Analytical Performance Characteristics of the Cepheid GeneXpert Ebola Assay for the Detection of Ebola Virus

Cepheid GeneXpert Ebola 检测试剂盒用于检测埃博拉病毒的分析性能特征

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作者:Benjamin A Pinsky, Malaya K Sahoo, Johanna Sandlund, Marika Kleman, Medha Kulkarni, Per Grufman, Malin Nygren, Robert Kwiatkowski, Ellen Jo Baron, Fred Tenover, Blake Denison, Russell Higuchi, Reuel Van Atta, Neil Reginald Beer, Alda Celena Carrillo, Pejman Naraghi-Arani, Chad E Mire, Charlene Ranad

Background

The recently developed Xpert® Ebola Assay is a novel nucleic acid amplification test for simplified detection of Ebola virus (EBOV) in whole blood and buccal swab samples. The assay targets sequences in two EBOV genes, lowering the risk for new variants to escape detection in the test. The

Conclusion

In summary, we found the Xpert® Ebola Assay to have high analytical sensitivity and specificity for the detection of EBOV in whole blood. It offers ease of use, fast turnaround time, and remote monitoring. The test has an efficient viral inactivation protocol, fulfills inclusivity and exclusivity criteria, and has specimen stability characteristics consistent with the need for decentralized testing. The simplicity of the assay should enable testing in a wide variety of laboratory settings, including remote laboratories that are not capable of performing highly complex nucleic acid amplification tests, and during outbreaks where time to detection is critical.

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