digene® HC2 HPV DNA Test Instructions for Use

Intended Use

The digene® HC2 HPV DNA Test is an in vitro nucleic acid hybridization assay with signal amplification using microplate chemiluminescence for the qualitative detection of eighteen types of Human Papillomavirus (HPV) DNA in cervical specimens. It differentiates between low-risk HPV types (6/11/42/43/44) and high/intermediate-risk HPV types (16/18/31/33/35/39/45/51/52/56/58/59/68).

Summary and Explanation

This document provides comprehensive instructions for the digene® HC2 HPV DNA Test, a diagnostic tool used to identify specific types of HPV infections in women. It details the assay's principle, reagents, procedures, and interpretation of results, designed for professional use in laboratory settings.

Key Information

Product: digene® HC2 HPV DNA Test
Manufacturer: QIAGEN
Catalog Number (REF): 5198-1220
Detection Method: Microplate Chemiluminescence
Specimen Type: Cervical Specimens
Intended Use: Qualitative detection of 18 HPV types
Usage: For Professional Use Only

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Intended Use

Summary and Explanation

Key Information

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