents of Xpert HPV Assay, kit for 10 tests
Secondary packaging: One kit Xpert HPV Assay, 10 tests

Useful links:
WHO PQ Public Report