GeneXpert Testing Quality Controls

This guide is substantially based on a pre-publication version which was developed and piloted by the Foundation for Innovative New Diagnostics (FIND) and the U.S. Centers for Disease Control and Prevention (CDC), with funding from the United States President’s Emergency Plan for AIDS Relief (PEPFAR) under Cooperative Agreement 3U2GPS002746. The following people contributed to the development and review of the original version:

Lead writers: André Trollip and Heidi Albert (FIND, Cape Town, South Africa). Reviewers: Heather Alexander, Kyle DeGruy, Patricia Hall, Peter Minchella, Bill Coggin (CDC), Daniela Cirillo, Elisa Tagliani (San Raffaele Scientific Institute, Milan, Italy), Martina Casenghi (Médecins Sans Frontières-Access The campaign, Geneva, Switzerland), Kekeletso Kao, Jesse Wambugu (FIND, Geneva, Switzerland). Revision and finalization of the guide: led by Thomas Shinnick (independent consultant), Heidi Albert (FIND, South Africa), and Josephine San Pedro (CDC) with technical contributions from Andre Trollip (FIND, South Africa), Kyle de Gruy, and Patricia Hall (CDC). A critical review was provided by members of the Global Laboratory Initiative (GLI) Core Group, including Lice Gonzalez Angulo, Maka Akhalaia, Kathleen England, Marguerite Massinga Loembe, Alaine Umubyeyi Nyaruhirira, and Abiola Tubi. Copy editing: Beatrice Gordis (FIND, Switzerland)

The mention of specific companies or of GeneXpert Testing certain manufacturers’ products does not imply that they are recommended in preference to others of a similar nature that are not mentioned. Errors and omissions excepted, the names of proprietary products are distinguished by initial capital letters.

All reasonable precautions have been taken to verify the information contained in this publication. However, the published material is being distributed without warranty of any kind, either expressed or implied. The responsibility for the interpretation and use of the material lies with the reader. In no event shall there be a liability for damages arising from its use. The findings and conclusions in this report are those of the authors and do not necessarily represent the official position of the Centers for Disease Control and Prevention/ The Agency for Toxic Substances and Disease Registry.

The revision and finalization of the guide were made possible through funding from the African Society for Laboratory Medicine (ASLM) as part of a project supported by the United States President’s Emergency Plan for AIDS Relief (PEPFAR) under Grant No.NU2GGH000710.

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